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    MATERIALISE AND CARESTREAM TO RELEASE BROWSER-DRIVEN PRE-OP AND 3D PRINTING SOFTWARE

    Dec 13, 2018

    Materialise, a company that 3D prints millions of unique medical parts every year, has partnered with Carestream Health to release a browser-driven pre-operative planning solution. The product will give orthopedic surgeons the ability to plan surgeries and order custom surgical guides and other 3D p...


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    https://Pharmaceutical.report/news-article.aspx?ID=22692269

    MYLAN, BIOCON COPY INCHES CLOSER TO CHALLENGING SANOFI'S LONG-SUFFERING LANTUS

    Dec 13, 2018

    Sanofi’s Lantus is already facing off against generic competition from Eli Lilly and Boehringer’s Basaglar, but now Mylan is adding to the pressure by prevailing in a patent challenge at the U.S. Patent and Trademark Office. The PTO’s Patent Trial and Appeal Board invalidated two L...


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    https://Pharmaceutical.report/news-article.aspx?ID=22702270

    GARMIN TO DEVELOP WEARABLES FOR CLINICAL TRIALS WITH ACTIGRAPH

    Dec 13, 2018

    Tech-giant Garmin is stepping into the medical wearables space through a new collaboration with ActiGraph. The partnership will explore health and activity monitoring innovations combining Garmin wearables with ActiGraph‘s Centrepoint data analytics platform for academic research, clinical tri...


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    https://Pharmaceutical.report/news-article.aspx?ID=22712271

    FDA HAILS 2018 AS BUMPER YEAR FOR DRUG DEVELOPMENT SUCCESSES

    Dec 13, 2018

    The FDA has hailed 2018 as a standout year for drug development and approvals, both in terms of the quantity and quality of activity. With the FDA approving 55 new molecular entities (NMEs) over the first 11 months of the year, 2018 has eased past 1996 to become the busiest year ever. Perhaps more i...


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    https://Pharmaceutical.report/news-article.aspx?ID=22722272

    MERCK AND BRAZIL'S INSTITUTO BUTANTAN TEAM TO DEVELOP AT LEAST TWO DENGUE VACCINES

    Dec 13, 2018

    Merck & Company inked a research collaboration deal with Instituto Butantan, based in Sao Paulo, Brazil, to develop vaccines against dengue virus disease. Dengue fever infects as many as 400 million people annually, according to the U.S. Centers for Disease Control and Prevention (CDC). It is th...


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    https://Pharmaceutical.report/news-article.aspx?ID=22732273

    JOHNSON & JOHNSON CHIEF FIGURES AMAZON COULD SHAKE UP PHARMA'S DISTRIBUTION, REBATES AND MORE

    Dec 11, 2018

    There’s been plenty of speculation about Amazon's intentions in pharmaceuticals, and now Johnson & Johnson’s CEO has weighed in on how the tech giant could affect drug markets by shaking up pharma distribution and reimbursement. Speaking with Fortune’s Susie Gharib, J&J...


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    https://Pharmaceutical.report/news-article.aspx?ID=22592259

    ABBVIE CONTINUES CHARITABLE GIVING, DONATES $50 MILLION TO ST. JUDE

    Dec 11, 2018

    Christmas came a little early for St. Jude Children's Research Hospital in the form of a $50 million contribution from pharma giant AbbVie – the largest single contribution made to the famed hospital. The multi-million donation will be used to support the construction of a new Family Commo...


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    https://Pharmaceutical.report/news-article.aspx?ID=22602260

    NICE REVEALS NEW STANDARDS FOR DIGITAL TECH

    Dec 11, 2018

    NICE has published new standards set out the requirements needed to develop digital health technologies for the NHS and speed up the uptake of products like healthcare apps and wearable devices. Working collaboratively NHS England, NICE, NHS Digital, MedCity, Public Health England, and DigitalHealth...


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    https://Pharmaceutical.report/news-article.aspx?ID=22612261

    AKORN SEARCHES FOR NEW CEO AFTER FAILED FRESENIUS MERGER

    Dec 11, 2018

    US generics firm Akorn is searching for a new CEO in the wake of a failed merger with Fresenius Kabi last year. Akorn had been set to merge with Fresenius Kabi in 2017, but the German pharma axed the deal citing problems with data integrity at the US pharma. The deal was undone when whistleblowers f...


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    https://Pharmaceutical.report/news-article.aspx?ID=22622262

    BOEHRINGER FOLLOWS SANOFI WITH JOB CUTS IN FRANCE

    Dec 11, 2018

    Boehringer Ingelheim has confirmed it plans to axe more than 10% of its workforce in France, or more than 300 jobs, adding to several hundred losses at Sanofi last week. The privately-held German drugmaker says it will eliminate 327 positions – 197 in human health and 130 in its animal health ...


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    https://Pharmaceutical.report/news-article.aspx?ID=22632263

    AXOVANT ABANDONS ANOTHER DEMENTIA DRUG AFTER FAILED TRIAL

    Dec 10, 2018

    There is very little doubt that developing drugs for neuroscience disorders in general and dementias, in particular, is a high-risk business. Axovant Sciences, unfortunately, seems to be finding that out the hard way. The company announced today that its Phase II clinical trial of nelotanserin for t...


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    https://Pharmaceutical.report/news-article.aspx?ID=22492249

    QED THERAPEUTICS ANNOUNCES A COLLABORATION WITH FOUNDATION MEDICINE TO DEVELOP COMPANION DIAGNOSTICS FOR INFIGRATINIB

    Dec 10, 2018

    QED Therapeutics today announced that it has entered into an agreement with Foundation Medicine to develop a companion diagnostic for infigratinib, an FGFR1-3 selective tyrosine kinase inhibitor, in patients with cholangiocarcinoma. The companion diagnostic, which will include detection of activatin...


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    https://Pharmaceutical.report/news-article.aspx?ID=22502250

    GILEAD HIRES ROCHE’S PHARMA CHIEF DANIEL O’DAY AS CEO

    Dec 10, 2018

    Roche executive Daniel O’Day is to take the helm at Gilead after John Milligan steps down as CEO at the end of this year, the company has announced. Currently CEO of Roche Pharmaceuticals since 2012, O’Day was previously leader of Roche’s Diagnostics division and has a career spann...


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    https://Pharmaceutical.report/news-article.aspx?ID=22512251

    PHARMA COMPANIES WARNED OVER ‘NO DEAL’ BREXIT DISRUPTION

    Dec 10, 2018

    The government is asking pharma companies to introduce additional measures, over and above the stockpiles already in place, in the event of a ‘no-deal’ Brexit. Health secretary Matt Hancock said that after Brexit, the government will find ways to ensure goods can continue to flow into th...


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    https://Pharmaceutical.report/news-article.aspx?ID=22522252

    MACROGENICS HALTS TRIALS OF CANCER DRUG AFTER FDA PARTIAL HOLD

    Dec 10, 2018

    Potential liver-related side effects have led to the FDA placing a partial clinical hold on a MacroGenics-developed bispecific antibody for cancer. The regulator sent Rockville, Maryland-based MacroGenics a letter last week placing the hold on a phase 1 trial of MGD009 as a monotherapy as well as a ...


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    https://Pharmaceutical.report/news-article.aspx?ID=22532253

    SUPERNUS SAYS ADHD DRUG TROUNCES RIVALS, BUT SHARES SLIDE

    Dec 07, 2018

    Supernus Pharma has two phase III trials showing its attention-deficit hyperactivity disorder (ADHD) drug SPN-812 met its objectives, but still saw its shares fall as investors digested the data. The US biotech has been positioning the non-stimulant drug as a safer, more tolerable alternative to alr...


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    https://Pharmaceutical.report/news-article.aspx?ID=22392239

    CANCER VACCINE VALIDATED IN MICE

    Dec 07, 2018

    The idea of a cancer vaccine is something researchers have been working on for over 50 years, but until recently they were never able to prove exactly how such a vaccine would work. Now, a team of researchers at the Institute for Research in Immunology and Cancer (IRIC) at Université de Montr...


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    https://Pharmaceutical.report/news-article.aspx?ID=22402240

    ELIMINATING HIV'S LATENT RESERVOIR

    Dec 07, 2018

    A new study suggests that a genetic switch that causes latent HIV inside cells to begin to replicate can be manipulated to completely eradicate the virus from the human body. Cells harboring latent HIV are “invisible” to the natural defenses of the immune system. The findings, which sugg...


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    https://Pharmaceutical.report/news-article.aspx?ID=22412241

    SEEING STRESS WITH SUPERCOMPUTERS

    Dec 07, 2018

    Supercomputer simulations show that at the atomic level, material stress doesn't behave symmetrically. Molecular model of a crystal containing a dissociated dislocation, atoms are encoded with the atomic shear strain. Below, snapshots of simulation results showing the relative positions of atoms...


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    https://Pharmaceutical.report/news-article.aspx?ID=22422242

    VITAMIN D DEFICIENCY INCREASES SCHIZOPHRENIA RISK

    Dec 07, 2018

    Some research suggests a link between low vitamin D levels and a person's risk of developing schizophrenia. New evidence indicates that this notion may be correct. According to the National Institute of Mental Health, schizophrenia is one of the leading causes of disability worldwide. Symptoms s...


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    https://Pharmaceutical.report/news-article.aspx?ID=22432243

    SHAREHOLDERS APPROVE TAKEDA’S $59BN TAKEOVER OF SHIRE

    Dec 06, 2018

    Takeda’s $59 billion acquisition of Shire has been backed by shareholders from both companies, clearing the way for the deal to close early next year. Shareholder approval was the final hurdle to clear the deal, after a small but influential minority actively campaigned against it. Including m...


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    https://Pharmaceutical.report/news-article.aspx?ID=22302230

    AFTER DELAYED IPO, MEREO GETS US LISTING VIA ONCOMED MERGER

    Dec 06, 2018

    UK biotech Mereo BioPharma is merging with Californian biotech OncoMed in an all-stock deal that swells its pipeline and gives it a potential licensing deal with Celgene. The offer is a premium of around a third on OncoMed’s closing share price ahead of the announcement, and values the US comp...


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    https://Pharmaceutical.report/news-article.aspx?ID=22312231

    HOW PERCEPTIONS OF HIGH DRUG PRICES DO NOT NECESSARILY MATCH REALITY

    Dec 06, 2018

    The U.S. public apparently believes that drug prices are too high. At the same time, they seem largely opposed to government efforts to control health care costs, alternately supportive and non-supportive of efforts to eliminate the Affordable Care Act, better known as Obamacare. There is no doubt t...


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    https://Pharmaceutical.report/news-article.aspx?ID=22322232

    OBESITY UPS SURVIVAL IN HEART FAILURE, BUT THAT'S NO REASON TO PILE ON POUNDS

    Dec 06, 2018

    (HealthDay) Obese people with heart failure may live longer than those who are thinner especially if they are "metabolically healthy," a new study suggests. The study, of more than 3,500 heart failure patients, is the latest to look into the so-called "obesity paradox." The term ...


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    https://Pharmaceutical.report/news-article.aspx?ID=22332233

    UCB, ROCHE, AND IQVIA TAKE LEAD IN UK LIFE SCIENCES INVESTMENT

    Dec 05, 2018

    Pharma giant UCB is to invest around £1 billion in the UK as part of a second life sciences sector deal with the UK government, with industry names such as Roche and IQVIA also committing to projects. The deals are part of the government’s second Life Sciences Sector Deal, with 10 compan...


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    https://Pharmaceutical.report/news-article.aspx?ID=22222222

    NOVARTIS TAKES XOLAIR FOLLOW-UP INTO PHASE III HIVES TRIAL

    Dec 05, 2018

    Novartis says it intends to move a drug for chronic spontaneous urticaria (CSU), a severe form of hives, into a phase III programme on the strength of a mid-stage study. The new drug – called ligelizumab (QGE031) – is being positioned as an improved follow-up to the Swiss company’s...


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    https://Pharmaceutical.report/news-article.aspx?ID=22232223

    OPEN HEALTH MERGES WITH MED COMMS SERVICES PROVIDER PELOTON

    Dec 05, 2018

    UK-based Open Health Communications has merged with Peloton Advantage to create a global healthcare communications and market access group. The combined company will continue under the Open Health brand and be led by Open’s CEO David Rowley, with an executive team of Open Health co-founder San...


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    https://Pharmaceutical.report/news-article.aspx?ID=22242224

    NEW DRUG TARGET DISCOVERED FOR POTENTIAL BLOOD PRESSURE TREATMENT

    Dec 05, 2018

    Scientists have identified a key player in blood pressure regulation and have shown that switching it off reduces blood pressure in mice, according to new research in eLife. Their study ends much uncertainty about the contribution this molecule makes to high blood pressure and could lead to the deve...


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    https://Pharmaceutical.report/news-article.aspx?ID=22252225

    GENES LINKED TO DEMENTIA IDENTIFIED

    Dec 04, 2018

    A UCLA-led research team has identified genetic processes involved in the neurodegeneration that occurs in dementia – an important step on the path toward developing therapies that could slow or halt the course of the disease. The researchers discovered two major groups of genes involved in mu...


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    https://Pharmaceutical.report/news-article.aspx?ID=22142214

    URINE TEST TO IMPROVE BLADDER CANCER DETECTION

    Dec 04, 2018

    A research team led by Tufts University engineers has developed a non-invasive method for detecting bladder cancer that might make screening easier and more accurate than current invasive clinical tests involving visual inspection of the bladder. In the first successful use of atomic force microscop...


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    https://Pharmaceutical.report/news-article.aspx?ID=22152215

    SEMA4, MOUNT SINAI, SANOFI ANNOUNCE LAUNCH OF NEW COLLABORATIVE ASTHMA STUDY

    Dec 04, 2018

    Sema4, a patient-centered predictive health company, and the Mount Sinai Health System today announced the launch of a five-year collaborative study with Sanofi designed to provide new insights into the biological mechanisms and other factors implicated in asthma. The project will follow nearly 1,20...


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    https://Pharmaceutical.report/news-article.aspx?ID=22162216

    ASURAGEN LAUNCHES ASSAY TO HELP DIAGNOSE STEINERT’S DISEASE

    Dec 04, 2018

    Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, today announced the CE marking and launch of the AmplideX DM1 Dx Kit, which simplifies the analysis of repeat expansions within the DMPK gene and is intended to aid in the di...


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    https://Pharmaceutical.report/news-article.aspx?ID=22172217

    CELGENE SCORES AT ASH18 WITH DOUBLE LUSPATERCEPT DATA

    Dec 03, 2018

    A pair of clinical trial wins for Celgene’s luspatercept at the American Society of Haematology (ASH) meeting have set up a filing for the new drug in mid-2019. The MEDALIST trial in second-line myelodysplastic syndrome (MDS) and BELIEVE study in transfusion-dependent thalassemia (TDT) both me...


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    https://Pharmaceutical.report/news-article.aspx?ID=22062206

    REGENERON RECORDS 80% COMPLETE RESPONSE RATE IN LYMPHOMA TRIAL

    Dec 03, 2018

    Regeneron’s CD20xCD3 bispecific antibody has achieved an 80% complete response rate in a small trial of patients with relapsed or refractory follicular lymphoma. The strong early signs of efficacy led Regeneron to target a 2019 start date for a potentially registrational phase 2 study. REGN197...


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    https://Pharmaceutical.report/news-article.aspx?ID=22072207

    ASH18: J&J SHELLS OUT $500M TO SEW UP ARGENYX'S BLOOD CANCER HOPEFUL CUSATUZUMAB

    Dec 03, 2018

    As the biggest and brightest in the blood cancer world came together for the ASH conference this weekend, European biotech Argenx was busy making a big biobucks deal. It has teamed up with Cilag, a subsidiary of Janssen, to work on the company’s cusatuzumab. The team is testing the candidate, ...


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    https://Pharmaceutical.report/news-article.aspx?ID=22082208

    STENTRODE DEVELOPED FOR BRAIN TREATMENTS WITHOUT MAJOR SURGERY

    Dec 03, 2018

    Australian researchers have developed a tiny device that electrically stimulates the brain and could one day be used to treat conditions such as epilepsy and Parkinson's disease without invasive surgery. They have shown for the first time that electrical stimulation can be delivered into the bra...


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    https://Pharmaceutical.report/news-article.aspx?ID=22092209

    VIACYTE BAGS $80M TO TRIAL DIABETES STEM CELL THERAPIES

    Nov 29, 2018

    ViaCyte has raised $80 million to continue clinical development of its cell therapy treatments for diabetes. The series D positions ViaCyte to generate phase 1/2 data on one candidate while working to get another back into the clinic. San Diego-based ViaCyte is at the forefront of efforts to develop...


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    https://Pharmaceutical.report/news-article.aspx?ID=21982198

    ASTELLAS’ XOSPATA WINS FDA NOD IN AML, WITH DAIICHI COMPETITION LOOMING

    Nov 29, 2018

    On an acute myeloid leukemia (AML) roll, the FDA has green-lighted Astellas’ Xospata, also known as gilteritinib. For Astellas, it marks the first step toward challenging Novartis’ Rydapt and likely just a slim head start against Daiichi Sankyo. Xospata’s nod makes it the first mon...


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    https://Pharmaceutical.report/news-article.aspx?ID=21992199

    PHILADELPHIA LOOKS TO CRACK DOWN ON PHARMA REPS WITH REGISTRATION, GIFT BANNING

    Nov 29, 2018

    It may soon be tougher to be a pharma sales rep in Philadelphia. Its city council will hold a public hearing Friday on a proposed bill (PDF) to regulate pharma manufacturer reps, with measures including registering with the city and prohibiting any gifts to healthcare providers and office staff. The...


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    https://Pharmaceutical.report/news-article.aspx?ID=22002200

    THE TOP 3 HOUSE DEMOCRAT LEADERS HAVE POCKETED MILLIONS FROM PHARMA

    Nov 29, 2018

    Three of the lawmakers who will lead the House next year as Congress focuses on skyrocketing drug costs are among the biggest recipients of campaign contributions from the pharmaceutical industry, a new KHN analysis shows. On Wednesday, House Democrats selected Rep. Steny Hoyer of Maryland to serve ...


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    https://Pharmaceutical.report/news-article.aspx?ID=22012201

    HEALIOS BEGINS TRIALS OF MENTAL HEALTH APP FOR SCHOOLCHILDREN

    Nov 28, 2018

    Digital health firm Healios is beginning clinical trials of ThinkNinja, an app designed to help children with mental health problems. ThinkNinja is aimed at helping young people aged 11 to 17 years old with their mental health, emotional well-being, and resilience, and supports symptoms of anxiety a...


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    https://Pharmaceutical.report/news-article.aspx?ID=21902190

    BAYER/LOXO DRUG APPROVED IN CANCERS WITH CERTAIN MUTATION

    Nov 28, 2018

    The FDA has approved Bayer and Loxo’s Vitravki (larotrectinib) for adults and children whose cancers have a specific genetic feature, or biomarker. This is only the second time the agency has approved a cancer treatment on the basis of its efficacy against a specific biomarker, rather than the...


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    https://Pharmaceutical.report/news-article.aspx?ID=21912191

    'MINI-PLACENTAS' COULD PROVIDE A MODEL FOR EARLY PREGNANCY

    Nov 28, 2018

    Researchers say that new 'mini-placentas'—a cellular model of the early stages of the placenta—could provide a window into early pregnancy and help transform our understanding of reproductive disorders. Details of this new research are published today in the journal Nature. Many ...


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    https://Pharmaceutical.report/news-article.aspx?ID=21922192

    ANTIBIOTIC COULD PROTECT AGAINST NEURODEGENERATIVE DISEASES DURING AGING

    Nov 28, 2018

    An antibiotic, minocycline, can increase the lifespan of roundworms by preventing the build-up of proteins during aging, a study in the open-access journal eLife reports. Protein aggregation causes several progressive age-related brain diseases, including amyotrophic lateral sclerosis, Alzheimer'...


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    https://Pharmaceutical.report/news-article.aspx?ID=21932193

    NHS SAVING £300M WITH HUMIRA BIOSIMILAR DEAL

    Nov 27, 2018

    The NHS is to save £300 million after striking deals with several manufacturers of low cost biosimilars of AbbVie’s Humira inflammatory diseases drug. Before the deal, NHS England spent more on Humira (adalimumab) than any other drug, and the deal, which also included a cut-price bid fro...


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    https://Pharmaceutical.report/news-article.aspx?ID=21822182

    SIEMENS HEALTHINEERS UNVEILS MAGNETOM ALTEA 1.5 TESLA MRI SCANNER

    Nov 27, 2018

    Siemens Healthineers has unveiled a new 1.5 Tesla MRI scanner, the MAGNETOM Altea, at the RSNA conference in Chicago. The device features a generous 70-centimeter bore that will fit some of the largest patients, as well as the company’s BioMatrix technology that helps to prepare for scans base...


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    https://Pharmaceutical.report/news-article.aspx?ID=21832183

    LUNG DISEASE MAY INCREASE DEMENTIA RISK

    Nov 27, 2018

    Dementia refers to a series of neurodegenerative diseases, such as Alzheimer's, where a person's memory and other cognitive abilities decline. A recent study may have found a new risk factor that might predispose people to dementia: lung disease. According to the study by researchers from th...


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    https://Pharmaceutical.report/news-article.aspx?ID=21842184

    COPD AND ANXIETY: RESEARCHERS TEST PROMISING APPROACH

    Nov 27, 2018

    The chronic obstructive pulmonary disease affects millions of people worldwide. Its main symptom is breathlessness, which can be distressing and causes many people with this lung condition to experience anxiety. According to data from the World Health Organization (WHO), an estimated 3.17 million pe...


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    https://Pharmaceutical.report/news-article.aspx?ID=21852185

    SLUGGISH BRAINWAVE ACTIVITY IN DEMENTIA PREDICTS SEVERITY OF COGNITIVE IMPAIRMENT

    Nov 26, 2018

    To turn back the clock on Alzheimer’s disease, many researchers are seeking ways to effectively diagnose the neurodegenerative disorder earlier. One potential way to do this is by tracking a person’s brainwave activity, which slows down in certain brain regions that are likely to be affe...


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    https://Pharmaceutical.report/news-article.aspx?ID=21702170

    TYPE 2 DIABETES: HOW DO FRUCTOSE-SWEETENED DRINKS AFFECT RISK?

    Nov 26, 2018

    A new review of existing studies published in The BMJ finds that sugary drinks that contain fructose raise the risk of type 2 diabetes more than other fructose-containing foods. A range of recent studies has pointed out the potential health risks of sugary drinks. Studies have confirmed that there i...


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    https://Pharmaceutical.report/news-article.aspx?ID=21712171

    MINIMAL RESIDUAL DISEASE: APPLICATION IN BLOOD CANCERS

    Nov 26, 2018

    A diagnosis of chronic lymphocytic leukemia (CLL) can mean a long road with many twists and turns as patients try to achieve long-term remission from this chronic, complex and progressive form of blood cancer. Living with CLL has meant co-existing with a disease often marked by a cycle of remissions...


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    https://Pharmaceutical.report/news-article.aspx?ID=21762176

    ‘GENERATION Z’ HAPPY TO BE DIAGNOSED BY CHATBOTS

    Nov 26, 2018

    A survey involving young people from ‘Generation Z’ has revealed they want to see the NHS introduce digital solutions to help manage their care, with nearly two-thirds saying they would be comfortable with a chatbot giving them a diagnosis. The new research from Roche UK showed 82% of th...


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    https://Pharmaceutical.report/news-article.aspx?ID=21772177

    ITALY FREE TO REIMBURSE OFF-LABEL AVASTIN, RULES EU COURT

    Nov 23, 2018

    Novartis and Roche’s long-running battle to try to prevent off-label prescribing of Roche’s Avastin in place of their approved Lucentis product for the eye disease age-related macular degeneration (AMD) has been dealt a blow by the European Court of Justice. Four years ago, Italy’s...


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    https://Pharmaceutical.report/news-article.aspx?ID=21662166

    CELLULAR MECHANOSENSING KEY FOR 3D FORMATION

    Nov 23, 2018

    If you want to build an organ, such as for transplant, you need to think in 3D. Using stem cells, scientists for some time have been able to grow parts of organs in the lab, but that is a far cry from constructing an actual, fully-formed, functioning, three-dimensional organ. For students of regener...


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    https://Pharmaceutical.report/news-article.aspx?ID=21672167

    THE SURPRISING CULPRIT FOR HIV PERSISTENCE DURING THERAPY

    Nov 23, 2018

    Reducing the population size of this "reservoir" of infected cells represents the largest challenge for the cure of HIV. Based on these results, study authors believe reducing cellular proliferation could help to deplete the reservoir and potentially lead to a functional cure. Led by Drs. ...


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    https://Pharmaceutical.report/news-article.aspx?ID=21682168

    BREAST CANCERS ENHANCE THEIR GROWTH BY RECRUITING CELLS FROM BONE MARROW

    Nov 23, 2018

    Researchers in Israel have discovered that breast tumors can boost their growth by recruiting stromal cells originally formed in the bone marrow. The study, which will be published November 23 in the Journal of Experimental Medicine, reveals that the recruitment of bone marrow-derived fibroblasts lo...


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    https://Pharmaceutical.report/news-article.aspx?ID=21692169

    THOUSANDS TO BENEFIT AS NHS FUNDS KEYTRUDA LUNG CANCER COMBO

    Nov 22, 2018

    NICE has said MSD’s cancer immunotherapy, Keytruda, should receive interim funding on the NHS in certain patients with untreated lung cancer, in combination with chemotherapy. In the first draft guidance, NICE said Keytruda (pembrolizumab) will be reimbursed by the Cancer Drugs Fund, with peme...


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    https://Pharmaceutical.report/news-article.aspx?ID=21592159

    FDA APPROVES SOBI’S GAMIFANT FOR RARE, FATAL CHILDHOOD DISEASE

    Nov 22, 2018

    The FDA has approved Sobi’s Gamifant, a treatment for primary hemophagocytic lymphohistiocytosis (HLH). The extremely rare condition usually manifests within the first year of life, progresses quickly and is usually fatal, with a median survival of fewer than two months. HLH is caused by hyper...


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    https://Pharmaceutical.report/news-article.aspx?ID=21602160

    SONS OF FATHERS WHO SMOKE HAVE 51% LOWER SPERM COUNT

    Nov 22, 2018

    Studies have repeatedly linked maternal smoking during pregnancy with reduced sperm counts in male offspring. Now a research team at Lund University in Sweden has discovered that, independently of nicotine exposure from the mother, men whose fathers smoked at the time of pregnancy had half as many s...


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    https://Pharmaceutical.report/news-article.aspx?ID=21612161

    CEO OF UK DRUGS REGULATOR QUITS, AS BREXIT NEARS

    Nov 21, 2018

    The CEO of the UK’s medicine regulator has announced he will leave his post in September next year. With just months to go before the Brexit deadline, Dr. Ian Hudson, who has worked at the Medicines and Healthcare products Regulatory Agency (MHRA) for 17 years, said he was stepping down for &l...


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    https://Pharmaceutical.report/news-article.aspx?ID=21522152

    MACHINE LEARNING MODELS HELP PREDICT WHICH PATIENTS NEED A&E

    Nov 21, 2018

    Machine learning a field of artificial intelligence that uses statistical techniques to enable computer systems to ‘learn’ from data can be used to analyze electronic health records and predict the risk of emergency hospital admissions, a new study from The George Institute for Global He...


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    https://Pharmaceutical.report/news-article.aspx?ID=21532153

    TAKEDA MUST SELL GASTRO DRUG TO MERGE WITH SHIRE – EU REGULATORS

    Nov 21, 2018

    European regulators have officially rubber-stamped Takeda’s $62 billion takeovers of Shire, although the merged company will have to sell off a pipeline clinical trial drug for inflammatory bowel disease. Takeda already markets Entyvio (vedolizumab) and EU regulators are concerned that the mer...


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    https://Pharmaceutical.report/news-article.aspx?ID=21542154

    HOW ASPIRIN AND OMEGA-3 MAY REDUCE CANCER RISK

    Nov 20, 2018

    Acetylsalicylic acid, best known as aspirin, and omega-3 fatty acids support various aspects of health, and scientists continue to uncover how these substances work. One recent study suggests that both could have an impact on colon cancer risk. The National Cancer Institute estimates that doctors wi...


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    https://Pharmaceutical.report/news-article.aspx?ID=21472147

    MERCK AND PFIZER CHALK UP ANOTHER FAIL FOR BAVENCIO

    Nov 20, 2018

    Merck KGaA and Pfizer’s late entrant to the checkpoint inhibitor category has failed a phase III trial in ovarian cancer, denting their hopes of building momentum for the product. The JAVELIN Ovarian 200 study was testing Bavencio (avelumab) alone or in combination with chemotherapy (pegylated...


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    https://Pharmaceutical.report/news-article.aspx?ID=21482148

    NEJM PAPER BUOYS AIMMUNE’S PEANUT ALLERGY DRUG PROSPECTS

    Nov 19, 2018

    Results from Aimmune’s phase 3 trial of oral immunotherapy AR101 for peanut allergy have been published and bode well for the program’s planned FDA filing next month. The PALISADE study shows that children who were classed as highly allergic to peanuts were able to tolerate a much higher...


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    https://Pharmaceutical.report/news-article.aspx?ID=21422142

    INFLAZOME RAISES €40M TO GET NLRP3 DRUG INTO HUMANS

    Nov 19, 2018

    Inflazome has raised €40 million ($46 million). The Forbion-led series B tees up Inflazome to trial its NLRP3 inflammasome inhibitors in several inflammatory diseases. Irish-British biotech Inflazome is working on a pipeline of small molecules designed to block signals that lead to unwanted inf...


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    https://Pharmaceutical.report/news-article.aspx?ID=21432143

    NOVARTIS’ CAR-T CANCER DRUG AVAILABLE ON NHS TO YOUNG PEOPLE

    Nov 16, 2018

    Novartis’ cutting-edge CAR-T therapy Kymriah has officially become available on the NHS for young people with blood cancer. The chimeric antigen receptor T-cell (CAR-T) drug, also known as tisagenlecleucel, is available for young people with relapsed or refractory B-cell acute lymphoblastic le...


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    https://Pharmaceutical.report/news-article.aspx?ID=21372137

    BLUEPRINT EYES QUICK FILING FOR GIST DRUG AVAPRITINIB

    Nov 16, 2018

    Blueprint Medicines has new data for its lead cancer drug avapritinib in gastrointestinal stromal tumours (GIST) that set it on course for regulatory filings – and a close race to market with rival Deciphera. Avapritinib is an oral inhibitor of KIT and PDGFRA kinases and is being developed for...


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    https://Pharmaceutical.report/news-article.aspx?ID=21382138

    DEFINED HEALTH BECOMES CELLO HEALTH BIOCONSULTING

    Nov 15, 2018

    Cello’s US health consulting business Defined Health has been rebranded as Cello Health BioConsulting, following its acquisition by the group last year. Cello said the move was prompted by industry evolution and outlined how even the most scientifically-driven biotech companies need to think c...


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    https://Pharmaceutical.report/news-article.aspx?ID=21322132

    LITMUS HEALTH PUBLISHES CENSUS OF WEARABLE DEVICES FOR CLINICAL RESEARCH

    Nov 15, 2018

    Real-world data firm Litmus Health has published its first census of wearable devices for clinical research, profiling the body and wrist-worn hardware offerings from over 190 brands and manufacturers. The company recommends its 15 top devices based on a rubric scoring the transparency of their data...


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    https://Pharmaceutical.report/news-article.aspx?ID=21332133

    AI DEVICE COULD BE CHEAPER AND MORE ACCURATE THAN SMEAR TESTS

    Nov 14, 2018

    UK startup Lancor Scientific has secured funding to launch a medical device that aims to use artificial intelligence (AI) to detect cervical cancer with 90% accuracy and at a lower cost than currently available tests. Conventional smear tests have an accuracy of 60%-70%, but the company hopes its Tu...


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    https://Pharmaceutical.report/news-article.aspx?ID=21262126

    ATLANTIC NETS DE NOVO CLEARANCE FOR PELVIC FLOOR MUSCLE STIMULATOR FOR URINARY INCONTINENCE

    Nov 14, 2018

    The FDA granted a de novo clearance to Atlantic Therapeutics’ electrical muscle stimulator for women, for treating stress urinary (SUI) incontinence. The externally worn Innovo device, the first transcutaneous stimulation device cleared by the FDA for incontinence, according to the company, ca...


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    https://Pharmaceutical.report/news-article.aspx?ID=21272127

    EYEING NOVARTIS DEAL, AKCEA TRUMPETS LIPOPROTEIN DRUG DATA

    Nov 14, 2018

    Ionis affiliate Akcea Pharma has new data for its antisense drug for elevated lipoprotein levels in patients with cardiovascular disease that it hopes will entice Novartis into a licensing deal. The phase II results – reported at the American Heart Association meeting – show that AKCEA-A...


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    https://Pharmaceutical.report/news-article.aspx?ID=21282128

    GOOGLE HIRES GEISINGER CEO AS NEW HEALTH STRATEGY LEADER

    Nov 13, 2018

    Google has hired Geisinger Health CEO David Feinberg to provide strategic leadership as the tech giant moves into the health sector. In a statement, the Pennsylvania-based health firm Geisinger said Feinberg is leaving on 3 January, with chief medical officer Jaewon Ryu taking over as interim presid...


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    https://Pharmaceutical.report/news-article.aspx?ID=21202120

    NANONEEDLE SKIN PATCH TO INJECT DRUGS INTO CELLS

    Nov 13, 2018

    Delivering drugs directly into skin cells using microscopic nanoneedles may allow for highly effective treatment of skin conditions without injuring the cells that are treated. Silicon nanoneedles have been developed in the past that can do such a trick, but they’re stiff and can be painful, i...


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    https://Pharmaceutical.report/news-article.aspx?ID=21212121

    ROCHE’S TECENTRIQ GETS FAST REVIEW IN TRIPLE NEGATIVE BREAST CANCER

    Nov 13, 2018

    The FDA has granted a fast review for Roche/Genentech’s Tecentriq in combination with Celgene’s Abraxane for certain patients with tough-to-treat ‘triple negative’ breast cancer. The regulator has granted the immunotherapy Tecentriq (atezolizumab) and Abraxane (nab-paclitaxel...


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    https://Pharmaceutical.report/news-article.aspx?ID=21222122

    CARDIVA’S VASCULAR CLOSURE STUDY SHOWS REDUCTIONS IN BED REST, OPIOID USAGE FOLLOWING ABLATION PROCEDURES

    Nov 12, 2018

    A clinical study by Cardiva Medical evaluating its bioabsorbable vascular closure system for electrophysiology procedures met all of its primary and secondary endpoints compared to manual compression, the current standard of care. The company’ s Vascade MVP system—designed for multi-acce...


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    https://Pharmaceutical.report/news-article.aspx?ID=21142114

    T CELL’S ‘SUICIDE’ HANDSHAKE COULD FEND OFF AUTOIMMUNE DISEASES

    Nov 12, 2018

    Autoimmune diseases like rheumatoid arthritis and multiple sclerosis occur when immune cells become overactive and attack healthy tissues in the body. Researchers at the Georgia Institute of Technology have discovered a process the body uses to eliminate the T cells that cause autoimmune disorders&m...


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    https://Pharmaceutical.report/news-article.aspx?ID=21152115

    HARPOON RAISES $70M TO TRIAL SOLID TUMOR T-CELL ENGAGERS

    Nov 12, 2018

    Harpoon Therapeutics has raised $70 million to advance its pipeline of T-cell engagers. The series C sets Harpoon up to move candidates targeting mesothelin and BCMA into human testing next year. South San Francisco-based Harpoon set up shop to create T-cell engagers capable of treating solid tumors...

    NICK PAUL TAYLOR
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    https://Pharmaceutical.report/news-article.aspx?ID=21162116

    VERTEX WINS EUROPEAN APPROVAL FOR NEW CYSTIC FIBROSIS COMBINATION

    Nov 02, 2018

    European regulators have approved Vertex’s new cystic fibrosis (CF) combination treatment Symkevi. The European Commission’s greenlight for Symkevi (tezacaftor/ivacaftor) will allow it to be used in combination with Kalydeco (ivacaftor) for patients aged 12-plus. In doing so it will offe...


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    https://Pharmaceutical.report/news-article.aspx?ID=21082108

    SINGLE-CELL ANALYSIS REVEALS HOW MELANOMA CELLS RESIST IMMUNOTHERAPY

    Nov 02, 2018

    Unleashing the immune system to fight tumors—an approach enabled by immunotherapy—has led to remarkable outcomes in some cancer patients, but in many more, cancer cells evade the treatment and continue to spread. Now, a team led by researchers from Broad Institute of MIT and Harvard and ...


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    https://Pharmaceutical.report/news-article.aspx?ID=21092109

    GENE PPM1D GIVES STEM CELLS A 'WINNING BOOST' AFTER CHEMOTHERAPY

    Nov 02, 2018

    Chemotherapy has been associated with an increased risk of leukemia years after the treatment, but what leads to that association is not clear. In this study published in the journal Cell Stem Cell, a team led by researchers at Baylor College of Medicine and MD Anderson Cancer Center combined clinic...

    BAYLOR COLLEGE OF MEDICINE
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    https://Pharmaceutical.report/news-article.aspx?ID=21102110

    ABBVIE, ROCHE EYE FIRST-LINE USE OF VENCLEXTA IN LEUKAEMIA

    Nov 01, 2018

    AbbVie and Roche’s Venclexta has hit the mark in a combination trial that could help it move into the treatment-naive chronic lymphocytic leukemia (CLL) arena. Top-line results from the CLL14 study showed that giving Venclexta (venetoclax) alongside Roche’s Gazyva (obinutuzumab) improved...


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    https://Pharmaceutical.report/news-article.aspx?ID=21032103

    UK OPENS DOORS TO CANNABIS-BASED THERAPIES VIA NHS

    Nov 01, 2018

    Medical cannabis is available to certain patients across the UK for the first time from today. The groundbreaking decision was made so that people suffering from illnesses where other medicines have failed, have a way to treat their symptoms. It follows a campaign mounted in June after two boys with...


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    https://Pharmaceutical.report/news-article.aspx?ID=21042104

    BAXTER’S PRIXMAX RENAL REPLACEMENT AND ORGAN SUPPORT SYSTEM CLEARED IN EUROPE

    Oct 31, 2018

    Baxter won European CE mark approval to bring to the continent its PrisMax continuous renal replacement and organ support therapy system, as well as the TherMax blood warmer. The PrixMax is based on the company’s Prismaflex system and is designed to make extracorporeal simpler, faster, and mor...


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    https://Pharmaceutical.report/news-article.aspx?ID=20962096

    APPENDIX IDENTIFIED AS A POTENTIAL STARTING POINT FOR PARKINSON'S DISEASE

    Oct 31, 2018

    Removing the appendix early in life reduces the risk of developing Parkinson's disease by 19 to 25 percent, according to the largest and most comprehensive study of its kind, published today in Science Translational Medicine. The findings also solidify the role of the gut and immune system in th...


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    https://Pharmaceutical.report/news-article.aspx?ID=20972097

    INCREASE COLLABORATION TO WIDEN ACCESS TO DMD DRUGS, TRIALS AND CARE

    Oct 31, 2018

    When it comes to fighting a rare disease like Duchenne muscular dystrophy (DMD), it’s a matter of strength in numbers. Three Duchenne experts talk to us about how international collaboration between patients, pharma, clinicians and regulators could accelerate access to drugs, trials, and quali...


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    https://Pharmaceutical.report/news-article.aspx?ID=21022102

    NOVEL TECHNIQUE CAN POTENTIALLY IMPROVE SUCCESS OF OVARIAN CANCER TREATMENT, STUDY REVEALS

    Oct 30, 2018

    Novel Technique Can Potentially Improve Success of Ovarian Cancer Treatment, Study Reveals Instead of destroying a tumor's blood supply, a first-ever University of Guelph study has proven that opening up the vessels is potentially more effective when it comes to fighting ovarian cancer. This is ...


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    https://Pharmaceutical.report/news-article.aspx?ID=20912091

    AUGMENTED REALITY PRE-SURGERY TECH APPROVED BY US REGULATOR

    Oct 30, 2018

    The US Food and Drug Administration (FDA) has approved a pre-surgery augmented reality imaging system that will allow doctors to see inside patients before a surgical procedure. Tech firm Novarad’s OpenSight Augmented Reality System was given the green light by the US regulator, who granted 51...


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    https://Pharmaceutical.report/news-article.aspx?ID=20922092

    LEO PHARMA TEAMS UP WITH WEARIFI FOR DERMATOLOGY RESEARCH WEARABLE

    Oct 29, 2018

    LEO Pharma is developing a wearable device based on miniature sensors and plans to assess its clinical potential in dermatology drug development. The pharmaceutical company’s Boston-based R&D innovation unit, the LEO Science & Tech Hub, will work on the device with Illinois’ Nort...


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    https://Pharmaceutical.report/news-article.aspx?ID=20862086

    BIOLOGISTS DISCOVER SOURCE FOR BOOSTING TUMOR CELL DRUG SENSITIVITY

    Oct 29, 2018

    DNA-damaging agents, or "DDAs," make up the most widely used group of cancer drugs. Yet their therapeutic success has been curtailed by drug resistance either present in cancer cells from the disease onset or arising during treatment. Now, biologists at the University of California San Die...


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    https://Pharmaceutical.report/news-article.aspx?ID=20872087

    NOVIOSENSE ANNOUNCES POSITIVE CLINICAL TRIAL RESULTS OF TEAR GLUCOSE MEASUREMENT TECHNOLOGY

    Oct 25, 2018

    NovioSense has demonstrated the measurement of tear glucose in diabetic patients and a close correlation to blood glucose with clinically relevant accuracy. A second, 24-patient study, to validate the use of the new glucose sensor in type 1 diabetic patients is already commencing. NovioSense BV, a c...


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    https://Pharmaceutical.report/news-article.aspx?ID=20812081

    OPTOACOUSTIC GUIDEWIRE SYSTEM FOR BREAST CANCER LOCALIZATION

    Oct 25, 2018

    Breast lumpectomy for breast CA is an imprecise procedure that too often results in cancerous tissue being left behind. About a quarter of patients have to come back and go through the surgery yet again. This is in large part due to the fact that guidewires are the standard way to point to the locat...


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    https://Pharmaceutical.report/news-article.aspx?ID=20822082

    BAYER PLANS FILINGS FOR PROSTATE CANCER DRUG DAROLUTAMIDE

    Oct 24, 2018

    Bayer is planning regulatory filings of darolutamide in prostate cancer following phase III trial results showing it helped prevent the disease from spreading, in a niche where Pfizer and Johnson & Johnson have already gained a foothold. The German pharma developed darolutamide in partnership wi...


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    https://Pharmaceutical.report/news-article.aspx?ID=20762076

    STUDY FINDS TALLER PEOPLE MORE LIKELY TO GET CERTAIN CANCERS DUE TO CELL NUMBERS

    Oct 24, 2018

    A researcher at the University of California's Department of Evolution, Ecology and Organismal Biology has found evidence that taller people are more prone to getting cancer due to their larger number of cells. In his paper published in Proceedings of the Royal Society B, Leonard Nunney describe...


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    https://Pharmaceutical.report/news-article.aspx?ID=20772077

    NEW COMBINATION TREATMENT FLIPS THE SWITCH ON MELANOMA CELLS

    Oct 23, 2018

    Think of the protein BH3 like a finger that turns off a cancer cell survival switch. The problem is that most cancer cells have found ways to remove this "finger commonly, by breaking the action of a gene called p53 that puts the BH3 finger in motion. Now think of Bcl-2 as the switch itself. Wh...


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    https://Pharmaceutical.report/news-article.aspx?ID=20692069

    WEEK 34 OF PREGNANCY REDUCES BREAST CANCER RISK: STUDY

    Oct 23, 2018

    Women's bodies undergo a "striking" change during a specific week of pregnancy that can significantly reduce their risk of developing breast cancer later in life, scientists said Tuesday. Previous research has highlighted how women under the age of 30 can reduce their risk of contracti...


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    https://Pharmaceutical.report/news-article.aspx?ID=20702070

    SANGAMO VET GARY LEE JOINS SYNTHETIC BIOLOGY OUTFIT SENTI AS CSO

    Oct 23, 2018

    Gary Lee, Ph.D.a 13-year veteran of Sangamo Therapeutics, has joined Senti Biosciences as its new chief scientific officer. In his new role, Lee will head up the expansion of Senti’s synthetic biology platform and oversee the advancement of oncology cell therapy programs into the clinic. Durin...


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    https://Pharmaceutical.report/news-article.aspx?ID=20722072

    ASTRAZENECA AND IONIS TARGET DIABETES WITH ANTISENSE APPROACH TO REGENERATING PANCREATIC CELLS

    Oct 22, 2018

    Type 2 diabetes is caused by a progressive loss of insulin-producing beta cells in the pancreas, and current remedies can’t do much beyond just relieving symptoms. Now AstraZeneca and Ionis are working together to investigate a new way to target beta cells with antisense oligonucleotides (ASOs...


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    https://Pharmaceutical.report/news-article.aspx?ID=20712071

    NEW AT-HOME FETAL HEART RATE MONITOR WITH CLINICAL ACCURACY

    Oct 22, 2018

    These days patients that are still in the womb have their heart rates measured on a regular basis to spot conditions such as fetal bradycardia or tachycardia or decreased variability. This is typically done in a hospital using specialty equipment that is too expensive for use in the home. Now resear...

    UNIVERSITY OF SUSSEX
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    https://Pharmaceutical.report/news-article.aspx?ID=20602060

    NOVARTIS WANTS TO BLAZE A TRAIL IN BREAST CANCER WITH PIK3 DRUG

    Oct 22, 2018

    Novartis is preparing to file its PIK3 drug combination for a certain group of breast cancer patients, after late stage trial results showed its alpelisib combination stopped the disease progressing for twice as long as standard therapy, with “manageable” side effects. Drugs from this cl...


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    https://Pharmaceutical.report/news-article.aspx?ID=20622062

    GILEAD, AELIX ALLY TO TRIAL HIV-SUPPRESSING COMBINATION

    Oct 18, 2018

    Gilead has teamed up with Aelix Therapeutics to trial a combination designed to free people with HIV from the need to take antiretroviral drugs. The planned clinical trial will test Gilead’s TLR7 agonist in combination with Aelix’s T-cell vaccine. Gilead began testing the TLR7 agonist, v...


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    https://Pharmaceutical.report/news-article.aspx?ID=20562056

    IMPROVING CANCER IMMUNOTHERAPY BY CONTROLLING RNA EXPRESSION

    Oct 18, 2018

    Gene therapy has become one of the hottest areas of biotech research. Some gene therapies, like Spark Therapeutics’ eye drug Luxturna, deliver healthy genes to replace mutated ones, while others, such as Alnylam Pharmaceuticals’ RNA interference therapy Onpattro, work by silencing diseas...


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    https://Pharmaceutical.report/news-article.aspx?ID=20572057

    PFIZER’S TALZENNA PARP BREAST CANCER DRUG APPROVED IN US

    Oct 17, 2018

    The US drug regulator has approved Pfizer’s breast cancer medicine Talzenna (talazoparib) for patients with a certain mutation. The drug was approved by the US Food and Drug Administration (FDA) for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negativ...


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    https://Pharmaceutical.report/news-article.aspx?ID=20512051

    MEDICAL MANAGEMENT OF OPIOID-INDUCED CONSTIPATION DIFFERS FROM OTHER FORMS OF CONDITION

    Oct 17, 2018

    Traditional laxatives are recommended as first-line agents to treat patients with a confirmed diagnosis of opioid-induced constipation (OIC), according to a new guideline from the American Gastroenterological Association (AGA). If an adequate trial of laxatives results in suboptimal symptom control,...


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    https://Pharmaceutical.report/news-article.aspx?ID=20522052

    NEW TEST RAPIDLY IDENTIFIES ANTIBIOTIC-RESISTANT SUPERBUGS

    Oct 16, 2018

    When you get sick, you want the right treatment fast. But certain infectious microbes are experts at evading the very anti-bacterial drugs designed to fight them. A simple and inexpensive new test developed by UC Berkeley researchers can diagnose patients with antibiotic-resistant strains of bacteri...

    UNIVERSITY OF CALIFORNIA - BERKELEY
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    https://Pharmaceutical.report/news-article.aspx?ID=20462046

    MICROLAPAROSCOPIC ROBOTIC SURGERIES NOW CLEARED ON TRANSENTERIX SENHANCE SYSTEM

    Oct 16, 2018

    TransEnterix, the maker of the Senhance robotic surgical system, won FDA clearance for its new 3-millimeter line of instruments, as well as some more 5 mm instruments. At only 3 mm in diameter, the new instruments make it possible to use the Senhance system for micro-laparoscopic surgeries with inci...

    TRANSENTERIX
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    https://Pharmaceutical.report/news-article.aspx?ID=20472047

    ANTIDEPRESSANTS COULD STAVE OFF DEMENTIA

    Oct 15, 2018

    People with a diagnosis of dementia can also face depression. For this reason, they may end up taking antidepressant drugs. Now, a study has found that these drugs may be able to treat not just depression, but dementia itself. According to data cited by the Alzheimer's Association, 1 in 10 ...

    MARIA COHUT
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    https://Pharmaceutical.report/news-article.aspx?ID=20412041

    ASPIRIN MAY REDUCE LIVER CANCER RISK

    Oct 15, 2018

    Researchers at Massachusetts General Hospital have found that regular aspirin use can reduce the risk of developing liver cancer. The findings — which appear in JAMA Oncology — support the results of prior studies on the same topic. Data from this report show that taking aspirin on a reg...


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    https://Pharmaceutical.report/news-article.aspx?ID=20422042

    CANCER STEM CELLS USE 'NORMAL' GENES IN ABNORMAL WAYS

    Oct 12, 2018

    CDK1 is a "normal" protein its presence drives cells through the cycle of replication. And MHC Class I molecules are "normal" as well they present bits of proteins on the surfaces of cells for examination by the immune system. But a University of Colorado Cancer Center study publ...


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    https://Pharmaceutical.report/news-article.aspx?ID=20362036

    NUMBER OF UK CLINICAL TRIALS IN DECLINE SINCE BREXIT VOTE

    Oct 12, 2018

    Ongoing uncertainty and concern about Brexit have already cut the number of clinical trials carried out in the UK. The number of drug trials started in Britain in 2017 was a staggering 25% lower than the average for 2009-2016. A Fitch analysis showed that 597 trials were initiated in Britain in 2017...

    JOY PERSAUD
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    https://Pharmaceutical.report/news-article.aspx?ID=20372037

    BIODEGRADABLE IMPLANT STIMULATES INJURED NERVES TO SPEED UP HEALING

    Oct 11, 2018

    Scientists at Washington University School of Medicine and Northwestern University created an implant to deliver electric impulses to damaged nerves, helping to heal them, and that eventually biodegrades and leaves the body. It’s about the size of a U.S. quarter coin and operates for about two...


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    https://Pharmaceutical.report/news-article.aspx?ID=20312031

    NEUROCRINE, JNANA TEAM UP TO DISCOVER CNS DRUGS

    Oct 11, 2018

    Neurocrine Biosciences has teamed up with Jnana Therapeutics to develop drugs that target solute carrier (SLC) metabolite transporters. The collaboration gives Neurocrine a potential source of small molecules to treat disorders of the central nervous system. SLCs are a 400-strong family of membrane ...


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    https://Pharmaceutical.report/news-article.aspx?ID=20322032

    ANTI-PSYCHOTIC DRUG COULD TREAT AGGRESSIVE BREAST CANCER

    Oct 09, 2018

    A commonly-used anti-psychotic drug could also be effective against triple negative breast cancer, the form of the disease that is most difficult to treat, new research has found. The study, led by the University of Bradford in the UK, also showed that the drug, Pimozide, has the potential to treat ...


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    https://Pharmaceutical.report/news-article.aspx?ID=20262026

    GENE THERAPY BREAKTHROUGH IN TREATING RARE FORM OF BLINDNESS

    Oct 09, 2018

    Positive results of the world's first gene therapy trial for a genetic cause of blindness known as choroideremia have been reported in Nature Medicine. The trial involved 14 patients receiving a single injection into the back of the eye of a virus containing the missing gene and began in 2011 at...


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    https://Pharmaceutical.report/news-article.aspx?ID=20272027

    SCIENTISTS CREATE NEW MAP OF BRAIN REGION LINKED TO ALZHEIMER'S DISEASE

    Oct 08, 2018

    Curing some of the most vexing diseases first requires navigating the world's most complex structure—the human brain. So, USC scientists have created the most detailed atlas yet of the brain's memory bank. Cartographers of the cranium, a USC research team has illustrated the internal c...


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    https://Pharmaceutical.report/news-article.aspx?ID=20212021

    NERVE DAMAGE: USING ELECTRONIC IMPLANTS TO HASTEN HEALING

    Oct 08, 2018

    An implantable electronic device that can heal injured peripheral nerves by stimulating them with electric pulses before the body biodegrades and absorbs it has shown successful results in preliminary tests. A study led by Washington University School of Medicine in St. Louis, MO, and Northwestern U...


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    https://Pharmaceutical.report/news-article.aspx?ID=20222022

    SANDOZ ENCOURAGES DIGITAL HEALTH INNOVATION IN SECOND COMPETITION

    Oct 05, 2018

    Sandoz has announced a second competition inviting entrepreneurs and innovators in digital health to submit ideas that could complement or even disrupt established approaches to access to healthcare. The competition, known as the Sandoz Healthcare Access-Challenge (HACk) opened this week and entries...


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    https://Pharmaceutical.report/news-article.aspx?ID=20162016

    DNA SEQUENCING AND PATIENT DATA USED TO HALT INFECTION OUTBREAK

    Oct 05, 2018

    Clinical and research teams at Oxford University Hospitals (OUH) NHS Foundation Trust, using infection prevention and control best practice, whole genome sequencing, and electronic patient data, have halted an outbreak of a potentially deadly fungal pathogen after detecting that multi-use patient eq...


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    https://Pharmaceutical.report/news-article.aspx?ID=20172017

    PERSONALIZING CROHN’S DISEASE THERAPIES WITH MICRORNA AS INDICATOR

    Oct 04, 2018

    Crohn’s disease is an inflammatory bowel disease that involves lifelong management. Because disease development and potential complications vary among patients, it’s hard for physicians to determine a prognosis for each patient or to devise the best management plan accordingly. But a Uni...


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    https://Pharmaceutical.report/news-article.aspx?ID=20112011

    SAREPTA SEES MUSCLE FUNCTION GAINS WITH DMD GENE THERAPY

    Oct 04, 2018

    Sarepta’s case for its Duchenne muscular dystrophy (DMD) gene therapy is getting stronger, with early data now linking its effects on a critical protein with improved muscle function. An earlier readout from the phase 1/2 trial in June from three patients treated with the gene therapy showed t...


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    https://Pharmaceutical.report/news-article.aspx?ID=20122012

    GOLD NANOPARTICLES WITH ANTI-INFLAMMATORY ADD-ON HELP INJURED MUSCLES HEAL RAPIDLY

    Oct 02, 2018

    Inflammation in the body is an important mechanism that helps to heal. But, as is well known, it can also create problems by aggravating injuries and intensifying various medical conditions. Researchers at the Wyss Institute at Harvard University have been working on getting a handle on the process ...

    WYSS INSTITUTE
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    https://Pharmaceutical.report/news-article.aspx?ID=20052005

    POWERFUL NEW X-RAY LASER IMAGES BIOMOLECULES LIKE NEVER BEFORE

    Oct 02, 2018

    At the Deutsches Elektronen-Synchrotron (DESY), a research center of the Helmholtz Association in Germany, a team of scientists working within the newly built European X-Ray Free-Electron Laser Facility, have unveiled the structure of an enzyme involved in antibiotic resistance. While the finding is...

    DEUTSCHES ELEKTRONEN SYNCHROTRON
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    https://Pharmaceutical.report/news-article.aspx?ID=20062006

    SUPER-RESOLUTION MICROSCOPY BUILDS MULTICOLOUR 3D IMAGES FROM 2D

    Oct 01, 2018

    Super-resolution microscopy is a method that can ‘see’ beyond the limits of light. By exploiting fluorescence, super-resolution microscopy allows scientists to observe cells and their interior structures and organelles. The interior structures of cells are made up of multiple proteins, a...

    IQRA FAROOQ
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    https://Pharmaceutical.report/news-article.aspx?ID=20002000

    INEXPENSIVE TB TEST HOLDS PROMISE FOR LOW-INCOME COUNTRIES

    Oct 01, 2018

    A low-cost, easy-to-replicate test for tuberculosis might help developing nations better identify and treat the infectious and sometimes deadly disease, new research suggests. A study of the $2 test in rural Malawi in southeastern Africa found that it was reliable and could be easily employed in are...


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    https://Pharmaceutical.report/news-article.aspx?ID=20012001

    ‘STAR TREK’ PROTEIN COULD BE KEY TO REPURPOSING EGFR LUNG CANCER DRUGS IN LEUKEMIA

    Sep 27, 2018

    EGFR inhibitors, which block a key signaling pathway in solid tumor growth, are best known as treatments for lung cancer. But a new study led by scientists at the University of Liverpool found that some of them could potentially be used against blood cancers, too.
    Their effectiveness in blood...


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    https://Pharmaceutical.report/news-article.aspx?ID=19951995

    ALEXION PREPARES FILINGS FOR NEW RARE DISEASE USE FOR SOLIRIS

    Sep 27, 2018

    Alexion is preparing filings in major markets for its rare disease drug Soliris in a new indication after a positive readout in a rare neurological disease. The Boston biotech enjoys blockbuster revenues thanks to Soliris, which is already approved in three other rare diseases. Approved since 2007 i...


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    https://Pharmaceutical.report/news-article.aspx?ID=19961996

    ZIKA AND YELLOW FEVER—VACCINES WITHOUT EGGS

    Sep 26, 2018

    A team led by researchers from the Max Planck Institute for Dynamics of Complex Technical Systems in Magdeburg is developing methods with which viruses for vaccines can be replicated in significantly higher concentrations than before. The researchers produce the pathogens in cell cultures in small b...


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    https://Pharmaceutical.report/news-article.aspx?ID=19901990

    MICROBIAL DARK MATTER DOMINATES EARTH'S ENVIRONMENTS

    Sep 26, 2018

    Uncultured microbes those whose characteristics have never been described because they have not yet been grown in a lab culture could be dominating nearly all the environments on Earth except for the human body, according to a new study published in systems. The research was led by Karen Lloyd, asso...

    UNIVERSITY OF TENNESSEE AT KNOXVILLE
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    https://Pharmaceutical.report/news-article.aspx?ID=19911991

    DEEP CONVOLUTIONAL NEURAL NETWORK IDENTIFIES LUNG CANCER TYPES FROM BIOPSY SLICES

    Sep 24, 2018

    Many of us think of artificial intelligence (AI) as computers mimicking humans in thinking and behavior. Thankfully, the reality is still very different and AI is more of an evolving tool that can tackle narrow tasks that humans are otherwise not good enough at. One of those tasks is looking at comp...


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    https://Pharmaceutical.report/news-article.aspx?ID=19851985

    SPINAL CORD EPIDURAL STIMULATION LETS PARALYZED WALK AGAIN

    Sep 24, 2018

    While paralysis is common following a serious spinal injury, it seems that many patients may be treated with a new therapy that has already proven to restore walking and standing in a few study volunteers. Researchers at the University of Louisville in Kentucky, reporting in New England Journal of M...

    UNIVERSITY OF LOUISVILLE
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    https://Pharmaceutical.report/news-article.aspx?ID=19861986

    PEROVSKITE SEMICONDUCTORS SEEING RIGHT THROUGH NEXT GENERATION X-RAY DETECTORS

    Sep 21, 2018

    From observing celestial objects to medical imaging, the sensitive detection of X-rays plays a central role in countless applications. However, the methods used to detect them have undergone an interesting evolution of their own.
    X-ray detector designs vary in shape, function and ultimately p...

    KU LEUVEN SCIENCE, ENGINEERING & TECHNOLOGY GROUP
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    https://Pharmaceutical.report/news-article.aspx?ID=19801980

    EARLY WARNING SIGN OF PSYCHOSIS DETECTED

    Sep 21, 2018

    Brains of people at risk of psychosis exhibit a pattern that can help predict whether they will go on to develop full-fledged schizophrenia, a new Yale-led study shows. The findings could help doctors begin early intervention therapies for those most likely to develop the disabling disorder.
    ...


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    https://Pharmaceutical.report/news-article.aspx?ID=19811981

    STUDY IDENTIFIES STEM CELL THAT GIVES RISE TO NEW BONE AND CARTILAGE IN HUMANS

    Sep 20, 2018

    A decade-long effort led by Stanford University School of Medicine scientists has been rewarded with the identification of the human skeletal stem cell. The cell, which can be isolated from human bone or generated from specialized cells in fat, gives rise to progenitor cells that can make new bone, ...

    STANFORD UNIVERSITY MEDICAL CENTER
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    https://Pharmaceutical.report/news-article.aspx?ID=19751975

    EXICURE PLANS CHECKPOINT COMBO AFTER TLR9 DRUG CLEARS EARLY TEST

    Sep 20, 2018

    Exicure is set to move toll-like receptor 9 (TLR9) agonist AST-008 into a phase 1b/2 trial after getting a look at data from healthy volunteers. The first-in-human clinical trial suggested that AST-008 is safe, tolerable and boosts cytokine levels.
    AST-008, Exicure’s lead asset, is base...


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    https://Pharmaceutical.report/news-article.aspx?ID=19761976

    FIRST GUT BACTERIA MAY HAVE LASTING EFFECT ON ABILITY TO FIGHT CHRONIC DISEASES

    Sep 18, 2018

    New research showing that the first bacteria introduced into the gut have a lasting impact may one day allow scientists to adjust microbiomes the one-of-a-kind microbial communities that live in our gastrointestinal tracts to help ward off serious chronic diseases. Findings by U of A microbial ecolo...


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    https://Pharmaceutical.report/news-article.aspx?ID=19681968

    SCIENTISTS SEE AT-HOME BIOHACKING AS FUTURE OF MEDICINE

    Sep 17, 2018

    The cost and regulatory environment in which drugs are currently created lead to a number of difficulties for patients, providers, and drug manufacturers. Clearances and approvals, patents, and terms of use agreements, among other things, have forced some patients to turn to “biohacking”...

    COLORADO STATE
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    https://Pharmaceutical.report/news-article.aspx?ID=19651965

    STUDY OF ONE MILLION PEOPLE LEADS TO WORLD'S BIGGEST ADVANCE IN BLOOD PRESSURE GENETICS

    Sep 17, 2018

    Over 500 new gene regions that influence people's blood pressure have been discovered in the largest global genetic study of blood pressure to date, led by the Queen Mary University of London and Imperial College London. Involving more than one million participants, the results more than triple ...

    UNIVERSITY OF LONDON
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    https://Pharmaceutical.report/news-article.aspx?ID=19661966

    FDA APPROVES TEVA’S HIGHER-DOSE OPIOID DEPENDENCE THERAPY

    Sep 10, 2018

    US regulators have approved Teva’s under-the-tongue film Cassipa for maintenance and treatment of opioid dependence. The decision gives a new dose strength of 16 milligrams and 4 milligrams of the respective active ingredients, buprenorphine, and naloxone. With an opioid addiction crisis gripp...


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    https://Pharmaceutical.report/news-article.aspx?ID=19641964

    IS REGULAR SCREENING FOR PROSTATE CANCER REALLY NECESSARY?

    Sep 07, 2018

    A BMJ commission considered whether or not regular screening for prostate cancer using the prostate-specific antigen test is truly necessary, despite the possible risks it carries.
    According to an official statement released by the United States Preventive Services Task Force in JAMA, men in ...


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    https://Pharmaceutical.report/news-article.aspx?ID=19491949

    ELECTRON MICROSCOPY PROVIDES NEW VIEW OF TINY VIRUS WITH THERAPEUTIC POTENTIAL

    Sep 07, 2018

    The imaging method called cryo-electron microscopy (cryo-EM) allows researchers to visualize the shapes of biological molecules with an unprecedented level of detail. Now, a team led by researchers from the Salk Institute and the University of Florida is reporting how they used cryo-EM to show the s...


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    https://Pharmaceutical.report/news-article.aspx?ID=19501950

    A NEW THEORY FOR PHANTOM LIMB PAIN POINTS THE WAY TO MORE EFFECTIVE TREATMENT

    Sep 06, 2018

    Dr. Max Ortiz Catalan of Chalmers University of Technology, Sweden, has developed a new theory for the origin of the mysterious condition, 'phantom limb pain'. Published in the journal Frontiers in Neurology, his hypothesis builds upon his previous work on a revolutionary treatment for the c...

    CHALMERS UNIVERSITY OF TECHNOLOGY
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    https://Pharmaceutical.report/news-article.aspx?ID=19411941

    HISTORIC FLUORINE DISCOVERY

    Sep 06, 2018

    A groundbreaking discovery by chemists at The University of Texas at San Antonio (UTSA) will have a significant impact on how pharmaceutical companies develop new drug treatments. The breakthrough involves fluorine, which forms the second strongest carbon bond (C-F) known to science, after the carbo...


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    https://Pharmaceutical.report/news-article.aspx?ID=19441944

    DEMENTIA: 10-YEAR RISK ESTIMATES MAY INFORM PREVENTION

    Sep 05, 2018

    A large study provides 10-year absolute estimates for dementia risk. The scientists hope that by identifying people at high risk, specialists might be able to put in place early strategies for prevention.
    According to the World Health Organization (WHO), every 3 seconds a new case of dementia...


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    https://Pharmaceutical.report/news-article.aspx?ID=19391939

    NEW SMALLER FLEXIBLE ROBOTIC SURGICAL SYSTEM FROM SOUTH KOREA

    Sep 05, 2018

    At KAIST, a major South Korean science, and technology university, researchers have developed a flexible robotic surgical system that is designed to work on difficult to reach places. The K-FLEX endoscopic surgical robot has arms that are only 3.7 mm in diameter, allowing them to work through standa...


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    https://Pharmaceutical.report/news-article.aspx?ID=19401940

    WEIGHT LOSS: PLANT-BASED DRUG 'SWITCHES OFF' HUNGER

    Sep 04, 2018

    Designing a pill that is able to dampen hunger without causing significant side effects is the holy grail of obesity research. According to a new study, we might be one step closer. Obesity affects more than 1 in 3 people in the United States that's more than 93 million people. Worryingly, that ...


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    https://Pharmaceutical.report/news-article.aspx?ID=19341934

    REGULATOR PROTEIN KEY TO MALARIA PARASITE'S LIFECYCLE

    Sep 04, 2018

    Malaria remains a significant threat to human health with approximately 216 million cases annually and over 400,000 deaths worldwide. It is caused by the Plasmodium parasite, which has a complex lifecycle involving transmission to humans via the Anopheles mosquito. 

    New experimental re...

    UNIVERSITY OF GLASGOW
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    https://Pharmaceutical.report/news-article.aspx?ID=19351935

    MORE US ADOLESCENTS UP TO DATE ON HPV VACCINATION

    Sep 03, 2018

    The number of adolescents who are up to date on HPV vaccination – meaning they started and completed the HPV vaccine series – increased five percentage points from 2016 to 2017, according to results from a national survey published in CDC’s Morbidity and Mortality Weekly Report (MM...


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    https://Pharmaceutical.report/news-article.aspx?ID=19291929

    CHAOS-INDUCING GENETIC APPROACH STYMIES ANTIBIOTIC-RESISTANT SUPERBUGS

    Sep 03, 2018

    A genetic disruption strategy developed by University of Colorado Boulder researchers effectively stymies the evolution of antibiotic-resistant bacteria such as E. coli, giving scientists a crucial leg up in the ongoing battle against deadly superbugs. These multidrug-resistant pathogens—which...


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    https://Pharmaceutical.report/news-article.aspx?ID=19301930

    DECTIN-1 PATHWAY MAY BE CRUCIAL FOR TREATING FUNGAL INFLAMMATION AND PAIN

    Aug 31, 2018

    Researchers from Osaka University identified how the Dectin-1 to TRP channel pathway is a signaling mechanism in the onset of pain, and how inhibition of the VNUT ATP transporter blocks candidiasis-mediated pain. Candidiasis, Candida albicans infection, can cause skin, genital or oral pain. Many stu...


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    https://Pharmaceutical.report/news-article.aspx?ID=19241924

    ASTRAZENECA IMPROVES DIABETES PEN TO MAINTAIN ITS MARKET SHARE

    Aug 31, 2018

    The European Commission (EC) has approved AstraZeneca’s Bydureon BCise, a new weekly formulation of established GLP-1 diabetes drug with the added benefit of glucose reduction, better weight loss results and a new injection pen. AstraZeneca announced that the EC green-lighted the new formulati...


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    https://Pharmaceutical.report/news-article.aspx?ID=19251925

    PFIZER DRUG REDUCES MORTALITY IN PATIENTS WITH FATAL HEART DISEASE

    Aug 30, 2018

    Transthyretin amyloid cardiomyopathy (ATTR-CM) is a rare, fatal under-diagnosed disease that usually affects men aged 60-plus, whereby amyloid fibrils made from misfolded transthyretin protein accumulate in the heart. In most patients, death is caused by sudden heart failure or heart-related issues....

    PERRY ELLIOTT
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    https://Pharmaceutical.report/news-article.aspx?ID=19191919

    FDA WARNS OF COMMON DIABETES MEDS' LINK TO DANGEROUS GENITAL INFECTION

    Aug 30, 2018

    (HealthDay) Rare but serious genital infections, as well as one death, have been reported in some patients taking a certain class of type 2 diabetes medicine, the U.S. Food and Drug Administration says. As a result, the FDA has ordered a new warning about this risk to be added to the prescribing inf...


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    https://Pharmaceutical.report/news-article.aspx?ID=19201920

    DIGITAL HEALTH TECHNOLOGY HAS POTENTIAL TO TRANSFORM CANCER CARE

    Aug 29, 2018

    Digital and connected health technology has real potential to transform cancer care, writes Piotr Wnuk. Start-ups are utilizing well-established devices from technology firms like Microsoft and Apple to implement their specialized software, targeting particular conditions. Recent developments and in...


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    https://Pharmaceutical.report/news-article.aspx?ID=19141914

    HOW UNSECURED, OBSOLETE MEDICAL RECORD SYSTEMS AND MEDICAL DEVICES PUT PATIENT LIVES AT RISK

    Aug 29, 2018

    A team of physicians and computer scientists at the University of California has shown that it is easy to modify medical test results remotely by attacking the connection between hospital laboratory devices and medical record systems. These types of attacks might be more likely used against high-pro...


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    https://Pharmaceutical.report/news-article.aspx?ID=19151915

    LIVIO AI HEARING AIDS WITH PHYSICAL AND COGNITIVE HEALTH MONITORING

    Aug 28, 2018

    Starkey, one of the big hearing aid firms, is releasing a new device that works as a combination hearing aid, fitness monitor, and, surprisingly, as a tracker of cognitive health. In addition to all this, the new Livio AI hearing aids feature integrated language translation, connectivity to Amazon A...

    STARKEY
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    https://Pharmaceutical.report/news-article.aspx?ID=19091909

    SECOND TIME LUCKY? ALZHEON TRIES FOR MUCH-REDUCED IPO

    Aug 28, 2018

    After an aborted attempt earlier this year, Alzheon is having another go at an IPO to help fund new trials of its Alzheimer’s candidate tramiprosate. However, the biotech has dialed down its target for the fundraising, and bookrunners on the IPO have also changed from Piper Jaffray and Citi to...

    PHIL TAYLOR
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    https://Pharmaceutical.report/news-article.aspx?ID=19101910

    FIRMS URGED TO STOCKPILE DRUGS TO PREVENT BREXIT SHORTAGES

    Aug 27, 2018

    The UK government has outlined how it will ensure the supply of medicines continues in the event of a “no deal” Brexit, urging companies to stockpile six weeks’ worth of medicine. With the March 2019 Brexit deadline looming ever closer, there are mounting concerns that the UK will ...


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    https://Pharmaceutical.report/news-article.aspx?ID=19041904

    EBOLA SPECIES FOUND IN BATS AHEAD OF ANY POTENTIAL OUTBREAK

    Aug 27, 2018

    For the first time, scientists discovered a new ebolavirus species in a host prior to detection in an infected human or sick animal. The discovery of the Bombali virus in bats in Sierra Leone and the sequencing of the complete genome was officially published today in the journal Nature Microbiology....


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    https://Pharmaceutical.report/news-article.aspx?ID=19051905

    FOR FIRST TIME IN 40 YEARS, CURE FOR ACUTE LEUKEMIA WITHIN REACH

    Aug 24, 2018

    Acute myeloid leukemia is one of the most aggressive cancers. While other cancers have benefitted from new treatments, there has been no encouraging news for most leukemia patients for the past 40 years. Until now. As published today in the scientific journal Cell, Professor Yinon Ben-Neriah and his...


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    https://Pharmaceutical.report/news-article.aspx?ID=19001900

    TRACKING THE EVOLUTION AND TRANSMISSION OF YELLOW FEVER

    Aug 23, 2018

    A pioneering Oxford University research collaboration into yellow fever virus (YFV) has shed new light on the exceptional recent outbreak in Brazil and how the virus spreads. The findings have implications for monitoring viral transmission and could potentially contribute to a strategy for eliminati...


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    https://Pharmaceutical.report/news-article.aspx?ID=18941894

    KEEPING CANCER OUT OF BREATH BLOCKS DRUG RESISTANCE

    Aug 23, 2018

    A new combination of existing drugs shows promise that it could reduce the size of cancerous tumors much more effectively than current treatments. As cancer patients know all too well, many highly effective anti-cancer drugs don't stay effective long. Most tumors will become drug resistant over ...


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    https://Pharmaceutical.report/news-article.aspx?ID=18951895

    CELLULAR CHANGES LEAD TO CHRONIC ALLERGIC INFLAMMATION IN THE SINUS

    Aug 22, 2018

    Chronic rhinosinusitis is distinct from your average case of seasonal allergies. It causes the sinuses to become inflamed and swollen for months to years at a time, leading to difficulty breathing and other symptoms that make patients feel miserable. In some people, this condition also produces tiss...

    MASSACHUSETTS INSTITUTE OF TECHNOLOGY
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    https://Pharmaceutical.report/news-article.aspx?ID=18891889

    NEW IMPLANT FOR GERD AVOIDS SWALLOWING COMPLICATIONS

    Aug 22, 2018

    A new implantable device has been approved for use in Europe to help treat acid reflux disease. The IM RefluxStop device from Implantica, a company based in Zug, Switzerland, is designed to avoid some of the limitations of current minimally invasive reconstructive acid reflux procedures, such as dif...

    REFLUXSTOP
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    https://Pharmaceutical.report/news-article.aspx?ID=18901890

    DEHYDRATION ALTERS HUMAN BRAIN SHAPE AND ACTIVITY, SLACKENS TASK PERFORMANCE

    Aug 21, 2018

    When dehydration strikes, part of the brain can swell, neural signaling can intensify, and do monotonous tasks can get harder. With the help of brain scans and a simple, repetitive task to test responsiveness, exercise physiologists at the Georgia Institute of Technology studied volunteer subjects w...

    GEORGIA INSTITUTE OF TECHNOLOGY
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    https://Pharmaceutical.report/news-article.aspx?ID=18841884

    NO CANCER RISK FOR TELOMERASE GENE THERAPY

    Aug 21, 2018

    Representative images of lungs treated with gene therapy vectors. The nuclei are in blue, alveolar type II cells in green and telomeres in red. Notice that lung cells treated with active telomerase present more intense telomeres indicating that they are longer as compared to lung cells treated with ...


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    https://Pharmaceutical.report/news-article.aspx?ID=18851885

    NEW DEVICE FOR STUDYING BACTERIAL BIOFILM FORMATION

    Aug 20, 2018

    Biofilms are large groups of bacterial cells that stick together and protect each other like a Roman legion. Drugs and other therapies can poke at the exterior of a biofilm, but killing the mass can be extremely challenging. Researchers at the Okinawa Institute of Science and Technology in Japan dec...


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    https://Pharmaceutical.report/news-article.aspx?ID=18791879

    BRAINSWAY TRANSCRANIAL STIMULATION CLEARED IN U.S. FOR OBSESSIVE COMPULSIVE DISORDER

    Aug 20, 2018

    Brainsway, Israel’s leading magnetic stimulation company, won FDA de novo clearance for its system to be used to treat obsessive compulsive disorder (OCD) in the United States. The company’s Deep Transcranial Magnetic Stimulation system is used to deliver magnetic field pulses to the fro...

    FDA
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    https://Pharmaceutical.report/news-article.aspx?ID=18801880

    REGENERON/TEVA PAIN DRUG FASINUMAB ON TARGET IN PHASE 3

    Aug 17, 2018

    Regeneron and Teva have announced positive top-line phase 3 results from their fasinumab, as the companies chase Pfizer and Lilly in the race to market a new class of non-opioid painkillers. Fasinumab is from a class of drugs targeting nerve growth factor (NGF), which plays a central role in the reg...


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    https://Pharmaceutical.report/news-article.aspx?ID=18751875

    HACKERS COULD TAKE CONTROL OF MEDICAL DEVICES, MCAFEE WARNS

    Aug 16, 2018

    Research published by the cybersecurity company, McAfee, shows it is possible to modify real-time patient heart monitor data by hacking into a hospital network and gaining control of medical devices. The report published by McAfee proves that hackers could easily alter patients’ vital signs by...


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    https://Pharmaceutical.report/news-article.aspx?ID=18741874

    ACTISOUND INTENSE THERAPEUTIC ULTRASOUND DEVICE CLEARED IN EUROPE

    Aug 14, 2018

    Guided Therapy Systems, based in Mesa, Arizona, landed EU CE mark approval (via Ardent Sound Inc., Guided’s partner, and manufacturer) for the Actisound Intense Therapeutic Ultrasound device. It’s intended to help recover from a variety of injuries and chronic pain resulting from interna...


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    https://Pharmaceutical.report/news-article.aspx?ID=18691869

    GN HEARING UNVEILS RESOUND LINX QUATTRO ADVANCED HEARING AID

    Aug 14, 2018

    GN Hearing, a company that makes audio technology that appears under names such as Beltone, Interton, and Jabra, just announced new hearing aid called ReSound LiNX Quattro. The firm describes it as “the world’s first Premium-Plus hearing aid,” delivering what it believes is the bes...

    GN HEARING
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    https://Pharmaceutical.report/news-article.aspx?ID=18701870

    STUDY REVEALS BROAD 'GENETIC ARCHITECTURES' OF TRAITS AND DISEASES

    Aug 13, 2018

    Scientists at Johns Hopkins Bloomberg School of Public Health have developed a powerful method for characterizing the broad patterns of genetic contributions to traits and diseases. The new method provides a "big picture" of genetic influences that should be particularly helpful in designi...

    UNIVERSITY BLOOMBERG
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    https://Pharmaceutical.report/news-article.aspx?ID=18611861

    HAILIE INHALER MONITORING SYSTEM NOW AVAILABLE DIRECT TO CONSUMERS

    Aug 13, 2018

    Adherium, a Silicon Valley firm, is releasing its Hailie system for inhaler monitoring in the United States. The company received FDA clearance to sell the product over the counter, allowing patients to work toward improved compliance with regards to their medications. The system includes a sensor t...

    ADHERIUM
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    https://Pharmaceutical.report/news-article.aspx?ID=18651865

    FIRST PATIENT RECEIVES MEDTRONIC’S EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    Aug 10, 2018

    A pilot study is getting underway to evaluate a new Medtronic implantable cardioverter defibrillator that doesn’t require leads to be placed inside the heart or veins. The Extravascular Implantable Cardioverter Defibrillator (EV ICD) system can deliver defibrillation shocks as well as pacing s...

    MEDTRONIC
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    https://Pharmaceutical.report/news-article.aspx?ID=18601860

    NEW DEVICE FOR TESTING IMMUNOTHERAPIES ON TUMOR FRAGMENTS

    Aug 09, 2018

    Immuno-oncology, a rapidly developing field that harnesses the body’s immune system to attack cancers, lacks effective methods of testing potential therapies. In addition to animal studies, tiny bits of tumors are placed, along with chemical compounds being tested, within multiwell plates and ...


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    https://Pharmaceutical.report/news-article.aspx?ID=18591859

    MOLECULAR SENSOR TO DETECT IF CANCER DRUG IS WORKING

    Aug 08, 2018

    Being able to monitor the chemical content of cancer cells may help scientists develop new anti-cancer medications. Additionally, it may also lead to personalized drug therapies for cancer patients that all too often end up trying multiple medications before finding one that works. Chemists at MIT h...

    MIT
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    https://Pharmaceutical.report/news-article.aspx?ID=18541854

    WRISTBAND PERFORMS BLOOD CELL COUNTS TO MONITOR HEALTH ANYWHERE

    Aug 08, 2018

    The popularity of smartwatches, activity trackers, and other wearable devices is in large part due to the hope that such tools can help monitor health. While new products keep coming out, progress on embedding sensors that can monitor things other than one’s heart rate and activity level has s...

    RUTGERS
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    https://Pharmaceutical.report/news-article.aspx?ID=18551855

    NOVEL PET IMAGING COULD GUIDE THERAPY FOR TYPE 1 DIABETES

    Aug 07, 2018

    Researchers have discovered a new positron imaging tomography (PET) imaging method to improve the care of patients with type 1 diabetes. The new PET method could measure beta-cell mass which would enhance the ability to monitor a diabetes patient and guide their therapy. Dr. Jason Bini, Yale Un...


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=18501850

    GENETIC DIVERSITY IMPACTS DISEASE SEVERITY

    Aug 07, 2018

    New research offers clues as to why some diseases are highly variable between individuals. The phenomenon is apparent in people with retinitis pigmentosa, a condition that causes the light-sensing cells in the eye to degenerate. While some only develop night blindness, others completely lose their s...

    UNIVERSITY OF UTAH
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    https://Pharmaceutical.report/news-article.aspx?ID=18511851

    FLOW DIVERTER WITH HEMODYNAMIC SENSOR TO MONITOR ANEURYSM TREATMENT

    Aug 06, 2018

    Flow diverters are implants that are commonly used to prevent blood from flowing into aneurysms. They look very similar to stents and are often combined into one device, but instead of providing structural strength, they provide a way for blood to pass from one part of a vessel to another without fl...


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=18411841

    REGENERON FORGES CAR-T R&D PARTNERSHIP WITH BLUEBIRD BIO

    Aug 06, 2018

    Regeneron is pushing forward with its investment in cancer immunotherapy, striking a deal with bluebird bio to develop cell therapies. Through its partnership with Sanofi, Regeneron is poised to bring the sixth checkpoint inhibitor therapy to the market with its cemiplimab, which the FDA is set to m...


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=18421842

    REGENERA PHARMA STARTS PHASE III STUDY, LOOKS TO TAP US VENTURE CAPITAL

    Aug 03, 2018

    An Israeli drugmaker has come out of stealth and enrolled the first patient in its Phase III study that aims to treat an eye disorder using a drug derived from a type of tree resin. Regenera Pharma announced Thursday the enrollment of the first patient in the 234-patient study of RPh201 in nonarteri...

    ALARIC DEARMENT
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    https://Pharmaceutical.report/news-article.aspx?ID=18361836

    HOW HOSPITALS ARE INTEGRATING AUGMENTED REALITY AND OTHER TECH TO IMPROVE THE PATIENT EXPERIENCE

    Aug 03, 2018

    New, emerging technologies are turning patients into savvy healthcare consumers with higher expectations around the services they receive. From wearables to telemedicine, virtual and augmented reality, 3D imaging, and artificial intelligence, patients are increasingly drawn to cutting-edge experienc...


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    https://Pharmaceutical.report/news-article.aspx?ID=18371837

    NEW TUBERCULOSIS DRUG COULD HELP ERADICATE GLOBAL KILLER

    Aug 02, 2018

    A groundbreaking drug, rifampin, could help to end the global tuberculosis epidemic, according to researchers. Clinical trials carried out at the McGill University Health Centre showed that rifampin is less toxic and is more effective than the standard of care treatment, isoniazid. The results of tw...


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=18311831

    FDA GRANTS LEUKAEMIA DRUG ‘BREAKTHROUGH’ STATUS

    Aug 02, 2018

    A leukemia drug has been granted ‘breakthrough therapy’ status by the US drug regulator. Daiichi Sankyo announced that it had been awarded the designation by the US Food and Drug Administration (FDA) for quizartinib, which is used to treat acute myeloid leukemia (AML). This means the pro...


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    https://Pharmaceutical.report/news-article.aspx?ID=18321832

    JOHNSON & JOHNSON LEADS THE WAY TO A WORLD WITHOUT DISEASE

    Aug 01, 2018

    Cat Oyler, Global Head of External Innovation Strategy and Operations at Johnson & Johnson (J&J), has an ambitious and compelling vision for the future of healthcare: a world without disease. She spoke to pharmaphorum as part of the latest in the eye-on-innovation series of articles. As one ...


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    https://Pharmaceutical.report/news-article.aspx?ID=18261826

    FDA APPROVES FIRST DRUG TO TREAT RARE ADRENAL CANCER

    Aug 01, 2018

    Azedra has received FDA approval to become the first and only treatment for a type of rare adrenal cancer. Progenics Pharmaceuticals shares soared after its drug Azedra, a new version of the radiopharmaceutical injectable drug iobenguane I-131, was given the green light by the US Food and Drug Admin...


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    https://Pharmaceutical.report/news-article.aspx?ID=18271827

    A MINIATURIZED SEMICONDUCTOR BIOCHIP TO IDENTIFY DRUG-RESISTANT PATHOGENS

    Jul 31, 2018

    Evolving strains of multi-drug resistant pathogens are a growing global concern, outpacing drug discovery efforts and undermining the efficacy of existing antibiotics. The development of comprehensive diagnostics for clinical applications will become crucial to control escalating health risks. Exist...


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    https://Pharmaceutical.report/news-article.aspx?ID=18211821

    PARKINSON'S DISEASE: BREATH TEST FOR EARLY DIAGNOSIS STEPS CLOSER

    Jul 31, 2018

    Scientists in Israel have developed a breath test that can detect people with early-stage Parkinson's disease. Neurons in Parkinson's disease The team from Technion Israel Institute of Technology had previously shown that the test can detect people with Parkinson's disease who are alread...


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    https://Pharmaceutical.report/news-article.aspx?ID=18221822

    NANO-OPTIC ENDOSCOPE SEES DEEP INTO TISSUE AT HIGH RESOLUTION

    Jul 30, 2018

    The diagnosis of diseases based on internal organs often relies on biopsy samples collected from affected regions. But collecting such samples is highly error-prone due to the inability of current endoscopic imaging techniques to accurately visualize sites of disease. The conventional optical elemen...

    HARVARD JOHN A. PAULSON SCHOOL OF ENGINEERING AND APPLIED SCIENCES
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    https://Pharmaceutical.report/news-article.aspx?ID=18161816

    HOW CELLS ACTIVELY STOP BREAST CANCER FROM BECOMING INVASIVE

    Jul 30, 2018

    A new study shows that the cells surrounding the breast's milk ducts form an active barrier that extends and grabs cancer cells before they spread to the rest of the body. The American Cancer Society estimates that in 2017, there were over 310,000 new cases of breast cancer among American women....


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    https://Pharmaceutical.report/news-article.aspx?ID=18171817

    BLOCKING ONE ENZYME COULD HELP TREAT MANY CHRONIC DISORDERS

    Jul 27, 2018

    Researchers have identified an enzyme that plays a key role in a biological mechanism common to many chronic inflammatory disorders. The discovery — which has been reported in a paper now published in the journal Nature — could lead to new drugs for treating diverse inflammation-related ...

    CATHARINE PADDOCK PHD
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    https://Pharmaceutical.report/news-article.aspx?ID=18101810

    MERCK & CO’S KEYTRUDA SHOWS POTENTIAL IN HEAD AND NECK CANCER USE

    Jul 27, 2018

    Merck & Co might be able to find another use for its immunotherapy Keytruda in first-line head and neck cancer, after revealing promising phase 3 trial results. US-based Merck said the pivotal phase 3 trial investigating Keytruda monotherapy as a first-line treatment in recurrent or metastatic h...


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    https://Pharmaceutical.report/news-article.aspx?ID=18111811

    HOW DO JUMPING GENES CAUSE DISEASE, DRIVE EVOLUTION?

    Jul 26, 2018

    Almost half of our DNA sequences are made up of jumping genes also known as transposons. They jump around the genome in developing sperm and egg cells and are important to evolution. But their mobilization can also cause new mutations that lead to diseases, such as hemophilia and cancer. Remarkably ...

    CARNEGIE INSTITUTION FOR SCIENCE
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    https://Pharmaceutical.report/news-article.aspx?ID=18061806

    MADE AT THE UNIVERSITY OF IOWA TURNS CLINICIANS’ IDEAS INTO MEDICAL PRODUCTS

    Jul 26, 2018

    New medical devices and technologies are being unveiled on a daily basis, as readers of Medgadget know well. Medical professionals are provided so much newly discovered knowledge that they end up creating new devices to take advantage of that knowledge. The medical device industry has a problem keep...

    JORDAN KAUFMANN
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    https://Pharmaceutical.report/news-article.aspx?ID=18071807

    ACCU-CHEK SOLO TUBE-FREE INSULIN MICROPUMP CLEARED IN EUROPE

    Jul 25, 2018

    Roche will soon release in Europe its tube-free Accu-Chek Solo insulin micropump following the CE marking of the device. The micropump comes with a smartphone-like wireless remote control that features glucose monitoring and provides advice on how much insulin to administer. Moreover, the remote con...

    ROCHE
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    https://Pharmaceutical.report/news-article.aspx?ID=17991799

    THE DARK SIDE OF ANTIBIOTIC CIPROFLOXACIN

    Jul 25, 2018

    `The use of ciprofloxacin and other antibiotics of the class of fluoroquinolones may be associated with disruption of the normal functions of connective tissue, including tendon rupture, tendonitis, and retinal detachment. These observations reported in a number of journals resulted in the drugs cur...

    BAYLOR COLLEGE OF MEDICINE
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    https://Pharmaceutical.report/news-article.aspx?ID=18021802

    POSSIBLE BREAKTHROUGH IN UNDERSTANDING HOW ANTIBIOTICS TREAT BACTERIA

    Jul 24, 2018

    Scientists from Newcastle University and the UK's ISIS Neutron and Muon research facility have worked together on a new project that is increasing our understanding of how antibiotics treat bacteria. With the number of antibiotic-resistant bacteria increasing in recent years, the ability to deve...


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    https://Pharmaceutical.report/news-article.aspx?ID=17961796

    ANTIBIOTIC RESISTANCE IN A LEECH'S GUT: EVEN TRACE AMOUNTS OF ANTIBIOTICS BOOST RESISTANT BACTERIA

    Jul 24, 2018

    Plastic surgery patients were getting infections with antibiotic-resistant bacteria, and no one knew why. UConn microbiologists found the answer in a leech's gut. Their research, published today in mBio, provides proof that tiny levels of antibiotics found in the environment can encourage bacter...

    UNIVERSITY OF CONNECTICUT
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    https://Pharmaceutical.report/news-article.aspx?ID=17971797

    LOW-DOSE ASPIRIN IMPROVES MEMORY IN MICE WITH ALZHEIMER’S SYMPTOMS

    Jul 23, 2018

    Aspirin is one of the most widely used drugs. Besides providing pain relief, it has been shown to reduce the risk of colon cancer and heart attacks. Some suggest that aspirin might also protect against Alzheimer’s disease because the disease is less common in aspirin users than nonusers. But w...


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    https://Pharmaceutical.report/news-article.aspx?ID=17911791

    FDA OPENS DOOR TO IMPORTING DRUGS

    Jul 23, 2018

    Rising pressure to do more to control drug prices is prompting Trump administration officials to explore where more flexible import policies may help ensure access to safe, effective, and more affordable medicines. For years, consumer advocates and state officials have pushed for access to less expe...


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    https://Pharmaceutical.report/news-article.aspx?ID=17921792

    LINK BETWEEN DIABETES AND CANCER RISK FIRMLY ESTABLISHED

    Jul 20, 2018

    That diabetes and cancer are linked in some way is by no means a new idea, but it had never previously been confirmed. Now, a major new study draws a firm conclusion: diabetes raises a person's risk of developing cancer. The person taking blood sugar test New research warns that the risk of canc...


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    https://Pharmaceutical.report/news-article.aspx?ID=17871787

    NOVARTIS PAYS UP TO $1 BILLION FOR POTENTIAL ECZEMA DRUG

    Jul 19, 2018

    Swiss pharma Novartis is to pay up to $1 billion to Galapagos and MorphoSys for exclusive rights to a skin drug, which will further strengthen Novartis’s leadership position in the immunology field. Belgo-Dutch biotech Galapagos and Germany’s MorphoSys have signed a global license agreem...

    PIOTR WNUK
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    https://Pharmaceutical.report/news-article.aspx?ID=17831783

    AZ SUFFERS SETBACK AS NICE SLAPS RESTRICTIONS ON FASENRA

    Jul 19, 2018

    NICE has recommended in a draft decision that AstraZeneca’s latest lung drug Fasenra can be funded by the NHS in severe asthma – but only in patients that are ineligible for GlaxoSmithKline’s rival. AstraZeneca’s Fasenra (benralizumab) is one of a group of new drugs it hopes ...


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    https://Pharmaceutical.report/news-article.aspx?ID=17841784

    RISK OF HEART ATTACK RISING FOR PREGNANT WOMEN

    Jul 18, 2018

    Heart disease is the leading cause of death among women in the United States who are pregnant or have given birth. Heart disease can lead to heart failure, heart attack, stroke, and sudden cardiac arrest. A recent study from the NYU School of Medicine shows that heart attack rates are on the rise in...

    LABROOTS INC.
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    https://Pharmaceutical.report/news-article.aspx?ID=17781778

    IMMUNOTHERAPY INCREASES SURVIVAL OF MELANOMA BRAIN METASTASES PATIENTS

    Jul 18, 2018

    Melanoma, a form of skin cancer, accounts for about 1% of all skin cancer cases and a vast majority of skin cancer deaths. In Stage IV melanoma more than 60% of patients will develop brain metastases, which is difficult to treat and carries an overall survival of about 4-5 months. A recent study out...

    LABROOTS
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    https://Pharmaceutical.report/news-article.aspx?ID=17791779

    CANCER: CAN TESTOSTERONE IMPROVE PATIENTS' QUALITY OF LIFE?

    Jul 17, 2018

    Studies have noted that "[a]pproximately half of all patients with cancer experience cachexia," severely impairing their quality of life. It appears to be "responsible for the death of 22 [percent] of cancer patients." What exactly causes this condition which appears in some pati...


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    https://Pharmaceutical.report/news-article.aspx?ID=17701770

    TACKLING CANCER AT GROUND ZERO WITH DESIGNER MOLECULES

    Jul 17, 2018

    A new molecule designed by University of Adelaide researchers shows great promise for future treatment of many cancers. The new molecule successfully targets a protein that plays a major role in the growth of most cancers. This protein target is called proliferating cell nuclear antigen (PCNA), othe...

    UNIVERSITY OF ADELAIDE
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    https://Pharmaceutical.report/news-article.aspx?ID=17711771

    TREATMENT PREVENTS SYMPTOMS OF SCHIZOPHENIA IN TESTS WITH RATS

    Jul 16, 2018

    Researchers at the Federal University of São Paulo (UNIFESP) in Brazil have tested a treatment with sodium nitroprusside in a strain of rats that spontaneously develop some of the symptoms associated with schizophrenia. The results obtained with a group of adolescent animals suggest that prev...

    FOUNDATION FOR RESEARCH SUPPORT OF THE STATE OF SAO PAULO
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    https://Pharmaceutical.report/news-article.aspx?ID=17651765

    FDA ANNOUNCES VOLUNTARY RECALL OF SEVERAL MEDICINES CONTAINING VALSARTAN

    Jul 16, 2018

    The U.S. Food and Drug Administration is alerting healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan used to treat high blood pressure and heart failure. This recall is due to an impurity, N-nitrosodimethylamine (NDMA), whi...

    U.S. FOOD AND DRUG ADMINISTRATION
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    https://Pharmaceutical.report/news-article.aspx?ID=17661766

    SCIENTISTS A STEP CLOSER TO PREDICTING EPIDEMICS

    Jul 13, 2018

    Ecologists at the University of Georgia have taken an important step in their efforts to develop an early warning system for infectious disease outbreaks. A team led by Eamon B. O'Dea created a mathematical model that analyzes statistical patterns in public health reports to identify when a popu...

    UNIVERSITY OF GEORGIA
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    https://Pharmaceutical.report/news-article.aspx?ID=17631763

    RESMED JOINS GOOGLE TO RESEARCH SLEEP APNOEA THERAPIES

    Jul 13, 2018

    Sleep apnoea firm ResMed has joined with Google’s life science division Verily to form a new joint venture studying the health and financial impact of the undiagnosed and untreated disease and find new ways to treat it. The joint venture will combine ResMed’s expertise in sleep apnoea an...


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    https://Pharmaceutical.report/news-article.aspx?ID=17641764

    PFIZER BACKED OFF, BUT THE PRICE HIKE GAME CONTINUES

    Jul 12, 2018

    Donald Trump may have convinced the US pharma giant Pfizer to defer a price increase for dozens of drugs, but there are others that have escaped such intense scrutiny according to a report. According to the story published today by Bloomberg at least ten other leading pharmaceutical companies increa...


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    https://Pharmaceutical.report/news-article.aspx?ID=17581758

    RESEARCHERS NARROW IN ON GENETIC FACTORS THAT CAUSE PRETERM BIRTH

    Jul 12, 2018

    Mutations in a gene involved in steroid signaling likely contribute to preterm birth, report Johanna Huusko of the University of Oulu and Cincinnati Children's Hospital Medical Center and colleagues, in a study of European women who had experienced at least one early delivery. The researchers re...

    PLOS GENETICS
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    https://Pharmaceutical.report/news-article.aspx?ID=17591759

    AZ HOPES DIABETES DRUG COULD BE AS EFFECTIVE AS GASTRIC BAND

    Jul 11, 2018

    AstraZeneca is preparing an assault on the growing market for GLP-1-class diabetes drugs with a dual action molecule that the firm hopes could be as effective as a gastric band – and may even have potential in the lucrative market to treat “fatty liver” disease nicknamed NASH. In a...


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    https://Pharmaceutical.report/news-article.aspx?ID=17501750

    JOHNSON & JOHNSON, LOOKING FOR ITS TREMFYA NICHE, STARTS UP NEW TRIAL PROGRAM IN CROHN'S

    Jul 11, 2018

    Johnson & Johnson immunology newcomer Tremfya is looking to follow in the footsteps of its big brother. MorphoSys, partnered with the New Jersey drugmaker’s Janssen unit, said Tuesday that the drug giant had started up a phase 2/3 clinical trial program in Crohn’s disease, reaching f...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17531753

    AXOVANT AND BENITEC ESTBALISH GENE THERAPY PARTNERSHIP

    Jul 10, 2018

    Pharmaceutical company Axovant Sciences has signed a gene therapy licensing and development deal with Australia-based Benitec Biopharma to expand its pipeline of products. Under the terms of the collaboration, Axovant will have exclusive global licensing rights to Benitec’s Silence-and-Replace...

    PHARMACEUTICAL TECHNOLOGY
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    https://Pharmaceutical.report/news-article.aspx?ID=17451745

    BLOOD PRESSURE DRUG VERAPAMIL MAY HELP TYPE 1 DIABETICS

    Jul 10, 2018

    A human clinical trial has found that a common blood pressure drug called verapamil can decrease insulin requirements and hypoglycaemic episodes in adults with recent-onset type 1 diabetes. The study, conducted by the University of Alabama at Birmingham Comprehensive Diabetes Center, revealed oral v...

    PHARMACEUTICAL TECHNOLOGY
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    https://Pharmaceutical.report/news-article.aspx?ID=17461746

    MORE RESEARCH WITH LAB-GROWN ORGANOIDS

    Jul 09, 2018

    When researching diseases that affect the brain, it's difficult to ethically use human patients. There are experiments that cannot be performed on living subjects. Brain banks are an option for tissue samples, but the need is greater than the supply. What researchers often need to do is cre...

    LABROOTS
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    https://Pharmaceutical.report/news-article.aspx?ID=17401740

    PHARMA TAKES LEADING ROLE IN NHS 70TH ANNIVERSARY CELEBRATIONS

    Jul 06, 2018

    The pharmaceutical industry celebrated the 70th anniversary of the NHS by recognizing the myriad contributions that the sector has made to the lives of many people. The Association of the British Pharmaceutical Industry (ABPI) ran a series of announcements headlining the life-changing effects o...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=17331733

    ORION HAS STARTED A PHASE III TRIAL TO DEVELOP A DRUG FOR ALS

    Jul 06, 2018

    Orion has recruited the first patients in the Phase III clinical trial (REFALS) in which orally administered levosimendan (ODM-109) is being evaluated for the treatment of symptoms of amyotrophic lateral sclerosis (ALS). The purpose of the trial is to demonstrate that orally administered levosimenda...

    PIPE LINE REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=17341734

    NICE REJECTS BMS IMMUNOTHERAPY IN ADVANCED BLADDER CANCER

    Jul 05, 2018

    Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) will not be available to advanced bladder cancer patients for at least three years in much of the UK after NICE published final guidance that rejected the drug for regular NHS funding in this use. Following its usual review process, NICE ...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=17291729

    PFIZER INCREASES PRICES IN THE US FOR THE SECOND TIME THIS YEAR

    Jul 04, 2018

    The largest standalone drug maker in the US, announced it increase the prices of around 100 drugs for the second time this year, despite president Donald Trump’s pledge to slash the cost of drugs and treatments. The Financial Times reported on Monday that Pfizer upped the prices of prescriptio...

    PHARMAPHORUM MEDIA LIMITED
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    https://Pharmaceutical.report/news-article.aspx?ID=17261726

    ABBVIE, PARTNER ORDERED TO PAY $448M IN ANDROGEL ANTITRUST CASE BROUGHT BY FTC

    Jul 02, 2018

    Even as AbbVie defends against thousands of AndroGel liability cases, the company and partner Besins Healthcare must pay nearly $450 million for illegally blocking generic competition to the testosterone product with "baseless" patent litigation, a judge said.U.S. District Judge Harvey Bar...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17231723

    JOHNSON & JOHNSON SHAKEUP LEAVES JOAQUIN DUATO WITH LARGEST PORTFOLIO

    Jun 25, 2018

    The executive pyramid at Johnson & Johnson is going through a significant revamp with head of pharmaceuticals Joaquin Duato taking on most of the responsibilities held by Group Worldwide Chairman Sandra Peterson as she prepares to retire. Duarto will become a vice chairman of the executive commi...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17171717

    IN RARE SLIP, PFIZER STEAMROLLER IBRANCE FAILS TO SHOW IT HELPS PATIENTS LIVE LONGER

    Jun 25, 2018

    More than two years ago, Pfizer’s Ibrance won an FDA nod to treat some breast cancer patients whose disease had progressed after endocrine therapy. But new study results suggest the drug may not actually help patients live longer.On Monday, Pfizer said Ibrance, in combination with fulvestrant,...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17191719

    FDA GREENLIGHTS GW'S EPIDIOLEX, THE FIRST U.S. DRUG MADE FROM MARIJUANA

    Jun 25, 2018

    The FDA just approved Epidiolex, the GW Pharma seizure drug derived from cannabis, giving children with two rare and serious forms of epilepsy a new treatment—and companies looking to develop marijuana-based drugs a model for their own path to market. The agency approved Epidiolex, or purified...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17211721

    OPIOID MAKER PURDUE DEEP-SIXES SALES TEAM AMID MASS LAYOFF AND MOUNTING LEGAL WOES

    Jun 20, 2018

    Even though opioid addiction emerged years ago as an epidemic, it wasn’t until February of this year that OxyContin maker Purdue Pharma finally stopped promoting the drug to physicians and laid off 200 salespeople. Now the company—which is facing a mountain of legal woes related to the o...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17151715

    UNIVERSAL FLU VACCINE BIOTECH SEEKS BIG PHARMA PARTNERSHIP FOR PHASE 3 TESTING: CEO

    Jun 19, 2018

    Problems with seasonal flu shots have been well documented, and now U.K. biotech Imutex believes it has the next big advance for flu vaccine technology. The company this week reported phase 2b data showing that its universal flu shot, FLU-v, boosted immune responses and lowered infection rates. Imut...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17091709

    VALEANT DEALT 'A MAJOR SETBACK' AS PSORIASIS DUAL-DRUG LOTION DUOBRII FAILS TO IMPRESS FDA

    Jun 18, 2018

    Besides getting a new name, troubled Valeant is also in desperate need of some regulatory success to rebuild its image. But it’s not going to get it from a key plaque psoriasis combo drug Doubrii—at least not soon. The FDA has just rejected Doubrii, one of the seven products that Valeant...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17111711

    CORPORATE RESPONSIBILITY INVESTOR GROUP TOUTS SUPPORT OF FIRST-YEAR RESOLUTIONS OVER EXECUTIVE PAY, DRUG PRICING

    Jun 18, 2018

    After pressing five pharma companies for answers about how executive pay plays into drug pricing decisions, the Interfaith Center on Corporate Responsibility has generated some interest in the issue among the investor community. A group of investors at AbbVie, Amgen, Biogen, Bristol-Myers Squibb and...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17071707

    NICE DOGS ROCHE'S PERJETA AGAIN, THIS TIME IN POSTSURGERY BREAST CANCER PATIENTS

    Jun 15, 2018

    Earlier this month, European regulators approved Roche’s Perjeta for some postsurgery patients with early breast cancer. But England’s cost watchdogs are blocking its path.Friday, the National Institute for Health and Care Excellence released draft guidance recommending against NHS use o...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17131713

    CAN SANOFI COMPETE IN LUNG CANCER? WITH I-O MED CEMIPLUMAB, IT’S AIMING FOR THIRD

    Jun 14, 2018

    Same or different that’s a big question rattling around the immuno-oncology field, where PD-1 and PD-L1 checkpoint inhibitors have put up differing results in clinical trials.The assessment from Sanofi? The PD-1 drugs themselves are essentially equal. It’s the trial designs that make the...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17051705

    TRUST PHARMA? NOT SO MUCH, ANNUAL SURVEY SHOWS, WITH BIGGEST LOSS EVER

    Jun 13, 2018

    Trust has hit a new low for pharma in Edelman’s annual Trust Barometer survey. The 13-point drop from 51% to 38% in the U.S. was the category’s biggest plummet in the five years the public relations and marketing firm has been tracking sentiment.Plus, it’s a turnaround in the wrong...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17031703

    SPROUT'S OLD CEO IS BACK, AND SHE'S GOT SOME NEW MARKETING IDEAS FOR FEMALE LIBIDO DRUG ADDYI

    Jun 12, 2018

    Now that former shareholders of Sprout Pharmaceuticals, maker of controversial female libido pill Addyi, have the company back in their hands, they’ve reinstalled a familiar face at the helm. Cindy Eckert, who went by Cindy Whitehead during her last stint as CEO, is once again in the company&r...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=17011701

    DOCTORS ARE COMING AROUND TO TEVA'S AUSTEDO AS TD DRUGS GET MORE PLAY: ANALYST

    Jun 11, 2018

    In the brand-new tardive dyskinesia market, doctors initially preferred Neurocrine’s Ingrezza over Teva’s Austedo. But that edge is weakening, one analyst says. These days, doctors are viewing the two drugs as “more similar than different,” Leerink Partners analyst Ami Fadia ...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16981698

    CITING 'SUBSTANTIAL BENEFIT' FOR PATIENTS, SANOFI HIKED FLUBLOK PRICE 12.5% LAST SEASON

    Jun 06, 2018

    Amid an industrywide look into pharma's pricing, Sanofi has pledged to limit its drug price hikes to the rate of medical inflation. The company recently tweaked its policy to provide rationale for any hikes above that level, and in the first year of the policy, detailed a 12.5% increase for a fl...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16921692

    ROCHE'S MULTIPLE SCLEROSIS DRUG OCREVUS LOWERED PATIENTS' VACCINE RESPONSES: STUDY

    Jun 06, 2018

    Roche’s multiple sclerosis newcomer Ocrevus was approved by the FDA last March bearing a warning about immunization. Now, researchers have gathered clinical data showing it could weaken the effectiveness of certain vaccines. In a Roche-sponsored phase 3b study, scientists examined over 100 MS ...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16941694

    ASTRAZENECA PRESSURES FELLOW PHARMAS WITH VOW TO REVEAL DOCTOR PAYMENTS WORLDWIDE

    Jun 04, 2018

    Pharmas’ payments to doctors raise concerns about prescription bias and have triggered bribery investigations, too. So, to win patients' trust, transparency matters. And now, AstraZeneca is going beyond its Big Pharma fellows to disclose all its doc payments, even in regions where it's...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16961696

    MEDICARE WANTS INSURERS TO MONITOR SUSPICIOUS PRESCRIBING OF LAUGHING DRUG NUEDEXTA

    Jun 04, 2018

    For years, the Centers for Medicare & Medicaid Services has been hearing concerns that laughing drug Nuedexta was being aggressively pushed by maker Avenair Pharmaceuticals and some doctors for questionable use on dementia patients. Now, the CMS is asking insurers to be on alert for that kind of...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16901690

    AMGEN IS THE LATEST DRUGMAKER TO HAVE A HERCEPTIN BIOSIM SIDELINED BY A CRL

    Jun 01, 2018

    Amgen, in a two-sentence announcement today, said it received a complete response letter for the biosimilar of Roche’s cancer med Herceptin it developed with Allergan. It marks the third Herceptin biosimilar that has been stalled by the FDA but has won approval in Europe. The Thousand Oaks, Ca...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16881688

    GILEAD WINS CHINESE APPROVAL FOR EPCLUSA, BUT THE EMERGING MARKET IS GETTING CROWDED

    May 31, 2018

    Epclusa was just greenlighted by China’s Drug Administration (CDA). For hepatitis C patients in China, that means the first pangenotypic treatment will soon be available to them. But for Gilead, it might be too little, too late.The Chinese authority based its decision on five international pha...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16861686

    JOHNSON & JOHNSON HAS THE MOST BUCKS FOR BIOPHARMA M&A, ASTELLAS THE EASIEST TARGET: ANALYST

    May 29, 2018

    The $62 billion Takeda-Shire deal surprised everyone—and worries some—as Takeda is borrowing an enormous $31 billion to help pay for the purchase. Does it refresh the industry’s understanding of M&A affordability and open up more possibilities for future deals? Leerink’s ...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16751675

    FDA HITS CHINESE API MAKER JILIN SHULAN SYNTHETIC PHARMA WITH WARNING LETTER

    May 29, 2018

    Chinese API maker Jilin Shulan Synthetic Pharma was hit with a warning letter by the FDA, which cited numerous quality control and data integrity issues.The letter, which was posted on the regulatory agency’s website, came in reaction to the company’s response to an FDA inspection conduc...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16781678

    NOVARTIS' UNDER-PRESSURE SANDOZ UNIT OFFLOADS QUEBEC PLANT TO FAST-GROWING AVARA

    May 25, 2018

    Novartis has been looking to jettison some assets in its North American generics business, but as it turns out, it is a manufacturing facility in Canada that will be sold off first. Avara Pharmaceutical Services has inked a deal to buy Novartis Technical Operations’ sterile manufacturing facil...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16841684

    HELLO, $200B: SUPER-PRICEY NEW CANCER DRUGS DRIVE MEGA INCREASES IN TREATMENT SPENDING

    May 24, 2018

    It wasn't all that long ago that a six-figure price on a debut cancer drug was big news. Now, it would be more surprising if an oncology launch didn't carry a price tag of $100,000 or more—and the high cost of those new rollouts is helping drive cancer treatment costs toward $100 billi...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16721672

    LILLY'S CANCER BUSINESS LOSES ITS CHIEF JUST AS IT'S LEANING ON ONCOLOGY FOR GROWTH

    May 24, 2018

    Eli Lilly is leaning on oncology as a key pillar for growth going forward, but with news that its president of the business, Sue Mahony, is retiring, the drugmaker will need to find new leadership for the unit. During her 18 years at Lilly, Mahony has ascended the ranks—earning a spot on the e...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16731673

    ASTELLAS CUTS 600 POSITIONS IN JAPAN AS NEW CEO MAKES HIS MARK

    May 23, 2018

    Joining a host of other drug companies announcing slim-down efforts in recent months, Astellas is shedding 600 positions in Japan in R&D and sales and marketing. The company announced an early retirement program for eligible employees, hoping to enroll 600 staffers for an early exit.As part of t...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16701670

    NOTE TO PHARMA AI COMPANIES COULD USE YOUR HELP DETAILING DOCTORS

    May 16, 2018

    Artificial intelligence companies are coming up with all kinds of ways to help pharma improve clinical trials, zero in on which patients will benefit most from their drugs and go well beyond the pill. So how can pharma return the favor? By convincing reluctant doctors to jump on board, for starters....

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16681668

    AZAR THREATENS DRUGMAKERS WITH TRUMP'S TEMPER IF THEY HIKE PRICES FOR NO REASON

    May 15, 2018

    HHS Secretary Alex Azar hinted Monday that drugmakers intent on raising prices could not only see some public shame, but a crackdown from Medicare Part D plans pushing discounts.Drug companies looking for intel about how the Trump administration plans to deploy its "friendly to pharma" pri...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16651665

    FROM OLD BEHEMOTH LIPITOR TO NEW KING HUMIRA: BEST-SELLING U.S. DRUGS OVER 25 YEARS

    May 14, 2018

    Take a look at 25 years' worth of drug sales, and some familiar names pop up: the megablockbuster cholesterol drug Lipitor, for one. But you'll also find some drugs that aren't the mass-market successes Lipitor was. Amgen's staple anemia treatment Epogen, for one.Beyond the drugs the...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16661666

    MERCK'S EXPERIMENTAL EBOLA SHOT GETS SET TO FIGHT DEADLY NEW OUTBREAK IN CONGO

    May 14, 2018

    As the death toll mounts in a new Ebola outbreak in the Democratic Republic of Congo, health officials are preparing to deploy Merck & Co.'s experimental vaccine against the virus. The pharma giant revved up the development project amid a major Ebola breakout in 2014 and 2015.The new outbrea...

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    https://Pharmaceutical.report/news-article.aspx?ID=16621662

    SANOFI’S SHIFT TO ROBOTS AND ‘DIGITAL TWINS’ AT U.S. BIOLOGICS SITE COSTS 95 JOBS

    May 10, 2018

    Sanofi is investing more than $300 million in its Framingham, Massachusetts, plant as it continues a global manufacturing transformation that at some plants leans heavily on robots and digital processes. But more robots translates into fewer people and so the company will cut nearly 100 jobs at the ...

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    https://Pharmaceutical.report/news-article.aspx?ID=16561656

    GILEAD SHELVED SAFER HIV DRUGS FOR YEARS TO PROTECT ITS TDF MONOPOLY, ANOTHER LAWSUIT SAYS

    May 09, 2018

    Gilead Sciences is no stranger to furious patients and advocates, many of whom have said over the years that the company puts shareholder interests over their own. Now, two patients allege that the drugmaker shelved better HIV treatments in favor of monopoly sales and at the detriment of their healt...

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    https://Pharmaceutical.report/news-article.aspx?ID=16571657

    WHO DO YOU TRUST? FOR DOCTORS, IT'S BRISTOL-MYERS SQUIBB AND BIOGEN

    May 09, 2018

    When it comes to pharma partners, doctors prefer quality digital content. While that makes sense, new research shows that it also fosters trust with U.S. physicians.For the first time, DRG Digital’s Manhattan Research queried doctors about which pharma companies they trust in its annual Taking...

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    https://Pharmaceutical.report/news-article.aspx?ID=16511651

    HYPE OR HOPE? NEW E-BOOK TACKLES ARTIFICIAL INTELLIGENCE IN PHARMA AND HEALTHCARE

    May 07, 2018

    Pharma companies want to know what all the hype's about when it comes to artificial intelligence. Intouch Solutions and Digital Health Coalition have been asked that question often, so the two teamed up to write a book about AI. The e-book will be released in stages, eventually with five chapter...

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    https://Pharmaceutical.report/news-article.aspx?ID=16521652

    FRESENIUS ALLEGES ‘BLATANT FRAUD AT THE VERY TOP LEVEL’ OF AKORN OPERATIONS

    May 07, 2018

    Fresenius continues to hammer Akorn with allegations of fraud in its drug development and manufacturing as the German company battles to extract itself from its $4.3 billion buyout of the U.S. sterile injectables maker. Fresenius CEO Stephan Sturm in the German company’s earnings call Friday q...

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    https://Pharmaceutical.report/news-article.aspx?ID=16471647

    TEVA EXPECTS FDA PREAPPROVAL INSPECTION OF TROUBLED CELLTRION PLANT THIS YEAR

    May 04, 2018

    Teva said in its first-quarter earnings report that it expects an FDA pre-approval inspection in the coming months of the plant where its partner Celltrion produces the API for Teva's migraine treatment fremanezumab. Wall Street speculation had focused on the fremanezumab approval and rollout to...

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    https://Pharmaceutical.report/news-article.aspx?ID=16441644

    DRUG CONTAMINATION TEST MAKER RAPID MICRO SECURES $60M IN FINANCING TO EXPAND

    May 03, 2018

    Rapid Micro Biosystems, maker of microbial detection technology for drug manufacturers, secured $60 million in financing to expand its global reach and develop new products. The equity financing was led by Bain Capital Life Sciences and Xeraya Capital. Also included in the funding round were Asahi K...

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    https://Pharmaceutical.report/news-article.aspx?ID=16431643

    BIOGEN CEO’S PAY JUMPS AS HE TAKES THE TOP SEAT, BUT THE STOCK'S STILL FALLING

    Apr 30, 2018

    Biogen CEO Michel Vounatsos totted up a healthy $13.6 million in the usual mix of pay, shares and other compensation last year, but he'll likely need some big R&D deals and wins to boost the company's outlook—and lift his pay for 2018. Long-standing Biogen CEO George Scangos left t...

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    https://Pharmaceutical.report/news-article.aspx?ID=16401640

    SANOFI SUFFERS A DIABETES BLOODBATH AS MEDICARE AND PRICE CUTS COMPOUND THE FORMULARY PAIN

    Apr 27, 2018

    It was bad enough when Sanofi announced during its fourth-quarter earnings back in February that its diabetes sales in the U.S. fell nearly 30% after CVS Health and UnitedHealthcare axed the company’s top sellers from their formularies. But today the French pharma giant revealed that its pain ...

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    https://Pharmaceutical.report/news-article.aspx?ID=16361636

    ROCHE'S OCREVUS IS ONE OF THE BEST MS LAUNCHES EVER, BUT TECENTRIQ IN I-O? NOT SO MUCH

    Apr 26, 2018

    Don't worry about biosimilars, Roche says. Our new drugs will have it handled. In fact, we're in the middle of one of the most successful multiple sclerosis launches ever. That was the essential message from the Swiss drugmaker's executives Thursday as they reported first-quarter results...

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    https://Pharmaceutical.report/news-article.aspx?ID=16391639

    FEDS ALMOST READY TO CHARGE DRUGMAKERS AND EXECUTIVES IN GENERICS PRICE-FIXING PROBE

    Apr 25, 2018

    U.S. prosecutors have been digging into potential price-fixing in the generics world, and along the way, they've searched corporate offices and tracked executive movements at industry conferences. Now they're close to slapping charges on two companies and several execs, Bloomberg reports. Th...

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    https://Pharmaceutical.report/news-article.aspx?ID=16351635

    SHIRE AND TAKEDA COME TO TERMS WITH A $64B DEAL, THE BIGGEST PHARMA M&A IN YEARS

    Apr 25, 2018

    Late Tuesday, after a fifth buyout offer from Takeda, Shire said the Japanese drugmaker had finally landed on a proposal worth recommending to shareholders. It's a cash-and-stock bid now worth $64 billion or so, about $4 billion more than its first offer. The deal still has to be approved by bot...

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    https://Pharmaceutical.report/news-article.aspx?ID=16481648

    SQUEEZED MYLAN AXING 500 JOBS IN WEST VIRGINIA TO 'RIGHT-SIZE' MASSIVE PLANT

    Apr 23, 2018

    To "right-size" what Mylan says is one of the world's largest pharmaceutical plants, the generic drugmaker is laying off about 500 employees in Morgantown, West Virginia. The cuts come during a tough time for the generic industry at large Mylan included but ahead of some potentially lu...

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    https://Pharmaceutical.report/news-article.aspx?ID=16261626

    AMID TOUGH RESPIRATORY COMPETITION, ASTRAZENECA INKS SYMBICORT OUTCOMES-BASED DEALS

    Apr 19, 2018

    It's no secret that respiratory drugs make up a crowded field, and forthcoming generics will make the competition tougher still. AstraZeneca's Symbicort is no stranger to the fallout, either, what with payers pressing prices and new rivals grabbing share. But AstraZeneca is fighting back wit...

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    https://Pharmaceutical.report/news-article.aspx?ID=16271627

    NOVO NORDISK TACKLES OUTCOMES AND AFFORDABILITY WITH PILOT TYING COPAYS TO ADHERENCE

    Apr 18, 2018

    In a new approach to the pricing and payer issues beleaguering pharma in general and diabetes drugmakers in particular, Novo Nordisk has teamed up on a project that puts patients with diabetes to work earning drug discounts for good behavior. The Danish drugmaker is working with Sempre Health on a p...

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    https://Pharmaceutical.report/news-article.aspx?ID=16151615

    ARMED WITH FIRST-EVER FDA NOD, RIGEL PREPS MAY LAUNCH FOR AUTOIMMUNE DRUG TAVALISSE

    Apr 18, 2018

    After one false alarm or false celebration, rather, with a premature website posting last week Rigel Pharmaceuticals has officially won FDA approval for its main product, Tavalisse. Regulators greenlighted the product Tuesday, opening up a new treatment avenue for patients with chronic immune thromb...

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    https://Pharmaceutical.report/news-article.aspx?ID=16191619

    AMAZON FINDS IT'S NOT SO EASY TO SELL DRUGS AND NIXES ONE PLAN ENTIRELY: CNBC

    Apr 17, 2018

    Amazon's potential leap into pharmaceuticals has weighed on drug distributors and pharmacies for months, but those companies are getting relief from news that the online retail giant has put at least one of its plans on ice. CNBC reported that Amazon Business a unit that sells bulk products to c...

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    https://Pharmaceutical.report/news-article.aspx?ID=16111611

    CHALLENGED BY GENERICS INDUSTRY, MARYLAND'S DRUG PRICING LAW FOUND UNCONSTITUTIONAL

    Apr 16, 2018

    With federal lawmakers dallying on drug pricing, Maryland's legislature decided to take action itself. But an appeals court struck down the state's price-gouging law, and that means legislators have to go back to the drawing board. In a 2-1 opinion, the U.S. Court of Appeals for the 4th Circ...

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    https://Pharmaceutical.report/news-article.aspx?ID=16201620

    THERMO FISHER SPOTLIGHTS ITS PROBLEM-SOLVERS IN CAMPAIGN AIMED AT PHARMA CLIENTS

    Apr 16, 2018

    Thermo Fisher is showing its real face to pharma clients. Make that faces those of its employees and the patients they help. In its new campaign directed at pharma companies, Thermo Fisher Scientific Pharma Services is looking to personalize its drug development and delivery services. Each print ad ...

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    https://Pharmaceutical.report/news-article.aspx?ID=16161616

    CAN CAR-T AND GENE THERAPY CURES REALLY SUSTAIN BIOPHARMA? NOT FOR ALL, ANALYST SAYS

    Apr 12, 2018

    Ever since 2012 when Novartis invested in personalized CAR-T cancer treatments being developed at the University of Pennsylvania, analysts have pondered a difficult question: How can pharma companies profit from curing patients? Now Novartis’s CAR-T, Kymriah, is on the market, as is a similar ...

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    https://Pharmaceutical.report/news-article.aspx?ID=16121612

    TRUST ME, PFIZER ISN'T INTERESTED IN BUYING BMS, ANALYST SAYS AT LEAST NOT YET

    Apr 12, 2018

    Investors who have been waiting to see whether serial acquirer Pfizer would strike a megadeal for Bristol-Myers Squibb can cool it, one analyst says. The Big Pharma isn’t interested in snagging its immuno-oncology rival, Citi analyst Andrew Baum wrote to clients in a note seen by The Fly, stre...

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    https://Pharmaceutical.report/news-article.aspx?ID=16071607

    DESPITE REPORTS FROM MERCK AND JOHNSON & JOHNSON, PHARMA'S NET PRICES 'LIKELY NOT COMING DOWN': ANALYST

    Apr 10, 2018

    Are drug prices coming down? Two leading drugmakers presented numbers suggesting the industry is facing increased pricing pressure, but Bernstein analyst Ronny Gal remains skeptical. Johnson & Johnson recently reported that net prices fell 4.6% in 2017 after the company paid out $15 billion in r...

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    https://Pharmaceutical.report/news-article.aspx?ID=16041604

    FUJIFILM EXPANDS ITS HEALTHCARE FOOTPRINT WITH $800M ACQUISITION OF CELL-CULTURE MANUFACTURERS

    Apr 05, 2018

    Fujifilm continues to expand its healthcare footprint with the recent acquisition of a pair of cell culture media units from Japan’s JXTG Holdings for about $800 million. The photography and imaging company, which has said it plans to be a major player in the healthcare sector, by June expects...

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    https://Pharmaceutical.report/news-article.aspx?ID=16001600

    GREEK PROSECUTOR RATCHETS UP INQUIRIES IN NOVARTIS BRIBERY PROBE: REPORT

    Apr 04, 2018

    At Novartis’ annual meeting last month, an investor was quoted lamenting that the “Greek thing will be the swamp that keeps on giving.” The "Greek thing" in question is a widening scandal involving allegations that the Swiss drugmaker paid Greek government officials bribe...

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    https://Pharmaceutical.report/news-article.aspx?ID=16011601

    BIOPHARMA CAUGHT IN THE CROSSHAIRS OF U.S.-CHINA TRADE TUSSLE

    Apr 04, 2018

    Just a week after Johnson & Johnson chief Alex Gorsky and Novartis CEO Vasant Narasimhan expressed longing for stable and fair trade, biopharmaceuticals and medical devices have been dragged into the $100 billion trade war between the U.S. and China, the world’s two largest economies. The ...

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    https://Pharmaceutical.report/news-article.aspx?ID=15921592

    FDA HITS DOMINICAN REPUBLIC DRUG MANUFACTURING PLANT WITH WARNING LETTER

    Apr 03, 2018

    The FDA issued a warning letter to Labocont Industrial following an inspection last year and cited the company for not taking more concrete actions in its follow-up response to the agency. During the inspection conducted last June, the agency found Labocont wasn’t separating the production of ...

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    https://Pharmaceutical.report/news-article.aspx?ID=15911591

    CADILA HEALTHCARE SAYS FDA INSPECTION AT AHMEDABAD FACILITY HAD NO OBSERVATIONS

    Mar 29, 2018

    Indian drugmaker Cadila Healthcare said a recent FDA inspection of its topical manufacturing facility at Changodar, Ahmedabad, resulted in no observations from the regulatory agency. The inspection was conducted from March 22 through Wednesday. Of the 10 ANDA approvals the company has received from ...

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    https://Pharmaceutical.report/news-article.aspx?ID=15871587

    CUREVAC GRANTED PATENT FOR ITS MANUFACTURING PROCESS TO PRODUCE RNA

    Mar 29, 2018

    CureVac, a biopharmaceutical maker focused on mRNA-based drugs, was granted a patent by the U.S. Patent and Trademark Office for its manufacturing process for producing RNA. The company said it is the first in its field to get a patent for the entire manufacturing process of in vitro transcribed RNA...

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    https://Pharmaceutical.report/news-article.aspx?ID=15791579

    AS HEMOPHILIA MARKET HEATS UP, ROCHE CONFIRMS 5 HEMLIBRA PATIENT DEATHS

    Mar 28, 2018

    After hemophilia patient groups this week posted information about deaths during treatment with Roche's Hemlibra, the drugmaker confirmed that five patients using the drug have died. None of the deaths was determined to be linked to the drug, a Roche spokesperson said. One patient who received H...

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    https://Pharmaceutical.report/news-article.aspx?ID=15781578

    BRISTOL-MYERS' OPDIVO-YERVOY COMBO SCORES AGAIN AT FDA, THIS TIME IN COLORECTAL CANCER

    Mar 27, 2018

    Last August, Bristol-Myers Squibb’s Opdivo nabbed an indication in certain types of colorectal cancer. And Tuesday, it took a step toward nabbing that indication again but this time alongside fellow BMS immunotherapy Yervoy. U.S. regulators granted the Opdivo-Yervoy pairing priority review sta...

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    https://Pharmaceutical.report/news-article.aspx?ID=15881588

    INVESTORS IN ABBVIE, LILLY, AMGEN AND MORE SET TO VOTE ON EXECUTIVE PAY, DRUG PRICING

    Mar 26, 2018

    Despite resistance from top pharma companies, shareholders are set to vote this spring on resolutions seeking more information about potential links between executive pay and rising drug prices. Several drug industry players resisted the proxy vote, but the SEC ruled in favor of the Interfaith Cente...

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    https://Pharmaceutical.report/news-article.aspx?ID=15971597

    WILL PFIZER SPIN OFF CONSUMER HEALTH NOW THAT ITS PROSPECTIVE BUYERS HAVE BALKED?

    Mar 26, 2018

    Pfizer’s top two bidders may have both walked away from a consumer health deal last week, but that doesn’t mean the pharma giant doesn’t still have options. On the contrary, it’s got one path left to unloading the unit, and it’s one the company’s plenty familiar w...

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    https://Pharmaceutical.report/news-article.aspx?ID=16241624

    ROCHE'S HEMLIBRA, GILEAD'S BIKTARVY TOP PHARMA'S BLOCKBUSTER 2018 LAUNCHES: REPORT

    Mar 23, 2018

    Despite concerns that payers are clamping down on new drug launches, a dozen new meds are slated to reel in blockbuster sales in the coming years, according to a new report. In fact, Clarivate Analytics expects pharma to launch more blockbusters in 2018 than in any year in recent history. The analys...

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    https://Pharmaceutical.report/news-article.aspx?ID=15961596

    SUN, PIVOTING TO SPECIALTY PHARMA, WINS PSORIASIS NOD FOR ILUMYA. CAN IT HANG WITH J&J?

    Mar 22, 2018

    Sun Pharma’s $80 million psoriasis licensing deal with Merck & Co. just paid off with an FDA approval. But now, another challenge begins: The new med will go up against established psoriasis player Johnson & Johnson. The FDA has officially green-lighted the Indian drugmaker’s Ilu...

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    https://Pharmaceutical.report/news-article.aspx?ID=15741574

    AMPLYX PHARMA’S ANTIFUNGAL PRODUCT CANDIDATE, APX001 RECEIVES FOURTH QIDP DESIGNATION FROM US FDA

    Mar 21, 2018

    Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, including, announced that the US Food and Drug Administration (FDA) has granted a fourth Qualified Infectious Disease Product (QIDP) designation to APX001, the company’s lead antifungal produc...

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    https://Pharmaceutical.report/news-article.aspx?ID=15651565

    ABBVIE, IMF TO PARTNER ON CANCER RESEARCH

    Mar 21, 2018

    "There are significant knowledge gaps about multiple myeloma, and among these gaps is the role of genetic mutations in response to treatment, and the related outcomes for patients," said Brian G.M. Durie, MD, IMF chairman, in a company press release. "This study has the potential to p...

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    https://Pharmaceutical.report/news-article.aspx?ID=15691569

    NANOLOGICA AND STERLING PARTNER ON SILICA PRODUCTION

    Mar 21, 2018

    Nanologica AB has entered into a service agreement with contract development and manufacturing organization (CDMO) Sterling Pharma Solutions for the large-scale production of silica particles. Nanologica specializes in the development and manufacture of silica for application in drug delivery and ch...

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    https://Pharmaceutical.report/news-article.aspx?ID=15701570

    NOVARTIS WAS 'BUYING SCRIPTS,' FEDS SAY, AS DOCTORS AND REPS PREPARE TO TESTIFY IN KICKBACKS CASE

    Mar 21, 2018

    Novartis sales reps and doctors plan to testify in a long-running kickbacks case, court filings show, as prosecutors marshal evidence they say will show the company traded fancy dinners and entertainment and in some cases, jobs for physicians' relatives to increase prescription numbers. The doct...

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    https://Pharmaceutical.report/news-article.aspx?ID=15731573

    ASIA PHARMA EXPO TO BOOST BANGLA PHARMA MANUFACTURING STANDARDS

    Mar 17, 2018

    More than 670 exhibiting companies representing 31 countries worldwide displayed their latest technologies at the three-day Asia Pharma Expo 2018 (APE 2018) & Asia Lab Expo 2018 held at Dhaka, Bangladesh, from February 8 to 10, 2018. According to experts, the expo will help take the pharma manuf...

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    https://Pharmaceutical.report/news-article.aspx?ID=15661566

    PRESCRIBED READING: NEURO'S COMEBACK TOUR

    Mar 16, 2018

    Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week. It was all about the neuroscience spac...

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    https://Pharmaceutical.report/news-article.aspx?ID=15611561

    NOVEL USES FOR ORAL SOLID DOSES DRIVING LIFECYCLE MANAGEMENT STRATEGIES

    Mar 15, 2018

    With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage (OSD) arena. Current areas of exploration include novel drug combinations, oral delivery of larg...

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    https://Pharmaceutical.report/news-article.aspx?ID=15621562

    USE OF HIV-PREVENTION DRUG GROWS, BUT LAGS AMONG NON-WHITES

    Mar 15, 2018

    Eric Russell, 24, recently joined a health support group for young Latino and black gay men, where he learned about the HIV-prevention pill known as PrEP. He resisted the medication at first, convinced he didn’t need it and fearful that taking it would stigmatize him. But after Russell learned...

    KHN.ORG
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    https://Pharmaceutical.report/news-article.aspx?ID=15571557

    OPIOID MAKER FUNDS EFFORTS TO FIGHT ADDICTION: IS IT ‘BLOOD MONEY’ OR CHARITY?

    Mar 14, 2018

    A program to give naloxone overdose-antidote kits and training to front-line officers. Funding for pill disposal boxes in pharmacies, clinics and police stations across North Carolina. A radio campaign in Connecticut warning of the dangers of opioid abuse. A new medicine to treat opioid-induced cons...

    KHN.ORG
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    https://Pharmaceutical.report/news-article.aspx?ID=15591559

    OREGON, THE LATEST STATE TO TACKLE HIGH DRUG PRICES, PUSHES THROUGH TRANSPARENCY LAW

    Mar 14, 2018

    Pharma has suffered another defeat in the state-by-state war over drug prices. On Tuesday, Oregon Gov. Kate Brown signed a bill that seeks to fight high costs and bring transparency to pharmaceutical pricing. Oregon's HB 4005 requires drugmakers to report R&D and marketing costs, profits and...

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    https://Pharmaceutical.report/news-article.aspx?ID=16081608

    SANOFI, REGENERON TO MAKE PRALUENT MORE ACCESSIBLE AND AFFORDABLE FOR PATIENTS WITH GREATEST HEALTH RISK AND UNMET NEED

    Mar 13, 2018

    To help ensure more affordable and timely access to patients most in need, Sanofi and Regeneron Pharmaceuticals, will offer US payers that agree to reduce burdensome access barriers for high-risk patients a further reduced net price for Praluent (alirocumab) injection in alignment with a new value a...

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    https://Pharmaceutical.report/news-article.aspx?ID=15541554

    AZ ANNOUNCES RESULTS DELAY FOR KEY LUNG CANCER TRIAL

    Mar 12, 2018

    The Phase III MYSTIC trial is evaluating Imfinzi (durvalumab) as monotherapy and in combination with tremelimumab, versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC). The drug giant had bee...

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    https://Pharmaceutical.report/news-article.aspx?ID=15491549

    SANOFI, REGENERON TO CUT PRICE OF PRALUENT

    Mar 12, 2018

    Data from the ODYSSEY OUTCOMES trial presented at the American College of Cardiology's annual scientific session (ACC) show that high-risk patients who added Praluent (alirocumab) Injection to maximally-tolerated statins experienced significantly fewer major adverse cardiovascular events (MACE) ...

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    https://Pharmaceutical.report/news-article.aspx?ID=15501550

    KSPC EMBARKS ON PRINT & TV ADVT CAMPAIGN TO HIGHLIGHT DANGERS OF SELLING DRUGS BY UNQUALIFIED PERSONS AT DRUG STORES

    Mar 12, 2018

    In order to highlight the dangers of selling drugs by unqualified persons in a pharmacy outlet, the Karnataka State Pharmacy Council (KSPC) is approaching the public directly through advertisements in print and electronic media. This is to educate them on the need for qualified pharmacist to be pres...

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    https://Pharmaceutical.report/news-article.aspx?ID=15531553

    RISING HEALTH COSTS, SOARING DRUG PRICES, CONFUSING BILLS! WHAT’S A CONSUMER TO DO?

    Mar 09, 2018

    What should you do when you get a four-figure hospital bill? Are there any simple ways to bring down health costs? Kaiser Health News correspondent Shefali Luthra tackled these and other questions in a Reddit “Ask Me Anything” chat on Friday. The takeaways: Health care prices are part of...

    KHN.ORG
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    https://Pharmaceutical.report/news-article.aspx?ID=15581558

    PFIZER CENTREONE RELEASES FIRST GREEN-CHEMISTRY-DRIVEN API

    Mar 08, 2018

    Pfizer CentreOne, a contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), has introduced Enviero progesterone to its contract customers. The API is made via a proprietary synthesis that significantly reduces waste, greenhouse gas emissio...

    PHARMTECH
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    https://Pharmaceutical.report/news-article.aspx?ID=15451545

    UK PM SIGNALS INTENT TO REMAIN WITH EMA

    Mar 05, 2018

    Prime Minister Theresa May has unveiled the government’s desire for the UK to remain part of the European Medicines Agency following its departure from the European Union. In a key speech on Brexit she revealed that the government will “explore with the EU the terms on which the UK could...

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    https://Pharmaceutical.report/news-article.aspx?ID=15411541

    AZ’ FORXIGA TO BE REVIEWED FOR DIABETES TYPE I

    Mar 05, 2018

    The European Medicines Agency has accepted AstraZeneca’s filing for Forxiga as a treatment for diabetes type I. The submission contains data from the Phase III DEPICT clinical programme, which showed that Forxiga, when given as an oral adjunct to adjustable insulin in patients with inadequatel...

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    https://Pharmaceutical.report/news-article.aspx?ID=15421542

    DOUBTING THE WONDER DRUG

    Mar 03, 2018

    Baclofen is a drug used to treat an alcohol use disorder. It has long been debuted as the "Wonder Drug" for several of its unique characteristics. For one, baclofen is secreted from the kidneys, not the liver which is particularly advantageous to individuals suffering from liver disease du...

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    https://Pharmaceutical.report/news-article.aspx?ID=15371537

    CAN EARLY DEVELOPMENT STRATEGIES AVOID LATER-STAGE DISASTERS?

    Mar 02, 2018

    Pfizer CentreOne, a contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), has introduced Enviero progesterone to its contract customers. The API is made via a proprietary synthesis that significantly reduces waste, greenhouse gas emissio...

    PHARMTECH
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    https://Pharmaceutical.report/news-article.aspx?ID=15461546

    THE 24 HOUR FLU-KILLING DRUG

    Mar 01, 2018

    Influenza, mainly known as the “flu”, is a respiratory illness caused by a virus. The flu virus usually flourishes during the winter season affecting many people who are not protected. Every year, there is a new virus strain and every year individuals are recommended to vaccinate themsel...

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    https://Pharmaceutical.report/news-article.aspx?ID=15361536

    RECORD NUMBER BENEFITTING FROM NHS TALKING THERAPIES

    Feb 27, 2018

    A record number of people are recovering from mental ill health after accessing talking therapies on the NHS, new figures show. The annual report on NHS England’s Improving Access to Talking Therapies (IAPT) programme shows that half of those completing a course of treatment recovered from the...

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    https://Pharmaceutical.report/news-article.aspx?ID=15321532

    TWENTY PERCENT OF ANTIBIOTICS PRESCRIBED INAPPROPRIATELY

    Feb 27, 2018

    At least 20 percent of all antibiotic prescriptions written in primary care in England are inappropriate, estimates research published by Public Health England (PHE) in the Journal of Antimicrobial Chemotherapy. Researchers found that the majority of antibiotic prescriptions in English primary care ...

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    https://Pharmaceutical.report/news-article.aspx?ID=15331533

    AFRICAN UNION TO COME UP WITH AFRICAN MEDICINE AGENCY TO HARMONISE DRUG REGULATION OF MEMBER STATES

    Feb 26, 2018

    African Union (AU) is coming up with an African Medicine Agency (AMA) which will be tasked with cooperation and strengthening of healthcare activities to harmonize medicine regulation of member states of the Union in line with European Medicine Agency (EMA). There are 55 countries in African Union. ...

    PHARMABIZ.COM
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    https://Pharmaceutical.report/news-article.aspx?ID=15281528

    REGULATORS TO USHER IN EFFECTIVE PHARMACOVIGILANCE WITH SENSITIZATION OF MAHS ON GOOD PV PRACTICES

    Feb 26, 2018

    To help pharma industry develop pharmacovigilance system as per the good pharmacovigilance practices, the Indian Pharmacopoeia Commission (IPC) will soon roll out a series of workshops in Mumbai and Ahmedabad considering the fact that Market Authorisation Holders (MAHs) and regulators have to jointl...

    PHARMABIZ.COM
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    https://Pharmaceutical.report/news-article.aspx?ID=15291529

    TEACHING THE IMMUNE SYSTEM TO IGNORE FOOD ALLERGENS

    Feb 22, 2018

    An allergic reaction of any kind is a result of the immune system responding to an otherwise harmless allergen as if it were a pathogen. However, sending the right messages to the immune system can change the way it operates, as Duke University scientists found in their new study aimed at reducing t...

    LABROOT
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    https://Pharmaceutical.report/news-article.aspx?ID=15231523

    BOOSTING HYDROGEN ELECTROCHEMICAL PRODUCTION-WITH EGGS

    Feb 22, 2018

    We are not talking about cracking open eggs and put them into hydrogen fuel cells (not even during Easter). Chemical researchers from the Osaka City University (OCU) have reported their innovative idea of producing carbon-free hydrogen using a photocatalytic matrix made of an egg white ingredient, l...

    LABROOT
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    https://Pharmaceutical.report/news-article.aspx?ID=15241524

    DIFFUSION KURTOSIS IMAGING DIFFERENTIATES BENIGN BREAST LESIONS FROM MALIGNANCIES

    Feb 20, 2018

    An MRI breast imaging technique that requires no contrast agent, combined with sophisticated data analysis, could reduce the number of unnecessary breast biopsies, according to a new study. Researchers recently studied an alternative approach that eliminates the need for contrast agents in some case...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=15161516

    SHIRE, MICROSOFT AND EURODIS FORM RARE DISEASES ALLIANCE

    Feb 20, 2018

    According to the parties, the “long road to diagnosis” is key issue that affects the health, longevity and well-being for rare disease patients and their families. The Global Commission to End the Diagnostic Odyssey for Children is a multi-disciplinary group of experts who will develop a...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=15191519

    SMC APPROVES NHS FUNDING FOR UCB’S VIMPAT IN CHILDREN

    Feb 20, 2018

    The Scottish Medicines Consortium has accepted Vimpat (lacosamide) for NHS use as an adjunctive therapy for partial-onset (focal) seizures with or without secondary generalisation in children aged four years and older. In Scotland there are around 55,000 people living with epilepsy but, despite its ...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=15201520

    PSORIASIS DRUG FOUND TO REDUCE AORTIC VASCULAR INFLAMMATION

    Feb 19, 2018

    Researchers from the Perelman School of Medicine at the University of Pennsylvania, in collaboration with the National Heart, Lung, and Blood Institute, led a randomised, double-blind, placebo-controlled study and found patients who took the drug ustekinumab had a 19 percent improvement in aortic in...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=15151515

    HEROIN VACCINE BLOCKS LETHAL OVERDOSE

    Feb 15, 2018

    Scientists have achieved a major milestone toward designing a safe and effective vaccine to both treat heroin addiction and block lethal overdose of the drug. Their research shows how a new anti-heroin formulation that is safe in animal models remains stable at room temperature for at least 30 days....

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=15071507

    CABOZANTINIB SHOWS PROMISE AS FIRST LINE TREATMENT FOR DIFFERENTIATED THYROID CANCER

    Feb 15, 2018

    A kinase inhibitor called cabozantinib could be a viable therapy option for patients with metastatic, radioactive iodine-resistant thyroid cancer. In a trial initiated and led by the Abramson Cancer Center and the Perelman School of Medicine at the University of Pennsylvania, tumours shrunk in 34 ou...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=15081508

    SCOTLAND ENDORSES FIVE NEW THERAPIES FOR NHS USE

    Feb 13, 2018

    The Scottish Medicines Consortium (SMC) has accepted MSD’s Keytruda (pembrolizumab) for the treatment of advanced bladder cancer following consideration through SMC’s Patient and Clinician Engagement (PACE) process for medicines used to treat very rare and end of life conditions.

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=15031503

    MSD’S VERUBECESTAT FAILS AGAIN IN ALZHEIMER’S TRIAL

    Feb 13, 2018

    Five new medicines are to be funded by the NHS in Scotland, bringing new treatment options for cancer, multiple sclerosis and rheumatoid arthritis, as well as a new contraceptive. The Scottish Medicines Consortium (SMC) has accepted MSD’s Keytruda (pembrolizumab) for the treatment of advanced ...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=15041504

    RE-CLASSIFICATION OF MSME CRITERIA FROM INVESTMENT TO TURNOVER WILL BRING IN MORE TRANSPARENCY

    Feb 12, 2018

    The Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) sees that the Union government's effort to make a change in the criteria for classifying micro, small and medium enterprises (MSMEs) from investment in plant and machinery to annual turnover would make the process more tran...

    PHARMACEUTICAL EXECUTIVE
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    https://Pharmaceutical.report/news-article.aspx?ID=14951495

    VIIV HEALTHCARE FILES PATENT INFRINGEMENT LITIGATION AGAINST GILEAD SCIENCES OVER BICTEGRAVIR IN US & CANADA

    Feb 12, 2018

    ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has filed patent infringement litigation against Gilead Sciences Inc. over bictegravir in the United States and Canada. The United States case is filed in the US District ...

    PHARMACEUTICAL EXECUTIVE
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    https://Pharmaceutical.report/news-article.aspx?ID=14961496

    V CLINBIO ACQUIRES CELLIX TO GAIN PATENTED DRUG DELIVERY TECHNOLOGY

    Feb 09, 2018

    V ClinBio, a biopharmaceutical company focused on converting existing compounds into new therapeutics for treating immune and other related diseases, announced the acquisition of a 49.98% equity stake in Cellix Bio, a drug design and development biopharmaceutical company.
    The acquisition stre...

    PHARMACEUTICAL TECHNOLOGY MAGAZINE
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    https://Pharmaceutical.report/news-article.aspx?ID=14991499

    J&J AND THERAVANCE IN $1-BILLION DEAL FOR INFLAMMATORY BOWEL DISEASE

    Feb 07, 2018

    The Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) announced that they have entered into a worldwide collaboration with Theravance Biopharma Ireland, a subsidiary of Theravance Biopharma, to develop TD-1473, an oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibi...

    PHARMACEUTICAL TECHNOLOGY MAGAZINE
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    https://Pharmaceutical.report/news-article.aspx?ID=15001500

    PHARMA WADES INTO THE WORLD OF VIRTUAL REALITY MARKETING

    Feb 07, 2018

    The scene opens with ambulance alarms sounding. Emily, a bicyclist struck by a car, lies on the pavement as a team of EMT workers maneuver her onto a backboard. Viewers watch it all through the eyes of one of those workers, Han, a migraine sufferer. His vision slowly gets blurrier and the whooping o...

    BIOPHARMADIVE
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    https://Pharmaceutical.report/news-article.aspx?ID=15831583

    ROBOTIC METHOD ISOLATES HIGH-PRODUCING CELL LINES FOR HIV VACCINE PRODUCTION

    Feb 06, 2018

    Research on HIV over the past decade has led to many promising ideas for vaccines to prevent infection by the AIDS virus, but very few candidate vaccines have been tested in clinical trials. One reason for this is the technical difficulty of manufacturing vaccines based on the envelope proteins of t...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=14911491

    NEW TECHNOLOGY FOR ACCELERATED WOUND HEALING DISCOVERED

    Feb 06, 2018

    Researchers have found a new way of accelerating wound healing. The technology and the mode of action involve using lactic acid bacteria as vectors to produce and deliver a human chemokine on site in the wounds. The research group is the first in the world to have developed the concept for topical u...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=14921492

    BLOOD TEST DETECTS EARLY STAGES OF ALZHEIMER’S DISEASE

    Feb 05, 2018

    Scientists have developed and validated a blood test for Alzheimer’s disease, with the potential to massively ramp up the pace of Alzheimer’s disease drug trials. Scientists have teamed up to develop and validate a blood test for Alzheimer’s disease, with the potential to massively...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=14871487

    BLOOD TEST DETECTS EARLY STAGES OF ALZHEIMER’S DISEASE

    Feb 05, 2018

    Scientists have developed and validated a blood test for Alzheimer’s disease, with the potential to massively ramp up the pace of Alzheimer’s disease drug trials. Scientists have teamed up to develop and validate a blood test for Alzheimer’s disease, with the potential to massively...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=14881488

    BIOPHARMA IN CHARTS: KEY TAKEAWAYS FROM Q4 EARNINGS

    Feb 05, 2018

    Biopharma in Charts aims to complement BioPharma Dive's daily news coverage with a data-driven look at a few of the top trends affecting the industry. This edition focuses on key takeaways from fourth quarter earnings, including strong returns from cancer drugs, growth drivers living up to the n...

    BIOPHARMADIVE
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    https://Pharmaceutical.report/news-article.aspx?ID=15841584

    NICE BACKS ROCHE’S PERJETA FOR BREAST CANCER

    Feb 01, 2018

    The National Institute for Health and Care Excellence has issued a final green light securing routine NHS funding for Roche’s Perjeta in patients with a certain type of breast cancer. The guidelines follow a confidential commercial agreement for Perjeta (pertuzumab) agreed between NHS England ...


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    https://Pharmaceutical.report/news-article.aspx?ID=14831483

    AS STATES TARGET HIGH DRUG PRICES, PHARMA TARGETS STATE LAWMAKERS

    Feb 01, 2018

    It was expected to be a perfunctory statehouse meeting — three lobbyists and a legislator discussing a proposal to educate Louisiana doctors about the price of drugs they prescribe. The bill seemed like a no-brainer in a country where even decades-old medicines can cost thousands and consumers...


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    https://Pharmaceutical.report/news-article.aspx?ID=14841484

    MICROBUBBLES MAKE BREAST CANCER MORE SUSCEPTIBLE TO RADIATION THERAPY

    Jan 31, 2018

    Bursting oxygen-filled microbubbles in breast cancer makes tumours three times more sensitive to radiation therapy in preliminary tests with animal models of the disease Injecting breast cancer with oxygen-filled microbubbles makes tumours three-times more sensitive to radiation therapy and improves...

    EUROPEAN PHARMACEUTICAL REVIEW
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    https://Pharmaceutical.report/news-article.aspx?ID=14861486

    BLOOD VESSEL-ON-A-CHIPS SHOW ANTI-CANCER DRUG EFFECTS IN HUMAN CELLS

    Jan 30, 2018

    Researchers at the Institute of Industrial Science (IIS), the University of Tokyo, CNRS and INSERM, report a new organ-on-a-chip technology for the study of blood vessel formation and drugs targeting this event. The technology recreates a human blood vessel and shows how new capillaries grow from a ...


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    https://Pharmaceutical.report/news-article.aspx?ID=14781478

    UK PHARMA R&D PIPELINE ‘STRONGEST IN EUROPE’

    Jan 29, 2018

    The report, released by UK industry group the BioIndustry Association (BIA) and Informa Pharma Intelligence, shows that the UK held the largest number of clinical trials in Europe in 2017, with 351 pre-clinical trials, 43 in Phase I, 70 in Phase II, and 15 in Phase III. The next highest, France, hel...


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    https://Pharmaceutical.report/news-article.aspx?ID=14811481

    ACCUSED OF STEALING TEVA SECRETS, APOTEX CEO EXITS ABRUPTLY EVEN AS FOUNDER'S DEATH RULED HOMICIDE

    Jan 29, 2018

    The turmoil at Canada’s largest homegrown pharma company, generics maker Apotex, continues with the resignation of CEO Jeremy Desai even as the company deals with the fallout from the murders of the company’s founder and his wife. Apotex said on Friday that Desai had resigned and was bei...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16311631

    CARDIOME PHARMA RECEIVES EXTENDED INDICATIONS FOR AGGRASTAT IN CHINA

    Jan 25, 2018

    Canada-based Cardiome Pharma has received expanded indications from the Chinese Center for Drug Evaluation (CDE) for the use of its Aggrastat (tirofiban hydrochloride) in ST-segment elevation myocardial infarction (STEMI) patients intended for primary percutaneous coronary intervention (PCI). The ag...


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    https://Pharmaceutical.report/news-article.aspx?ID=14761476

    BIOCRYST AND IDERA SIGN MERGER AGREEMENT FOR RARE DISEASE DRUGS

    Jan 24, 2018

    US-based BioCryst Pharmaceuticals and Idera Pharmaceuticals have entered a definitive merger agreement focused on the development and commercialisation of medicines for patients with rare diseases. To be renamed and led by Idera CEO Vincent Milano upon closing, the combined entity is set to leverage...


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    https://Pharmaceutical.report/news-article.aspx?ID=14771477

    UK TO OFFER FUNDING FOR NEW MEDICINE MANUFACTURING CENTRES

    Jan 23, 2018

    The UK Government is set to offer a new grant through the Industrial Strategy Challenge Fund (ISCF) to create new manufacturing facilities to accelerate drug development. Announced by new Universities and Science Minister Sam Gyimah, the £70m funding will also be utilized for new medical proje...


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    https://Pharmaceutical.report/news-article.aspx?ID=14731473

    NEW RESEARCH PAPER SHOWS THAT ASTRAZENECA HAS ACHIEVED GREATER THAN FOUR-FOLD IMPROVEMENT IN R&D PRODUCTIVITY

    Jan 19, 2018

    In a research paper published today by Nature Reviews Drug Discovery, AstraZeneca's IMED Biotech Unit documents a more than four-fold improvement in R&D productivity following significant revision of its approach and adoption of a '5R framework' - right target, right patient, right t...


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    https://Pharmaceutical.report/news-article.aspx?ID=14701470

    SANDOZ ANNOUNCES EXCLUSIVE GLOBAL COLLABORATION WITH BIOCON ON NEXT-GENERATION BIOSIMILARS

    Jan 18, 2018

    Sandoz, a Novartis division and the global leader in biosimilars, today announced a global partnership with Asia's premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the ...


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    https://Pharmaceutical.report/news-article.aspx?ID=14661466

    MERCK TO DEVELOP ONCOLOGY DRUGS WITH CANCER RESEARCH UK AND ICR

    Jan 18, 2018

    Merck has entered a multi-project collaboration and licensing deal with Cancer Research UK and the Institute of Cancer Research, London (ICR) for the discovery and development of new drugs to treat cancer. The entities will collaborate on three different research projects. The scope of the R&D a...


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    https://Pharmaceutical.report/news-article.aspx?ID=14681468

    HOSPITALS, SICK OF DRUG SHORTAGES, TAKE MATTERS INTO THEIR OWN HANDS

    Jan 18, 2018

    Sick and tired of dealing with generic drug shortages and unpredictable price increases, five large U.S. health systems are taking an unusual step: They're forming their own nonprofit generic drugmaker. Representing more than 450 hospitals, nonprofit groups Intermountain Healthcare, Ascension, S...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16301630

    NEW RESEARCH COULD SIGNIFICANTLY ACCELERATE DRUG DISCOVERY

    Jan 17, 2018

    Many drugs work by inhibiting protein enzymes associated with a particular disease. Unfortunately, the same drugs can inhibit protein enzymes unrelated to the disease, resulting in harmful side effects. One potential solution is to better identify structural features that determine a protein enzyme&...


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    https://Pharmaceutical.report/news-article.aspx?ID=14631463

    CABOMETYX TRIAL HALTED EARLY ON SUCCESS IN LIVER CANCE

    Jan 17, 2018

    A late-stage trial assessing Ipsen and Exelixis’ Cabometyx in advanced liver cancer has been halted early after a significant improvement in overall survival was observed.

    Results of the Phase III CELESTIAL trial showed a median overall survival of 10.2 months in patients taking...


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    https://Pharmaceutical.report/news-article.aspx?ID=14641464

    US EXPANDS SCOPE OF BI’S LUNG CANCER DRUG GILOTRIF

    Jan 16, 2018

    US regulators have approved a supplemental New Drug Application for Boehringer Ingelheim’s lung cancer drug Gilotrif for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have non-resistant epidermal growth factor receptor (EGFRs). The new label ...


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    https://Pharmaceutical.report/news-article.aspx?ID=14601460

    MEDTRONIC RECEIVES FDA CLEARANCE FOR RIPTIDE(TM) ASPIRATION SYSTEM

    Jan 16, 2018

    Medtronic plc (NYSE: MDT) today announced that the company's Neurovascular business unit received U.S. Food and Drug Administration (FDA) clearance of the Riptide(TM) Aspiration System, adding a valuable tool to the Acute Ischemic Stroke (AIS) product portfolio. The Riptide Aspiration System is ...


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    https://Pharmaceutical.report/news-article.aspx?ID=14611461

    FDA APPROVES FIRST TREATMENT FOR BREAST CANCER WITH A CERTAIN INHERITED GENETIC MUTATION

    Jan 12, 2018

    The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first dr...


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    https://Pharmaceutical.report/news-article.aspx?ID=14541454

    NHS ENGLAND TO FUND MORE GP-BASED PHARMACISTS

    Jan 11, 2018

    NHS England has approved funding for more than 160 additional GP surgery-based clinical pharmacists able to offer expert medical advice and treatment to patients. Including previously approved posts, the move will increase the number of clinical pharmacists in general practice from around 580 to ove...


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    https://Pharmaceutical.report/news-article.aspx?ID=14511451

    PSYCHIATRY'S BRAVE NEW WORLD--FDA APPROVES DIGITAL SENSOR IN ANTIPSYCHOTIC DRUG TO ENFORCE PRESCRIPTION COMPLIANCE

    Jan 11, 2018

    The U.S. Food and Drug Administration has approved an antipsychotic, aripiprazole, as the first drug to contain a "digital ingestion tracking system" that can tell whether the drug has been taken a technology that even a leading U.S. psychiatrist likened to "a biomedical Big Brother.&...


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    https://Pharmaceutical.report/news-article.aspx?ID=14531453

    BEACON ENTERS DRUG DISCOVERY COLLABORATION WITH JANSSEN

    Jan 08, 2018

    US-based drug discovery firm Beacon Discovery has entered a multi-year collaboration agreement with Janssen Pharmaceuticals for small molecule compounds to treat metabolic diseases. The partnership is set to discover and develop compounds for various undisclosed G-protein coupled receptor (GPCR) tar...


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    https://Pharmaceutical.report/news-article.aspx?ID=14571457

    PFIZER, NOVARTIS AND MORE POST PRICE HIKES ON DOZENS OF DRUGS, BUT ABBVIE’S IS WORTH THE MOST

    Jan 04, 2018

    It's not just specialty drugmakers raising prices in recent days. Big Pharma has pushed through a spate of increases, and while all of them are sub-10% the cap some companies have adopted—some of them will cost payers and consumers plenty. A single price increase, in fact, could add more t...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16291629

    ALLERGAN, TEVA AND OTHERS START 2018 WITH PRICE HIKES: ANALYST

    Jan 02, 2018

    A New Year often rings in higher drug prices, and many top drugmakers marked the occasion in just that way this year. List price increases hit dozens of drugs, including staple drugs and blockbuster hopefuls. None of the increases, however, topped the 10% price-hike cap that's been trendy in pha...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=16281628

    PROTALIX BIOTHERAPEUTICS’ PRX-102 GRANTED ORPHAN DRUG DESIGNATION BY THE EUROPEAN COMMISSION

    Dec 27, 2017

    Protalix BioTherapeutics, Inc, a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, announced today that the European Commission granted Orphan Drug Designatio...


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    https://Pharmaceutical.report/news-article.aspx?ID=14491449

    EU OKS FIRST-LINE USE OF ROCHE’S LUNG CANCER DRUG ALECENSA

    Dec 21, 2017

    Roche’s Alecesna has been cleared for use in Europe as a first-line treatment for ALK-positive non-small cell lung cancer (NSCLC), offering a new option for patients newly diagnosed with the disease. The approval is based on data from the Phase III ALEX study, which showed that the drug signif...


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    https://Pharmaceutical.report/news-article.aspx?ID=14481448

    ARTHRITIS DRUG SHOWS POTENTIAL IN SKIN CANCER

    Dec 19, 2017

    The effectiveness of melanoma treatment could be boosted if combined with a well-known drug for rheumatoid arthritis (RA), indicates early UK research. Scientists at the University of East Anglia (UEA) found that combining the RA therapy leflunomide with the melanoma treatment selumetinib almost com...


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    https://Pharmaceutical.report/news-article.aspx?ID=14441444

    US FDA ACCEPTS REGULATORY SUBMISSION FOR TAGRISSO IN 1ST-LINE EGFR-MUTATED NON-SMALL CELL LUNG CANCER

    Dec 18, 2017

    AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity ag...


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    https://Pharmaceutical.report/news-article.aspx?ID=14431443

    US CLEARS SANOFI’S ‘FOLLOW-ON’ INSULIN ADMELOG

    Dec 12, 2017

    The US Food and Drug Administration has cleared Sanofi's Admelog, the first follow-on biologic version of Eli Lilly’s Humalog, to manage mealtime blood sugar levels in people with diabetes. Admelog is a short-acting insulin approved on the back of a clinical development programme involving...


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    https://Pharmaceutical.report/news-article.aspx?ID=14381438

    PITTING PATHOGENS AGAINST EACH OTHER COULD PREVENT DRUG RESISTANCE EMERGING

    Dec 12, 2017

    Limiting the nutrient resources that pathogens depend on for replication could prevent the emergence of drug resistance, according to research findings. In a study published in Proceedings of the National Academy of Sciences, scientists have taken advantage of the competition that occurs between hos...


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    https://Pharmaceutical.report/news-article.aspx?ID=14411441

    NOVARTIS’ KYMRIAH SHOWS DURABLE RESPONSE IN BLOOD CANCER

    Dec 11, 2017

    A new analysis of trial data on Novartis’ CAR-T therapy Kymriah presented at the 59th American Society of Hematology (ASH) annual meeting show that the drug sustained complete responses at six months in adults with a difficult to treat a form of blood cancer. CAR-T offers a new treatment appro...


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    https://Pharmaceutical.report/news-article.aspx?ID=14341434

    US SCIENTISTS FIND POTENTIAL THERAPY FOR EBOLA VIRUS INFECTION

    Dec 11, 2017

    Scientists from SRI International and Collaborations Pharmaceuticals in the US have identified a potential new inhibitor, tilorone dihydrochloride, for infection by Ebola virus. The researchers used machine learning methods to find the immunomodulatory drug, which is reported to have demonstrated si...


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    https://Pharmaceutical.report/news-article.aspx?ID=14371437

    APHIOS PHARMA RAISING EQUITY CAPITAL TO DEVELOP FDA-APPROVED, CANNABIS-BASED DRUG FOR OPIOID ADDICTION

    Dec 08, 2017

    Aphios Pharma today announced plans to raise equity capital from investors to develop an FDA-approved, cannabis-based drug for treating opioid addiction, a highly unmet Central Nervous System (CNS) disorder. Opioid addiction has grown to epidemic proportions.  Current statistics indicate that h...


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    https://Pharmaceutical.report/news-article.aspx?ID=14321432

    WORLD PHARMACY INFORMATION SYSTEM MARKET - OPPORTUNITIES & FORECASTS TO 2022 - RESEARCH AND MARKETS

    Dec 08, 2017

    The "World Pharmacy Information System Market - Opportunities and Forecasts, 2014 - 2022" report has been added to Research and Markets' offering. Pharmacy information system plays an important role in minimizing the errors that often take place when dispensing medication. Besides this...


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    https://Pharmaceutical.report/news-article.aspx?ID=14331433

    SHALBY LIMITED IPO SEES TEPID RESPONSE FROM INVESTORS ON DAY 1

    Dec 07, 2017

    Shalby Limited, Ahmedabad-based multi-speciality hospital chain, on Tuesday launched it's initial public offering (IPO)  received a tepid response from investors during the day.
    At 1526 hours, as per NSE data, the company received bids of 25,91,700 equity shares, subscribing by just ...

    ZEEBIZ.COM
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    https://Pharmaceutical.report/news-article.aspx?ID=14251425

    SANOFI EXPLORES COMBINATION TREATMENTS FOR MULTIPLE MYELOMA IN NEW LATE-STAGE TRIALS

    Dec 07, 2017

    Sanofi has launched two new late-stage clinical studies to determine if an investigational biologic called isatuximab, when used in combination with other commonly used cancer treatments, might be an effective treatment option for certain people with multiple myeloma, a rare blood cancer related to ...


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    https://Pharmaceutical.report/news-article.aspx?ID=14261426

    SCIENTISTS FROM SRI INTERNATIONAL AND COLLABORATIONS PHARMACEUTICALS, INC. IDENTIFY POTENTIAL NEW EBOLA VIRUS THERAPY

    Dec 07, 2017

    In the search for drugs that are effective against Ebola virus, scientists from SRI International and Collaborations Pharmaceuticals, Inc., led a study that used machine learning methods to identify tilorone dihydrochloride as a potential new inhibitor of viral infection. The low molecular weight im...


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    https://Pharmaceutical.report/news-article.aspx?ID=14291429

    INTERIM RESULTS OF FIRST-EVER GLOBAL SURVEY SHOW PEOPLE WITH TYPE 2 DIABETES UNDERESTIMATE THEIR CARDIOVASCULAR RISK

    Dec 06, 2017

    Today the International Diabetes Federation (IDF) presented the interim results of the first ever multi-country online survey on CVD risk awareness and knowledge among people living with type 2 diabetes, indicating low levels of awareness and limited dialogue between patients and healthcare professi...


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    https://Pharmaceutical.report/news-article.aspx?ID=14211421

    FDA ACCEPTS NEW DRUG APPLICATION (NDA) FOR BUPRENORPHINE SUBLINGUAL SPRAY FROM INSYS THERAPEUTICS

    Dec 06, 2017

    INSYS Therapeutics, Inc. (“INSYS” or “the company”), announced today that its New Drug Application (NDA) for a novel formulation of buprenorphine as a sublingual spray for the management of moderate-to-severe acute pain has been accepted for filing by the U.S. Food and Drug A...


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    https://Pharmaceutical.report/news-article.aspx?ID=14241424

    GIVE HONEY AND LEMON, NOT OTC COUGH MEDICINES, TO CHILDREN WITH COUGHS, SAYS LEADING PAEDIATRICIAN

    Dec 05, 2017

    Children with troublesome coughs should be treated with ‘old-fashioned’ honey and lemon rather than over-the-counter (OTC) cough medicines, a leading paediatrician has advised. When taken in large doses, many OTC cough and cold medicines and medications can be toxic or have adverse effec...


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    https://Pharmaceutical.report/news-article.aspx?ID=14181418

    AMPEL BIOSOLUTIONS, HORIZON PHARMA PLC, AND LUPUS RESEARCH ALLIANCE PARTNER ON UNIQUE CLINICAL TRIAL FOR PATIENTS WITH LUPUS

    Dec 05, 2017

    AMPEL BioSolutions, a leading biomedical research firm based in Charlottesville, Va., Horizon Pharma plc and The Lupus Research Alliance today announced the launch of the RIFLE (RAYOS (delayed release prednisone) Inhibits Fatigue in Lupus Erythematosus) trial for patients with Systemic Lupus Erythem...


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    https://Pharmaceutical.report/news-article.aspx?ID=14201420

    FUNCTIONAL MEDICINE CLINICS OF ALASKA OFFERS NEW ED TREATMENT

    Dec 04, 2017

    Functional Medicine Clinics of Alaska is pleased to announce they now offer GAINSWave™! This breakthrough noninvasive medical therapy uses low-intensity shockwave therapy to enhance sexual performance and to treat Erectile Dysfunction symptoms. As men age, the vessels in their penis weaken con...


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    https://Pharmaceutical.report/news-article.aspx?ID=14161416

    DEALS THIS WEEK: XIANGXUE PHARMACEUTICAL, ASTRAZENECA, VANC PHARMACEUTICALS

    Dec 01, 2017

    Xiangxue Pharmaceutical has raised CNY500m ($75.56m) through the second tranche of a public offering of corporate bonds.


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    https://Pharmaceutical.report/news-article.aspx?ID=14101410

    RXI PHARMACEUTICALS AND THE CENTER FOR CANCER IMMUNE THERAPY AT HERLEV HOSPITAL ANNOUNCE RESEARCH COLLABORATION

    Dec 01, 2017

    RXi Pharmaceuticals Corporation (NASDAQ: RXII) a clinical-stage company developing a new class of RNAi-based therapeutics and the Center for Cancer Immune Therapy (CCIT) at Herlev Hospital.


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    https://Pharmaceutical.report/news-article.aspx?ID=14121412

    FDA APPROVES FIRST BIOSIMILAR FOR THE TREATMENT OF CERTAIN BREAST AND STOMACH CANCERS

    Dec 01, 2017

    The U.S. Food and Drug Administration today approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivr...


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    https://Pharmaceutical.report/news-article.aspx?ID=14131413

    NICE ASKS MERCK TO SUBMIT CANCER DRUGS FUND PROPOSAL FOR IMMUNOTHERAPY DRUG

    Nov 30, 2017

    The National Institute for Health and Care Excellence (NICE) has asked the pharmaceutical company, Merck, to submit a Cancer Drugs Fund (CDF) proposal for its immunotherapy drug avelumab (Bavencio; Merck).


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    https://Pharmaceutical.report/news-article.aspx?ID=14071407

    COMMUNITY PHARMACISTS IN WALES TO HAVE ACCESS TO GP RECORDS BY MARCH 2018

    Nov 30, 2017

    All pharmacies with access to the Choose Pharmacy IT system in Wales will be able to access the Welsh GP record by March 2018, it was announced at the Royal Pharmaceutical Society (RPS) Wales Medicines Safety Conference on 29 November 2017.


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    https://Pharmaceutical.report/news-article.aspx?ID=14081408

    AZ TEAMS UP WITH G1 ON LUNG CANCER COMBO

    Nov 29, 2017

    AstraZeneca has signed a deal with US group G1 Therapeutics to test the potential of a new combination therapy for lung cancer.


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    https://Pharmaceutical.report/news-article.aspx?ID=14021402

    SCOTLAND’S PHARMA INDUSTRY ‘A DRIVING FORCE’ FOR ECONOMIC GROWTH

    Nov 28, 2017

    New analysis highlights that Scotland’s pharmaceutical industry “can be a driving force” for long-term sustainable economic growth, says the Association of the British Pharmaceutical Industry Scotland.


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    https://Pharmaceutical.report/news-article.aspx?ID=13971397

    HIGHMARK HEALTH'S VITAL INNOVATION PROGRAM VALIDATES EFFECTIVE DRUG-FREE TREATMENT FOR PANIC ATTACKS

    Nov 28, 2017

    Highmark Health, Allegheny Health Network and Palo Alto Health Sciences, a manufacturer of Freespira, today announced the results of a pilot program completed through Highmark Health's VITAL Program.


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    https://Pharmaceutical.report/news-article.aspx?ID=14001400

    UK TRIAL ASSESSING AZ’ AZD1775 IN HEAD AND NECK CANCER

    Nov 27, 2017

    A clinical trial testing AstraZeneca’s experimental drug AZD1775, an inhibitor of the cell cycle regulating protein WEE1, in patients with head and neck cancer has now launched in the UK.


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    https://Pharmaceutical.report/news-article.aspx?ID=13941394

    TEEWINOT, A GLOBAL LEADER IN PHARMACEUTICAL CANNABINOID PRODUCTION, TO PRESENT AT CBI'S BIOPHARMA FORUM ON CANNABIS-BASED THERAPIE

    Nov 27, 2017

    Teewinot Life Sciences Corporation ("Teewinot"), is an international cannabinoid biotechnology company focused on advanced pharmaceutical research and commercialization. Teewinot is a leader in the formulation, manufacturing.


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    https://Pharmaceutical.report/news-article.aspx?ID=13961396

    GSK, INNOVIVA SEEK TO EXPAND SCOPE OF TRELEGY ELLIPTA

    Nov 23, 2017

    GlaxoSmithKline and Innoviva have submitted new data to regulators in the US in support of expanding the label of Trelegy Ellipta in chronic obstructive pulmonary disease.


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    https://Pharmaceutical.report/news-article.aspx?ID=13901390

    BAD NEWS FOR INNATE PHARMA AS BMS-BACKED DRUG STUMBLES

    Nov 23, 2017

    French biotech Innate Pharma says it can’t see a development path forward for its lead cancer drug lirilumab after another clinical trial miss. The Bristol-Myers Squibb-partnered checkpoint inhibitor, licensed in a $465m deal in 2011.


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    https://Pharmaceutical.report/news-article.aspx?ID=13921392

    AMERICAN HEALTH COUNCIL HONORS PAUL M. COLOMBANI, MD, FACS, FAAP AS “BEST IN MEDICINE”

    Nov 22, 2017

    Dr. Paul M. Colombani, Chairman of the Pediatric Surgery at Johns Hopkins All Children's Hospital, Professor of Surgery, Pediatrics, and Oncology at the Johns Hopkins University School of Medicine and the Robert Garrett Professor (Emeritus) of Pediatric.


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    https://Pharmaceutical.report/news-article.aspx?ID=13871387

    NOVARTIS' ORPHAN DRUG TASIGNA WINS EU EXPANDED INDICATION

    Nov 22, 2017

    Novartis has claimed another regulatory milestone for its chronic myeloid leukaemia (CML) drug Tasigna (nilotinib), winning approval for its use to treat children in the EU.


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    https://Pharmaceutical.report/news-article.aspx?ID=13881388

    JANSSEN’S ZYTIGA APPROVED FOR EARLIER USE IN PROSTATE CANCER

    Nov 21, 2017

    European regulators are allowing earlier use of Janssen’s Zytiga in the treatment pathway for metastatic prostate cancer.


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    https://Pharmaceutical.report/news-article.aspx?ID=13831383

    NEW STUDY RESULTS SUPPORT USE OF DIVITUM FOR EVALUATION OF PANCREATIC CANCER

    Nov 21, 2017

    In collaboration with University of Heidelberg, Germany, results from a clinical study of pancreatic cancer is published in the Pancreas scientific journal. The results demonstrate that Biovica’s DiviTum assay can provide an accurate prognosis and evaluation of treatment efficacy.


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    https://Pharmaceutical.report/news-article.aspx?ID=13841384

    ROCHE TO ACQUIRE VIEWICS, INC. TO PROVIDE DATA-DRIVEN LAB BUSINESS ANALYTICS AND ADD FURTHER DIGITAL CAPABILITIES ALONG THE LABORATORY VALUE CHAIN

    Nov 20, 2017

    Roche has announced an agreement with Viewics, Inc., a privately held software company focused on laboratory business analytics. Under the agreement, Roche is acquiring all shares of the company.


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    https://Pharmaceutical.report/news-article.aspx?ID=13781378

    2017 TECHNOLOGIES EMPOWERING DRUG DISCOVERY AND DEVELOPMENT - RESEARCH AND MARKETS

    Nov 20, 2017

    The "Technologies Empowering Drug Discovery and Development" report has been added to Research and Markets' offering. This Drug Discovery TechVision Opportunity Engine (TOE) provides insights into new approaches fueling therapeutic advancements.


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    https://Pharmaceutical.report/news-article.aspx?ID=13801380

    CAN-FITE’S FORMER SUBSIDIARY OPHTHALIX SUCCESSFULLY COMPLETES MERGER WITH WIZE PHARMA

    Nov 17, 2017

    Can-Fite BioPharma Ltd, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver, and inflammatory diseases, today announced that its previously majority-owned subsidiary OphthaliX, Inc.


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    https://Pharmaceutical.report/news-article.aspx?ID=13751375

    WUXI APPTEC ELECTED BY IQVIA STEM CELL CENTER TO SERVE AS GMP MANUFACTURER OF ADVANCED THERAPIES

    Nov 17, 2017

    WuXi AppTec (WuXi), a leading global pharmaceutical, biotechnology and medical device open-access capability and technology platform company, announced that its Advanced Therapy Unit based in Philadelphia has been selected as a manufacturing partner for advanced therapies through the California Inst...


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    https://Pharmaceutical.report/news-article.aspx?ID=13761376

    FIRST DRUG WITH AN INGESTIBLE SENSOR APPROVED

    Nov 16, 2017

    The FDA has approved Abilify MyCite (Otsuka), tablets of aripiprazole embedded with an ingestible sensor that can record that the medication was taken. The tablet with the sensor is an attempt to help increase adherence to medication regimens.


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    https://Pharmaceutical.report/news-article.aspx?ID=13711371

    SONOMA PHARMACEUTICALS ANNOUNCES FDA APPROVAL OF EXPANDED INDICATION FOR ALEVICYN™ TO ADD ANTIMICROBIAL LANGUAGE

    Nov 16, 2017

    Sonoma Pharmaceuticals, Inc. (Nasdaq: SNOA, warrants SNOAW), a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care.


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    https://Pharmaceutical.report/news-article.aspx?ID=13721372

    AZ’ FASENRA GETS US NOD FOR EOSINOPHILIC ASTHMA

    Nov 15, 2017

    AstraZeneca’s biologic Fasenra has picked up its first global approval in the US as a treatment for severe, eosinophilic asthma, a difficult to treat a form of the condition.


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    https://Pharmaceutical.report/news-article.aspx?ID=13661366

    NOVARTIS, ASCP AND ACS JOIN FORCES TO FIGHT CANCER IN ETHIOPIA, UGANDA AND TANZANIA

    Nov 15, 2017

    Novartis, the American Society for Clinical Pathology (ASCP) and the American Cancer Society (ACS) announced today they will work together to devise a common approach to improve access to cancer treatment in Sub-Saharan Africa.


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    https://Pharmaceutical.report/news-article.aspx?ID=13681368

    EU PRIME STATUS FOR MEREO’S BRITTLE BONE DRUG

    Nov 14, 2017

    London, UK-based Mereo BioPharma’s experimental drug targeting brittle bone disease has been designated PRIME status by the European Medicines Agency (EMA). Brittle bone disease, or osteoporosis imperfect (OI), is a rare genetic disorder characterized by fragile bones and reduced bone mass res...


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    https://Pharmaceutical.report/news-article.aspx?ID=13621362

    MEDICARE MONDAY: SAME BAD IDEAS CONTINUE TO THREATEN PART D AND BENEFICIARY ACCESS TO MEDICINES

    Nov 13, 2017

    Perhaps the biggest fact that is often overlooked in Part D is that there is already significant price negotiation in the program. Thanks to Part D’s competitive structure, large purchasers often negotiate steep discounts and rebates with prescription drug manufacturers.


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    https://Pharmaceutical.report/news-article.aspx?ID=13631363

    BIOTHERA PHARMACEUTICALS PRESENTS DATA BROADENING IMPRIME PGG MECHANISM OF ACTION

    Nov 13, 2017

    Biothera Pharmaceuticals, Inc. announced today the presentation of clinical and preclinical research supporting the mechanism of action for the Company’s cancer immunotherapy Imprime PGG, which is currently being evaluated in combination with immune checkpoint inhibitor therapy in multiple Pha...


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    https://Pharmaceutical.report/news-article.aspx?ID=13591359

    ARUP LABORATORIES AND APPLIED SPECTRAL IMAGING BRING MEDICAL INNOVATION TO PATHOLOGY

    Nov 13, 2017

    ARUP Laboratories, a national pathology reference laboratory, and Applied Spectral Imaging (ASI), a global leader in computer-assisted biomedical imaging, announced today they have completed a multi-year collaboration, leading to the launch of ASI's PathFusion™, a cutting-edge solution tha...


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    https://Pharmaceutical.report/news-article.aspx?ID=13601360

    SUNOVION ANNOUNCES FDA ACCEPTANCE FOR REVIEW OF NEW DRUG APPLICATION FOR DASOTRALINE FOR THE TREATMENT OF ADHD

    Nov 10, 2017

    Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) being evaluated for the treatment of attention d...


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    https://Pharmaceutical.report/news-article.aspx?ID=13561356

    SUPER-RESOLUTION PHOTOACOUSTIC IMAGING COULD ALLOW SCIENTISTS TO WATCH BLOOD VESSELS WITH IMPROVED RESOLUTION

    Nov 09, 2017

    Researchers have reported an approach to photoacoustic imaging that offers a vastly improved resolution, setting the stage for detailed in vivo imaging of deep tissue. The technique is based on computational improvements, so it can be performed with existing imaging hardware, and thus could provide ...


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    https://Pharmaceutical.report/news-article.aspx?ID=13521352

    SANOFI, PRINCIPIA AGREE TO DEVELOP MULTIPLE SCLEROSIS DRUG CANDIDATE

    Nov 09, 2017

    Sanofi will develop Principia Biopharma Inc.'s experimental oral treatment that shows promise in multiple sclerosis (MS) and, potentially, another central nervous system (CNS) diseases. Under the license agreement signed this week.


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    https://Pharmaceutical.report/news-article.aspx?ID=13531353

    REDHILL BIOPHARMA PRICES PUBLIC OFFERING OF ITS AMERICAN DEPOSITARY SHARES

    Nov 08, 2017

    RedHill Biopharma Ltd. (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal and inflammatory diseases and cancer...


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    https://Pharmaceutical.report/news-article.aspx?ID=13471347

    NEURALSTEM STRENGTHENS EXECUTIVE LEADERSHIP TEAM WITH APPOINTMENT OF DR. DAVID RECKER AS CHIEF MEDICAL OFFICER

    Nov 08, 2017

    Neuralstem, Inc. a biopharmaceutical company developing novel treatments for nervous system diseases, today announced the appointment of David Recker, MD, FACR, FACP, as Chief Medical Officer.


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    https://Pharmaceutical.report/news-article.aspx?ID=13481348

    SPARK THERAPEUTICS AND PFIZER AMEND LICENSE AGREEMENT FOR INVESTIGATIONAL SPK-9001 IN HEMOPHILIA B

    Nov 08, 2017

    Spark Therapeutics and Pfizer Inc. has entered into an amendment to their license agreement for SPK-9001, an investigational gene therapy for hemophilia B. Spark Therapeutics will enroll up to five additional participants in the current Phase 1/2 clinical trial who will receive SPK-9001 manufactured...


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    https://Pharmaceutical.report/news-article.aspx?ID=13491349

    AETNA INTRODUCES NEW LOW-COST PRESCRIPTION DRUG PLAN (PDP)

    Nov 07, 2017

    Aetna announced the launch of Aetna Medicare Rx® Select (PDP). This new, low-cost prescription drug plan is designed for active, cost-conscious consumers. The plan will be available beginning January 1, 2018, in 27 states2 and the District of Columbia.


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    https://Pharmaceutical.report/news-article.aspx?ID=13441344

    GSK’S R&D CHIEF TO LEAVE FOR UK GOV ROLE?

    Nov 06, 2017

    GlaxoSmithKline’s head of R&D Patrick Vallance is reportedly leaving the firm to take on the role of chief scientific advisor at the government. According to the Financial Times, which cited “two people briefed on the situation”, Vallance will also become head of the Government...


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    https://Pharmaceutical.report/news-article.aspx?ID=13391339

    CAN CANNABINOIDS BE USED TO TREAT CANCER?

    Nov 06, 2017

    When cannabinoids activate signaling pathways in cancer cells they can stimulate a cell death mechanism called apoptosis, unleashing a potent anti-tumor effect. Yet cannabinoids, which have also shown strong activity against human tumor tissue grown in animal models, have undergone minimal testing i...


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    https://Pharmaceutical.report/news-article.aspx?ID=13411341

    BASF TO ENTER MEDICAL FOODS MARKET IN THE US WITH DIEM LABS

    Nov 03, 2017

    As part of this agreement, BASF will use its scientific expertise and state-of-the-art manufacturing capabilities to provide a first-to-the-market medical food product to patients with NAFLD. DIEM Labs will market the product to health care professionals in the U.S. and sell it through an online hub...


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    https://Pharmaceutical.report/news-article.aspx?ID=13361336

    AMGEN AND NOVARTIS ANNOUNCE EXPANDED COLLABORATION WITH BANNER ALZHEIMER'S INSTITUTE IN PIONEERING PREVENTION PROGRAM

    Nov 03, 2017

    Amgen and Novartis announced an expanded collaboration with the Banner Alzheimer's Institute (BAI) to initiate a new trial - the Alzheimer's Prevention Initiative (API) Generation Study 2. This trial follows the launch of the Generation Study 1, and will determine whether the BACE1 inhibitor...


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    https://Pharmaceutical.report/news-article.aspx?ID=13381338

    US FDA GRANTS ORPHAN DRUG DESIGNATION FOR RETROTOPE’S RT001 IN THE TREATMENT OF PHOSPHOLIPASE 2G6 (PLA2G6)-ASSOCIATED NEURODEGENERATION

    Nov 02, 2017

    Retrotope announced today that the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Products Development (OOPD) granted orphan drug designation for its chemically-modified polyunsaturated fatty acid drug (RT001) for the treatment of PLA2G6 associated neurodegeneration (PLAN).


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    https://Pharmaceutical.report/news-article.aspx?ID=13311331

    UROGEN PHARMA APPOINTS FORMER KITE PHARMA CHIEF OPERATING OFFICER CYNTHIA M. BUTITTA TO ITS BOARD OF DIRECTORS

    Nov 02, 2017

    UroGen Pharma Ltd, a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced the appointment of Cynthia M. Butitta to its board of directors, effective immediately.


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    https://Pharmaceutical.report/news-article.aspx?ID=13321332

    AS AMAZON ENTRY INTO PHARMA LOOMS, CEOS SEE PLENTY OF ROOM FOR CHANGE IN DISTRIBUTION

    Nov 02, 2017

    Online retailing giant Amazon has yet to publicly disclose any plans to get into drug sales, but the mere speculation has pharma CEOs thinking, and speaking, about how it could entirely remake their world.


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    https://Pharmaceutical.report/news-article.aspx?ID=13341334

    CATAPULT OFFERS UK SMES HIGH-RESOLUTION ANALYSIS

    Nov 01, 2017

    Medicines Discovery Catapult is inviting UK SMEs working in medicines development to work together on high-resolution analysis of potential drug targets.


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    https://Pharmaceutical.report/news-article.aspx?ID=13261326

    CYCLACEL PHARMACEUTICALS ANNOUNCES THAT FULL RESULTS FROM THE PHASE 3 SEAMLESS TRIAL HAVE BEEN SELECTED FOR ORAL PRESENTATION AT ASH ANNUAL MEETING

    Nov 01, 2017

    Cyclacel Pharmaceuticals, Inc. (Cyclacel or the Company), a clinical-stage biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative, targeted medicines for cancer and other proliferative diseases.


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    https://Pharmaceutical.report/news-article.aspx?ID=13271327

    SYSTEMATIC REVIEW LOOKS AT THE EFFECTIVENESS AND SIDE EFFECTS OF MEFLOQUINE

    Oct 31, 2017

    Researchers have published two systematic reviews revealing the safety of mefloquine (Lariam) for preventing malaria in travellers. “Mefloquine is at least as effective as other options,” says Dr Tickell-Painter, from the Liverpool School of Tropical Medicine, lead author on both papers, “But patien...


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    https://Pharmaceutical.report/news-article.aspx?ID=13231323

    AZ FARMS OUT RARE DISEASE THERAPY TO MEREO

    Oct 31, 2017

    AstraZeneca has licensed an experimental rare disease therapy to UK-based Mereo BioPharma, as it continues to shed products outside of its area of strategic focus.


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    https://Pharmaceutical.report/news-article.aspx?ID=13241324

    NOVARTIS ANNOUNCES THE PLANNED ACQUISITION OF ADVANCED ACCELERATOR APPLICATIONS TO STRENGTHEN ONCOLOGY PORTFOLIO

    Oct 30, 2017

    Novartis announced today, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions.


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    https://Pharmaceutical.report/news-article.aspx?ID=13171317

    2016 SAW JUMP IN COMPLAINTS TO UK PHARMA REGULATOR

    Oct 30, 2017

    The number of complaints to the Prescription Medicines Code of Practice Authority, which polices adherence to the Association of the British Pharmaceutical Industry’s Code of Practice, jumped significantly last year.


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    https://Pharmaceutical.report/news-article.aspx?ID=13181318

    SHIRE’S HAE DRUG FIRAZYR CLEARED FOR CHILDREN

    Oct 27, 2017

    European regulators have approved a label extension for Shire’s Firazyr, broadening its use include adolescents and children aged two years and older with a particular type of HAE.


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    https://Pharmaceutical.report/news-article.aspx?ID=13131313

    NEW INITIATIVE TO ACCELERATE DEVELOPMENT OF UNIVERSAL INFLUENZA VACCINES

    Oct 27, 2017

    The Human Vaccines Project, a public-private partnership with a mission to decode the immune system to advance human health, has announced the launch of the Universal Influenza Vaccine Initiative (UIVI).


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    https://Pharmaceutical.report/news-article.aspx?ID=13161316

    FDA REJECTS PTC’S DMD DRUG TRANSLARNA

    Oct 26, 2017

    PTC Therapeutics will need to carry out at least one further trial to demonstrate the effectiveness of its Duchenne Muscular Dystrophy therapy Translarna if it is to have a chance of bagging its approval in the US.


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    https://Pharmaceutical.report/news-article.aspx?ID=13081308

    FDA REJECTS PTC’S DMD DRUG TRANSLARNA

    Oct 26, 2017

    PTC Therapeutics will need to carry out at least one further trial to demonstrate the effectiveness of its Duchenne Muscular Dystrophy therapy Translarna if it is to have a chance of bagging its approval in the US.


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    https://Pharmaceutical.report/news-article.aspx?ID=13091309

    TRANSPLANTED HEMATOPOIETIC STEM CELLS REVERSE DAMAGE CAUSED BY NEURO-MUSCULAR DISORDER

    Oct 26, 2017

    Researchers at University of California San Diego School of Medicine report that a single infusion of wildtype hematopoietic stem and progenitor cells (HSPCs) into a mouse model of Friedreich's ataxia (FA) measurably halted cellular damage caused by the degenerative disease.


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    https://Pharmaceutical.report/news-article.aspx?ID=13101310

    GILEAD PRESENTS PROMISING DATA FOR NASH DRUG

    Oct 25, 2017

    Gilead has presented promising Phase II results for its experimental NASH drug GS-0976, showing significant reductions in the buildup of liver fat and a marker of fibrosis.


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    https://Pharmaceutical.report/news-article.aspx?ID=13041304

    FDA RECOGNIZES ORPHAN DRUG EXCLUSIVITY FOR ADAMAS’ GOCOVRI

    Oct 25, 2017

    Adamas Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Drug Products (OOPD) has recognized by letter to the company the seven-years of orphan drug exclusivity for GOCOVRI (amantadine) extended release capsules, the first and only FDA-approved m...


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    https://Pharmaceutical.report/news-article.aspx?ID=13071307

    EX-COPS + ORANGE IS THE NEW BLACK ACTOR SAY NO TO THE DRUG WAR ON CANNABIS PLANET

    Oct 24, 2017

    Actor Matt Peters from the hit NETFLIX original series Orange is the New Black and a group of former law enforcement officers will speak out about the hypocrisy of America's war on drugs this weekend on Cannabis Planet.


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    https://Pharmaceutical.report/news-article.aspx?ID=13021302

    INNOVATION PHARMACEUTICALS PROVIDES DEVELOPMENT UPDATE ON BRILACIDIN FOR INFLAMMATORY BOWEL DISEASE

    Oct 24, 2017

    Innovation Pharmaceuticals Inc, a clinical stage biopharmaceutical company, is pleased to provide a development update for Brilacidin as a promising novel, non-corticosteroid, non-biologic treatment for Inflammatory Bowel Disease (IBD).


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    https://Pharmaceutical.report/news-article.aspx?ID=13031303

    MEDICINES DISCOVERY CATAPULT, ANTRUK START ANTIBIOTICS PROJECT

    Oct 20, 2017

    Medicines Discovery Catapult and ANTRUK Enterprises, a wholly owned subsidiary of the charity Antibiotic Research UK, are working together on the inaugural project at the former’s new facility at the University.


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    https://Pharmaceutical.report/news-article.aspx?ID=12961296

    CPHI ANNUAL REPORT REVEALS SLOW AND DISCOURAGING TRENDS IN CURRENT DRUG PIPELINES

    Oct 19, 2017

    The current drugs pipeline is discouraging and slowing simple manufacturing innovations according to the CPhI Annual Report, undertaken by UBM, which focuses on the immediate and long-term trends in pharmaceutical manufacturing and ingredients.


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    https://Pharmaceutical.report/news-article.aspx?ID=12991299

    BMS SCORES AN EARLY VICTORY IN THE NEW CANCER BIOMARKER BATTLE

    Oct 16, 2017

    This is a measurement of the quantity of mutations carried by a tumour – and it is thought that cancer cells with a high TMB may have more antigens that could be targeted by cancer immunotherapies. Cancer cells with high TMB tend to have acquired, or somatic mutations, that have developed as the dis...


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    https://Pharmaceutical.report/news-article.aspx?ID=12921292

    IMMUNOGEN ANNOUNCES INVESTIGATIONAL NEW DRUG APPLICATION FOR IMGN632 FOR HEMATOLOGICAL MALIGNANCIES IS ACTIVE

    Oct 16, 2017

    ImmunoGen, Inc., a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has completed the safety review of its investigational new drug (IND) application for IMGN632 in patients with CD123-posit...


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    https://Pharmaceutical.report/news-article.aspx?ID=12951295

    ROCHE’S SKIN CANCER DRUG ERIVEDGE PULLED FROM CDF

    Oct 13, 2017

    Roche’s Erivedge could be removed from the Cancer Drugs Fund within months after the National Institute for Health and Care Excellence ruled that the drug was not a cost-effective treatment for skin cancer.


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    https://Pharmaceutical.report/news-article.aspx?ID=12891289

    MEDTRONIC AND MERCY ANNOUNCE DATA SHARING PARTNERSHIP TO ACCELERATE MEDICAL DEVICE INNOVATION

    Oct 13, 2017

    Medtronic plc, the global leader in medical technology, and Mercy, the fifth largest Catholic health care system in the U.S, together will establish a new data sharing and analysis network that helps gather clinical evidence for medical device innovation and patient access.


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    https://Pharmaceutical.report/news-article.aspx?ID=12911291

    MSD PULLS PLUG ON CHOLESTEROL DRUG ANACETRAPIB

    Oct 12, 2017

    MSD has decided to pull the plug on its late-stage cholesterol drug anacetrapib after a lacklustre performance in clinical trials. The company said it would not file for approval of the investigational cholesteryl ester transfer protein (CETP) inhibitor on the back of a review of its clinical profil...


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    https://Pharmaceutical.report/news-article.aspx?ID=12861286

    FIRST PATIENT TREATED WITH TITAN PHARMACEUTICALS' SUBDERMAL IMPLANT FOR PARKINSON'S DISEASE

    Oct 11, 2017

    Titan Pharmaceuticals, Inc, a company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura long-term, continuous drug delivery technology, announced today that the first patient has been treated in a Phase 1/2 trial of the company's ropinirole impla...


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    https://Pharmaceutical.report/news-article.aspx?ID=12821282

    INNOVUS PHARMACEUTICALS EXPANDS ITS INTERNATIONAL PROPRIETARY PRODUCT PATENT PORTFOLIO WITH ITS FIRST CHINESE PATENT

    Oct 11, 2017

    Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging over-the-counter (“OTC”) consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and con...


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    https://Pharmaceutical.report/news-article.aspx?ID=12831283

    ALLERGY DRUG IMPROVES FUNCTION IN PATIENTS WITH CHRONIC INJURY FROM MULTIPLE SCLEROSIS

    Oct 11, 2017

    In a remarkably rapid translation of laboratory research findings into a treatment with the potential to benefit patients, UC San Francisco scientists have successfully completed a Phase II clinical trial showing that an FDA-approved antihistamine restores nervous system function in patients with ch...


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    https://Pharmaceutical.report/news-article.aspx?ID=12841284

    AKCEA’S RARE LIPID DISORDER DRUG WINS PIM STATUS

    Oct 10, 2017

    Akcea Therapeutics’s volanesorsen has been granted a Promising Innovative Medicine (PIM) designation by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of familial chylomicronaemia syndrome (FCS), a rare genetic lipid disorder.


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    https://Pharmaceutical.report/news-article.aspx?ID=12781278

    AZ’ LUNG CANCER DRUG TAGRISSO BAGS BREAKTHROUGH STATUS

    Oct 10, 2017

    AstraZeneca’s Tagrisso has been awarded breakthrough status in the US as a first-line treatment for a specific type of non-small cell lung cancer (NSCLC), potentially speeding up its development and regulatory pathway.


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    https://Pharmaceutical.report/news-article.aspx?ID=12791279

    FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION TO TAGRISSO FOR NSCLC

    Oct 09, 2017

    AstraZeneca has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).


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    https://Pharmaceutical.report/news-article.aspx?ID=12751275

    FDA AWARDS 15 GRANTS FOR CLINICAL TRIALS TO STIMULATE PRODUCT DEVELOPMENT FOR RARE DISEASES

    Oct 06, 2017

    The U.S. Food and Drug Administration today announced that it has awarded 15 new clinical trial research grants totaling more than $22 million over the next four years to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from ...


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    https://Pharmaceutical.report/news-article.aspx?ID=12731273

    ENGINEERING APPROACH COMBINES DRUGS TO CONTROL PARASITIC WORMS

    Oct 05, 2017

    Researchers have developed an experiment that demonstrates an engineering technology – which can quickly identify potential drug combinations that are effective on a small-animal model organism. The experiment could lead to further work that produces effective treatments for parasitic roundworms, or...


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    https://Pharmaceutical.report/news-article.aspx?ID=12701270

    MOST CANCER DRUGS APPROVED BY EMA SHOW LITTLE BENEFIT: STUDY

    Oct 05, 2017

    The research, published in the BMJ, looked at the 48 cancer drugs in 68 indications approved by the Agency over the four-year time period. Of these, eight indications (12%) were approved on the basis of a single-arm study. At the time of market approval, 24 (35%) of the indications showed significan...


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    https://Pharmaceutical.report/news-article.aspx?ID=12711271

    FDA APPROVES MYLAN'S GENERIC COPAXONE

    Oct 04, 2017

    The US Food and Drug Administration has approved Mylan’s generic version of Teva’s blockbuster multiple sclerosis (MS) drug Copaxone. Several companies have already developed their own versions of Copaxone (glatiramer acetate), but it is a lucrative market with a great deal of scope: the branded pro...


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    https://Pharmaceutical.report/news-article.aspx?ID=12671267

    INNOVUS PHARMA ANNOUNCES THE AVAILABILITY OF THE FULL LABEL FOR ITS NASAL DRUG FLUTICARE FOR ALLERGY SYMPTOM RELIEF ON DAILYMED

    Oct 03, 2017

    Innovus Pharmaceuticals, Inc. ("Innovus Pharma" or the “Company”) (OTCQB Venture Market: INNV), an emerging over-the-counter (“OTC”) consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine and con...


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    https://Pharmaceutical.report/news-article.aspx?ID=12631263

    AMGEN AND CYTOMX THERAPEUTICS ANNOUNCE STRATEGIC COLLABORATION IN IMMUNO-ONCOLOGY

    Oct 03, 2017

    Amgen and CytomX Therapeutics, Inc, today announced that the companies have entered into a strategic collaboration in immuno-oncology. The companies will co-develop a CytomX ProbodyTM T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target e...


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    https://Pharmaceutical.report/news-article.aspx?ID=12641264

    COMPUTER MODEL SHOWS AN OPTIMAL ANTI-AMYLOID TREATMENT

    Oct 02, 2017

    A group of scientists have created a computer model to analyse amyloid beta accumulation. Scientists from the Institute for Systems Biology Moscow took information from published papers and clinical studies, analysed it and described the laws by equations. Although there is a huge amount of the data...


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    https://Pharmaceutical.report/news-article.aspx?ID=12611261

    COMPUTER MODEL SHOWS AN OPTIMAL ANTI-AMYLOID TREATMENT

    Oct 02, 2017

    A group of scientists have created a computer model to analyse amyloid beta accumulation. Scientists from the Institute for Systems Biology Moscow took information from published papers and clinical studies, analysed it and described the laws by equations. Although there is a huge amount of the data...


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    https://Pharmaceutical.report/news-article.aspx?ID=12621262

    IDF AND NOVO NORDISK LAUNCH FIRST-EVER GLOBAL SURVEY ON CARDIOVASCULAR DISEASE AWARENESS AMONG PEOPLE WITH TYPE 2 DIABETES

    Sep 29, 2017

    To mark World Heart Day today, the International Diabetes Federation (IDF) has partnered with Novo Nordisk to launch the first-ever multi-country online survey investigating the level of CVD awareness and knowledge among people living with type 2 diabetes. The global survey - Taking Diabetes to Hear...


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    https://Pharmaceutical.report/news-article.aspx?ID=12551255

    PATIENT GROUPS SHARPEN THEIR CAPABILITIES TO PROTECT ACCESS TO MEDICINES FOR TREATING RARE BLEEDING DISORDERS

    Sep 29, 2017

    The Great Lakes Hemophilia Foundation (GLHF) headquartered in Milwaukee, Wis., the New York City Hemophilia Chapter (NYCHC) and the Ohio Bleeding Disorders Council (OBDC) in Columbus take on complex legislative and public policy issues to ensure patients' voices are heard in their statehouses.


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    https://Pharmaceutical.report/news-article.aspx?ID=12571257

    PARKINSON’S DISEASE DRUG CARBIDOPA SHOWS ANTICANCER EFFECTS

    Sep 29, 2017

    Research shows the Parkinson’s disease drug carbidopa displays significant anticancer effects in both human cell lines and mice when given at normal patient dosage levels. This discovery may explain the low incidence of many cancers in patients with Parkinson’s disease and could lead the way to carb...


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    https://Pharmaceutical.report/news-article.aspx?ID=12581258

    NOVARTIS AND UC BERKELEY COLLABORATE TO TACKLE 'UNDRUGGABLE' DISEASE TARGETS

    Sep 28, 2017

    Novartis has joined forces with researchers from the University of California, Berkeley, to develop new technologies for the discovery of next-generation therapeutics, pursuing the vast number of disease targets in cancer and other illnesses that have eluded traditional small-molecule compounds and ...


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    https://Pharmaceutical.report/news-article.aspx?ID=12511251

    NICE KNOCKS-BACK JANSSEN'S IMBRUVICA IN MANTLE CELL LYMPHOMA

    Sep 28, 2017

    Janssen has received mixed news from the UK’s cost-effectiveness watchdog for its cancer drug Imbruvica (ibrutinib). In draft guidance NICE has declined to recommend Imbruvica’s use in England and Wales to treat mantle cell lymphoma.


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    https://Pharmaceutical.report/news-article.aspx?ID=12541254

    FDA LUKEWARM ON PTC’S TRANSLARNA

    Sep 27, 2017

    PTC Therapeutics has been dealt a blow by the US Food and Drug Administration, which has published a lukewarm background briefing on Duchenne muscular dystrophy (DMD) drug Translarna (ataluren) ahead of a key FDA advisory committee meeting this week.


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    https://Pharmaceutical.report/news-article.aspx?ID=12471247

    NATIONAL CANCER INSTITUTE SELECTS APEXIAN PHARMACEUTICALS TO PARTICIPATE IN THE SMALL BUSINESS INNOVATION RESEARCH (SBIR) INITIATIVE PROGRAM

    Sep 27, 2017

    Apexian Pharmaceuticals is pleased to announce that the National Cancer Institute (NCI) has selected the company to participate in its highly competitive Small Business Innovation Research (SBIR) Investor Initiatives program, that encourages domestic small businesses to engage in Research and Develo...


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    https://Pharmaceutical.report/news-article.aspx?ID=12501250

    FDA CONDUCTS MAJOR GLOBAL OPERATION TO PROTECT CONSUMERS FROM POTENTIALLY DANGEROUS PRESCRIPTION DRUGS SOLD ONLINE

    Sep 26, 2017

    The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved versions of prescription medicines, including opioids, antibiotics and injectabl...


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    https://Pharmaceutical.report/news-article.aspx?ID=12431243

    DAIICHI SANKYO ANNOUNCES TANEDS GLOBAL 2018 COLLABORATIVE DRUG DISCOVERY PROGRAM

    Sep 26, 2017

    Daiichi Sankyo Company, Limited today announced details of the application for its Take a New Challenge for Drug Discovery (TaNeDS) Global 2018, a collaborative drug discovery initiative for universities and research institutes in Europe and the East Coast of the United States.


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    https://Pharmaceutical.report/news-article.aspx?ID=12441244

    BEVESPI AEROSPHERE DEMONSTRATES STATISTICALLY SIGNIFICANT IMPROVEMENT IN LUNG FUNCTION IN PATIENTS WITH COPD

    Sep 25, 2017

    AstraZeneca today announced positive top-line results of the Phase III, PINNACLE 4 trial in which Bevespi Aerosphere* (glycopyrronium and formoterol fumarate 14.4/9.6 µg) demonstrated a statistically significant improvement in lung function as measured by trough forced expiratory volume in one secon...


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    https://Pharmaceutical.report/news-article.aspx?ID=12391239

    STRONGBRIDGE BIOPHARMA PLC LAUNCHES THE UNCOVERING PERIODIC PARALYSIS GENETIC TESTING PROGRAM

    Sep 25, 2017

    Strongbridge Biopharma plc, a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced the launch of a genetic testing program for hyperkalemic or hypokalemic periodic paralysis.


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    https://Pharmaceutical.report/news-article.aspx?ID=12421242

    NOVARTIS AND THE MAX FOUNDATION TRANSFORM PIONEERING CANCER ACCESS PROGRAM FOR PEOPLE IN LOWER-INCOME COUNTRIES

    Sep 22, 2017

    Novartis announced a new collaboration with The Max Foundation to support continued access to treatment at no cost for nearly 34,000 current patients with chronic myeloid leukemia (CML), gastrointestinal tumors (GIST) and other rare cancers.


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    https://Pharmaceutical.report/news-article.aspx?ID=12351235

    AVROBIO, INC. EXPANDS RARE DISEASE PIPELINE WITH GENE THERAPY TO TREAT POMPE DISEASE

    Sep 22, 2017

    AVROBIO, Inc., a clinical-stage biotechnology company developing transformative, life-changing gene therapies for rare diseases, today announced the expansion of its pipeline to Pompe disease. This pre-clinical program becomes AVROBIO’s third gene therapy for Lysosomal Storage Disorders (LSDs), foll...


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    https://Pharmaceutical.report/news-article.aspx?ID=12381238

    NEW INTELLIGENCE TOOL TO HELP CUT DOWN ON LATE NIGHTS FOR DRUG DEVELOPMENT SCIENTISTS

    Sep 21, 2017

    Hanson Wade, the London-based life sciences knowledge services specialist, has launched Beacon Targeted Therapies (www.beacon-intelligence.com) to create clarity for scientists struggling to make sense of the vast volumes of unstructured clinical and preclinical drug development data.


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    https://Pharmaceutical.report/news-article.aspx?ID=12331233

    ATLANT CLINICAL HAS SUCCESSFULLY COMPLETED A STUDY INCLUDING OVER SIX THOUSAND PATIENTS WITH COPD

    Sep 21, 2017

    Atlant Clinical has successfully completed an international, multicenter, randomized, phase IV study in patients with chronic obstructive pulmonary disease (COPD). The trial was conducted for an international pharma company and included 6,065 patients at 53 sites in 37 cities worldwide.


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    https://Pharmaceutical.report/news-article.aspx?ID=12341234

    NEW NOVARTIS BLOOD CANCER DRUG APPROVED IN EU

    Sep 20, 2017

    For the first time, patients with a rare and life-threatening blood disorder have a treatment option after Novartis’ Rydapt got an EU licence for aggressive systemic mastocytosis, related blood cancers, and acute myeloid leukaemia.


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    https://Pharmaceutical.report/news-article.aspx?ID=12271227

    UK FIRMS LINK TO DEVELOP ADCS FOR CANCER

    Sep 20, 2017

    UK groups Glythera and IONTAS are working together on the development of antibody drug conjugates for difficult-to-treat cancers. The companies have signed a deal under which IONTAS will generate novel, fully human antibodies against specified targets for proof-of-concept studies.

    SELINA MCKEE
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    https://Pharmaceutical.report/news-article.aspx?ID=12291229

    NHS SEAL OF APPROVAL FOR GESTATIONAL DIABETES APP

    Sep 19, 2017

    A smartphone app to help pregnant women manage gestational has been approved to become part of the NHS Apps Library. Developed by Drayson Technologies, GDm-Health addresses gestational diabetes mellitus (GDm) – a form of glucose intolerance that begins during pregnancy and resolves following birth.


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    https://Pharmaceutical.report/news-article.aspx?ID=12241224

    SIRIS MEDICAL INC. RAISES $4 MILLION TO IMPROVE CANCER RADIATION TREATMENT WITH ARTIFICIAL INTELLIGENCE

    Sep 19, 2017

    Siris Medical, a Redwood City-based company which has commercialized the first artificial intelligence treatment decision support system in radiation therapy, announced today it has raised $4.0 million in Series A1 financing. The proceeds will be used to expand commercialization of its QuickMatch™ s...


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    https://Pharmaceutical.report/news-article.aspx?ID=12261226

    BAYER’S RARE CANCER DRUG ALIQOPA BAGS SPEEDY APPROVAL

    Sep 18, 2017

    US regulators have issued an accelerated approval for Bayer’s relapsed follicular lymphoma therapy Aliqopa. The decision allows physicians in the country to prescribe the drug to patients who have received at least two prior systemic therapies. Follicular lymphoma is a slow-growing type of non-Hodgk...


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    https://Pharmaceutical.report/news-article.aspx?ID=12201220

    GLOBAL CANCER PHOTODYNAMIC THERAPY MARKET & CANCER PHOTOSENSITISERS CLINICAL TRIAL OUTLOOK 2023

    Sep 18, 2017

    Efficacy and safety of a therapeutic method has always been the prime concern during treatment of an ailment. Any therapeutic method that fulfills the above criteria has been deemed to be a successful procedure. Nonetheless, patients and health professionals not only seek the efficacy and safety of ...


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    https://Pharmaceutical.report/news-article.aspx?ID=12221222

    FDA APPROVES FIRST CANCER BIOSIMILAR

    Sep 15, 2017

    The US Food and Drug Administration has approved Amgen’s Mvasi (bevacizumab-awwb) as a biosimilar to Roche/Genentech’s Avastin (bevacizumab) for the treatment of multiple types of cancer, making it the first biosimilar approved in the country for the treatment of cancer. Mvasi is approved for the tr...


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    https://Pharmaceutical.report/news-article.aspx?ID=12151215

    JAGUAR HEALTH SUBSIDIARY NAPO PHARMACEUTICALS EXPANDS MYTESI SALESFORCE WITH HIRE OF EXPERIENCED HIV & GI DRUG SALES REPS IN KEY U.S. MARKETS

    Sep 15, 2017

    Jaguar Health, Inc, a natural-products pharmaceuticals company focused on developing and commercializing novel, sustainably derived gastrointestinal products for both human prescription use and animals on a global basis, announced today that its wholly-owned subsidiary.


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    https://Pharmaceutical.report/news-article.aspx?ID=12181218

    ACADEMIC DRUG DISCOVERY IN MICHIGAN SYMPOSIUM PRESENTED BY MICHBIO AND UNIVERSITY RESEARCH CORRIDOR

    Sep 14, 2017

    The “Cutting Edge / Drug Discovery & Development in Michigan Symposium” will feature how new therapeutic entities are being discovered and advanced from idea to clinical proof-of-concept at the University of Michigan, Wayne State University and Michigan State University, that make up the University ...


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    https://Pharmaceutical.report/news-article.aspx?ID=12131213

    TEMPUS AND CLEVELAND CLINIC COLLABORATE ON PERSONALIZED MEDICINE INITIATIVE

    Sep 14, 2017

    Tempus, a technology company focused on helping doctors personalize cancer care by collecting and analyzing large volumes of molecular and clinical data, and Cleveland Clinic Taussig Cancer Institute will collaborate on a precision medicine initiative aimed at improving outcomes for patients diagnos...


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    https://Pharmaceutical.report/news-article.aspx?ID=12141214

    FDA GRANTS FAST-TRACK DESIGNATION FOR SHIRE'S LUNG DRUG

    Sep 13, 2017

    The FDA has granted Fast Track designation to Shire's SHP607 for the prevention of chronic lung disease in extremely premature infants. SHP607, currently in phase 2 clinical development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1)...


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    https://Pharmaceutical.report/news-article.aspx?ID=12071207

    INSPYR THERAPEUTICS AND LEWIS AND CLARK PHARMACEUTICALS COMPLETE MERGER

    Sep 13, 2017

    Inspyr Therapeutics, a clinical-stage biotechnology company, and Lewis and Clark Pharmaceuticals today announced the successful completion of a merger to create an integrated biotechnology company. The newly combined company creates a second proprietary technology platform, broad capability laborato...


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    https://Pharmaceutical.report/news-article.aspx?ID=12101210

    SMC ACCEPTS 4 NEW MEDICINES

    Sep 12, 2017

    The Scottish Medicines Consortium (SMC) has today published advice accepting four new medicines for use by NHS Scotland. Alan Pharmaceuticals' Diacomit (stiripentol) has been accepted for the treatment of children with a very rare type of epilepsy known as Dravet’s syndrome. This type of epilepsy ap...


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    https://Pharmaceutical.report/news-article.aspx?ID=12031203

    FIP ON AGGRESSIVE MODE TO INVEST IN PHARMACEUTICAL WORKFORCE TO WORK BEYOND DRUG DISPENSING

    Sep 12, 2017

    The International Pharmaceutical Federation (FIP) is on an aggressive mode to increase in the investment of work force for the pharmaceutical sector. New FIP global survey shows clear contribution of pharmacy to health beyond dispensing. Initiatives promoting pharmacists’ value in cancer screening, ...


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    https://Pharmaceutical.report/news-article.aspx?ID=12041204

    GLOBAL MARKET FOR PAIN MANAGEMENT DRUGS AND DEVICES - EXPECTED TO REACH $52 BILLION BY 2022 - RESEARCH AND MARKETS

    Sep 11, 2017

    The report includes an overview of the global market for pain management drugs, which will address acute vs. chronic pain, treatments, and issues facing healthcare workers. It analyses of global market trends, with data from 2015 and 2016, estimates for 2017, and projections of compound annual growt...


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    https://Pharmaceutical.report/news-article.aspx?ID=12011201

    NIVOLUMAB CUTS RELAPSE BY ONE THIRD COMPARED TO IPILIMUMAB

    Sep 11, 2017

    The immunotherapy drug nivolumab is safer and more effective than ipilimumab the current standard of care in treating patients with resected stage III and stage IV melanoma, according to an international clinical trial the study involved two groups of 453 participants–one treated with nivolumab and ...


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    https://Pharmaceutical.report/news-article.aspx?ID=12021202

    MERCK TO ACQUIRE RIGONTEC, RIG-I THERAPEUTICS PIONEER, ADVANCING LEADERSHIP IN IMMUNO-ONCOLOGY

    Sep 08, 2017

    Merck, known as MSD outside the United States and Canada, and Rigontec announced that Merck will acquire Rigontec. Rigontec is a pioneer in accessing the retinoic acid-inducible gene I (RIG-I) pathway, part of the innate immune system, as a novel and distinct approach in cancer immunotherapy to indu...


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    https://Pharmaceutical.report/news-article.aspx?ID=11961196

    BIOPHYTIS CLINICAL STAGE DRUG-CANDIDATE SARCONEOS DEMONSTRATES EFFICACY IN PRECLINICAL MODELS OF DUCHENNE MUSCULAR DYSTROPHY

    Sep 08, 2017

    BIOPHYTIS a biotechnology company specializing in the development of drug candidates to treat age-related diseases, today announced an abstract entitled “Sarconeos demonstrates sharp functional improvement and anti-fibrotic properties in an animal model of Duchenne muscular dystrophy” has been selec...


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    https://Pharmaceutical.report/news-article.aspx?ID=11971197

    HOW BIOPHARMACEUTICAL COLLABORATION IS DRIVING A NEW ERA OF MEDICINE

    Sep 07, 2017

    Biopharmaceutical innovation, coupled with technological advancements, has brought a new era of medicine transforming how we research and develop new medicines to benefit patients At our recent event, in partnership with The Atlantic, “Innovation Pipeline: Examining Modern Medicine,” we explored Cal...


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    https://Pharmaceutical.report/news-article.aspx?ID=11931193

    CERTAIN PATIENTS WITH TYPE 2 DIABETES LESS LIKELY TO SUFFER HEART FAILURE WHILE TAKING NEW CLASS OF ANTIDIABETIC DRUG

    Sep 07, 2017

    Seniors with type 2 diabetes or those with diabetic complications were less likely to be hospitalized for heart failure while taking a sodium-glucose co-transporter 2 (SGLT2) inhibitor compared to dipeptidyl peptidase-4 (DPP4) inhibitors, another new class of oral antidiabetic drug, according to a s...


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    https://Pharmaceutical.report/news-article.aspx?ID=11941194

    MUNDIPHARMA BAGS RIGHTS TO SELL JANSSEN’S INVOKANA, VOKANAMET

    Sep 06, 2017

    Janssen Pharmaceutica has entered into an exclusive agreement with Mundipharma under which the latter will distribute its diabetes drugs Invokana and Vokanamet in countries in the European Economic Area (EEA) and Switzerland. Currently the deal relates to territories where the products have obtained...


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    https://Pharmaceutical.report/news-article.aspx?ID=11871187

    ALCAMI TO ESTABLISH ACTIVE PHARMACEUTICAL INGREDIENT CENTER OF EXCELLENCE IN GERMANTOWN, WISCONSIN

    Sep 06, 2017

    Alcami Corporation, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces the formation of a Center of Excellence at its world-class active pharmaceutical ingredient (API) development and manufacturing facility in Ger...


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    https://Pharmaceutical.report/news-article.aspx?ID=11881188

    ROCHE’S ALECENSA GETS GREEN LIGHT FOR EARLY ACCESS SCHEME

    Sep 04, 2017

    UK patients with a rare form of lung cancer will be able to access Roche’s Alecensa without the need for prior chemotherapy before official approval is obtained, following its inclusion in the country’s Early Access to Medicines Scheme (EAMS). The Medicines and Healthcare products Regulatory Agency ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11841184

    MERCK’S ERBITUX BACKED BY NICE FOR HEAD AND NECK CANCER

    Sep 04, 2017

    Merck’s Erbitux is being recommended for routine NHS use to treat recurrent or metastatic squamous cell cancer of the head and neck. The National Institute for Health and Care Excellence has published final guidance backing the drug’s use to treat the condition, but only if the cancer started in the...


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    https://Pharmaceutical.report/news-article.aspx?ID=11851185

    HEPTARES DOSES FIRST SUBJECT IN ALZHEIMER’S DRUG TRIAL

    Sep 01, 2017

    London, UK-based Heptares Therapeutics says the first healthy subject has now been dosed with its first-in-class, selective muscarinic M4 receptor agonist HTL0016878 in a Phase I clinical study. The move triggers a $15 million milestone payment from Allergan under a global R&D and commercialization ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11801180

    FDA APPROVES CAR T CELL THERAPY FOR CHILDREN WITH LEUKAEMIA

    Sep 01, 2017

    The U.S. Food and Drugs Administration (FDA) has approved CAR T cell therapy for treatment of children with acute lymphoblastic leukemia (ALL). “This is a landmark moment for cancer research and for paediatric oncology, as a whole new kind of cancer treatment, CAR T therapy, is approved,” said Dr St...


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    https://Pharmaceutical.report/news-article.aspx?ID=11821182

    FINAL NHS GREEN LIGHT FOR ALLERGAN’S IBS-D DRUG

    Aug 31, 2017

    Allergan’s Truberzi has become the first treatment for irritable bowel syndrome with diarrhoea (IBS-D) to be reviewed and recommended by the National Institute for Health and Care Excellence for use on the NHS in England and Wales. Final guidelines published by the Institute have backed the drug for...


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    https://Pharmaceutical.report/news-article.aspx?ID=11741174

    ATHENEX PHARMACEUTICAL DIVISION AND SUNGEN PHARMA ANNOUNCE TERBUTALINE SULFATE INJECTION PRODUCT LAUNCH

    Aug 31, 2017

    Athenex, Inc. a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, today announced the launch of Terbutaline Sulfate Injection, the first product launch by Athenex Pharmaceutical Division (APD) through their ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11751175

    QUANTZIG CONDUCTED A BUDGET IMPACT OPTIMIZATION FOR A PHARMA MANUFACTURER TO IDENTIFY THE BEST VACCINATION STRATEGY

    Aug 30, 2017

    A leading pharma manufacturer in Europe approached Quantzig for assistance in evaluating the best vaccination strategy that is available in the manufacturing landscape. Quantzig assessed the budget impact of vaccinations using different vaccines. Since the incidence of vaccination in the market is i...


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    https://Pharmaceutical.report/news-article.aspx?ID=11701170

    FDA APPROVES FIRST U.S. TREATMENT FOR CHAGAS DISEASE

    Aug 30, 2017

    The U.S. Food and Drug Administration has granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease. Chagas disease, or American trypanosomiasis, is a parasi...


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    https://Pharmaceutical.report/news-article.aspx?ID=11711171

    ASTRAZENECA AND TAKEDA ESTABLISH COLLABORATION TO DEVELOP AND COMMERCIALISE MEDI1341 FOR PARKINSON'S DISEASE

    Aug 29, 2017

    AstraZeneca and Takeda Pharmaceutical Company Limited today announced that they have entered an agreement to jointly develop and commercialise MEDI1341, an alpha-synuclein antibody currently in development as a potential treatment for Parkinson’s disease (PD). Alpha-synuclein (α-synuclein) is an agg...


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    https://Pharmaceutical.report/news-article.aspx?ID=11661166

    EUSA BAGS EU APPROVAL FOR KIDNEY CANCER DRUG

    Aug 29, 2017

    The European Commission has licensed EUSA Pharma’s Fotivda for the management of adult patients with advanced kidney cancer across the European Union as well as Norway and Iceland. Fotivda (tivozanib) is indicated for the first line treatment of adults with advanced renal cell carcinoma (RCC) and fo...


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    https://Pharmaceutical.report/news-article.aspx?ID=11671167

    BOEHRINGER INGELHEIM INITIATES PHASE IIA STUDY OF COMPOUND ACQUIRED FROM PHARMAXIS IN DEBILITATING LIVER DISEASE NASH

    Aug 25, 2017

    Boehringer Ingelheim and pharmaceutical company Pharmaxis announce that Boehringer Ingelheim has initiated a European and North American Phase IIa trial in NASH with BI 1467335 (formerly known as PXS-4728A), acquired from Pharmaxis in May 2015. The compound is an oral inhibitor of amine oxidase, cop...


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    https://Pharmaceutical.report/news-article.aspx?ID=11631163

    US OKS FIRST DRUG FOR DYSKINAESIA IN PARKINSON’S PATIENTS

    Aug 25, 2017

    US regulators have approved the first and only treatment option to treat dyskinaesia in patients with Parkinson's disease. The US Food and Drug Administration has cleared Adamas Pharmaceuticals’ Gocovri (amantadine; previously ADS-5102) extended release capsules for dyskinesia in Parkinson’s disease...


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    https://Pharmaceutical.report/news-article.aspx?ID=11651165

    MERCK SEES PROMISE IN MACROPHAGE PHARMA

    Aug 24, 2017

    Merck Ventures has become the latest group to invest in Macrophage Pharma and take a position on the UK biotech’s board of directors. The venture capital arm of German drugmaker Merck is streaming new funds into the group equal to that already provided individually by existing investors the CRT Pion...


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    https://Pharmaceutical.report/news-article.aspx?ID=11591159

    EXTENDED TREATMENT WITH BRILINTA REDUCES RISK OF CARDIOVASCULAR DEATH BY 29% IN PATIENTS WITH HISTORY OF HEART ATTACK

    Aug 24, 2017

    AstraZeneca today announced results from a new sub-analysis of data from the Phase III PEGASUS-TIMI 54 trial demonstrating a 29% risk reduction in CV death (p=0.0041) from treatment with Brilinta (ticagrelor) 60mg twice daily, versus placebo, in patients taking low-dose aspirin but still at high ris...


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    https://Pharmaceutical.report/news-article.aspx?ID=11601160

    OCTAPHARMA USA ANNOUNCES FDA APPROVAL OF NUWIQ NEW PRODUCT STRENGTHS, EXPANDING HEMOPHILIA A PATIENT TREATMENT OPTIONS

    Aug 23, 2017

    Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved new product strengths for NUWIQ, offering added convenience by potentially reducing the number of vials needed for Hemophilia A patients. The agency approved new single dose NUWIQ vial strengths of 2500, 3000 and...


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    https://Pharmaceutical.report/news-article.aspx?ID=11541154

    MMIP CALL FOR SUPPORT TO BOOST MEDICINES MANUFACTURING IN THE UK

    Aug 23, 2017

    The Medicines Manufacturing Industry Partnership (MMIP) is requesting government funds to help set up four new Centres of Excellence for medicines manufacturing across the UK, in line with wider plans to build on the exporting strengths of the UK's biopharma sector. According to the Partnership’s ‘M...


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    https://Pharmaceutical.report/news-article.aspx?ID=11551155

    FDA APPROVES IRONWOOD’S GOUT COMBINATION DRUG

    Aug 22, 2017

    The FDA has approved Ironwood Pharmaceuticals’ gout drug, Duzallo, although the regulator has required a black box warning highlighting risk of kidney failure. A once-daily drug, Duzallo combines the standard of care treatment, allopurinol, with Ironwood’s lesinurad. Ironwood said the drug offers a ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11501150

    NEW FLU VACCINE APPROVED FOR UK USE

    Aug 22, 2017

    The Medicines and Healthcare Products Regulatory Agency has cleared the adjuvanted trivalent influenza vaccine Fluad for use in people aged 65 years or older. Fluad, which is manufactured by CSL company Seqirus, has been available in Europe since 1997 but has only now been launched in the UK. Accord...


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    https://Pharmaceutical.report/news-article.aspx?ID=11531153

    PFIZER OBJECTS TO NICE METHODS IN LEUKAEMIA DRUG REJECTION

    Aug 21, 2017

    NICE has caused controversy by rejecting Pfizer’s Besponsa – a blood cancer drug that can give patients the chance to receive a potentially curative bone marrow transplant. Experts said Besponsa (inotuzumab ozogamicin) could revolutionise management of patients with relapsed acute lymphoblastic leuk...


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    https://Pharmaceutical.report/news-article.aspx?ID=11461146

    NOVARTIS AND MEDICINES FOR MALARIA VENTURE LAUNCH PATIENT TRIAL IN AFRICA FOR KAF156, A NOVEL COMPOUND AGAINST MULTIDRUG-RESISTANT MALARIA

    Aug 21, 2017

    Novartis and Medicines for Malaria Venture (MMV) have launched a patient trial for KAF156, a next-generation antimalarial compound with the potential to treat drug-resistant strains of the malaria parasite. The trial will test the efficacy of KAF156 in combination with a new, improved formulation of...


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    https://Pharmaceutical.report/news-article.aspx?ID=11471147

    US REGULATORS WAVE THROUGH PFIZER’S LEUKAEMIA DRUG

    Aug 18, 2017

    The US Food and Drug Administration has approved Pfizer’s Besponsa, the first and only CD22-directed antibody-drug conjugate indicated to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL). B-cell precursor ALL is a rapidly progressing type of cancer in which the bone ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11421142

    FDA GRANTS TWO ORPHAN DRUG DESIGNATIONS FOR HCC

    Aug 18, 2017

    The U.S. Food and Drugs Administration (FDA) has granted two orphan drug designations (ODD) for T cell therapy products for the treatment of hepatocellular carcinoma (HCC). Biotech company Lion TCR Pte Ltd, are developing two product candidates HBV specific TCR redirected T cell therapies against HC...


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    https://Pharmaceutical.report/news-article.aspx?ID=11441144

    NOVO’S SEMAGLUTIDE SUPERIOR TO LILLY’S TRULICITY IN DIABETES TRIAL

    Aug 17, 2017

    Novo Nordisk’s once-weekly diabetes drug semaglutide has beaten Eli Lilly’s once-weekly therapy dulaglutide on reducing blood sugar and weight in patients taking part in a late-stage trial. In the 40-week, Phase IIIb study, semaglutide 0.5mg achieved a statistically significant and superior reductio...


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    https://Pharmaceutical.report/news-article.aspx?ID=11391139

    ACCELERATED DRUGS APPROVAL EVALUATED

    Aug 16, 2017

    Researchers have evaluated the features of pre-approval and post-approval clinical trials of drugs granted Accelerated Approval by the U.S Food and Drugs Administration (FDA). To understand how this pathway is implemented, researchers examined the pre-approval and post-approval clinical trials of dr...


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    https://Pharmaceutical.report/news-article.aspx?ID=11411141

    NICE TURNS DOWN KIDNEY CANCER DRUGS

    Aug 14, 2017

    It is looking unlikely that patients in England and Wales with advanced renal cell carcinoma will be getting routine NHS access to Eisai’s Kisplyx or Eusa Pharma’s Fotivda, after cost regulators issued draft guidelines turning down their use. The National Institute for Health and Care Excellence sai...


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    https://Pharmaceutical.report/news-article.aspx?ID=11351135

    GSK WALKS AWAY FROM IONIS ANTISENSE DRUGS

    Aug 14, 2017

    GlaxoSmithkline has turned down options to take on board Ionis Pharmaceuticals' experimental antisense therapies inotersen and IONIS-FB-LRx following a pipeline revamp. Inotersen is being developed for patients with TTR amyloidosis (ATTR), a rare disease caused by the build-up of amyloid within the ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11361136

    ALEXION AND SEMA4 PARTNER IN RARE DISEASE DIAGNOSTICS

    Aug 11, 2017

    Alexion has partnered with Sema4 to leverage their shared experience in data science and systems biology to accelerate rare disease diagnosis and therapeutic discovery. This new partnership will combine Alexion's rare disease SmartPanel analytics with Sema4's sequencing and genomic interpretation to...


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    https://Pharmaceutical.report/news-article.aspx?ID=11291129

    SMC RECOMMENDS THREE NEW MEDICINES FOR ROUTINE USE

    Aug 11, 2017

    The Scottish Medicines Consortium (SMC) has published advice accepting three new medicines for routine use by NHS Scotland. Carfilzomib (Kyprolis) was accepted for use in combination with another medicine, dexamethasone, for the treatment of multiple myeloma. Carfilzomib was considered through SMC’s...


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    https://Pharmaceutical.report/news-article.aspx?ID=11301130

    CANCER RESEARCH UK AND BIOTECNOL TO TRIAL NEW IMMUNOTHERAPY

    Aug 10, 2017

    A new collaboration agreement between Cancer Research UK and Biotecnol will see an experimental immuno-oncology treatment move into early phase clinical trials for patients with advanced solid tumours, including lung cancers. Cancer Research UK will support the early clinical development of the comp...


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    https://Pharmaceutical.report/news-article.aspx?ID=11251125

    BIOTECH TO DRIVE BIGGEST CANCER ADVANCEMENTS IN DECADES – REPORT

    Aug 10, 2017

    A new report on the prospects of immunotherapy treatments has identified smaller, nimble biotechs and early stage companies as the single biggest factor behind the next generation of approaches in development. The report concludes that the next five years will be the most promising in the fight agai...


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    https://Pharmaceutical.report/news-article.aspx?ID=11261126

    VERONA PHARMA ANNOUNCES CLINICAL DEVELOPMENT UPDATES OF RPL554 TO TREAT COPD,CF AND POTENTIALLY ASTHMA

    Aug 09, 2017

    Verona Pharma, a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces a clinical development update and interim results for the six months ended June 30, 2017. The company’s lead product candidate RPL554, is a fir...


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    https://Pharmaceutical.report/news-article.aspx?ID=11211121

    CLEVELAND CLINIC STUDY INDICATES HIGH INCIDENCE OF FATALITY IN INDIA WITH HEART DISEASE

    Aug 09, 2017

    Cleveland Clinic has reported that one in four Indians succumbs with a heart disease. Research from the American Heart Association shows Indians are reporting an alarming fatality rate at very early ages which is almost a decade younger than Europeans. Furthermore, India’s heart disease sufferers ar...


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    https://Pharmaceutical.report/news-article.aspx?ID=11221122

    INDIA’S PHARMACEUTICAL MARKET SET TO HIT $100BN BY 2025

    Aug 08, 2017

    India’s pharmaceutical market value is expected to grow to US $100bn by 2025, driven in part by increased buying power of the country’s middle class, and rapid urbanisation. There is growing demand domestically for health services and treatments for chronic disease. The industry boasts an impressive...


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    https://Pharmaceutical.report/news-article.aspx?ID=11201120

    SMC RECOMMENDS THREE NEW MEDICINES

    Aug 07, 2017

    The Scottish Medicines Consortium (SMC) has accepted three new medicines for routine use by NHS Scotland. Amgen’s Kyprolis (carfilzomib) was accepted for use in combination with another medicine, dexamethasone, for the treatment of multiple myeloma, an incurable and complex cancer of the blood cells...


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    https://Pharmaceutical.report/news-article.aspx?ID=11181118

    PANCREATIC CANCER PATIENTS IN ENGLAND GET CDF ACCESS TO ABRAXANE

    Aug 04, 2017

    Patients with pancreatic cancer living in England can from today potentially get access to a new treatment option after funding for Celgene’s Abraxane was approved for NHS use. The National Institute for Health and Care Excellence has deemed the drug a cost-effective use of NHS resources, but has cl...


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    https://Pharmaceutical.report/news-article.aspx?ID=11151115

    BRISTOL-MYERS SQUIBB TO ACQUIRE IFM THERAPEUTICS TO STRENGTHEN ONCOLOGY PIPELINE FOCUS ON INNATE IMMUNITY

    Aug 03, 2017

    Bristol-Myers Squibb Company and IFM Therapeutics (IFM) announced today that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11141114

    GREEN LIGHT FOR CELGENE’S TARGETED AML DRUG

    Aug 02, 2017

    US regulators have issued a green light for Celgene and Agios’ Idhifa, the first and only targeted treatment for adult patients with relapsed/refractory acute myeloid leukaemia and an isocitrate dehydrogenase-2 mutation. Acute myeloid leukaemia (AML) is a rapidly progressing cancer that forms in the...


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    https://Pharmaceutical.report/news-article.aspx?ID=11101110

    FDA APPROVES NEW TARGETED TREATMENT FOR ACUTE MYELOID LEUKEMIA

    Aug 02, 2017

    The U.S. Food and Drug Administration has granted the approval of Idhifa to Celgene Corporation and RealTime IDH2 Assay to Abbott Laboratories. Idhifa was approved for the treatment of adult patients with relapsed or refractory acute myeloid leukaemia (AML) who have a specific genetic mutation. The ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11121112

    AMGEN, ALLERGAN’S HERCEPTIN BIOSIMILAR FILED IN THE US

    Aug 01, 2017

    US biotech giant Amgen and Dublin, Ireland-based Allergan have now filed ABP 980 - a biosimilar version of Roche’s blockbuster biologic trastuzumab - with the US Food and Drug Administration. In the US, trastuzumab is approved under the brand name Herceptin for the treatment of HER2-positive adjuvan...


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    https://Pharmaceutical.report/news-article.aspx?ID=11051105

    FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION STATUS FOR ACALABRUTINIB

    Aug 01, 2017

    AstraZeneca and Acerta Pharma – its haematology R&D centre of excellence – have announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib. This potential drug aims to treat patients with mantle cell lymphoma (MCL) who have received at lea...


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    https://Pharmaceutical.report/news-article.aspx?ID=11081108

    NEW HEPATITIS C THERAPIES APPROVED IN EUROPE

    Jul 31, 2017

    Patients with hepatitis C in Europe could soon gain access to two new pan-genotypic treatment options after the European Commission issued approval for AbbVie’s Maviret and Gilead’s Vosevi following an accelerated review. Maviret is a once-daily regimen that combines two distinct antiviral agents - ...


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    https://Pharmaceutical.report/news-article.aspx?ID=11011101

    SHORT SELLERS EYE TEVA AND MYLAN AS U.S. GENERICS MARKET TROUBLES PERSIST, ANALYST SAYS

    Jul 31, 2017

    How bad is the generics market in the U.S. these days? Reports from some players are that it continues to be tough, but the picture will get a lot clearer when generics leader Teva reports Thursday, followed by Mylan next week. Indications are the short sellers are tuned in. Novartis provided an ink...


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    https://Pharmaceutical.report/news-article.aspx?ID=11031103

    SCIENTISTS DEVELOP NEW SURGICAL METHOD TO RECONNECT SENSORY NEURONS WITH SPINAL CORD AFTER INJURY

    Jul 28, 2017

    Scientists in the UK and Sweden previously developed a new surgical technique to reconnect sensory neurons to the spinal cord after traumatic spinal injuries. Now, they have gained new insight into how the technique works at a cellular level by recreating it in rats with implications for designing n...


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    https://Pharmaceutical.report/news-article.aspx?ID=10981098

    EU APPROVES CV BENEFIT CLAIM FOR NOVO’S VICTOZA

    Jul 28, 2017

    Novo Nordisk’s diabetes drug Victoza is now approved in Europe as the only GLP-1 analogue with a label including prevention of cardiovascular events. The European Commission has cleared an update to the drug’s label to reflect both improving blood sugar and cardiovascular (CV) events as key parts of...


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    https://Pharmaceutical.report/news-article.aspx?ID=11001100

    ASTRAZENECA AND MERCK ESTABLISH STRATEGIC ONCOLOGY COLLABORATION

    Jul 27, 2017

    AstraZeneca and Merck & Co., Inc., (Merck; known as MSD outside of the US and Canada) today announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca's Lynparza (olaparib) for multiple cancer types. Lynparza is an innovative, first-in-c...


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    https://Pharmaceutical.report/news-article.aspx?ID=10921092

    LONZA PHARMA&BIOTECH LAUNCHES IBEX™ SOLUTIONS – AN INNOVATIVE NEW CONCEPT IN BIOLOGICAL MANUFACTURING AND DEVELOPMENT

    Jul 27, 2017

    bex™ Solutions is an innovative new biological development and manufacturing concept, coupling flexibility in facility-build-out with fully tailored business models and leveraging Lonza’s expertise and service network in Visp (CH). Construction began in June with a formal groundbreaking ceremony exp...


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    https://Pharmaceutical.report/news-article.aspx?ID=10951095

    JOHNSON & JOHNSON ANNOUNCES ENCOURAGING FIRST-IN-HUMAN CLINICAL DATA FOR INVESTIGATIONAL HIV PREVENTIVE VACCINE

    Jul 26, 2017

    Johnson & Johnson has announced encouraging first-in-human clinical data for an investigational HIV-1 vaccine regimen in development at its Janssen Pharmaceutical Companies. In an oral presentation of the early stage Phase 1/2a APPROACH study at the 9th IAS Conference on HIV Science (IAS 2017), the ...


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    https://Pharmaceutical.report/news-article.aspx?ID=10931093

    VERONA PHARMA BEGINS DOSING RPL554 IN PHASE IIB COPD TRIAL

    Jul 26, 2017

    Patients have begun receiving Verona Pharma’s experimental respiratory drug RPL554 in a Phase IIb trial assessing its potential as a maintenance therapy for chronic obstructive pulmonary disease (COPD). RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE...


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    https://Pharmaceutical.report/news-article.aspx?ID=10881088

    HEALTH MINISTRY ISSUES LIST OF DRUG UNITS WHOSE MORE THAN 5 SAMPLES FAILED IN NATIONAL DRUG SURVEY

    Jul 26, 2017

    The Union health ministry has issued the list of drug manufacturers whose more than five samples have been failed in the National Drug Survey conducted by National Institute of Biologicals (NIB) across the country to check the proportion of drug samples failing in quality testing. There are a total ...


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    https://Pharmaceutical.report/news-article.aspx?ID=10901090

    MSD’S KEYTRUDA BACKED FOR BLADDER CANCER

    Jul 25, 2017

    European regulators have backed expanding approval of MSD’s immunotherapy Keytruda to include the treatment of locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. Clearance of the drug is recommended for adult patients with the condition who have received prior platinum-co...


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    https://Pharmaceutical.report/news-article.aspx?ID=10841084

    US OPHTHALMIC DRUGS MARKET SET TO PASS $34BN BY 2025

    Jul 25, 2017

    The US ophthalmic drugs market is set pass $34bn by 2025, fueled by an increasing incidence of eye diseases, according to a new report. Compound annual growth rate of 4.0% from 2017 to 2025 saw the value of the market rise from $24.4bn in 2016 to a predicted value of $34.3bn by 2025. Major market pl...


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    https://Pharmaceutical.report/news-article.aspx?ID=10871087

    ELEVEN MEDICINES LEAP CLOSER TO EU APPROVAL

    Jul 24, 2017

    Eleven therapies, including five targeting rare diseases, have taken a giant leap towards being approved in Europe after winning backing from the European Medicines Agency’s Committee for Medicinal Products for Human Use. Santen’s Verkazia (ciclosporin) has been recommended for severe vernal keratoc...


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    https://Pharmaceutical.report/news-article.aspx?ID=10801080

    NHS ENGLAND CONSULTS ON BLOCKING ‘WASTEFUL’ PRESCRIPTIONS

    Jul 24, 2017

    NHS England has unveiled detailed proposals of how prescriptions for “ineffective, over-priced and low value treatments” will be cut in order to shave millions off of the NHS’ drugs bill. A public consultation has now been launched on new national guidelines blocking 18 treatments which together cos...


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    https://Pharmaceutical.report/news-article.aspx?ID=10811081

    TENTATIVE US APPROVAL FOR MERCK’S DIABETES THERAPY

    Jul 21, 2017

    The US Food and Drug Administration has given a tentative green light to Merck & Co’s follow-on biologic basal insulin Lusduna Nexvue. The decision means that the drug has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is s...


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    https://Pharmaceutical.report/news-article.aspx?ID=10761076

    NICE U-TURN BACKS USE OF TEVA’S ASTHMA BIOLOGIC

    Jul 21, 2017

    The National Institute for Health and Care Excellence (NICE) is now backing routine NHS commissioning of Teva’s Cinqaero to treat a severe form of asthma after having initially been minded to block the drug’s use. The cost regulator has issued a Final Appraisal Determination outlining its support fo...


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    https://Pharmaceutical.report/news-article.aspx?ID=10771077

    EU APPROVES LEO PHARMA’S PSORIASIS BIOLOGIC

    Jul 20, 2017

    A new treatment option has been approved in the European Union for patients with psoriasis, paving the way for access to a novel approach for those with moderate-to-severe forms of the disease who are candidates for systemic therapy. LEO Pharma’s Kyntheum (brodalumab) is a novel biologic and the fir...


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    https://Pharmaceutical.report/news-article.aspx?ID=10731073

    AMO PHARMA ENTERS INTO DEVELOPMENT AND LICENSE AGREEMENT WITH NUMEDICUS LIMITED FOR RETT SYNDROME PROGRAM

    Jul 20, 2017

    AMO Pharma Limited ("AMO Pharma"), a privately held biopharmaceutical company focusing on debilitating diseases with limited or no treatment options, today announced it has entered into a Development and License Agreement with Numedicus Limited, a privately held UK biopharmaceutical company, to adva...


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    https://Pharmaceutical.report/news-article.aspx?ID=10751075

    US NOD FOR GILEAD’S PAN-GENOTYPIC HEP C PILL

    Jul 19, 2017

    US regulators have waved through Gilead’s Vosevi allowing the drug’s use to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi is a fixed-dose, combination tablet containing two previously approved drugs - sofosbuvir and v...


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    https://Pharmaceutical.report/news-article.aspx?ID=10691069

    UK SPENDS 20% LESS ON CANCER TREATMENT THAN REST OF EU

    Jul 19, 2017

    The UK spends 20% less of its total health budget on cancer and 10% less of its GDP on healthcare than the rest of the EU, finds a report commissioned and funded by industry trade body, the Association of the British Pharmaceutical Industry (ABPI). Lower levels of investment are linked to poorer sur...


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    https://Pharmaceutical.report/news-article.aspx?ID=10701070

    AMGEN AND ARRAY BIOPHARMA ANNOUNCE PRECLINICAL LICENSE AND COLLABORATION AGREEMENT IN INFLAMMATION

    Jul 18, 2017

    Amgen and Array BioPharma today announced a collaboration agreement for the discovery and development of novel drugs for autoimmune disorders. The undisclosed target and lead inhibitors were discovered through Array's proprietary platform that leverages Array's expertise in chemistry and early lead ...


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    https://Pharmaceutical.report/news-article.aspx?ID=10641064

    UK BEHIND EUROPE IN CANCER DIAGNOSIS, TREATMENT, SURVIVAL

    Jul 18, 2017

    The UK is lagging behind Europe in the diagnosis and treatment of cancer, finds a new report compiled by Swedish Institute for Health Economics for the Association of the British Pharmaceutical Industry. The report, launched alongside a new toolkit to help compare the data, shows that cancer patient...


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    https://Pharmaceutical.report/news-article.aspx?ID=10661066

    US REGULATORS TURN AWAY AMGEN/UCB’S BONE DRUG EVENITY

    Jul 17, 2017

    Amgen and UCB’s application to market bone-boosting drug Evenity as a treatment for postmenopausal women with osteoporosis has hit a setback, having been turned down by US regulators. The US Food and Drug Administration has issued a Complete Response Letter asking for new safety and efficacy data fr...


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    https://Pharmaceutical.report/news-article.aspx?ID=10601060

    NIH RESEARCHERS SHOW HOW INVESTIGATIONAL DRUG WORKS AGAINST RARE, FATAL GENETIC DISEASE

    Jul 17, 2017

    Scientists have demonstrated how an investigational drug works against a rare, fatal genetic disease, Niemann-Pick type C1 (NPC1). They found that a closely related compound will activate an enzyme, AMPK, triggering a cellular "recycling" system that helps reduce elevated cholesterol and other accum...


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    https://Pharmaceutical.report/news-article.aspx?ID=10621062

    GILEAD’S NEW HIV THERAPY UNDER EU REVIEW

    Jul 14, 2017

    European regulators are now reviewing Gilead’s fixed-dose combination of bictegravir (BIC), emtricitabine and tenofovir alafenamide as a treatment for HIV-1 infection. The once-daily single tablet regimen, combing a novel investigational integrase strand transfer inhibitor with emtricitabine/tenofov...


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    https://Pharmaceutical.report/news-article.aspx?ID=10571057

    GOVERNMENT REFRESHES PLANS TO CUT ILLICIT DRUG USE AND ADDICTION

    Jul 14, 2017

    The Home Office is set to appoint a new national recovery champion to support recovering drug addicts to turn their lives around by making sure they have access to adequate housing, employment, and mental health services, under plans announced today to cut illicit drug use and boost the number of pe...


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    https://Pharmaceutical.report/news-article.aspx?ID=10581058

    STEMSYNERGY ANNOUNCES BREAKTHROUGH IN COLORECTAL CANCER DRUG DEVELOPMENT

    Jul 14, 2017

    StemSynergy Therapeutics, Inc. announces advances in drug development for treatment of colorectal cancer, the third most common cancer diagnosed in the US. Mutations in a cell communication process called the “Wnt pathway” are responsible for over 90% of all colorectal cancers. A major hurdle in dev...


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    https://Pharmaceutical.report/news-article.aspx?ID=10591059

    EU & UK PHARMA LEADERS WRITE TO BREXIT NEGOTIATORS

    Jul 13, 2017

    In an unprecedented move, eight leaders from associations representing the entire EU and UK pharmaceutical sector have written a joint letter to chief Brexit negotiators Michel Barnier and David Davis requesting that ongoing cooperation between the two territories for medicines be a negotiating prio...


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    https://Pharmaceutical.report/news-article.aspx?ID=10531053

    BEAUMONT HEALTH FIRST IN MICHIGAN TO TREAT CANCER PATIENT WITH PROTONS BEAUMONT HEALTH

    Jul 13, 2017

    Bill Baker, an 86-year-old Mid-Michigan man with brain cancer, is the first patient to receive treatment at Beaumont Health's new Proton Therapy Center in Royal Oak, Michigan. Said Craig Stevens, M.D., Ph.D., chairman, Radiation Oncology, Beaumont Health, Beaumont's Proton Therapy Center is the firs...


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    https://Pharmaceutical.report/news-article.aspx?ID=10551055

    FIRST UK PATIENT ENROLLED IN PEANUT ALLERGY TRIAL

    Jul 12, 2017

    Children and adolescents in the UK with peanut allergy are among the first to enrol in a Europe-wide study investigating a new oral immunotherapy for the condition. The Phase III ARTEMIS trial is assessing the safety and effectiveness of Aimmune Therapeutics’ oral biologic AR101 in desensitising pat...


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    https://Pharmaceutical.report/news-article.aspx?ID=10481048

    GOVERNMENT FUNDS DWINDLE FOR CARDIAC ARREST RESEARCH

    Jul 12, 2017

    National Institutes of Health (NIH) funding to conduct cardiac arrest research has dwindled in the last decade and is a fraction of what the government spends to study other leading causes of death, according to new research in Journal of the American Heart Association, the Open Access Journal of th...


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    https://Pharmaceutical.report/news-article.aspx?ID=10511051

    UAB IMPROVES DRY EYE TREATMENT WITH DEVELOPMENT OF NEW GUIDELINES AND EXPANSION OF CLINIC

    Jul 11, 2017

    Clinical practice and research of dry eye relief in the University of Alabama at Birmingham School of Optometry is progressing with the development and release of new guidelines for diagnosis and treatment of dry eye, as well as the expansion of services offered by the UAB Dry Eye Relief Clinic. "Wi...


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    https://Pharmaceutical.report/news-article.aspx?ID=10471047

    OWLSTONE MEDICAL, CR UK TEST POTENTIAL OF BREATH TEST FOR CANCER

    Jul 10, 2017

    UK diagnostics group Owlstone Medical and Cancer Research UK have kicked off a study aiming to identify breath biomarkers to improve the early detection and diagnosis of multiple cancer types. The PAN Cancer trial will evaluate the use of Owlstone’s Breath Biopsy platform in developing breath biopsy...


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    https://Pharmaceutical.report/news-article.aspx?ID=10421042

    SANDOZ RECEIVES APPROVAL IN EUROPE FOR RIXATHON TO TREAT BLOOD CANCERS AND IMMUNOLOGICAL DISEASES

    Jul 10, 2017

    Today's approval of Rixathon represents a big win for patients in Europe with blood cancers or immunological diseases because it enables increased access to biologics. It also allows healthcare systems to redeploy resources to other areas of high need, particularly innovative therapies said Carol Ly...


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    https://Pharmaceutical.report/news-article.aspx?ID=10431043

    POSITIVE PHASE III RESULTS FOR ROCHE’S EMICIZUMAB IN HAEMOPHILIA A PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE

    Jul 10, 2017

    Roche today announced that data from HAVEN 1, a phase III study evaluating once-weekly subcutaneous emicizumab prophylaxis (preventative) in adults and adolescents with haemophilia A with inhibitors, were published in The New England Journal of Medicine (NEJM). The primary endpoint showed a clinical...


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    https://Pharmaceutical.report/news-article.aspx?ID=10461046

    EISAI TEMPORARILY WITHDRAWS NEW DRUG APPLICATION FOR ANTICANCER AGENT HALAVEN IN CHINA

    Jul 07, 2017

    Eisai Co., Ltd. announced today that, in alignment with Chinese regulations, it has temporarily withdrawn its new drug application for anticancer agent eribulin mesylate (Brand name: Halaven) in China in order to submit additional documentation. No additional clinical trials have been scheduled, and...


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    https://Pharmaceutical.report/news-article.aspx?ID=10371037

    WAITING LISTS ARE ALREADY FORMING FOR NOVARTIS AG (NVS) AND KITE PHARMA (KITE)'S NOT-YET APPROVED CAR-T DRUGS

    Jul 07, 2017

    As the promise of CAR-T therapies becomes closer and closer, consumers are taking notice and lining up for the revolutionary cancer treatments that will soon be available from companies like Kite Pharma (KITE) and Novartis AG (NVS). But before the treatments can make it to patients, there are some l...


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    https://Pharmaceutical.report/news-article.aspx?ID=10381038

    CANNABICS PHARMACEUTICALS RECEIVES POSITIVE RESULTS IN DRUG SENSITIVITY TESTS ON CTCS

    Jul 06, 2017

    Cannabics Pharmaceuticals Inc announced it received positive results from screening necrosis (cell death) of circulating tumor cells, from cancer patients, treated with the cannabinoids CBD and CBDA. These results greatly strengthen the company's previously accumulated data on cannabinoid anti-tumor...


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    https://Pharmaceutical.report/news-article.aspx?ID=10311031

    US ORPHAN STATUS FOR ALMAC’S OVARIAN CANCER DRUG

    Jul 05, 2017

    In big news for Northern Ireland-headquartered drug discovery group Almac, US regulators have awarded orphan drug status to the firm’s experimental therapy for ovarian cancer. ALM201 is a first-in-class therapeutic peptide developed to mimic some of the properties of the naturally occurring protein ...


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    https://Pharmaceutical.report/news-article.aspx?ID=10301030

    STATEMENT FROM FDA COMMISSIONER SCOTT GOTTLIEB ON THE IMPORTANCE OF THE DRUG QUALITY AND SECURITY ACT AND OVERSEEING THE SAFETY OF COMPOUNDED DRUGS

    Jun 26, 2017

    In late 2012, the United States faced the most serious outbreak associated with contaminated compounded drugs in recent history, involving hundreds of people, in many states, who developed fungal infections related to a compounded product. It was an incident that resulted in dozens of deaths.


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    https://Pharmaceutical.report/news-article.aspx?ID=10251025

    NICE TURNAROUND FOR ASTRAZENECA’S COPD DRUG DAXAS

    Jun 23, 2017

    The National Institute has now issued draft guidance recommending Daxas (roflumilast) in COPD patients whose disease is class as severe and when symptoms continue to worsen despite other treatments, after two new trials showed that it helped ease symptoms not under control with inhalers.


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    https://Pharmaceutical.report/news-article.aspx?ID=10221022

    FDA CALLS CARA THERAPEUTICS (CARA)' KIDNEY DISEASE DRUG A BREAKTHROUGH, STOCK SOARS

    Jun 23, 2017

    Shares of pain-relief company Cara Therapeutics (CARA) are up more than 16 percent this morning after the company grabbed the Breakthrough Therapy Designation for its chronic kidney disease treatment CR845.Cara’s treatment is designed to alleviate pain and pruritus by selectively targeting periphera...


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    https://Pharmaceutical.report/news-article.aspx?ID=10241024

    NOVARTIS DRUG CUTS CARDIOVASCULAR RISK IN HEART ATTACK SURVIVORS

    Jun 22, 2017

    An experimental antibody being developed by Novartis has cut cardiovascular risk in patients who have survived a heart attack in a late-stage study. The Phase III CANTOS study met the primary endpoint showing that ACZ885 (canakinumab) reduced the risk of heart attack, stroke and cardiovascular death...


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    https://Pharmaceutical.report/news-article.aspx?ID=10191019

    SHIRE SECURES US NOD FOR ONCE-DAILY ADHD DRUG

    Jun 22, 2017

    The drug, which was first submitted in the country back in 2006, has the same active ingredient as the firm's Adderall XR (mixed amphetamine salts), but is designed to provide symptom control for adults with ADHD for up to 16 hours as opposed to the 12 to 14 hours currently offered by alternative tr...


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    https://Pharmaceutical.report/news-article.aspx?ID=10201020

    INTERNATIONAL DRUG COMPANIES JOIN BIO VENTURES FOR GLOBAL HEALTH TO TACKLE CANCER CRISIS IN AFRICA

    Jun 21, 2017

    BIO Ventures for Global Health (BVGH), is launching the African Access Initiative (AAI) at 10:30 am today at the Biotechnology Innovation Organization (BIO) International Convention at the San Diego Convention Center, Room 28AB, to address Africa’s emerging cancer crisis. Led by BVGH in partnership ...


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    https://Pharmaceutical.report/news-article.aspx?ID=10151015

    EMPLOYEE IN CRITICAL CONDITION AFTER SHOOTING AT SAN DIEGO BIOTECH PHAMATECH

    Jun 21, 2017

    Violence broke out at a Pharmatech facility on Tuesday with one employee being shot in the head by a coworker. According to reports, an as-of-yet unidentified employee pulled a small-caliber pistol and shot a colleague two times in the head. The shooter was quickly subdued and taken into custody by ...


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    https://Pharmaceutical.report/news-article.aspx?ID=10161016

    BIOAUXILIUM IS PROUD TO COMPLETE DEVELOPMENT OF ITS 100TH TR-FRET ASSAY KIT FOR DRUG DISCOVERY AND LIFE SCIENCE RESEARCH

    Jun 20, 2017

    BioAuxilium Research Inc., a Canadian biotech specialized in the development of custom TR-FRET assay kits, announced today at the 2017 BIO International Convention the successful development of its 100th custom TR-FRET immunoassay kit. These easy-to-use, fully validated assay kits provide researcher...


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    https://Pharmaceutical.report/news-article.aspx?ID=10111011

    SCIENTISTS DISCOVER NEW TYPE OF IMMUNE CELL

    Jun 20, 2017

    The study, funded by Cancer Research UK and published in Nature Immunotherapy, showed that lung cancer patients with a high level of tissue-resident memory T-cells in their tumour were 34 percent less likely to die.


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    https://Pharmaceutical.report/news-article.aspx?ID=10121012

    RESEARCHERS DEVELOP NEW TEST TO TARGET PROSTATE CANCER TREATMENT

    Jun 19, 2017

    By testing cancer DNA in the bloodstream, researchers from The Institute of Cancer Research (ICR), London, and The Royal Marsden NHS Foundation Trust, were also able to pick out patients not responding to treatment so that they could be switched to alternative therapy in just four to eight weeks.


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    https://Pharmaceutical.report/news-article.aspx?ID=10051005

    ENABLE INJECTIONS INTRODUCES FIRST MULTI-VIAL/MULTI-SYRINGE BIOLOGICS DELIVERY SYSTEM FOR SEVERAL PHARMA PARTNERS AT BIO 2017

    Jun 19, 2017

    Enable Injections, Inc. the developer of advanced large volume wearable injectors (LVWI) for subcutaneous delivery of biologics and high volume drugs, today announced a new single, partial or multi-vial/syringe transfer system for filling its LVWIs. The system provides maximum flexibility by allowi...


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    https://Pharmaceutical.report/news-article.aspx?ID=10061006

    PHARMA HEADS LAUNCH ALLIANCE FOR TRANSPARENT & AFFORDABLE PRESCRIPTIONS

    Jun 15, 2017

    Health leaders announced the launch of the Alliance for Transparent & Affordable Prescriptions (ATAP), a coalition of provider and patient groups concerned about the practices of pharmacy benefit managers (PBMs) driving up drug costs.


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    https://Pharmaceutical.report/news-article.aspx?ID=999999

    NUMERATE AND TAKEDA ENTER AGREEMENT TO GENERATE NOVEL CLINICAL CANDIDATES USING AI-DRIVEN DRUG DISCOVERY

    Jun 15, 2017

    Numerate, Inc., a computational drug design company applying artificial intelligence (AI) at cloud scale to transform small molecule drug discovery, announced the formation of a multi-year agreement with Takeda Pharmaceutical Company Limited under which Numerate will identify and deliver multiple cl...


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    https://Pharmaceutical.report/news-article.aspx?ID=10001000

    ROCHE GETS NICE APPROVAL FOR BREAST CANCER DRUG KADCYLA AFTER YEARS OF BATTLES

    Jun 15, 2017

    Following four years of beating up on each other over the cost-benefit of Roche’s cutting-edge breast cancer drug Kadcyla, and heavy lobbying from cancer advocacy groups, the Swiss drugmaker and the U.K. drug cost watchdog have come to an accommodation.


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    https://Pharmaceutical.report/news-article.aspx?ID=10031003

    NICE REJECTS PFIZER’S ALL DRUG BESPONSA

    Jun 14, 2017

    The drug is being appraised by the Institute for treating adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Besponsa (inotuzumab) is an antibody drug conjugate which is comprised of a monoclonal antibody targeting CD22, a cell surface antigen expr...


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    https://Pharmaceutical.report/news-article.aspx?ID=997997

    DRUG COSTS VARY BY MORE THAN 600% IN STUDY OF 10 HIGH-INCOME COUNTRIES

    Jun 13, 2017

    In a study of 10 high-income countries with universal health care, costs for prescription drugs in 6 of the largest categories of primary care medicines varied by more than 600%, according to research published in CMAJ (Canadian Medical Association Journal). All countries except Canada offered unive...

    DRUG
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    https://Pharmaceutical.report/news-article.aspx?ID=990990

    EISAI ENTERS INTO JOINT RESEARCH AGREEMENT WITH THE BROAD INSTITUTE TO DEVELOP AN ANTIMALARIAL MEDICINE

    Jun 13, 2017

    Eisai Co Ltd announced that it has entered into a new joint research agreement with the Broad Institute , a collaborative research institute which includes researchers from the Massachusetts Institute of Technology and Harvard University to develop a new antimalarial medicine based on antimalarial d...


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    https://Pharmaceutical.report/news-article.aspx?ID=992992

    LILLY’S SARCOMA DRUG LARTRUVO RECOMMENDED VIA CANCER DRUGS FUND

    Jun 13, 2017

    Lartruvo (olaratumab) in combination with current standard treatmeant doxorubicin is now recommended for use as an option for some adults with advanced soft tissue sarcoma. To be eligible, patients must have not had any previous systemic chemotherapy for the condition, and cannot have curative tr...


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    https://Pharmaceutical.report/news-article.aspx?ID=995995

    NICE REFUSES TO EXPAND USE OF ROCHE’S IPF DRUG ESBRIET

    Jun 12, 2017

    Essentially, this means that patients will have to wait until their disease has worsened - and lung function has been lost - before getting routine NHS access to the drug. “This is an illogical decision, to deny effective treatment in a condition that is irreversibly progressive and ultimately fatal...


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    https://Pharmaceutical.report/news-article.aspx?ID=986986

    SOCAL'S REGULUS (RGLS) SINKS AFTER ASTRAZENECA PLC (AZN) BAILS ON LEAD NASH DRUG

    Jun 12, 2017

    The troubles appear to be continuing for beleaguered Regulus Therapeutics (RGLS). Shares of Regulus are down more than 23 percent this morning after pharma giant AstraZeneca (AZN) terminated its involvement with the company’s clinical development program for the treatment of non-alcoholic steatohepa...


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    https://Pharmaceutical.report/news-article.aspx?ID=988988

    ACELRX PHARMACEUTICALS ZALVISO RECOGNIZED FOR INNOVATIVE DESIGN WITH PRESTIGIOUS RED DOT AWARD

    Jun 09, 2017

    Announced that ZALVISO® (sufentanil sublingual tablet system) has been selected for a Red Dot Award in the category of Product Design – Life Sciences and MedicineThe Red Dot Awards in this category are presented to products that display innovative design features that improve or enhance patient expe...

    ACELRX PHARMACEUTICALS
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    https://Pharmaceutical.report/news-article.aspx?ID=984984

    ACELRX PHARMACEUTICALS ZALVISO RECOGNIZED FOR INNOVATIVE DESIGN WITH PRESTIGIOUS RED DOT AWARD

    Jun 08, 2017

    Announced that ZALVISO® (sufentanil sublingual tablet system) has been selected for a Red Dot Award in the category of Product Design – Life Sciences and MedicineThe Red Dot Awards in this category are presented to products that display innovative design features that improve or enhance patient expe...


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    https://Pharmaceutical.report/news-article.aspx?ID=979979

    JOHNSON & JOHNSON (JNJ) POACHES MERCK & CO. (MRK) EXEC TO RUN PHARMA R&D

    Jun 08, 2017

    Johnson & Johnson (JNJ) appears to be planning some big moves with its pharma pipeline. The company reportedly hired Merck (MRK)’s Mathai Mammen to helm J&J’s research and development unit. Mammen will replace Bill Hait who is taking over the reins of external innovation at J&J, Endpoints first repo...


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    https://Pharmaceutical.report/news-article.aspx?ID=980980

    MSD INVESTMENT CONFIRMS THRIVING BIOPHARMACEUTICAL HUB

    Jun 08, 2017

    BioPharmaChem Ireland, the Ibec group that represents business in the sector, said the announcement of MSD to invest €280 million in Ireland over the next three years bolsters the country’s status as a thriving hub for the biopharmaceutical sector.


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    https://Pharmaceutical.report/news-article.aspx?ID=981981

    AZ DIVESTS MIGRAINE DRUG TO GRÜNENTHAL

    Jun 07, 2017

    Upon completion of the deal, expected in the second quarter of this year, Grünenthal will pay AZ $200 million followed by up to $102 million in future milestone payments. AZ will continue to manufacture and supply the medicine during a transition period.


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    https://Pharmaceutical.report/news-article.aspx?ID=973973

    EU NOD FOR NOVO’S LONG-ACTING HAEMOPHILIA DRUG

    Jun 07, 2017

    The European Commission has now approved the drug’s use for prophylaxis, on-demand treatment of bleeding and surgical procedures in adults and adolescents with the condition.


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    https://Pharmaceutical.report/news-article.aspx?ID=974974

    NEW FINDINGS HIGHLIGHT POSSIBILITY OF DEVELOPING SPECIFIC CANCER DRUGS WITH FEWER SIDE EFFECTS

    Jun 06, 2017

    Scientists at Karolinska Institutet in Sweden report that cancer cells and normal cells use different 'gene switches' in order to regulate the expression of genes that control growth. In mice, the removal of a large regulatory region linked to different types of cancer caused a dramatic resistance t...


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    https://Pharmaceutical.report/news-article.aspx?ID=969969

    FOREIGN GOVERNMENT PRICE SETTING BY ANY NAME HARMS INNOVATION AND ACCESS TO MEDICINES

    Jun 06, 2017

    In an effort to contain health care spending, some foreign governments mandate prices for innovative medicines at levels below the value they provide to patients, health care systems, and the wider economy. By distorting market competition, these short-sighted measures do more harm than good, and fa...


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    https://Pharmaceutical.report/news-article.aspx?ID=970970

    NEW REPORTS HIGHLIGHT INCREASING GLOBAL COMPETITION IN BIOPHARMACEUTICAL R&D, POSING SIGNIFICANT CHALLENGES TO FUTURE U.S. STANDING

    Jun 05, 2017

    As the U.S. looks to maintain its global leadership in biopharmaceutical research and development, three new reports point to an increasingly competitive global environment—one that requires a thorough assessment of our current public policies, including our investments in science, technology, engin...


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    https://Pharmaceutical.report/news-article.aspx?ID=967967

    INTERNATIONAL MEDICAL DEVICES AND SUPPLIES FAIR OPENS IN HONG KONG

    Jun 05, 2017

    Organised by the Hong Kong Trade Development Council (HKTDC) and co-organised by the Hong Kong Medical and Healthcare Device Industries Association (HKMHDIA), the three-day fair (16-18 May) showcases the latest medical equipment, technology and related services, providing a one-stop business platfor...


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    https://Pharmaceutical.report/news-article.aspx?ID=968968

    AKEBIA AND VIFOR PHARMA ANNOUNCE EXCLUSIVE LICENSE AGREEMENT TO PROVIDE VADADUSTAT TO FRESENIUS MEDICAL CARE IN THE U.S. UPON FDA APPROVAL

    Jun 02, 2017

    By a News Reporter-Staff News Editor at Health & Medicine Week Akebia Therapeutics, Inc. (NASDAQ:AKBA) and Vifor Pharma Group. announced they have entered into an exclusive license agreement to sell vadadustat to Fresenius Medical Care dialysis clinics in the United States upon approval by the U.S. ...


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    https://Pharmaceutical.report/news-article.aspx?ID=962962

    AEQUUS PHARMACEUTICALS AND CDRD ANNOUNCE RESEARCH COLLABORATION TO IMPROVE CANNABINOID-BASED THERAPEUTICS

    Jun 01, 2017

    VANCOUVER, British Columbia(BUSINESS WIRE) Today Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (Aequus) a specialty pharmaceutical company with expertise in drug delivery and clinical development, and the Centre For Drug Research And Development (CDRD), Canada's national drug development an...


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    https://Pharmaceutical.report/news-article.aspx?ID=963963

    INMED PHARMACEUTICALS FILES PROVISIONAL PATENT APPLICATION FOR OPHTHALMIC DRUG DELIVERY

    Jun 01, 2017

    Glaucoma is a group of eye diseases which result in damage to the optic nerve and vision loss. Worldwide, it is the second-leading cause of blindness, and the current global market for drug therapies to treat glaucoma exceeds US$5 billion.


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    https://Pharmaceutical.report/news-article.aspx?ID=959959

    ACASTI PHARMA AND CORDENPHARMA ANNOUNCE LARGE SCALE PRODUCTION OF CAPREWITH NEW MANUFACTURING PROCESS

    Jun 01, 2017

    CaPre is a potentially best-in-class omega-3 drug derived of krill oil and being developed for the treatment of patients with hypertriglyceridemia,a metabolic condition that contributes to the risk of cardiovascular disease and pancreatitis.


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    https://Pharmaceutical.report/news-article.aspx?ID=960960

    JANSSEN INKS POTENTIAL $1BN DEAL FOR IBD DRUG

    May 31, 2017

    Janssen has swooped to buy rights to an early-stage oral inflammatory bowel disease drug from Protagonist Therapeutics in a deal worth up to $1 billion. The Johnson & Johnson unit will pay $50 million up front and up to $940 million in development and sales-related payments, plus around 10%-15% roya...


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    https://Pharmaceutical.report/news-article.aspx?ID=951951

    FDA REJECTS SUNOVION’S NEBULISED COPD DRUG

    May 30, 2017

    The US regulator has rejected Sunovion’s nebulised therapy for chronic obstructive pulmonary disease (COPD), leaving the company struggling to stay ahead of rivals. Late on Friday the Massachusetts-based biotech, owned by Sumitomo Dainippon, said the FDA had issued a dreaded Complete Response Letter...


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    https://Pharmaceutical.report/news-article.aspx?ID=953953

    ARRAY BIOPHARMA AND BRISTOL-MYERS SQUIBB ANNOUNCE STRATEGIC COLLABORATION

    May 30, 2017

    Array BioPharma (Nasdaq:ARRY) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the companies have entered into a clinical research collaboration to investigate the safety, tolerability and efficacy of Array's investigational MEK inhibitor, binimetinib in combination with Bristol-Myers Squ...


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    https://Pharmaceutical.report/news-article.aspx?ID=946946

    NEW DRUG CANDIDATE SHOWN TO DELAY MOTOR NEURONE DISEASE ONSET

    May 30, 2017

    Scientists at the University of Sheffield in the UK have reported encouraging early results in study of a potential drug to combat a form of motor neurone disease.


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    https://Pharmaceutical.report/news-article.aspx?ID=950950

    FACEBOOK AIMS TO SELL ADS TO THE US PHARMACEUTICAL INDUSTRY

    May 27, 2017

    According to a report in CNBC on Friday, the invitation-only summit is part of an initiative for advertisers called “Facebook Health”, run by a small team reporting into former Google Director Meredith Guerriero. The summit primarily focuses on gearing marketers in the pharmaceutical industry.


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    https://Pharmaceutical.report/news-article.aspx?ID=944944

    FACEBOOK AIMS TO SELL ADS TO THE US PHARMACEUTICAL INDUSTRY

    May 27, 2017

    According to a report in CNBC on Friday, the invitation-only summit is part of an initiative for advertisers called “Facebook Health”, run by a small team reporting into former Google Director Meredith Guerriero. The summit primarily focuses on gearing marketers in the pharmaceutical industry.


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    https://Pharmaceutical.report/news-article.aspx?ID=945945

    U.S. DRUG PRICE EROSION POSES INCREASED CHALLENGE FOR SUN PHARMA

    May 26, 2017

    Sun Pharmaceutical Industries Ltd., India’s largest drugmaker, faces mounting pressure to resolve regulatory issues at one of its biggest factories to help offset sharply deteriorating generic drug prices in the U.S.


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    https://Pharmaceutical.report/news-article.aspx?ID=940940

    CHALLENGES PROVIDING PHARMACEUTICAL PRODUCTS TO SYRIAN REFUGEES

    May 25, 2017

    Providing healthcare aid to civilians during war and crisis is a complicated task. The Syrian war has impacted the healthcare system inside Syria and the neighboring countries. Large and small humanitarian organizations have worked hard to provide pharmaceutical products to Syrian refugees. Ensuring...


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    https://Pharmaceutical.report/news-article.aspx?ID=934934

    AS OTHERS SEE IT: A BIPARTISAN WAY TO LOWER DRUG PRICES

    May 25, 2017

    White House budget director Mick Mulvaney has floated an idea to bring down drug prices that’s both promising and — if other Republicans can be persuaded to go along — bipartisan.


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    https://Pharmaceutical.report/news-article.aspx?ID=937937

    US FDA ACCEPTS APPLICATION FOR PSORIASIS DRUG: SUN PHARMA

    May 24, 2017

    Drug major Sun Pharmaceutical Industries today said the US health regulator has accepted biologics licence application (BLA) for tildrakizumab for the treatment of psoriasis.


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    https://Pharmaceutical.report/news-article.aspx?ID=941941

    GLOBAL SOCIAL MEDIA USE IN THE PHARMACEUTICAL INDUSTRY 2017

    May 24, 2017

    Social media covers a range of different online, interactive sites, such as Facebook and Twitter, and these different platforms have a considerable reach and following, with many sites boasting millions of users and daily visits. Despite the rapidly growing popularity of social media, the pharmaceut...


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    https://Pharmaceutical.report/news-article.aspx?ID=931931

    FDA APPROVES SANOFI AND REGENERON’S KEVZARA FOR ADULT RHEUMATOID ARTHRITIS

    May 23, 2017

    Sanofi and Regeneron Pharmaceuticals’ drug Kevzara (sarilumab) has received the US Food and Drug Administration (FDA) approval to treat adult patients affected with moderately to severely active rheumatoid arthritis (RA).


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    https://Pharmaceutical.report/news-article.aspx?ID=932932

    BONESUPPORT ENROLS FIRST PATIENT IN INJECTABLE BONE GRAFT SUBSTITUTE TRIAL

    May 22, 2017

    Bonesupport, the Scandinavian medical technology company, has enrolled their first patient at the University of Texas Health Science Center at San Antonio into the company’s pivotal Investigational Device Exemption (IDE) trial.


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    https://Pharmaceutical.report/news-article.aspx?ID=919919

    ANTIBIOTIC THERAPY FOR NEARLY 1 IN 4 ADULTS WITH PNEUMONIA DOES NOT WORK

    May 22, 2017

    Approximately one in four (22.1%) adults prescribed an antibiotic in an outpatient setting (such as a doctor’s office) for community-acquired pneumonia does not respond to treatment, according to a new study.


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    https://Pharmaceutical.report/news-article.aspx?ID=920920

    NEW WEIGHING EQUIPMENT HELPS PHARMACEUTICAL COMPANY PASS THE AUDIT RISK-BASED PROCESS VERIFICATION

    May 22, 2017

    For more than 200 years, the German-based company Klosterfrau Healthcare Group has been developing, manufacturing and selling pharmaceutical products. Its portfolio combines traditional remedies with modern drug therapies and encompasses more than 30 brands and nearly 220 over-the-counter products.


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    https://Pharmaceutical.report/news-article.aspx?ID=921921

    LOOK OUT, PHARMA MARKETERS. CALIFORNIA MAY TURN OFF SPEAKING FEES AND BAN PHARMA GIFTS

    May 22, 2017

    Pharma reps may soon have to cancel any doctor dinners they have planned in California. A state-level bill would cut off most drugmaker payments to physicians, including speaking fees for that staple of pharma marketing, the slideshow over dinner.


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    https://Pharmaceutical.report/news-article.aspx?ID=926926

    HOSPITALS SCRAMBLE FOR SODIUM BICARBONATE, 1 OF 8 DRUGS PFIZER SAYS ARE CURRENTLY IN SHORT SUPPLY

    May 22, 2017

    Hospitals are dealing with a shortage of sodium bicarbonate, a drug whose active ingredient is essentially the same one that cooks know as baking soda. Healthcare providers, which need the drug for uses that include heart surgery and chemo, are having to ration it right now because of supply issues ...


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    https://Pharmaceutical.report/news-article.aspx?ID=927927

    AMGEN'S ROMOSOZUMAB RED FLAG ON HEART SAFETY MEANS A BOOST FOR NEW RADIUS BONE DRUG

    May 22, 2017

    When Radius Health scored an early approval for its osteoporosis med Tymlos last month, industry watchers thought it wouldn't be long before the drug had to contend with another newcomer from Amgen. But now, Amgen says it’ll be a while before its drug hits the market—if ever.


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    https://Pharmaceutical.report/news-article.aspx?ID=928928

    FIERCEPHARMAASIA—CHINA’S DRUG POLICY OVERHAUL, TOP GENERIC DRUGMAKERS, BI’S CHINA BIOLOGICS PLANT

    May 19, 2017

    Welcome to this week's FiercePharmaAsia report, which includes China's new wave of policy changes aimed to streamline clinical trials and drug approvals, a special report on the top 15 generic drugmakers by 2016 revenue, a new biologics plant by Boehringer Ingelheim in Shanghai and more.


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    https://Pharmaceutical.report/news-article.aspx?ID=917917

    NO SCANDAL HERE, SAY RARE DISEASE DRUGMAKERS, AS PRICING SCRUTINY LANDS ON THEIR DOORSTEP

    May 19, 2017

    Rare disease drugmakers get that their typically high prices are under the lens these days—just like everyone else’s. But they don’t all necessarily agree that the scrutiny is fair.


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    https://Pharmaceutical.report/news-article.aspx?ID=918918

    PHARMA FIRMS GET NPPA NOTICE FOR VIOLATING PRICING NORMS FOR COMBINATION DRUGS

    May 18, 2017

    Drug pricing regulator, the National Pharmaceutical Pricing Authority (NPPA), has issued a notice to pharmaceutical companies that have launched combination drugs without taking its prior approval, in violation of the Drug Price Control Order (DPCO).


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    https://Pharmaceutical.report/news-article.aspx?ID=907907

    BIOGEN ACQUIRES REMEDY PHARMACEUTICALS’ LATE-STAGE DRUG CIRARA™ REMEDY PHARMACEUTICALS

    May 18, 2017

    Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving treatments to people affected by central nervous system diseases and injuries, today announced that Biogen (NASDAQ:BIIB) completed an asset purchase of its Phase 3 candidate.


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    https://Pharmaceutical.report/news-article.aspx?ID=908908

    PILOT PROGRAM IN CHINA TO COMMERCIALIZE NEW PHARMACEUTICAL DRUGS

    May 18, 2017

    Chinese pharmaceutical companies have always found it difficult to commercialize their patents. A national pilot program will help to solve that problem. More than 300 small- and medium-sized biopharma companies have settled in the Zhangjiang Hi-tech Park located in the Pudong district of Shanghai.


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    https://Pharmaceutical.report/news-article.aspx?ID=910910

    CLINICAL TRIAL PARTICIPANTS SHOULD HAVE A SAY IN NEW DRUG PRICING

    May 18, 2017

    People who volunteer to participate in clinical trials of new drugs provide a valuable service to pharmaceutical companies and to the rest of us. In return, I think that they should have a say in how much these drugs will cost when they hit the market.


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    https://Pharmaceutical.report/news-article.aspx?ID=911911

    INVESTING IN DRUG SAFETY MONITORING COULD AVOID COMPLICATIONS - AND SAVE MEDICAL COSTS

    May 17, 2017

    Increased investment in "pharmacovigilance surveillance" - systems to proactively monitor safety problems with new medications - has the potential to avoid harmful drug effects while lowering healthcare costs, according to a study in the June issue of Medical Care. The journal is published by Wolter...


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    https://Pharmaceutical.report/news-article.aspx?ID=914914

    WHAT AMAZON COULD DO TO THE BUSINESS OF SELLING PRESCRIPTION DRUGS

    May 17, 2017

    Investors sold off shares of pharmacy giant CVS Health and Walgreens on Wednesday amid renewed speculation that Amazon would enter the business of selling prescription drugs.


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    https://Pharmaceutical.report/news-article.aspx?ID=909909

    EC OPENS FORMAL INVESTIGATION INTO ASPEN PHARMA’S CANCER DRUG PRICE HIKES

    May 17, 2017

    The European Commission has opened a formal investigation into concerns that Aspen Pharma has engaged in excessive pricing concerning five life-saving cancer medicines.


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    https://Pharmaceutical.report/news-article.aspx?ID=905905

    PROGRESS REPORT ON BIOPHARMACEUTICAL INDUSTRY CONTRIBUTIONS TO THE GLOBAL FIGHT AGAINST NEGLECTED TROPICAL DISEASES (NTDS)

    May 17, 2017

    On the occasion of the 5th anniversary of the World Health Organization’s roadmap on NTDs and the London Declaration, IFPMA released today its latest report “Doing our part – Innovating to fight Neglected Tropical Diseases” that provides the most up-to-date record of active research and development ...


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    https://Pharmaceutical.report/news-article.aspx?ID=901901

    BOEHRINGER OPENS BIOPHARMACEUTICAL MANUFACTURING FACILITY IN CHINA

    May 17, 2017

    Germany’s Boehringer Ingelheim has officially opened its commercial production site for biopharmaceuticals in Zhang Jiang Hi-tech Park in Shanghai, China.


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    https://Pharmaceutical.report/news-article.aspx?ID=902902

    EU NATIONS URGE FUNDING TO RESEARCH NEW DRUGS AND VACCINES FOR TUBERCULOSIS

    May 16, 2017

    Leaders representing the French and Netherlands governments have urged for funding to develop new treatment and prevention tools against drug-resistant tuberculosis (TB) at a meeting held in Brussels.


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    https://Pharmaceutical.report/news-article.aspx?ID=903903

    FIRST-IN-CLASS INNOVATION A KEY STRATEGY FOR HARSH PHARMA MARKET ENVIRONMENT

    May 16, 2017

    Fewer than two in 10 medicines exceed the average pharmaceutical R&D cost required to bring a drug to market when the risks of failure to reach market approval are factored in.


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    https://Pharmaceutical.report/news-article.aspx?ID=887887

    LESSONS FROM EBOLA: HOW TO IMPROVE DISEASE OUTBREAK MANAGEMENT

    May 16, 2017

    A new approach to information gathering could allow scientists to quickly identify the most effective way to manage a disease outbreak, an advance that could save lives.


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    https://Pharmaceutical.report/news-article.aspx?ID=888888

    RELOCATING THE EMA: AN OPEN LETTER FROM EFPIA AND PHARMA HEADS OF RESEARCH

    May 16, 2017

    Our current system of medicines regulation offers an outstanding example of European cooperation at its finest. By joining forces across nation states.


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    https://Pharmaceutical.report/news-article.aspx?ID=889889