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    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...


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    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...


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    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...


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    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...


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    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...

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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...

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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...

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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...

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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...

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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...

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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 ...

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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...

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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 ...

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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...

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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...

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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...

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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...

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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 ...

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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...

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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...

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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...

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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...

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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...

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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....

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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...

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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...

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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...

    FIERCEPHARMA
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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...

    PHARMABIZ.COM
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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...

    PHARMTECH
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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...

    PHARMTECH
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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...

    FIERCEPHARMA
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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...

    PHARMABIZ.COM
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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...

    BIOPHARMA DIVE
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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...

    BIOPHARMA DIVE
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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...

    FIERCEPHARMA
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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...

    PHARMABIZ.COM
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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...

    PHARMATIMES
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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) ...

    PHARMATIMES
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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...

    PHARMABIZ.COM
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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...

    PHARMATIMES
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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...

    PHARMATIMES
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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...

    LABROOTS
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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...

    LABROOTS
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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...

    PHARMATIMES
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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 ...

    PHARMATIMES
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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

    BIG PHARMA HOPES RULE CHANGE WILL EASE CHINA SALES PAIN

    May 16, 2017

    The world’s largest pharmaceutical companies, which are struggling with pricing pressures in China, are hoping that wider access to drugs and a faster approval process will boost sales.


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    https://Pharmaceutical.report/news-article.aspx?ID=900900

    BOEHRINGER INGELHEIM INAUGURATES WORLD-CLASS BIOPHARMACEUTICAL MANUFACTURING FACILITY IN CHINA

    May 16, 2017

    Today, Boehringer Ingelheim inaugurated its commercial production site for biopharmaceuticals in Zhang Jiang Hi-tech Park of Shanghai (China). The site, with the first-phase investment of more than €70 million, is the first and only biopharmaceutical facility established by a leading multinational a...


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    https://Pharmaceutical.report/news-article.aspx?ID=915915

    DIABETES DRUG MAY HELP SYMPTOMS OF AUTISM-ASSOCIATED CONDITION

    May 15, 2017

    Metformin, the most widely used drug to treat type 2 diabetes, could potentially be used to treat symptoms of Fragile X syndrome, an inherited form of intellectual disability and a cause of some forms of autism.


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    https://Pharmaceutical.report/news-article.aspx?ID=916916

    A PATH TOWARD ENDING AIDS EPIDEMIC IN THE US BY 2025

    May 15, 2017

    A new study describes an ambitious but feasible path toward what may have seemed unachievable just a decade ago: an end to the AIDS epidemic in the US.


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    https://Pharmaceutical.report/news-article.aspx?ID=886886

    YELP FOR DRUGS? SERMO DEBUTS DRUG-RATING TOOL FOR DOCTORS FEATURING REVIEWS, RATINGS AND COMMENTS

    May 15, 2017

    Like consumers who scroll Amazon reviews, doctors looking for opinions on prescription drugs have a new place to turn. The Drug Ratings online database, launched last week by physician social network Sermo.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=891891

    PHARMA AND BIOTECH REBOUND IN ANNUAL TRUST STUDY, BUT THERE'S STILL ROOM FOR IMPROVEMENT

    May 15, 2017

    When it comes to pharma, consumers still have trust issues. But the good news from Edelman’s 2017 Trust Barometer study is that things are improving.


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    https://Pharmaceutical.report/news-article.aspx?ID=892892

    EC TO INVESTIGATE ASPEN PHARMA CANCER DRUG PRICE HIKES

    May 15, 2017

    The European Commission said today that it launched a formal investigation into whether Aspen Pharma has abused its dominant market position in cancer treatments to overcharge for five drugs—the first time the EC has ever probed concerns about excessive pricing practices in the pharmaceutical indust...


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    https://Pharmaceutical.report/news-article.aspx?ID=894894

    ROCHE VS INDIAN PHARMA: THE BATTLE FOR A CHEAPER CANCER DRUG

    May 14, 2017

    Let’s hark back to the Nineties. The HIV-AIDS epidemic was spreading across Africa, leaving thousands dead, in spite of the existence of anti-retroviral drugs (ARVs).


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    https://Pharmaceutical.report/news-article.aspx?ID=895895

    US FDA ISSUES CRL TO HIKMA’S GENERIC VERSION OF GSK’S ADVAIR DISKUS

    May 12, 2017

    Hikma Pharmaceuticals has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the abbreviated new drug application (ANDA) of its.


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    https://Pharmaceutical.report/news-article.aspx?ID=904904

    THE CONTINUUM OF HIV CARE: WHAT DOES IT MEAN AND HOW IS EUROPE DOING?

    May 12, 2017

    From diagnosis of HIV to successful viral suppression: this new ECDC report summarises key findings concerning and the Continuum of HIV Care in Europe.


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    https://Pharmaceutical.report/news-article.aspx?ID=873873

    ALZHEIMER’S EXPERTS CALL FOR CHANGES IN FDA DRUG APPROVAL STANDARDS

    May 12, 2017

    Leading Alzheimer’s disease researchers and a prominent patient advocate today published an analysis, Single Endpoint for New Drug Approvals for Alzheimer’s Disease, urging the Food and Drug.


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    https://Pharmaceutical.report/news-article.aspx?ID=874874

    EUROPEAN MEDICINES AGENCY’S 2016 ANNUAL REPORT PUBLISHED

    May 11, 2017

    The European Medicines Agency’s (EMA) 2016 annual report focuses on the Agency’s key achievements in the areas of medicine evaluation.


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    https://Pharmaceutical.report/news-article.aspx?ID=868868

    PHARMACEUTICAL COMPANIES RAISE HEALTH SERVICE SPONSORSHIP TO €58M

    May 11, 2017

    Pharmaceutical companies spent €58.5m sponsoring doctors, patients organisations and healthcare providers last year, the Volkskrant said on Thursday.


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    https://Pharmaceutical.report/news-article.aspx?ID=865865

    PMG-MAN UNVEILS INITIATIVES TO EXPLOIT PHARMACEUTICAL INDUSTRY’S POTENTIAL

    May 11, 2017

    In a bid to address concerns in the nation’s pharmaceutical industry, Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG-MAN) has concluded plans to hold a forum to explore initiatives that will aid local.


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    https://Pharmaceutical.report/news-article.aspx?ID=866866

    DESPITE PRICING OUTCRY, BRANDED PHARMA KEPT DOUBLE-DIGIT HIKES COMING IN 2016: REPORT

    May 10, 2017

    Even amid a series of high-profile pricing controversies—and as a few companies made public promises to limit hikes—the pharma industry continued to raise list prices at rates far above general inflation, a new report shows.


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    https://Pharmaceutical.report/news-article.aspx?ID=867867

    US AUTHORITIES PROBE MARKETING OF J&J DRUGS

    May 10, 2017

    Johnson & Johnson is under investigation by US authorities over marketing, rebates and payment support programmes, according to documents filed with the financial regulator.


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    https://Pharmaceutical.report/news-article.aspx?ID=861861

    TAKEDA SIGNS DEAL WITH UK BIOTECH GAMMADELTA THERAPEUTICS ON T CELL THERAPY

    May 10, 2017

    The Japanese pharma company, led by chief executive Christophe Weber, is looking to upgrade its R&D pipeline with some of the best cutting-edge science, and is investing in the newly launched biotech as part of this strategy.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=862862

    OUTRAGE OVER DUCHENNE DRUG PRICE REINFLAMED BY PTC’S $35,000 PRICE TAG

    May 10, 2017

    Emflaza’s active ingredient is deflazacort, an old steroid that families were using off-label to treat symptoms of DMD in boys affected by the genetic disease.

    RICHARD STAINES
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    https://Pharmaceutical.report/news-article.aspx?ID=863863

    SETBACK FOR AZ’ ASTHMA DRUG AS TRIAL MISSES ENDPOINT

    May 10, 2017

    AstraZeneca’s tralokinumab has failed to significantly reduce the rate of annual exacerbations in patients with uncontrolled asthma taking part in a late-stage trial.


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    https://Pharmaceutical.report/news-article.aspx?ID=858858

    ROCHE’S TECENTRIQ FAILS TO BOOST SURVIVAL IN BLADDER CANCER STUDY

    May 10, 2017

    Roche’s immunotherapy Tecentriq has failed to significantly improve overall survival compared to chemotherapy in pre-treated patients with advanced bladder cancer, marking a major setback for the drug.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=859859

    NEW CANADIAN CLINICAL GUIDELINE FOR PHYSICIANS TO REDUCE USE OF OPIOIDS

    May 10, 2017

    Canadian physicians are being advised to reduce their prescribing of opioid medication to patients with chronic non-cancer pain in a new guideline for clinical care that focuses on harm reduction.


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    https://Pharmaceutical.report/news-article.aspx?ID=869869

    SANOFI, EXSCIENTIA LINK TO DEVELOP BISPECIFIC SMALL MOLECULE DRUGS

    May 09, 2017

    Under the alliance, Exscientia will use its platform to seek out and validate combinations of drug targets that could work synergistically and be amenable to its bispecific-small-molecule design strategy.


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    https://Pharmaceutical.report/news-article.aspx?ID=860860

    IRELAND REITERATES BID TO HOST THE EUROPEAN MEDICINES AGENCY POST-BREXIT

    May 09, 2017

    Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated by Minister of Health, Simon Harris over the past week.


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    https://Pharmaceutical.report/news-article.aspx?ID=851851

    INDUCING PROTEIN AGGREGATION BY EXTENSIONAL FLOW MAKES DRUGS LESS EFFECTIVE

    May 09, 2017

    Biopharma and food businesses working with proteins now have access to better information about how a type of fluid flow commonly encountered in manufacturing processes can affect the quality of their products, following successful research.


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    https://Pharmaceutical.report/news-article.aspx?ID=852852

    COMPOUNDING PHARMACY CITED FOR UNLICENSED BIOLOGICS

    May 09, 2017

    FDA sent a warning letter to Pharmaceutic Labs, LLC, dated May 3, 2017 citing the company for violations of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA personnel inspected the company’s Albany.


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    https://Pharmaceutical.report/news-article.aspx?ID=885885

    IMPROVING PRODUCTIVITY TO DRIVE DRUG DISCOVERIES TO PATIENTS

    May 08, 2017

    Magid Abou-Gharbia, director of the Moulder Center for Drug Discovery Research at the Temple University School of Pharmacy.


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    https://Pharmaceutical.report/news-article.aspx?ID=884884

    SLINGSHOT TO SHOOT DRUGS ONTO THE SITE OF AN INFECTION

    May 08, 2017

    The molecular slingshot is only a few nanometres long and is composed of a synthetic DNA strand that can load a drug and then effectively act as the rubber band of the slingshot.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=844844

    ENGLAND'S CANCER DRUGS FUND 'FAILED TO DELIVER MEANINGFUL VALUE TO PATIENTS AND SOCIETY'

    May 08, 2017

    Analysis of the drugs that were approved for use by the NHS Cancer Drugs Fund (CDF) in England has shown that the fund was not good value for patients and society and may have resulted in patients suffering unnecessarily from toxic side effects of the drugs.


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    https://Pharmaceutical.report/news-article.aspx?ID=847847

    CUSTOMISED VIBRATING SEPARATORS FOR THE PHARMACEUTICAL INDUSTRY

    May 08, 2017

    In highly regulated environments such as the pharmaceutical industry, integrating industrial separation equipment into the manufacture of pharmaceutical preparations ensures that product quality and strict FDA hygiene standards are maintained.


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    https://Pharmaceutical.report/news-article.aspx?ID=849849

    APTAR PHARMA & KALI CARE TO DEVELOP MEDICATION MONITORING TECH FOR TRIALS

    May 08, 2017

    Aptar Pharma and Kali Care have entered into a partnership in order to address the challenge of monitoring adherence in ophthalmic clinical trials. The combination of Aptar Pharma’s ophthalmic device expertise, and Kali Care’s ground-breaking digital.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=850850

    BIG PHARMA'S BIOSIMILAR STALLING TACTICS COMING TO AN END

    May 08, 2017

    Historically, traditional small molecule products were the focus of the pharmaceutical industry. This was especially the case between 2010 and 2013, when many of the blockbuster brand name medications—those grossing more than $1 billion in annual sales—lost their patent protection.


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    https://Pharmaceutical.report/news-article.aspx?ID=880880

    CHEMISTS MAY HAVE FOUND A WAY TO MAKE PHARMACEUTICALS CHEAPER AND SAFER

    May 05, 2017

    Have you ever tried to shake someone's left hand with your right? Doesn't work that well. The chemistry in our bodies and the world around us relies heavily on things fitting together in the right way.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=881881

    FDA APPROVES DRUG TO TREAT ALS

    May 05, 2017

    The U.S. Food and Drug Administration today approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=848848

    FIRST EVER EVIDENCE OF TREATMENT-INDUCED REDUCTION IN HIV RESERVOIRS

    May 04, 2017

    Abivax’s lead therapeutic candidate ABX464 demonstrated the first reduction in HIV reservoirs ever observed in chronically infected HIV patients as measured by total HIV DNA detected in peripheral blood mononuclear cells (PBMCs).


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=853853

    FDA APPROVES ROCHE’S HIGH-VOLUME IMMUNOASSAY

    May 04, 2017

    Roche’s new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyser series, the cobas e 801 module, has received 510(k) clearance from the US Food and Drug Administration (FDA).


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=854854

    PRICING FUROR ASIDE, DRUG SPENDING GROWTH SLOWED LAST YEAR—BUT STILL HIT $323B

    May 04, 2017

    Despite what you may have heard about drug pricing and expenses getting out of hand, net spending growth actually fell in the U.S. last year. After discounts, pharmaceutical spending increased 4.8% in 2016, down from 8.9% growth recorded in 2015.


    READ MORE

    https://Pharmaceutical.report/news-article.aspx?ID=830830

    £50 BLOOD TEST COULD PREDICT PROSTATE CANCER DRUG RESPONSE

    May 04, 2017

    A team at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, along with colleagues in Europe, looked at blood samples from 265 men with advanced prostate cancer being treated with abiraterone or enzalutamide, either before or after docetaxel chemotherapy.


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    https://Pharmaceutical.report/news-article.aspx?ID=831831

    BIO ACCUSES INSURER REPORT OF SHIFTING BLAME ON DRUG PRICES

    May 04, 2017

    BIO, a major biotech trade group, is pushing back against a new report showing steady prescription drug price increases over the past seven years, claiming the "cherry-picked" findings don't accurately reflect market dynamics.


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    https://Pharmaceutical.report/news-article.aspx?ID=837837

    GSK INVESTS $139M TO BOOST LUPUS DRUG PRODUCTION

    May 04, 2017

    GlaxoSmithKline will invest $139 million in its Rockville, Maryland manufacturing site, boosting production capacity for its lupus drug Benlysta (belimumab) in response to growing demand.


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    https://Pharmaceutical.report/news-article.aspx?ID=838838

    PAYER, CONSUMER PUSHBACK EXPECTED TO DAMPEN DRUG SPENDING GROWTH

    May 04, 2017

    Payers' increased negotiating power, as well as consumer pushback on high-priced prescription medications, stand to dampen drug spending over the next five years, according to a new report from QuintilesIMS, a healthcare information and technology provider.


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    https://Pharmaceutical.report/news-article.aspx?ID=839839

    HOW DO POLICIES ON DETAILING AFFECT BRANDED DRUG RX?

    May 04, 2017

    If you work at a hospital like mine, it's probably been a long time since you've been treated to a lavish educational dinner sponsored by a pharmaceutical company. It's probably been a while since you've seen a pen with a drug name on it, actually.


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    https://Pharmaceutical.report/news-article.aspx?ID=882882

    PIERIS TEAMS UP WITH ASTRAZENECA ON RESPIRATORY DRUG DEVELOPMENT

    May 03, 2017

    Small Boston-based Pieris Pharmaceuticals is joining forces with AstraZeneca to speed development of its protein platform for application in respiratory diseases, announcing Wednesday a broad collaboration with the British pharma.


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    https://Pharmaceutical.report/news-article.aspx?ID=840840

    NICE NOD FOR AMGEN’S RARE LEUKAEMIA DRUG

    May 03, 2017

    The Institute has published final draft guidance recommending Blincyto (blinatumomab) as an option for treating adults with Philadelphia-chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL), on the basis of the discount agreed in the patient access scheme....


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    https://Pharmaceutical.report/news-article.aspx?ID=832832

    AETERNA ZENTARIS’ ENDOMETRIAL CANCER DRUG FAILS IN PHASE III

    May 03, 2017

    The median overall survival period for those treated with Zoptrex (zoptarelin doxorubicin) was 10.9 months compared to 10.8 months for patients treated with doxorubicin, which was not significantly different.


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    https://Pharmaceutical.report/news-article.aspx?ID=833833

    ASTRAZENECA’S BLADDER CANCER TREATMENT RECEIVES FDA APPROVAL

    May 03, 2017

    The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) to treat patients with locally advanced or metastatic urothelial carcinoma (mUC).


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    https://Pharmaceutical.report/news-article.aspx?ID=855855

    EC EXTENDS APPROVAL FOR JANSSEN’S DARATUMUMAB TO INCLUDE MULTIPLE MYELOMA PATIENTS

    May 03, 2017

    The European Commission (EC) has granted approval to Janssen‘s Daralex (daratumumab) for use in combination with lenalidomide and dexamethasone, or bortezomib (Velcade) and dexamethasone.


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    https://Pharmaceutical.report/news-article.aspx?ID=856856

    RSS OUTFIT ACCUSES GOVT DEPTS OF COLLUDING WITH PHARMA MAJORS

    May 03, 2017

    The Swadeshi Jagran Manch (SJM), an outfit affiliated to the Rashtriya Swayamsevak Sangh (RSS), has accused the Ministry of Health and Family Welfare, the Department of Pharmaceuticals and the NITI Aayog of working to benefit pharmaceutical companies.


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    https://Pharmaceutical.report/news-article.aspx?ID=823823

    3 REASONS TEVA PHARMACEUTICAL INDUSTRIES LOST ANOTHER $520 MILLION IN MARKET VALUE IN APRIL

    May 03, 2017

    Shares of Teva Pharmaceutical Industries (NYSE:TEVA), a developer of brand-name drugs and the largest manufacturer of generic drugs in the world, continued its fairly steady.


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    https://Pharmaceutical.report/news-article.aspx?ID=825825

    CURE PHARMACEUTICAL ADDS INDUSTRY VETERAN, ANTI-AGING SPECIALIST AND MEDICINAL CANNABIS SUPPORTER, ALAN EINSTEIN, TO ITS BOARD OF DIRECTORS

    May 03, 2017

    CURE Pharmaceutical (OTCQB:CURR), (“CURE”), a leading disruptive drug delivery technology company researching cannabinoid molecules for various healthcare applications, today announces the appointment of Dr. Alan E. Einstein to its board of directors.


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    https://Pharmaceutical.report/news-article.aspx?ID=826826

    PHARMA, STOP TRYING TO SELL DRUGS LIKE THEY'RE CARS OR SHOES, AGENCY VET URGES

    May 03, 2017

    Most people would agree that Oreos and arthritis meds probably shouldn’t be sold the same way. However, according to branding consultant Vince Parry, many pharma companies are doing just that by using consumer branding strategies to sell drugs.


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    https://Pharmaceutical.report/news-article.aspx?ID=827827

    COUNTY LIQUOR STORES TO START CARDING ALL BUYERS; PHARMACEUTICAL COMPANY PLANS MAJOR ROCKVILLE EXPANSION

    May 02, 2017

    New county rules will require alcohol sellers to card all purchasers, no matter their age. The policy will go into effect July 1 for all 27 liquor stores run by the county.


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    https://Pharmaceutical.report/news-article.aspx?ID=822822

    PHARMA: HERE'S WHAT ALL HAPPENED IN THE SECTOR LAST WEEK

    May 02, 2017

    Last week, the pharmaceutical and healthcare sector was in the news over the use of generic drug names in prescriptions. Also, fourth quarter earnings, debate over drug price control and regulatory issues kept the spotlight on the sector.


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    https://Pharmaceutical.report/news-article.aspx?ID=816816

    GOVT ARMS LOBBYING FOR PHARMA COMPANIES: SWADESHI JAGRAN MANCH

    May 02, 2017

    The Swadeshi Jagran Manch (SJM), an RSS outfit, has written to PM Narendra Modi accusing arms of the government- health ministry, department of pharmaceuticals (DoP).


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    https://Pharmaceutical.report/news-article.aspx?ID=818818

    PHARMACEUTICAL PACKAGING EQUIPMENT MARKET WORTH 8.24 BILLION USD BY 2022

    May 02, 2017

    According to a new market research report "Pharmaceutical Packaging Equipment Market by Package (Blister, Strip, Bottle, Tube, Aseptic Packaging, Wrapping, Labeling & Serialization), Product (Tablet, Powder, Cream, Syrup, Aseptic Liquid, Aerosol) - Global Forecast to 2022" published by MarketsandMar...


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    https://Pharmaceutical.report/news-article.aspx?ID=819819

    UNDER DEVELOPMENT: CBD PHARMACEUTICAL CHEWING GUM

    May 02, 2017

    AXIM® Biotechnologies, Inc., a company focused on cannabinoid research and development, today announced that the company’s product development partner Quay Pharmaceuticals.


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    https://Pharmaceutical.report/news-article.aspx?ID=820820

    BIOINSPIRED AGENT KILLS DRUG-RESISTANT BACTERIA

    May 02, 2017

    Microbial resistance to antibiotics and biocides is increasing, and our ability to effectively treat bacterial infections and contamination is under threat. It is important that scientists develop new antibiotic drugs, but we also need new strategies to deal with bacterial contamination that are not...


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    https://Pharmaceutical.report/news-article.aspx?ID=845845

    TAKEDA’S LUNG CANCER DRUG APPROVED IN THE US

    May 02, 2017

    The US Food and Drug Administration has given permission for the once-daily drug’s use as a second-line therapy for adults with non-small cell lung cancer (NSCLC) who also carry the anaplastic lymphoma kinase (ALK) mutation.


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    https://Pharmaceutical.report/news-article.aspx?ID=834834

    CANCER DRUGS FUND POOR VALUE FOR MONEY, STUDY FINDS

    May 02, 2017

    The CDF was set up in 2010 by the UK government in order to provide patients with access to cancer drugs not yet routinely available through the NHS.


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    https://Pharmaceutical.report/news-article.aspx?ID=835835

    PHARMACEUTICAL TAKE BACK EVENT PLANNED FOR SATURDAY

    May 01, 2017

    If you have pharmaceuticals you no longer need, Keep Scottsbluff-Gering Beautiful is encouraging everyone to drop by its Pharmaceutical Take Back event and turn them over to them rather than flushing them down the toilet.


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    https://Pharmaceutical.report/news-article.aspx?ID=821821

    WHO BOASTS THE BIGGEST OVERSEAS CASH COFFERS? AMGEN AND GILEAD, TO NAME A COUPLE

    May 01, 2017

    At January’s JPMorgan Healthcare Conference, Amgen CEO Robert Bradway proclaimed that his company would be “a clear beneficiary” of any corporate tax reform U.S. President Donald Trump could enact.


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    https://Pharmaceutical.report/news-article.aspx?ID=828828

    GENERIC PRICE EROSION WREAKS MORE PHARMA HAVOC, WITH NO END IN SIGHT

    May 01, 2017

    A portfolio of 42 generic meds it acquired from Teva and Allergan last summer wouldn’t be meeting 2017 sales guidance thanks to a “tough pricing deflation cycle” in the U.S. copycat market.


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    https://Pharmaceutical.report/news-article.aspx?ID=829829

    FDA GIVES THUMBS UP TO TAKEDA'S LUNG CANCER DRUG

    May 01, 2017

    Japanese pharma Takeda Pharmaceuticals on Friday secured approval for its drug targeting a specific group of lung cancer patients, putting the company in direct competition with several other heavyweight drug developers.


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    https://Pharmaceutical.report/news-article.aspx?ID=842842

    RADIUS TARGETS QUICK RAMP UP FOR NEWLY APPROVED OSTEOPOROSIS DRUG

    Apr 30, 2017

    Radius Health last week won U.S. approval of its osteoporosis drug Tymlos (abaloparatide), securing a green light from the Food and Drug Administration one month after the regulator had unexpectedly extended its review.


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    https://Pharmaceutical.report/news-article.aspx?ID=841841

    2 DOCTORS UNDER LENS FOR UNDUE FAVOURS TO PHARMA UNITS

    Apr 28, 2017

    Two senior doctors of the civil hospital in Palampur have come under the police scanner of for allegedly extending undue favours to private pharmaceutical companies for monetary benefits.


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    https://Pharmaceutical.report/news-article.aspx?ID=810810

    WHAT IS MADDENING ABOUT PHARMACEUTICAL PRICES

    Apr 28, 2017

    Imagine that you are gasping for breath, literally on the verge of death. Then someone injects you with a medicine and–miracle!–you are perfectly healthy again.


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    https://Pharmaceutical.report/news-article.aspx?ID=812812

    BRINGING REAL SCIENCE TO PHARMACEUTICAL CANNABIS

    Apr 28, 2017

    As the cannabis industry moves from purely medicinal use to also recreational-use markets, there is a certain amount of irony in this transition. The irony begins as follows: legalizing recreational use of cannabis is now taking place in large part because of the success in providing documented reli...


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    https://Pharmaceutical.report/news-article.aspx?ID=813813

    PUSH TO SUE PHARMACEUTICAL COMPANIES OVER OPIOID CRISIS

    Apr 28, 2017

    A group of Mainers struggling with addictions want some of the country's largest drug makers held responsible in court.


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    https://Pharmaceutical.report/news-article.aspx?ID=814814

    FOREIGN PHARMACEUTICALS WOULD HURT NORTH CAROLINA

    Apr 28, 2017

    Pharmaceutical giant Novo Nordisk recently announced plans for a new facility in Clayton. Building the life-sciences compound will create nearly 2,500 construction jobs, and the finished operation will employ 700 people.


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    https://Pharmaceutical.report/news-article.aspx?ID=815815

    NHS FUNDING SQUEEZE COULD SEE DRUGS FIRMS LEAVE BRITAIN, PHARMACEUTICAL INDUSTRY WARNS

    Apr 27, 2017

    The world's biggest drugs firms could abandon Britain and delay launching medicines unless an extra £20 billion is pumped into the NHS, according to a leading pharmaceutical association.


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    https://Pharmaceutical.report/news-article.aspx?ID=805805

    MISSION MARKETING GROUP BUYS PHARMACEUTICAL CONSULTANCY SERVICES PROVIDER

    Apr 27, 2017

    AIM-listed Mission Marketing Group has bought RJW & Partners, a provider of consultancy services to the pharmaceutical and medical devices industries, for up to £6.23m.


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    https://Pharmaceutical.report/news-article.aspx?ID=806806

    TACKLING "DRUG HOLIDAYS" LOOKS TO BE CRITICAL IN BEATING CANCER THERAPY RESISTANCE

    Apr 27, 2017

    Scientists from the Cleveland Clinic, University of Oxford, and Moffitt Cancer Center say that while resistance to targeted treatment in cancer is a moving target, there are opportunities to overcome the resistance that develops.


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    https://Pharmaceutical.report/news-article.aspx?ID=808808

    NHS FUNDING SQUEEZE COULD SEE DRUGS FIRMS LEAVE BRITAIN, PHARMACEUTICAL INDUSTRY WARNS

    Apr 27, 2017

    The world's biggest drugs firms could abandon Britain and delay launching medicines unless an extra £20 billion is pumped into the NHS, according to a leading pharmaceutical association.

    PHARMACEUTICAL
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    https://Pharmaceutical.report/news-article.aspx?ID=809809

    NOVARTIS TO GLOBALLY CO-COMMERCIALISE AMGEN’S MIGRAINE DRUG

    Apr 27, 2017

    Novartis has expanded their commercialisation agreement with Amgen for AMG 334 (erenumab), which is being investigated for the prevention of migraine.


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    https://Pharmaceutical.report/news-article.aspx?ID=870870

    PROTEIN TARGETING ANTIBIOTICS BRING NEW HOPE AGAINST MULTI-DRUG RESISTANCE

    Apr 27, 2017

    Polyphor presented promising data for their novel class of antibiotics, the Outer Membrane Protein Targeting Antibiotics (OMPTA).


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    https://Pharmaceutical.report/news-article.aspx?ID=875875

    FDA TAKES ACTION AGAINST 14 COMPANIES FOR SELLING ILLEGAL CANCER TREATMENTS

    Apr 26, 2017

    The US Food and Drug Administration (FDA) has posted warning letters addressed to 14 US-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer.


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    https://Pharmaceutical.report/news-article.aspx?ID=876876

    CPHI EXPERT SAYS QUICKER APPROVALS FOR ANDA’S WOULD LOWER DRUG COSTS

    Apr 26, 2017

    Girish Malhotra, President of EPCOT International, and CPhI Worldwide Annual Industry Report member, discusses the necessity of time reduction for ANDA (Abbreviated New Drug Application) approvals.


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    https://Pharmaceutical.report/news-article.aspx?ID=877877

    REDHILL BIOPHARMA ENROLS LAST PATIENT IN PHASE II IRRITABLE BOWEL SYNDROME TRIAL

    Apr 26, 2017

    RedHill Biopharma has enrolled the last patient in the Phase II study with Bekinda (RHB-102) 12 mg for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D).


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    https://Pharmaceutical.report/news-article.aspx?ID=878878

    GLENMARK PHARMACEUTICALS INITIATES CLINICAL INVESTIGATION FOR GBR 310, ITS PROPOSED BIOSIMILAR CANDIDATE FOR XOLAIR

    Apr 25, 2017

    Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) cleared the company's Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar, which will assess its pharmacokinetics in...


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    https://Pharmaceutical.report/news-article.aspx?ID=793793

    ALEMBIC PHARMA RISES AFTER USFDA APPROVALS FOR DRUGS

    Apr 25, 2017

    Alembic Pharmaceuticals gained 1.87% to Rs 616.45 at 14:05 IST on BSE after the company received USFDA final approvals for Olmesartan Medoxomil Tablets and Olmesartan Medoxomil with Hydrochlorothiazide Tablets.


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    https://Pharmaceutical.report/news-article.aspx?ID=794794

    EASL: BRISTOL-MYERS' DRUG CUTS LIVER FAT IN NASH

    Apr 24, 2017

    In a late-breaking oral presentation on Saturday at the International Liver Congress (EASL), held in the Netherlands, Bristol-Myers Squibb unveiled Phase 2 data from the study of BMS-986036, its pegylated analog of human fibroblast growth factor (FGF21).


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    https://Pharmaceutical.report/news-article.aspx?ID=791791

    DA WELCOMES PROBE OF TOP PHARMACEUTICAL COMPANY BY COMPETITION COMMISSION

    Apr 24, 2017

    The Competition Commission will conduct an investigation into the alleged anti-competitive conduct of Aspen Pharmacare, the Democratic Alliance said on Sunday.


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    https://Pharmaceutical.report/news-article.aspx?ID=781781

    CONSIDER A BULL SPREAD ON SUN PHARMA

    Apr 24, 2017

    Sun Pharmaceutical Industries (₹639.6) is ruling at a crucial level. The stock finds support at ₹610 and the crucial one at ₹572. A close below the latter will confirm the bearish trend.


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    https://Pharmaceutical.report/news-article.aspx?ID=782782

    NPPA WARNS PHARMACEUTICAL COMPANIES FOR CEILING PRICES OF CORONARY STENTS

    Apr 24, 2017

    National Pharmaceutical Pricing Authority (NPPA) on Monday warned the companies manufacturing and marketing coronary stents and hospitals to comply with the notified ceiling price of stents and to adhere the pricing norms, said Ministry of Chemicals & Fertilizers.


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    https://Pharmaceutical.report/news-article.aspx?ID=783783

    PHARMACEUTICAL GROUPS BACK PLANNED GENERICS BODY

    Apr 24, 2017

    The Philippine Chamber of the Pharmaceutical Industry (PCPI) recently expressed support for the formation of a government Inter-Agency Committee on Generic Drugs Development, saying this will help the growth of Filipino-manufactured generic drugs.


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    https://Pharmaceutical.report/news-article.aspx?ID=784784

    BIG PHARMACEUTICAL COMPANIES: ARE THEY CURING OR CAUSING DISEASES?

    Apr 24, 2017

    The drugs have brought us undeniable benefits. Thanks to modern medicines, many of us are now living healthier and longer lives ever than before.


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    https://Pharmaceutical.report/news-article.aspx?ID=785785

    MARATHON PHARMACEUTICAL DROPS OUT OF PHRMA FOLLOWING DRUG PRICE CONTROVERSY

    Apr 24, 2017

    With the sale of its controversial rare-disease drug finalized, Marathon Pharmaceuticals has taken the unusual step of resigning from the powerful industry lobbying group PhRMA.


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    https://Pharmaceutical.report/news-article.aspx?ID=786786

    DEALS THIS WEEK: GRIFOLS, CELLESCE, ARENA PHARMACEUTICALS

    Apr 21, 2017

    Spanish pharmaceutical company Grifols has raised €1bn ($1.06bn) through a public offering of bonds. Due 1 May 2025, the unsecured bonds carry a coupon rate of 3.2%.The offering is intended to refinance the bonds issued by the company in March 2014.


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    https://Pharmaceutical.report/news-article.aspx?ID=779779

    VALEANT PRICES PSORIASIS DRUG AT $42K PER YEAR

    Apr 21, 2017

    Valeant set the price for its recently approved psoriasis drug to $3,500 per month, or $42,000 a year, the company announced Friday.


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    https://Pharmaceutical.report/news-article.aspx?ID=790790

    GLYBERA, THE MOST EXPENSIVE DRUG IN THE WORLD, TO BE WITHDRAWN AFTER COMMERCIAL FLOP

    Apr 20, 2017

    Amsterdam-headquartered firm uniQure developed the drug for a small subset of patients with the rare familial lipoprotein lipase deficiency (LPLD), and gained a five year marketing authorisation to market the drug in the European Union in 2012.


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    https://Pharmaceutical.report/news-article.aspx?ID=767767

    UK AND US SPEARHEAD SEARCH FOR DRUGS TARGETING RAS MUTATIONS

    Apr 20, 2017

    Cancer Research UK and its Cancer Research Technology Pioneer Fund have joined with the US National Cancer Institute (NCI) to test new molecules targeting RAS mutations. These are “undruggable” mutations that often drive aggressive, hard to treat diseases including pancreatic and lung cancer.


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    https://Pharmaceutical.report/news-article.aspx?ID=768768

    ENZYVANT GAINS DOUBLE FAST-TRACK FOR RARE DISEASE DRUG

    Apr 18, 2017

    The investigational tissue-based therapy is for the treatment of complete DiGeorge Syndrome (cDGS), which represents a tiny subset of patients with the rare condition, DiGeorge Syndrome, caused by a single gene defect.


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    https://Pharmaceutical.report/news-article.aspx?ID=769769

    NOVARTIS AND ALLERGAN TO COMBINE DRUGS IN NASH

    Apr 18, 2017

    The Swiss pharma said it is to begin a phase IIb trial of one of its Farnesoid X receptor (FXR) agonists in combination with Allergan’s cenicriviroc in NASH.


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    https://Pharmaceutical.report/news-article.aspx?ID=770770

    UK HASN’T GIVEN UP ON KEEPING EUROPEAN MEDICINES AGENCY

    Apr 18, 2017

    The Financial Times has reported that the Brexit secretary doesn’t accept that the European drugs regulator and its 900 staff need to depart from London when the UK exits the European Union – despite Europe’s leaders indicating that this would be impossible.


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    https://Pharmaceutical.report/news-article.aspx?ID=771771

    RXI PHARMACEUTICALS ANNOUNCES NEW CHIEF DEVELOPMENT OFFICER AND KEY MANAGEMENT CHANGES

    Apr 18, 2017

    RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, today announced that Gerrit Dispersyn, Dr.


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    https://Pharmaceutical.report/news-article.aspx?ID=754754

    RESTRUCTURING IN THE JAPANESE PHARMA INDUSTRY

    Apr 18, 2017

    For years investment bankers had visions of mega fees flowing in from pharma company restructuring deals in Japan. It was never a question of “Will the deals come?” The only question was.


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    https://Pharmaceutical.report/news-article.aspx?ID=755755

    GOVERNMENT TO ISSUE 'DRUG MONITORING' SYSTEM TO COMBAT PHARMACEUTICAL FRAUD

    Apr 18, 2017

    The Ministry of Health has decided to issue a "drug monitoring" system which aims to control the pharmaceutical market, eliminate drug fraud and prevent the spread of illegal and unknown medicines in Egypt.


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    https://Pharmaceutical.report/news-article.aspx?ID=758758

    PHARMACEUTICAL SERIALIZATION FOR LATE STARTERS -- WITH LIVE INDUSTRY RESEARCH RESULTS FROM SEA VISION, NEW WEBINAR HOSTED BY XTALKS

    Apr 18, 2017

    In this live session, entitled 'pharmaceutical serialization for late starters', Carlos Machado, serialization director at SEA Vision US and Paolo Landriani, product manager at SEA Vision Italy will offer insight on how companies within the pharmaceutical industry can prepare for upcoming serializat...


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    https://Pharmaceutical.report/news-article.aspx?ID=759759

    PROGRESS REPORT ON BIOPHARMACEUTICAL INDUSTRY CONTRIBUTIONS TO THE GLOBAL FIGHT AGAINST NEGLECTED TROPICAL DISEASES (NTDS)

    Apr 17, 2017

    109 active R&D projects for NTDs, of which over 90% are collaborative involving over 50 universities, non-governmental organizations and public and private sector institutes. Promising NTD pipeline with 7 compounds targeting American Trypanosomiasis (Chagas disease), dengue, Human African trypanosom...


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    https://Pharmaceutical.report/news-article.aspx?ID=760760

    SUN PHARMA SHARE PRICE FALLS 3% ON 11 OBSERVATIONS FROM USFDA FOR DADRA UNIT

    Apr 17, 2017

    Sun Pharmaceutical Industries share price fell 3 percent intraday Monday. Investors turned cautious as sources told CNBC-TV18 that company's Dadra unit has received 11 observations from the US health regulator after an audit.


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    https://Pharmaceutical.report/news-article.aspx?ID=750750

    PRESCRIPTION DRUG SUPPLY SHORTAGES FUEL PRICE HIKES, NEW RESEARCH SHOWS

    Apr 17, 2017

    According to research published by the New England Journal of Medicine and reported by the Wall Street Journal, shortages of prescription drug supplies in the U.S. in recent years resulted in price increases for some drugs.


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    https://Pharmaceutical.report/news-article.aspx?ID=890890

    PHARMA GIANT 'PLOTTED TO DESTROY CANCER DRUGS TO DRIVE UP PRICES'

    Apr 16, 2017

    Leaked internal emails appear to show employees at one of the world's leading pharmaceutical companies calling for "celebration" over price hikes of cancer drugs, an investigation has revealed.


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    https://Pharmaceutical.report/news-article.aspx?ID=751751

    REBIOTIX MICROBIOME DRUG SUCCESS AGAINST C DIFF INFECTION

    Apr 13, 2017

    The results from the open label phase 2 trial confirm that Rebiotix’s drug, RBX2660, is the frontrunner among a coming wave of new microbiome treatments.


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    https://Pharmaceutical.report/news-article.aspx?ID=772772

    PREFER SUN PHARMACEUTICAL INDUSTRIES, SAYS VIJAY CHOPRA

    Apr 13, 2017

    Vijay Chopra of enochventures.com told CNBC-TV18, "I would recommend the investor to get out of power generation companies and get into a power trading company.


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    https://Pharmaceutical.report/news-article.aspx?ID=741741

    WINNING WITH ANALYTICS IN THE PHARMACEUTICAL INDUSTRY

    Apr 13, 2017

    With the global pharma market set to be worth as much as $1.6 trillion by 2020, the opportunities for companies to improve the efficiency of drug launches using analytics are manifold.


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    https://Pharmaceutical.report/news-article.aspx?ID=742742

    HYDERABAD TO HOST PHARMACEUTICAL EXPO THIS MONTH

    Apr 13, 2017

    The fifth edition of pharma show organised by the Pharmaceutical and Export Promotion Council (Pharmexcil) is going to be held in Hyderabad from 27 to 29 April.


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    https://Pharmaceutical.report/news-article.aspx?ID=743743

    WSI OFFERS BRAILLE EMBOSSING CAPABILITIES TO MEET PHARMACEUTICAL INDUSTRY PACKAGING REQUIREMENTS

    Apr 13, 2017

    Using the TaskMaster infeed system with Braille module, cartons are fed, aligned, embossed, and transferred to the folder gluer all in one operation – at up to 1000 feet per minute.


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    https://Pharmaceutical.report/news-article.aspx?ID=745745

    INDIAN DRUG MARKET GROWS AT 9.6% IN MARCH ON WANING DEMONETISATION EFFECT

    Apr 12, 2017

    The Indian pharmaceutical market (IPM) grew at a much better pace in March led by improved sales of drugs in chronic segment and acute segment bucking the trend of a sequential decline. The fading demonetization impact also aided the market growth.


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    https://Pharmaceutical.report/news-article.aspx?ID=732732

    CALIFORNIA PRESSES FORWARD IN FIGHT TO REGULATE PHARMA

    Apr 12, 2017

    In November, California voters defeated a ballot proposal that would have given state government more control over drug prices. It was a victory for pharmaceutical companies, which spent more than $100 million campaigning against the measure.


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    https://Pharmaceutical.report/news-article.aspx?ID=733733

    HITACHI ELECTED BY SUMITOMO DAINIPPON PHARMA FOR AUTOMATED CULTURE EQUIPMENT

    Apr 12, 2017

    Hitachi has received an order for automated cell mass culture equipment for regenerative medicine using human iPS cells from Sumitomo Dainippon Pharma Co.


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    https://Pharmaceutical.report/news-article.aspx?ID=734734

    DRUG TAKE-BACK EVENT SET IN HOUSTON

    Apr 12, 2017

    The 11th annual effort hosted by the Drug Enforcement Agency is set for 10 a.m. until 2 p.m., Saturday, April 29, at Walmart in Houston. All pharmaceuticals are accepted, including veterinary and over-the-counter drugs. No signatures are required and no questions are asked.


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    https://Pharmaceutical.report/news-article.aspx?ID=736736

    GEORGIA STEPS UP FIGHT AGAINST PHARMACEUTICAL DRUG ABUSE

    Apr 12, 2017

    Georgia introduced its internal quotas on certain medicines to defeat so-called pharmaceutical drug abuse.


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    https://Pharmaceutical.report/news-article.aspx?ID=737737

    TRUMP'S PICK FOR 'DRUG CZAR' -- A SERVANT OF BIG PHARMA AND BRUTAL PUNISHER OF DRUG ADDICTS AND POOR PEOPLE IN DEVELOPING COUNTRIES

    Apr 11, 2017

    Trump's Pick for 'Drug Czar' -- A Servant of Big Pharma and Brutal Punisher of Drug Addicts and Poor People in Developing Countries.


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    https://Pharmaceutical.report/news-article.aspx?ID=738738

    MARINUS PHARMACEUTICALS APPOINTS LORIANNE MASUOKA AS CHIEF MEDICAL OFFICER

    Apr 11, 2017

    USA-based Marinus Pharmaceuticals (Nasdaq: MRNS), a biotech company focused on developing treatments for epilepsy and neuropsychiatric disorders, has appointed Lorianne Masuoka as chief medical officer.


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    https://Pharmaceutical.report/news-article.aspx?ID=728728

    CRISPR MINES BACTERIAL GENOME FOR HIDDEN PHARMACEUTICAL TREASURE

    Apr 11, 2017

    In the fight against disease, many weapons in the medicinal arsenal have been plundered from bacteria themselves. Using CRISPR-Cas9 gene-editing technology, researchers have now uncovered even more potential treasure hidden in silent genes.


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    https://Pharmaceutical.report/news-article.aspx?ID=729729

    CHICAGO'S PHARMACEUTICAL REPRESENTATIVE LICENSING REQUIREMENTS JUST AROUND THE CORNER

    Apr 11, 2017

    Chicago has rolled up the welcome mat for pharmaceutical companies and their field representatives. Come July 1, 2017, the Second City essentially will ban pharmaceutical representatives from marketing or promoting any prescription drug within Chicago's city limits.


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    https://Pharmaceutical.report/news-article.aspx?ID=730730

    CANADA: YEAR IN REVIEW: SOME POSITIVE DEVELOPMENTS FOR PHARMACEUTICAL CLASS ACTIONS IN CANADA

    Apr 11, 2017

    The end of 2016 brought with it some good news for the defence in respect of pharmaceutical class actions, including a successful defence verdict in the first pharmaceutical product liability common issues trial in Canada. In 2016.


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    https://Pharmaceutical.report/news-article.aspx?ID=731731

    ARE PHARMA INDUSTRY COMPANIES CONVERTING PATIENTS WITH ORPHAN DISEASES INTO LOBBYISTS?

    Apr 10, 2017

    Wearing a blue T-shirt and worn jeans, Marc Yale stood near the welcome pole at the annual Rare Disease Legislative Advocates conference handing out money.


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    https://Pharmaceutical.report/news-article.aspx?ID=746746

    WORLDWIDE CLINICAL TRIALS EXPERT TO LEAD ROUNDTABLE DISCUSSION AT WORLD ORPHAN DRUG CONGRESS

    Apr 10, 2017

    Leslie Wetherell, Executive Director, Project Management and Rare Disease Franchise Lead at Worldwide Clinical Trials (www.worldwide.com), will lead a roundtable discussion, titled “Overcoming Operational Challenges in Rare Disease Trials,” during the World Orphan Drug Congress (WODC) 2017, being he...

    DRUG
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    https://Pharmaceutical.report/news-article.aspx?ID=753753

    ALLERGAN TO MOVE INTO PHASE III TRIALS WITH DEPRESSION DRUG THAT’S RAISING EYEBROWS

    Apr 07, 2017

    Botox (onabotulinumtoxinA), a treatment which made its name for its aesthetic potential in reducing facial wrinkles, is to be taken into Phase III trials in major depressive disorder (MDD).


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    https://Pharmaceutical.report/news-article.aspx?ID=756756

    JAZZ PHARMACEUTICALS SUBMITS FDA APPLICATION FOR LEUKAEMIA TREATMENT

    Apr 07, 2017

    Jazz Pharmaceuticals completed a rolling submission of a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of Vyxeos (cytarabine and daunorubicin) liposome for injection.


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    https://Pharmaceutical.report/news-article.aspx?ID=711711

    BTG RECEIVES CE MARK CERTIFICATION FOR RADIOPAQUE DRUG-ELUTING BEAD

    Apr 06, 2017

    BTG, a global specialist healthcare company, has received Class III CE Mark certification for DC Bead LUMI, the first commercially available radiopaque drug-eluting bead (DEB) in the EU which can be loaded with doxorubicin or irinotecan.


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    https://Pharmaceutical.report/news-article.aspx?ID=712712

    NEW DRUG REDUCES DAILY MENOPAUSAL HOT FLUSHES BY 73%

    Apr 06, 2017

    In a trial carried out at Imperial College London, researchers showed that women who suffered seven or more hot flushes a day could reduce the number by as much as 73%, as well as reducing their severity and impact.


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    https://Pharmaceutical.report/news-article.aspx?ID=713713

    FDA GRANTS KITOV WAIVER FOR NEW DRUG APPLICATION FILING FEE

    Apr 06, 2017

    The US Food and Drug Administration (FDA) has granted Kitov Pharmaceuticals a waiver related to the $2,038,100 new drug application filing fee for KIT-302.


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    https://Pharmaceutical.report/news-article.aspx?ID=714714

    PMO WANTS DRUG PRICING, PHARMA TO MOVE TO HEALTH FROM CHEMICAL MINISTRY

    Apr 06, 2017

    India’s drug pricing regulator to be moved to health ministry The PMO plans to transfer India’s apex drug pricing regulator from the ministry of chemicals and fertilizers to the health ministry because it has the technical expertise needed to take decisions on drug pricing.


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    https://Pharmaceutical.report/news-article.aspx?ID=704704

    BOOSTED BY NEW DRUGS, BOEHRINGER SHRUGS OFF PATENT EXPIRY

    Apr 06, 2017

    Formerly the company’s chief finance officer, Hubertus von Baumbach has been in post since last June when he took over from Andreas Barner, and is overseeing strong growth.


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    https://Pharmaceutical.report/news-article.aspx?ID=708708

    AFFORDABLE HEALTHCARE: GOVT TO REVIEW EXISTING DRUG PRICE CONTROL MEASURES

    Apr 06, 2017

    The government plans to review the existing drug price control measures to make medicines more affordable, while also undertaking "re-engineering" of price regulator NPPA to bring greater transparency amid allegations from the industry over arbitrary implementation of policy.


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    https://Pharmaceutical.report/news-article.aspx?ID=709709

    HOW PHARMA COMPANIES GAME THE SYSTEM TO KEEP DRUGS EXPENSIVE

    Apr 06, 2017

    I help the University of Utah hospital system manage its drug budgets and medication use policies, and in 2015 I got sticker shock. Our annual inpatient pharmacy cost for a single drug skyrocketed from $300,000 to $1.9 million.


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    https://Pharmaceutical.report/news-article.aspx?ID=710710

    NOVARTIS TO STRENGTHEN R&D PIPELINE BY IN-LICENSING ECF843 FOR OPHTHALMIC INDICATIONS

    Apr 06, 2017

    Novartis announced today that it has exercised an option to in-license ECF843 for ophthalmic indications worldwide (outside Europe). The closing of the deal is subject to customary closing conditions including regulatory approvals. The financial and other terms of this transaction are not disclosed....


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    https://Pharmaceutical.report/news-article.aspx?ID=749749

    GATEWAY ANALYTICAL FEATURES SERVICES FOR ORALLY INHALED DRUG PRODUCTS AT THE RESPIRATORY DRUG DELIVERY CONFERENCE IN PHOENIX

    Apr 06, 2017

    Gateway Analytical announced today that they will be exhibiting and presenting at the upcoming Respiratory Drug Delivery (RDD) conference in Phoenix.


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    https://Pharmaceutical.report/news-article.aspx?ID=803803

    DEEP LEARNING ALGORITHM COULD BOOST DRUG DEVELOPMENT

    Apr 05, 2017

    Artificially intelligent algorithms can learn to identify amazingly subtle information, enabling them to distinguish between people in photos or to screen medical images as well as a doctor.


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    https://Pharmaceutical.report/news-article.aspx?ID=706706

    ZUELLIG PHARMA INVESTING S$50M IN FIRST INNOVATION CENTRE IN SINGAPORE

    Apr 05, 2017

    Healthcare services provider Zuellig Pharma on Wednesday (Apr 5) launched its first innovation centre, Zuellig Health Solutions (ZHS), in Singapore and plans to invest over S$50 million over the next five years.


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    https://Pharmaceutical.report/news-article.aspx?ID=698698

    CRITICS POUNCE ON GOTTLIEB'S PHARMA TIES AS FDA COMMISSIONER HEARINGS BEGIN

    Apr 05, 2017

    The day before Scott Gottlieb faced a Senate committee on Wednesday, the FDA commissioner nominee hit pushback from Democrats who say he’s too entangled in the pharma industry to be an independent regulator. And that line of questioning continued on Wednesday as his confirmation got underway on Capi...


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    https://Pharmaceutical.report/news-article.aspx?ID=699699

    RA MEDICINES OFTEN DEMONSTRATE FAR GREATER BENEFITS TO PATIENTS THAN INITIALLY UNDERSTOOD

    Apr 05, 2017

    In the last decade, new therapies to treat rheumatoid arthritis (RA), a progressive and painful autoimmune disorder, have expanded patients’ treatment options and significantly improved outcomes, helping people with RA achieve disease remission.


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    https://Pharmaceutical.report/news-article.aspx?ID=718718

    NOVARTIS’ LUNG CANCER DRUG COMBINATION RECEIVES EU APPROVAL

    Apr 05, 2017

    The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).


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    https://Pharmaceutical.report/news-article.aspx?ID=715715

    ASTRAZENECA LUNG CANCER DRUG RECEIVES FDA APPROVAL

    Apr 04, 2017

    The US Food and Drug Administration (FDA) has granted full approval for AstraZeneca’s Tagrisso (osimertinib) tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR).


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    https://Pharmaceutical.report/news-article.aspx?ID=716716

    DR REDDY'S LABS SAYS USFDA RAISES FRESH CONCERNS AT SRIKAKULAM DRUG PLANT

    Apr 04, 2017

    Dr Reddy's Laboratories Ltd said on Tuesday that the US Food and Drug Administration has outlined two more concerns with the company's Srikakulam drug-making plant after an inspection of the facility.


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    https://Pharmaceutical.report/news-article.aspx?ID=700700

    NEW DRUG DELIVERY SYSTEM SHOWS PROMISE FOR FIGHTING SOLID TUMORS

    Apr 04, 2017

    A new cancer-drug delivery system shows the ability to exploit the oxygen-poor areas of solid tumors that make the growths resistant to standard chemotherapy and radiation treatment.


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    https://Pharmaceutical.report/news-article.aspx?ID=707707

    SUCAMPO PHARMACEUTICALS ACQUIRES RARE DISEASE COMPANY VTESSE FOR $200M

    Apr 04, 2017

    Global biopharmaceutical company Sucampo Pharmaceuticals has acquired US-based rare disease company Vtesse in a deal valued at $200m.


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    https://Pharmaceutical.report/news-article.aspx?ID=694694

    CSIRO SAYS RED TAPE HOLDING BACK AUSTRALIA'S MEDICAL TECHNOLOGY, PHARMACEUTICAL INDUSTRIES

    Apr 04, 2017

    The CSIRO is warning that slow and outdated regulation is holding back Australia's medical technology and pharmaceutical industry, and it risks losing work to countries with more "agile" systems in place.


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    https://Pharmaceutical.report/news-article.aspx?ID=690690

    NEW SAN JUAN TO PHILADELPHIA LINK REPRESENTS BOOST TO PHARMA TRANSPORT

    Apr 04, 2017

    American Airlines has launched a daily, non-stop Airbus A330-200 service between San Juan Luis Muñoz Marín Airport and Philadelphia International Airport.


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    https://Pharmaceutical.report/news-article.aspx?ID=691691

    TAKEDA AND MMV LAUNCH NEW PROGRAMME TO FIND LEAD COMPOUNDS FOR MALARIA TREATMENT

    Apr 03, 2017

    Japanese-based Takeda Pharmaceutical Company and Medicines for Malaria Venture in Switzerland (MMV) have signed an agreement to start a new joint research programme aimed at finding lead compounds for malaria treatment.


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    https://Pharmaceutical.report/news-article.aspx?ID=692692

    US RESEARCHERS DEVELOP NEW APPROACH TO IMPROVE HIV VACCINE EFFECTIVENESS

    Apr 03, 2017

    Researchers from the University of Nebraska-Lincoln in the US have developed a new approach that could improve the safety and effectiveness of a potential vaccine for the HIV virus.


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    https://Pharmaceutical.report/news-article.aspx?ID=693693

    BIG PHARMA'S ANTI-MARIJUANA STANCE AIMS TO SQUASH THE COMPETITION, ACTIVISTS SAY

    Apr 03, 2017

    As marijuana legalization swept the US in November, Arizona was alone in its rejection of legal weed. There, a pharmaceutical company called Insys was a major backer of the successful campaign to stop the state’s .


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    https://Pharmaceutical.report/news-article.aspx?ID=683683

    HAS THE INDIAN PHARMACEUTICAL SECTOR BECOME A SOFT TARGET?

    Apr 03, 2017

    The last one year has witnessed more than 400 Indian and foreign pharmaceutical companies going to the courts to resolve their grievances. Almost of all of them relate to implementation of the pricing policy and haphazard banning of fixed dose combinations (FDCs).


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    https://Pharmaceutical.report/news-article.aspx?ID=684684

    DEEP LEARNING ALGORITHM CREATED THAT COULD BOOST DRUG DEVELOPMENT

    Apr 03, 2017

    Artificially intelligent algorithms can learn to identify amazingly subtle information, enabling them to distinguish between people in photos or to screen medical images as well as a doctor.


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    https://Pharmaceutical.report/news-article.aspx?ID=685685

    ICYMI: REPORT HIGHLIGHTS OVERALL DECREASE IN CANCER DEATH RATES

    Apr 03, 2017

    In case you missed it, cancer death rates are continuing to decrease for men, women and children in the United States thanks in part to biopharmaceutical innovation, according to the Annual Report to the Nation on the Status of Cancer.


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    https://Pharmaceutical.report/news-article.aspx?ID=719719

    WILL CANCER RESEARCH ATROPHY UNDER TRUMP ADMINISTRATION?

    Apr 03, 2017

    Chatter at an early morning session on the third day of the 43rd annual meeting in Washington, D.C., was largely focused on the state of healthcare.


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    https://Pharmaceutical.report/news-article.aspx?ID=747747

    NOVARTIS DRUG COMBINATION TAFINLAR® + MEKINIST® RECEIVES EU APPROVAL FOR BRAF V600-POSITIVE ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC)

    Apr 03, 2017

    Novartis today announced the European Commission has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC).


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    https://Pharmaceutical.report/news-article.aspx?ID=748748

    MARYLAND BILL SEEKS TO STOP GENERIC DRUG PRICE GOUGING

    Mar 31, 2017

    A Maryland bill would start investigations and impose fines to stop generic drug companies from increasing their prices exorbitantly.


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    https://Pharmaceutical.report/news-article.aspx?ID=681681

    PROMETIC AND SRAM JV TO DEVELOP AND COMMERCIALISE THREE DRUG CANDIDATES IN CHINA

    Mar 31, 2017

    Prometic Life Sciences has signed a memorandum of terms with Shenzhen Royal Asset Management (SRAM) to establish a joint venture (JV) for the development, manufacture and commercialisation of three drug candidates, PBI-4050, PBI-4547 and PBI-4425, in China.


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    https://Pharmaceutical.report/news-article.aspx?ID=695695

    ANTI-CANCER DRUG GETS A BOOST WHEN COMBINED WITH ANTIRHEUMATIC

    Mar 30, 2017

    Scientists at EPFL and NTU have discovered that combining an anticancer drug with an antirheumatic produces improved effects against tumors. The discovery opens a new path for drug-drug synergy.


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    https://Pharmaceutical.report/news-article.aspx?ID=670670

    DAIICHI SANKYO ANNOUNCES COLLABORATIVE RESEARCH ON DRUGS FOR NEGLECTED TROPICAL DISEASES

    Mar 30, 2017

    Daiichi Sankyo Company, Limited (Daiichi Sankyo), announced that it has entered into a new joint research agreement with the Drugs for Neglected Diseases initiative (DNDi) with regard to a new research program, the Hit-to-Lead Project, with the aim of developing drug treatments for two neglected tro...


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    https://Pharmaceutical.report/news-article.aspx?ID=671671

    FDA APPROVES NEW ECZEMA DRUG DUPIXENT

    Mar 30, 2017

    The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisa...


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    https://Pharmaceutical.report/news-article.aspx?ID=672672

    NEW ANALYSIS: MORE THAN HALF OF PATIENTS’ OUT-OF-POCKET SPENDING FOR BRAND MEDICINES IS BASED ON FULL LIST PRICE

    Mar 29, 2017

    More than half of commercially insured patients’ out-of-pocket spending for brand medicines is based on full list prices, according to a new analysis from Amundsen Consulting, a division of QuintilesIMS. Even though rebates paid by biopharmaceutical companies can substantially reduce the prices insu...


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    https://Pharmaceutical.report/news-article.aspx?ID=720720

    DOUBLE CELEBRATION FOR TOPIVERT AND SYGNATURE DISCOVERY AS TWO DRUG CANDIDATES BEGIN CLINICAL TRIALS

    Mar 29, 2017

    One of Sygnature Discovery’s long-term clients, TopiVert Pharma, has recently initiated clinical trials with TOP1288 and TOP1630. Both compounds were first synthesised at Sygnature during the successful collaboration. TOP1288 and TOP1630 are Narrow Spectrum Kinase Inhibitors (NSKIs).


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    https://Pharmaceutical.report/news-article.aspx?ID=775775

    RESOURCES FOR UNDERSTANDING THE DANGERS OF DRUG IMPORTATION

    Mar 28, 2017

    Recent proposals to allow drug importation from other countries are dangerous for patients and the U.S. drug supply chain. To better understand how these importation schemes could negatively affect U.S. patients, here are some of the latest resources to keep in your back pocket.


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    https://Pharmaceutical.report/news-article.aspx?ID=721721

    ASTRAZENECA TO SHARE ITS ROBUST EARLY SCIENCE IN ONCOLOGY WITH THE MEDICAL COMMUNITY AT AACR 2017

    Mar 28, 2017

    AstraZeneca, along with its global biologics research and development arm, MedImmune, will present the strength and depth of its translational science, which is expected to deliver the Company's next wave of innovative oncology medicines, at the American Association for Cancer Research (AACR) Annual...


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    https://Pharmaceutical.report/news-article.aspx?ID=673673

    POTENTIAL DRUGS AND TARGETS FOR BRAIN REPAIR

    Mar 28, 2017

    New neurons, and support cells called oligodendrocytes, arise during development throughout adulthood from neural stem cells in the subventricular zone.


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    https://Pharmaceutical.report/news-article.aspx?ID=686686

    SCIENTISTS DISCOVER MECHANISM THAT CAUSES CANCER CELLS TO SELF-DESTRUCT

    Mar 27, 2017

    A new Tel Aviv University study published last month in Oncotarget discloses the role of three proteins in killing fast-duplicating cancer cells while they're dividing. The research, led by Prof.


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    https://Pharmaceutical.report/news-article.aspx?ID=674674

    KEYTRUDA IN NEW LYMPHOMA USE LEADS LATEST CHMP DECISIONS

    Mar 27, 2017

    Merck & Co’s Keytruda cancer immunotherapy is continuing its game of catch-up with Bristol-Myers Squibb’s Opdivo, after receiving backing in a new blood cancer indication from European regulators.


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    https://Pharmaceutical.report/news-article.aspx?ID=660660

    EUSA PHARMA AND APEIRON BIOLOGICS RECEIVE POSITIVE CHMP OPINION FOR DINUTUXIMAB BETA FOR THE TREATMENT OF HIGH-RISK NEUROBLASTOMA IN EUROPE

    Mar 27, 2017

    EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, and Apeiron Biologics today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approva...


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    https://Pharmaceutical.report/news-article.aspx?ID=662662

    MEDICARE MONDAY: A DISCUSSION ON AFFORDABILITY AND ACCESS TO MEDICINES

    Mar 27, 2017

    In case you missed it, the American Society on Aging held its annual conference last week in Chicago, IL, where Lori Reilly, PhRMA executive vice president of policy, research & membership, spoke about the importance of ensuring patients have affordable access to treatments.


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    https://Pharmaceutical.report/news-article.aspx?ID=722722

    DELIVERED AT THE 21ST WHO EXPERT COMMITTEE ON THE SELECTION AND USE OF ESSENTIAL MEDICINES

    Mar 27, 2017

    Thank you for the opportunity to make this statement today on behalf of the research-based pharmaceutical companies and associations across the globe. It seems appropriate that today.


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    https://Pharmaceutical.report/news-article.aspx?ID=761761

    TRENDS IN PHARMACEUTICAL PACKAGING AND DELIVERY

    Mar 26, 2017

    The global pharmaceutical market is evolving, driven by greater international regulatory requirements for improved quality as well as local healthcare policy such as the expansion of universal health coverage for China’s nearly 1.4 billion citizens launched in 2011.


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    https://Pharmaceutical.report/news-article.aspx?ID=665665

    IMMUNOTHERAPY DRUG BECOMES FIRST THERAPY APPROVED BY FDA FOR RARE SKIN CANCER

    Mar 24, 2017

    A rare and aggressive form of skin cancer, MCC, is 35 times less common than melanoma, but on average, it is about three times more likely to be deadly. Until now, there were no systemic.


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    https://Pharmaceutical.report/news-article.aspx?ID=687687

    NANOPARTICLE PAVES THE WAY FOR NEW TRIPLE NEGATIVE BREAST CANCER DRUG

    Mar 24, 2017

    Professor El-Tanani discovered the peptide drug which blocks a protein known as RAN. High levels of RAN have been linked to aggressive tumour growth, cancer spread, resistance to chemotherapy and poor prognosis in a number of cancers, including triple negative breast cancer (TNBC).


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    https://Pharmaceutical.report/news-article.aspx?ID=688688

    FDA APPROVES SYMPROIC® (NALDEMEDINE) ONCE-DAILY TABLETS C-II FOR THE TREATMENT OF OPIOID-INDUCED CONSTIPATION IN ADULTS WITH CHRONIC NON-CANCER PAIN

    Mar 23, 2017

    Shionogi Inc. and Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration (FDA) approved Symproic® (naldemedine) 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC)...


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    https://Pharmaceutical.report/news-article.aspx?ID=679679

    FDA FAST TRACKS SHIRE CLOTTING DISEASE DRUG

    Mar 23, 2017

    The US regulator has given a Fast Track designation to a Shire pipeline drug for a life-threatening blood clotting disease, hereditary thrombotic thrombocytopenic purpura.


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    https://Pharmaceutical.report/news-article.aspx?ID=656656

    BLOW FOR NOVARTIS AS HEART FAILURE DRUG FLOPS

    Mar 22, 2017

    Novartis’ heart failure drug serelaxin has failed in a late-stage trial, casting major doubts over the drug once seen as a potential blockbuster.


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    https://Pharmaceutical.report/news-article.aspx?ID=657657

    DRUG PRICE CRACKDOWN IMMINENT, SAYS TRUMP

    Mar 22, 2017

    President Donald Trump has issued a fresh threat against pharma, saying a drug price crackdown could be worked in to new healthcare reforms.


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    https://Pharmaceutical.report/news-article.aspx?ID=658658

    GUEST POST: THE IMPORTANCE OF A MODERN FDA IN DRUG DISCOVERY

    Mar 22, 2017

    When the Information Technology and Innovation Foundation (ITIF) published a report on the importance of the Prescription Drug User Fee Act (PDUFA) last month, one particular sentence caught my attention.


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    https://Pharmaceutical.report/news-article.aspx?ID=723723

    DELHI HC EXTENDS RELIEF TO PHARMA FIRMS IN DRUG BAN CASE

    Mar 21, 2017

    The Delhi High Court restrained the government from enforcing a ban on hundreds of drugs for another week on Monday until it has heard petitions from drugmakers .


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    https://Pharmaceutical.report/news-article.aspx?ID=799799

    DRUG PRICE CONTROVERSIES HIT PHARMA’S REPUTATION

    Mar 21, 2017

    Pharma’s reputation among patient groups has suffered in 2016, amid ongoing dissatisfaction with the high price of drugs, according to a new survey.


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    https://Pharmaceutical.report/news-article.aspx?ID=659659

    CMO ROUNDTABLE: WHAT’S NEXT FOR THE CONTRACT MANUFACTURING INDUSTRY

    Mar 21, 2017

    2016 saw a continued increase in outsourcing manufacturing operations to contract manufacturers in order for pharmaceutical companies to cut back on in-house costs and capacity while maintaining quality and improving time to market. With increased pressures for companies to reduce cost while still e...


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    https://Pharmaceutical.report/news-article.aspx?ID=666666

    CONCORDIA INTERNATIONAL CORP. GRANT OF TREBLE DAMAGES FURTHER VINDICATES MARKETING RIGHTS OF ITS DONNATAL® BRAND

    Mar 17, 2017

    Concordia International Corp. ("Concordia" or the "Company") (NASDAQ: CXRX) (TSX: CXR), an international specialty pharmaceutical company focused on generic and legacy pharmaceutical products, today announced that a U.S. district court has granted the Company treble damages related to false claims m...


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    https://Pharmaceutical.report/news-article.aspx?ID=669669

    INDIAN PHARMACOPOEIA COMMISSION AND U.S. PHARMACOPEIAL CONVENTION PARTNER TO STRENGTHEN THE QUALITY OF MEDICINES AND PUBLIC HEALTH

    Mar 17, 2017

    n an effort to promote the safety, quality, and effectiveness of medicines, the Indian Pharmacopoeia Commission, an autonomous institution of the Ministry of Health & Family Welfare, and the United States Pharmacopeial Convention (USP).


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    https://Pharmaceutical.report/news-article.aspx?ID=725725

    SUN PHARMA INDIRECT ARM TO ACQUIRE THALLION PHARMACEUTICALS

    Mar 17, 2017

    Sun Pharmaceutical Industries today said an indirect arm of its group firm Taro will fully acquire Canada's Thallion Pharmaceuticals for 2.7 million Canadian dollar.


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    https://Pharmaceutical.report/news-article.aspx?ID=701701

    SUN PHARMA'S MOHALI PLANT GETS A BREATHER; ALL EYES NOW ON HALOL

    Mar 16, 2017

    For Sun Pharmaceutical, the 'Ides of March' brings hope for a new beginning at the Mohali manufacturing unit in Punjab. This follows the March 14 note to the Bombay Stock .


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    https://Pharmaceutical.report/news-article.aspx?ID=796796

    AUROBINDO PHARMA GETS FINAL USFDA NOD FOR OSTEOPOROSIS DRUG

    Mar 15, 2017

    Drug firm Aurobindo Pharma has received final approval from USFDA to manufacture and market Ibandronate Sodium tablets.


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    https://Pharmaceutical.report/news-article.aspx?ID=800800

    GOVT RECEIVES RS 672-CRORE FINE FROM PHARMA FIRMS FOR OVERCHARGING

    Mar 14, 2017

    Drug pricing regulator NPPA has received Rs 672.28 crore fine till date from pharmaceutical companies for overcharging, Parliament was informed on Tuesday.


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    https://Pharmaceutical.report/news-article.aspx?ID=797797

    KEAPSTONE THERAPEUTICS AND SYGNATURE DISCOVERY COLLABORATE TO DISCOVER NEW THERAPIES FOR PARKINSON’S AND MOTOR NEURON DISEASE

    Mar 14, 2017

    Keapstone Therapeutics, a new biotech company formed by the University of Sheffield and Parkinson’s UK to develop new drugs for Parkinson’s and other neurodegenerative diseases, and Sygnature Discovery.


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    https://Pharmaceutical.report/news-article.aspx?ID=776776

    SUN PHARMA SAYS US REGULATOR TO LIFT BAN ON MOHALI DRUG PLANT

    Mar 14, 2017

    Sun Pharmaceutical Industries Ltd, India's largest drug maker, said on Tuesday that US regulators plan to lift a ban on its Mohali plant in Punjab, allowing the company to restart supplies from there after four years.


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    https://Pharmaceutical.report/news-article.aspx?ID=702702

    PHARMACEUTICAL PRICING BODY FIXES, REVISES PRICES OF 18 ESSENTIAL DRUGS

    Mar 11, 2017

    Drug price regulator NPPA has capped the prices of four essential drugs and revised 14 more, including the ones used for treatment of fungal infections and hypertension.


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    https://Pharmaceutical.report/news-article.aspx?ID=703703

    GLOBAL $9.6 BILLION PHARMACEUTICAL ANALYTICAL TESTING OUTSOURCING (BIOANALYTICAL TESTING, METHOD DEVELOPMENT AND VALIDATION, STABILITY TESTING)

    Mar 10, 2017

    Research and Markets has announced the addition of the "Pharmaceutical Analytical Testing Outsourcing Market Analysis By Services (Bioanalytical Testing, Method Development and Validation, Stability Testing), By Region And Segment Forecasts, 2014 - 2025" report to their offering.


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    https://Pharmaceutical.report/news-article.aspx?ID=651651

    KLÖCKNER PENTAPLAST TO SHARE PHARMACEUTICAL PACKAGING SOLUTIONS AT ASEAN PHARMA PACKAGING CONFERENCE 2017

    Mar 10, 2017

    Klöckner Pentaplast will present the latest range of pharmaceutical packaging solutions and services at ASEAN Pharma Packaging Conference 2017 (APPCON) March 16-17, 2017, in Singapore.


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    https://Pharmaceutical.report/news-article.aspx?ID=652652

    ZACKS INVESTMENT RESEARCH UPGRADES AVADEL PHARMACEUTICALS PLC – AMERICAN DEPOSITARY SHARES EACH REPRESENTING ONE ORDINARY SHARE (AVDL) TO HOLD

    Mar 10, 2017

    Avadel Pharmaceuticals plc – American Depositary Shares each representing one Ordinary Share (NASDAQ:AVDL) was upgraded by Zacks Investment Research from a “sell” rating to a “hold” rating in a note issued to investors on Wednesday.


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    https://Pharmaceutical.report/news-article.aspx?ID=653653

    OXYCONTIN MAKER PURDUE PHARMA HIT WITH UNPRECEDENTED LAWSUIT BY WASHINGTON CITY

    Mar 10, 2017

    In Everett, Washington, the jail is overflowing with addicts, the detox facility is set to double in size, and the city spends a fortune clearing its streets and parks of needles and tiny plastic bags.


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    https://Pharmaceutical.report/news-article.aspx?ID=648648

    CHINA'S FOSUN PHARMA SET TO JOIN BIDDING FOR GERMANY'S STADA: SOURCES

    Mar 10, 2017

    China's Shanghai Fosun Pharmaceutical is planning a bid for German generic drugmaker Stada, already the center of a 3.6 billion euro ($3.8 billion) takeover battle between two private equity consortia, two people close to the matter said.