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    SANOFI AND REGENERON'S DUPIXENT SCORES 3RD FDA APPROVAL IN SINUSITIS WITH NASAL POLYPS

    Jun 26, 2019

    Sanofi and Regeneron’s Dupixent has been charging ahead since its initial approval in moderate-to-severe atopic dermatitis, later picking up a follow-up nod in moderate-to-severe asthma. Wednesday, the drug scored FDA approval for its third use: to treat adults with chronic rhinosinusitis with...


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    https://Pharmaceutical.report/news-article.aspx?ID=32243224

    AFTER ROCHE, BMS SURPRISES, WHAT DOES ABBVIE NEED TO DO TO WIN FTC CLEARANCE FOR ALLERGAN BUY?

    Jun 26, 2019

    With mergers and acquisitions come antitrust reviews. And with the U.S. Federal Trade Commission (FTC) cracking down on pharma deals these days, it’s only natural to ask whether AbbVie’s proposed $63 billion acquisition of Allergan could face anti-competition scrutiny, despite across-boa...


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    https://Pharmaceutical.report/news-article.aspx?ID=32253225

    BMS’ OPDIVO DISAPPOINTS IN LATE-STAGE TRIAL

    Jun 26, 2019

    Bristol-Myers Squibb has announced topline results from its CheckMate -459 trial evaluating Opdivo (nivolumab) in patients with unresectable hepatocellular carcinoma (HCC). The results show that the cancer drug failed to show superiority to Nexavar (sorafenib), and did not achieve statistical signif...


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    https://Pharmaceutical.report/news-article.aspx?ID=32263226

    ALMIRALL TAKES OPTION ON DERMIRA’S ECZEMA DRUG LEBRIKIZUMAB

    Jun 25, 2019

    Spain’s Almirall has taken an option granting rights to develop and market Dermira’s eczema drug lebrikizumab in Europe, in a bid to take on Sanofi/Regeneron’s recently approved Dupixent. The companies had struck an option and license agreement in February which granted Almirall Eu...


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    https://Pharmaceutical.report/news-article.aspx?ID=32193219

    FDA PRIORITY REVIEW GRANTED FOR GSK’S ZEJULA

    Jun 25, 2019

    The US Food and Drug Administration (FDA) has accepted Glaxo Smith Kline’s application for Zejula (niraparib) in late stage ovarian cancer with priority review. The company announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental New Drug Application (sNDA)...


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    https://Pharmaceutical.report/news-article.aspx?ID=32203220

    NHS TO OPEN YOUNG PEOPLES GAMBLING ADDICTION SERVICE

    Jun 25, 2019

    NHS England has announced the opening of a new gambling clinic for children and young people, as part of the Long Term Plan. The news comes after a recent Gambling Comission report found that the number of children classed as having a gambling problem is 55,000, and that 450,000 are gambling regular...


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    https://Pharmaceutical.report/news-article.aspx?ID=32213221

    GSK WINS SPEEDY FDA ZEJULA REVIEW IN OVARIAN CANCER NICHE

    Jun 24, 2019

    GlaxoSmithKline has been working to restrengthen in cancer, particularly through a multibillion-dollar purchase of Tesaro. The main drug from the buyout, Zejula, is now up for a priority review in late-stage ovarian cancer, where it's working to pick up a niche nod its rivals don't have. The...


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    https://Pharmaceutical.report/news-article.aspx?ID=32103210

    BRISTOL-MYERS SQUIBB’S OPDIVO MISSES ITS SHOT AT EARLIER USE IN LIVER CANCER

    Jun 24, 2019

    Bristol-Myers Squibb’s Opdivo already boasts an FDA approval in liver cancer patients who have been treated with Bayer’s Nexavar. But its quest to jump into the front line just hit a snag. The BMS PD-1 drug failed to beat Nexavar at extending patients’ lives in a phase 3 study, the...


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    https://Pharmaceutical.report/news-article.aspx?ID=32113211

    CELGENE, SAY GOODBYE TO OTEZLA: BMS AGREES TO SELL PSORIASIS DRUG TO CLEAR $74B MERGER

    Jun 24, 2019

    With the Federal Trade Commission (FTC) sweating the details of Bristol-Myers Squibb and Celgene’s proposed $74 billion merger, all eyes were on the companies’ combined psoriasis portfolio, which regulators feared would corner the market. The feds found a solution: You can have your merg...


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    https://Pharmaceutical.report/news-article.aspx?ID=32123212

    COST-EFFECTIVENESS WATCHDOGS SKEWER NOVARTIS' MS DRUG MAYZENT AND J&J'S DEPRESSION SPRAY SPRAVATO

    Jun 21, 2019

    The Institute for Clinical and Economic Review (ICER) had a busy day Thursday, issuing final cost assessments on two highly anticipated neurology drugs: Spravato, the inhalable depression treatment from Johnson & Johnson’s Janssen, and Novartis’ Mayzent to treat secondary progressive...


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    https://Pharmaceutical.report/news-article.aspx?ID=32053205

    £8M DRUG-RESISTANCE GRANT FOR OXFORD DRUG DESIGN

    Jun 21, 2019

    Oxford Drug Design has received over 8 million pounds in grant and equity investment from CARB-X, the UK Department of Health and Social Care (DHSC) and o2h Ventures. The funding will help to develop new antibiotics effective against drug-resistant superbugs, and to expand Oxford Drug Design’s...


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    https://Pharmaceutical.report/news-article.aspx?ID=32063206

    J&J’S SPRAVATO FOR DEPRESSION ‘SHOULD BE MUCH CHEAPER’

    Jun 21, 2019

    Johnson & Johnson has priced its new Spravato nasal spray for treatment-resistant depression (TRD) too high to offer value for money, says a US cost-effectiveness body. The Institute for Clinical and Economic Review (ICER) has published its final report on Spravato (esketamine) and says the drug...


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    https://Pharmaceutical.report/news-article.aspx?ID=32073207

    DAIICHI WAITS ON FDA AS AML DRUG QUIZARTINIB APPROVED IN JAPAN

    Jun 20, 2019

    The Japanese regulator has approved Daiichi Sankyo’s quizartinib for certain patients with acute myeloid leukaemia (AML), amid doubts over the outcome of a regulatory review in the US. Japan’s Ministry of Health, Labor and Welfare (MHLW) approved quizartinib, newly branded as Vanflyta, f...


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    https://Pharmaceutical.report/news-article.aspx?ID=31983198

    BAYER’S REGORAFENIB KICKS OFF BRAIN CANCER PLATFORM TRIAL

    Jun 20, 2019

    Bayer has become the first pharma company to take part in a new platform trial designed to find new treatments for brain cancer. GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is an international trial testing several therapies for patients with newly diagnosed and recurren...


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    https://Pharmaceutical.report/news-article.aspx?ID=31993199

    PHARMACY TAKES FDA TO TASK IN CITIZEN PETITION OVER TAINTED VALSARTAN

    Jun 20, 2019

    The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FD...


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    https://Pharmaceutical.report/news-article.aspx?ID=32023202

    COGNIZANT JOINS FORCES WITH ZENITH TO DIGITISE PHARMA MANUFACTURING

    Jun 19, 2019

    Professional services firm Cognizant has struck a deal to buy Zenith Technologies, a privately-held life sciences manufacturing technology company specialising in digital technologies to manage, control and optimise drug and medical device production. Cognizant, which said it already works with the ...


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    https://Pharmaceutical.report/news-article.aspx?ID=31953195

    VACCINES MISTRUST A “GLOBAL CRISIS” SAYS WELCOME REPORT

    Jun 19, 2019

    A wide-ranging survey involving 140,000 people in 140 countries has revealed a worryingly high level of concern about the safety of vaccines, with scepticism highest in the developed world. While the report by the Wellcome Trust suggests that more than three-quarters of the world’s population ...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=31963196

    MERCK SCOUTS REPLACEMENTS FOR CEO FRAZIER LESS THAN A YEAR AFTER SCRAPPING RETIREMENT RULE: REPORT

    Jun 19, 2019

    It was less than a year ago that Mercks board scrapped a policy that CEOs must retire at the age of 65 in a move designed to keep Ken Frazier around longer. Now, the company is scouting replacements for the long-tenured helmsman, Bloomberg reports. Merck is preparing for Frazier’s exit and has...


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    https://Pharmaceutical.report/news-article.aspx?ID=31973197

    NOVO NORDISK’S VICTOZA GETS FDA OKAY FOR PAEDIATRIC USE

    Jun 18, 2019

    Novo Nordisk’s GLP-1 agonist Victoza has become the first non-insulin drug to be approved in the US as a treatment for type 2 diabetes in children for almost two decades. The FDA says the okay to use Victoza (liraglutide) in paediatric patients aged 10 or over comes “at a time when an in...


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    https://Pharmaceutical.report/news-article.aspx?ID=31903190

    JAPAN APPROVES ROCHE’S TUMOUR AGNOSTIC CANCER DRUG ROZLYTREK

    Jun 18, 2019

    Japan has become the first country to approve Roche’s personalised cancer drug Rozlytrek (entrectinib). Roche added entrectinib to its pipeline through its $1.7 billion buyout of Ignyta at the end of 2017 in a move that brought it into competition with Bayer and its newly acquired targeted the...


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    https://Pharmaceutical.report/news-article.aspx?ID=31913191

    MERCK'S KEYTRUDA GIVES BMS' OPDIVO SOME COMPANY WITH SMALL CELL LUNG CANCER NOD

    Jun 18, 2019

    Bristol-Myers Squibb's FDA approval for Opdivo in patients with previously treated small cell lung cancer (SCLC) already has looked shaky since the drug failed to extend patients' lives in a phase 3 trial. Now, Opdivo will have to make some room for its archrival, Merck & Co.’s Key...


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    https://Pharmaceutical.report/news-article.aspx?ID=31923192

    GREATER MANCHESTER JOINS CITIES CHANGING DIABETES INITIATIVE

    Jun 17, 2019

    Novo Nordisk has named Greater Manchester as the 22nd city, and second in the UK, to join Cities Changing Diabetes, a scheme designed to address the dramatic rise of type II diabetes in urban areas. Launched in 2014 by Novo, University College London and the Steno Diabetes Center Copenhagen, the pro...


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    https://Pharmaceutical.report/news-article.aspx?ID=31853185

    ASTRAZENECA'S CALQUENCE SETS IMBRUVICA IN ITS SIGHTS WITH BIG CLL SURVIVAL NUMBERS

    Jun 17, 2019

    When AstraZeneca ended a late-stage trial for Calquence early after seeing promising results, the news boded well for the drug’s chances in previously treated chronic lymphocytic leukemia (CLL). Now, the drugmaker has unveiled the detailed data it plans to take before regulators later this yea...


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    https://Pharmaceutical.report/news-article.aspx?ID=31863186

    LAWYERS PITCH MASSIVE OPIOID NEGOTIATION PLAN TO BRING 'GLOBAL PEACE' TO LEGAL BATTLE

    Jun 17, 2019

    Thousands of cities and counties have sued opioid drugmakers and distributors for an alleged role in a nationwide epidemic, and now lawyers for the plaintiffs have pitched a novel process to aid settlement talks. It's an idea that could simplify the legal process and offer drugmakers "globa...


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    https://Pharmaceutical.report/news-article.aspx?ID=31873187

    LILLY'S TALTZ SCRAPES WIN AGAINST HUMIRA IN PSORIATIC ARTHRITIS

    Jun 14, 2019

    Eli Lilly’s Taltz has beaten AbbVie’s blockbuster Humira in a psoriatic arthritis study involving patients who hadn’t been treated before with a disease-modifying drug, but only just. Lilly reported last year that the SPIRIT-H2H trial had shown Taltz (ixekizumab) met its primary en...


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    https://Pharmaceutical.report/news-article.aspx?ID=31813181

    TEVA EXPANDS BLOOD PRESSURE DRUG RECALL IN THE US AMID CANCER FEARS

    Jun 14, 2019

    Teva has expanded a recall of losartan potassium tablets after tests revealed a potential human carcinogen in the blood pressure drug. The Israeli pharma earlier this week recalled six lots of the drug containing unacceptable levels of a nitrosamine impurity. This builds on a decision in April when ...


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    https://Pharmaceutical.report/news-article.aspx?ID=31823182

    PFIZER'S XELJANZ MATCHES IMMUNOSUPPRESSANT COMBO IN RHEUMATOID ARTHRITIS STUDY

    Jun 13, 2019

    Pfizer’s troubled JAK inhibitor Xeljanz has had its share of hiccups after pulmonary embolism fears derailed the drug’s higher dose in rheumatoid arthritis. Now, Pfizer is hoping for better results using Xeljanz to treat RA patients who wean off immunosuppressants. Patients treated with ...


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    https://Pharmaceutical.report/news-article.aspx?ID=31763176

    ASTRAZENECA ADMITS ITS DELAY-RIDDEN HQ PROJECT WILL NOW COST ALMOST $1B

    Jun 13, 2019

    AstraZeneca has taken a lot of heat for its massive new headquarters and R&D facility in Cambridge, U.K., which has been beset by everything from cost overruns to a four-year completion delay. So it’s no wonder the drugmaker buried the latest details about the project on page 27 of its 244...


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    https://Pharmaceutical.report/news-article.aspx?ID=31773177

    BOEHRINGER, LILLY PRESENT POSITIVE TRAJENTA RESULTS AT ADA

    Jun 12, 2019

    Boehringer Ingelheim and Eli Lilly have announced full data from the CAROLINAtrial, in which Trajenta (linagliptin) demonstrated no increased cardiovascular risk compared to glimepiride  in adults with type II diabetes and cardiovascular risk. The study is the only active-comparator cardiovascu...


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    https://Pharmaceutical.report/news-article.aspx?ID=31723172

    COSENTYX SHOWS EFFICACY IN KEY MANIFESTATIONS OF PSORIATIC ARTHRITIS

    Jun 12, 2019

    Novartis has announced that its drug Cosentyx (secukinumab) has been found to show efficacy and safety of a biologic in the management of axial manifestations of psoriatic arthritis, in first-of-its kind data. The company announced that the ongoing 52-week Phase IIIb trial met both its primary and k...


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    https://Pharmaceutical.report/news-article.aspx?ID=31733173

    KEYTRUDA WINS FDA APPROVAL IN HEAD AND NECK CANCER

    Jun 12, 2019

    MSD’s blockbuster cancer drug Keytruda (pembrolizumab) has won approval from the US Food and Drug Administration (FDA) to treat a type of head and neck cancer. It was approved in the Indication of first-line treatment of patients with metastatic or with unresectable, recurrent head and neck sq...


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    https://Pharmaceutical.report/news-article.aspx?ID=31743174

    HOW TO CORRECT OPIOID MISINFORMATION? SPEND $285M ON COUNTER-MARKETING, EXPERT SAYS IN J&J TRIAL

    Jun 11, 2019

    Countless lawsuits have sought to estimate the costs of fixing the U.S. opioid and addiction epidemic. Now, thanks to an expert in Oklahoma's ongoing trial against Johnson & Johnson, we have one dollar figure. Oklahoma would have to spend nearly $285 million to mount a counter-marketing camp...


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    https://Pharmaceutical.report/news-article.aspx?ID=31663166

    ADA: J&J'S STRUGGLING INVOKANA SLASHES HEART, KIDNEY RISKS IN LATEST TRIAL WIN

    Jun 11, 2019

    Johnson & Johnson and its fellow SGLT2 drugmakers are all working to show benefits for patients with kidney disease. But in that group, J&J can tout data its rivals don’t have. Tuesday at the American Diabetes Association annual meeting, J&J’s Janssen unit rolled out a new an...


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    https://Pharmaceutical.report/news-article.aspx?ID=31693169

    ROCHE LAUNCHES FIRST IN VITRO LUNG CANCER DIAGNOSTIC TEST

    Jun 10, 2019

    Roche Diagnostics has launched its first in vitro diagnostic test to target ROS1 positive lung cancers, VENTANA ROS1 (SP384) Antibody. The biomarker is the first and only in vitro diagnostic ROS1 immunohistochemistry assay on the market and looks promising to provide a cost-effective and efficient m...


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    https://Pharmaceutical.report/news-article.aspx?ID=31613161

    POSITIVE RESULTS FOR NOVO’S XULTOPHY

    Jun 10, 2019

    Novo Nordisk’s Xultophy (degludec/liraglutide) has been found to significantly delay time-to-treatment intensification when compared to insulin glargine U100 in adults with type II diabetes inadequately controlled on oral treatments. The DUAL VIII trial results were presented at the 79th Scien...


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    https://Pharmaceutical.report/news-article.aspx?ID=31623162

    SOSEI HEPTARES TO GET $3M PFIZER MILESTONE PAYMENT

    Jun 10, 2019

    Sosei Heptares has announced that it is to receive a new $3 million milestone payment from its strategic alliance partner Pfizer, as it advances a second candidate from the GPCR collaboration for clinical development. The first clinical candidate under this collaboration was nominated by Pfizer in M...


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    https://Pharmaceutical.report/news-article.aspx?ID=31633163

    GLAXOSMITHKLINE'S NUCALA SCORES CONVENIENCE BOOST WITH AT-HOME DOSING OPTIONS

    Jun 07, 2019

    GlaxoSmithKline’s Nucala has suffered against a more convenient AstraZeneca rival, but the company finally has an answer. Thursday, the FDA greenlighted two new delivery options for Nucala: an autoinjector and a prefilled syringe, both of which severe eosinophilic asthma patients can self-admi...


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    https://Pharmaceutical.report/news-article.aspx?ID=31593159

    DIGITAL TOOL AIMS TO CUT COSTS AND RISKS OF UNDERPERFORMING TRIALS

    Jun 07, 2019

    ArcheMedx, which provides tech solutions for life sciences and healthcare, has launched a new digital service that aims to cut risks and costs associated with under-performing clinical trials. The company will unveil the tool called Ready at this year’s Drug Information Association (DIA) annua...


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    https://Pharmaceutical.report/news-article.aspx?ID=31603160

    COELIAC UK, INNOVATE UK ANNOUNCE £180K RESEARCH FUNDING AVAILABLE

    Jun 06, 2019

    Coeliac UK and Innovate UK have announced that the companies have £180k available for research and are inviting applications from UK businesses and researchers. The collaboration is launching a second research call to industry and researchers to make improvements for people living with the aut...


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    https://Pharmaceutical.report/news-article.aspx?ID=31543154

    INFLARX FLATLINES AFTER SKIN DISEASE DRUG FLOPS IN MIDSTAGE TRIAL

    Jun 06, 2019

    The phase 2b SHINE study of the anti-human complement factor C5a antibody was conducted in hidradenitis suppurativa (HS), a chronic inflammatory skin disease with limited treatment options that causes symptoms including inflamed nodules or boils in the armpits, groin and genital area. Unfortunately ...


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    https://Pharmaceutical.report/news-article.aspx?ID=31553155

    GLOBAL PHARMA GIANT DEVELOPS DLT-BASED CARE NETWORK FOR DIABETES PATIENTS

    Jun 06, 2019

    А leading pharmaceutical firm Boehringer Ingelheim has teamed up with blockchain-based healthcare platform Solve.Care, according to a press release shared with Cointelegraph on June 6. Germany-based Boehringer, one of the world’s 20 largest pharma companies, and Solve.Care are planning to buil...


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    https://Pharmaceutical.report/news-article.aspx?ID=31563156

    ASTRAZENECA SCOUTS REPLACEMENTS FOR LONGTIME CHAIRMAN JOHANSSON

    Jun 04, 2019

    During his seven-year stint as AstraZeneca chairman, Leif Johansson weathered some ups and downs and helped fend off one major hostile takeover attempt. Now, the drugmaker is getting ready to scout for successors, Sky News reports. The company hasn't set a timetable for a transition, but its nom...


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    https://Pharmaceutical.report/news-article.aspx?ID=31493149

    MACROGENICS LOOKS TO FUTURE WITH BREAST CANCER DRUG MARGETUXIMAB

    Jun 03, 2019

    A small biotech, MacroGenics, took the market by surprise earlier this year with some surprising data from its margetuximab essentially a tweaked version of Roche’s Herceptin (trastuzumab) where a few amino acid mutations are enough to produce a stronger cellular response to cancer.CEO Scott K...


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    https://Pharmaceutical.report/news-article.aspx?ID=31483148

    SANOFI, REGENERON DIVE DEEP ON ASTHMA IN DEBUT DIGITAL AWARENESS CAMPAIGN

    Jun 03, 2019

    Most people know what asthma is, but even asthma patients can underestimate it. Sanofi and Regeneron’s new online disease awareness campaign highlights the problems of uncontrolled asthma. “The Next Breath” campaign, launched on World Asthma Day in May, aims to make patients, careg...


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    https://Pharmaceutical.report/news-article.aspx?ID=31463146

    PFIZER, ASTELLAS' XTANDI RACKS UP MORE DATA FOR NEW PROSTATE CANCER APPROVAL

    Jun 02, 2019

    Pfizer and Astellas’ Xtandi is gunning for a new indication in prostate cancer, and they say Sunday's new data complement the supporting evidence they’ve already generated. Sunday at the American Society of Clinical Oncology annual meeting, researchers trumpeted datafrom an investiga...


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    https://Pharmaceutical.report/news-article.aspx?ID=31473147

    BIG PHARMA'S CHINA GROWTH; PFIZER'S NEW UPJOHN HQ; HANSOH'S $1B HONG KONG IPO

    May 31, 2019

    As the Chinese government pilots a bulk procurement program for generic drugs, Big Pharma's older medicines are under increasing pricing pressure. Pfizer is planning a push into China's rural areas in response to the headwinds, and it has moved the headquarters of its Upjohn established medi...


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    https://Pharmaceutical.report/news-article.aspx?ID=31433143

    PROSECUTORS STRIKE YET ANOTHER PHARMA KICKBACK SETTLEMENT, THIS TIME WITH ALMIRALL

    May 30, 2019

    One by one, drugmakers have been handing over millions of dollars to the U.S. government to settle kickback allegations. And Almirall is the latest.The Spain-based drugmaker agreed to pay $3.5 million to the Department of Justice (DOJ) and $3.1 million to the California Department of Insurance to wr...


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    https://Pharmaceutical.report/news-article.aspx?ID=31423142

    JOIN THE DOTS OR LOSE OUT, SYNEOS HEALTH ADVISES BIG PHARMA

    May 30, 2019

    Pharma companies need to rethink how they communicate and share information and insights within their own organisations, according to Syneos Health’s principal for real world and late phase development, Erwin De Cock. We spoke to him at the eyeforpharma conference in Barcelona to learn about t...


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    https://Pharmaceutical.report/news-article.aspx?ID=31383138

    PHS HEALTH SOLUTIONS ANNOUNCES REBRANDING ON AMPLITY HEALTH

    May 29, 2019

    New Brand Identity Paves the Way for New Pure Play Marketing Partner for the Pharmaceutical Industry PHS Health Solutions (PHS), a premier contract merchant organization that has been a trusted partner to its pharmaceutical industry customers for 35 years, announced today that the company is operati...


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    https://Pharmaceutical.report/news-article.aspx?ID=31393139

    ZOLGENSMA WINS FDA GREEN LIGHT IN CHILD SMA

    May 28, 2019

    The U.S. Food and Drug Administration (FDA) has approved Novartis’ Zolgensma (onasemnogene abeparvovec-xioi) at a cost of $2.1 milllion per treatment. The drug is the first gene therapy approved to treat children less than two years of age with spinal muscular atrophy (SMA), which is the most ...


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    https://Pharmaceutical.report/news-article.aspx?ID=31303130

    NEWRON PHARMA DELAYS SCHIZOPHRENIA TRIALS OVER SAFETY CONCERNS

    May 28, 2019

    Switzerland-based Newron Pharmaceuticals announced that it is delaying its Phase II/III clinical trials of evenamide for schizophrenia based on concerns raised by the U.S. Food and Drug Administration (FDA).The agency expressed concern over the results of recently finished studies in rats and dogs t...


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    https://Pharmaceutical.report/news-article.aspx?ID=31313131

    CHINA'S DRIVING SALES GROWTH AHEAD OF THE U.S. FOR BIG PHARMA. BUT CAN IT LAST?

    May 28, 2019

    If you follow Big Pharma companies’ investor updates, you’ll notice China popping up frequently these days. The world’s second-largest pharmaceutical market has been turning up sales increases that continuously surpass those in the U.S. and other developed regions. In the first qua...


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    https://Pharmaceutical.report/news-article.aspx?ID=31343134

    EMCURE INJECTED SCHIZOPHRENIA DRUG RECALLED AFTER CONTAMINATION DETECTED

    May 28, 2019

    Two injected drugs manufactured by an Indian company with a history of sterility problems are being recalled because of microbial contamination. The drugs were both manufactured by Emcure Pharmaceuticals but are distributed in the U.S. by Heritage Pharmaceuticals.East Brunswick, New Jersey-based Her...


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    https://Pharmaceutical.report/news-article.aspx?ID=31353135

    NHS TO UNDERGO ‘AMBITIOUS’ TECH OVERHAUL

    May 24, 2019

    Matt Hancock, health secretary, has announced major improvements to general practice IT and more support for NHS Trusts to improve cyber security, as part of a new “ambitious tech overhaul”.Under the new plans top technology companies will be challenged to develop new, innovative GP IT s...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=31253125

    CMA ACCUSES FOUR PHARMAS OF ANTICOMPETITIVE BEHAVIOUR

    May 23, 2019

    Four pharma companies stand accused in the UK of colluding to artificially inflate the price of prescription-only, anti-nausea and dizziness drug prochlorperazine, costing the NHS millions of pounds and breaking competition law.In a statement of objections, the UK's the Competition and Markets A...

    PHARMATIMES
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    https://Pharmaceutical.report/news-article.aspx?ID=31263126

    H1 2019 REPORT FEATURING DAEWOONG PHARMACEUTICAL, RAQUALIA PHARMA

    May 23, 2019

    Functional (Non Ulcer) Dyspepsia - Pipeline Review, H1 2019, provides comprehensive information on the therapeutics under development for Functional (Non Ulcer) Dyspepsia (Gastrointestinal), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administrati...

    BUSINESSWIRE
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    https://Pharmaceutical.report/news-article.aspx?ID=31193119

    700% PRICE SPIKE SPURS UK TO ALLEGE FOUR PHARMA COMPANIES AGREED TO RESTRICT COMPETITION

    May 23, 2019

    The UK’s Competition and Markets Authority (CMA) on Thursday alleged that Focus Pharmaceuticals, Medreich, Alliance Pharmaceuticals and Lexon have breached UK and EU law by entering into anti-competitive agreements that restricted the supply of the nausea and dizziness drug prochlorperazine.Un...

    RAPS.ORG
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    https://Pharmaceutical.report/news-article.aspx?ID=31203120

    ‘RECORD’ NUMBER OF PATIENTS TAKING PART IN CLINICAL TRIALS

    May 20, 2019

    The National Institute for Health Research (NIHR) has announced that a record number of patients are now taking part in clinical trials. The report states that over 870,250 participants were involved in health and social care studies supported by the organisation over the last twelve months, marking...


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    https://Pharmaceutical.report/news-article.aspx?ID=31113111

    NEW SCREENING TO HELP DETECT GROUP B STREP IN PREGNANT WOMEN

    May 20, 2019

    The National Institute for Health Research (NIHR) has announced a clinical trial to improve the diagnosis and treatment of a potentially life-threatening infection in newborn babies. The trial will test the effectiveness of two types of screening compared to no screening in 80 hospitals in England a...


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    https://Pharmaceutical.report/news-article.aspx?ID=31123112

    EMA’S PRAC TO REVIEW XELJANZ AND RECOMMENDS FENSPIRIDE WITHDRAWL

    May 20, 2019

    The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has announced its latest meeting highlights, including a restriction of the use of Xeljanz (tofacitinib), and a call for withdrawal of marketing authorisations for fenspiride medicines. The Xeljanz restric...


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    https://Pharmaceutical.report/news-article.aspx?ID=31133113

    REVLIMID, IMNOVID COMBOS RECEIVE EU APPROVAL

    May 17, 2019

    The European Commission has approved two of Celgene’s combination regimens involving Revlimid (lenalidomide) and Imnovid (pomalidomide). The first, Revlimid in combination with bortezomib and dexamethasone (RVd) is for the indication of adult patients with previously untreated multiple myeloma...


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    https://Pharmaceutical.report/news-article.aspx?ID=31053105

    FRAGMIN APPROVED BY FDA AS FIRST ANTICOAGULANT FOR CHILDREN

    May 17, 2019

    The US Food and Drug Administration has approved Pfizer’s Fragmin (dalteparin sodium) injection to reduce the recurrence of symptomatic venous thromboembolism (VTE) in paediatric patients one month of age and older. The drug was initially approved by the FDA in 1994 for adults and is a type of...


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    https://Pharmaceutical.report/news-article.aspx?ID=31063106

    WINNERS ANNOUNCED - 2019 INTERNATIONAL CLINICAL RESEARCHER OF THE YEAR!

    May 17, 2019

    The winners of the PharmaTimes International Clinical Researcher of the Year have been announced, find out who emerged victorious in the 2019 competition. Celebrating its 20th anniversary, the International Clinical Researcher of the Year awards ceremony took place last night at the Chelsea Harbour ...


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    https://Pharmaceutical.report/news-article.aspx?ID=31073107

    BOEHRINGER SETTLES HUMIRA LAWSUIT, JOINS BIOSIMILAR QUEUE IN US

    May 15, 2019

    Boehringer Ingelheim was the last man standing among challengers to AbbVie’s patents on immunology blockbuster Humira but has joined the pack and settled its litigation. The German company has agreed to delay the introduction of its Humira (adalimumab) biosimilar Cyltezo until 2023, following ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30933093

    NOT-FOR-PROFIT GENERIC DRUG COMPANY CIVICA RX INKS 1ST SUPPLIER DEAL WITH XELLIA PHARMA

    May 15, 2019

    In January 2018, Civica Rx was launched by five healthcare systems as a not-for-profit generic drug company. The systems were the U.S. Department of Veterans Affairs (VA), Intermountain Healthcare, Ascension, SSM Health and Trinity Health. It almost immediately expanded to seven health systems and t...


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    https://Pharmaceutical.report/news-article.aspx?ID=30943094

    R&D SMES AT RISK DUE TO TAX CREDIT SCHEME CHANGE

    May 14, 2019

    The BioIndustry Association (BIA) has announced that changes to small and medium enterprises (SME) research and development (R&D) tax credit schemes could harm a thriving sector. This is because the Government is proposing to introduce a cap on the value of cash payments loss-making SMEs can rec...


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    https://Pharmaceutical.report/news-article.aspx?ID=30883088

    SMC APPROVES NEW CANCER DRUGS, AMONG OTHERS

    May 14, 2019

    The latest round of Scottish Medicines Consortium (SMC) decisions have brought medicines for breast cancer, skin cancer and schizophrenia into the spotlight and recommended them for use on the NHS in Scotland.The governing body has firstly accepted Eli Lilly's Verzenios (abemaciclib) for the tre...


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    https://Pharmaceutical.report/news-article.aspx?ID=30893089

    UK SHOULD BE "PROUD" OF SERVICE AND SUPPLY SECTOR

    May 14, 2019

    A new report by the Medicines Discovery Catapult and the BioIndustry Association has unveiled a thriving service and supply sector for the UK's medicines discovery. The 2019 ‘State of the Discovery Nation’ report specifically highlights two breakthrough technologies set to influence ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30903090

    ‘GROUNDBREAKING’ NEW BRAIN CANCER TREATMENT AVAILABLE

    May 13, 2019

    A new treatment hailed as ‘groundbreaking’ has been rolled out across the country as part of the NHS' Long Term Plan, and could see as many as 2,000 patients benefit as a result. 5-ALA (5-AminoLevulinic Acid), dubbed ‘the pink drink’, uses fluorescent dye and ultraviolet ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30813081

    QUIETER INTENSIVE CARE UNITS MAY TRANSLATE TO BETTER OUTCOMES FOR INFANTS IN NEW STUDY

    May 13, 2019

    Excessive noise is widely known to have negative effects on health, and children in neonatal intensive care units are among the most vulnerable. To help preterm infants make a smooth transition to life outside of the womb, some NICUs have instituted set quiet times to limit children's exposure t...


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    https://Pharmaceutical.report/news-article.aspx?ID=30823082

    GPS NEED TRAINING TO TACKLE CHRONIC OPIOID USE

    May 13, 2019

    GPs must be better-equipped to support patients to manage the psychological challenge of reducing their opioid use—according to new research from the University of East Anglia. The  recommendation is part of a toolkit being launched today to help GPs reduce the amount of opioids they pres...


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    https://Pharmaceutical.report/news-article.aspx?ID=30833083

    ASTRAZENECA SHOWS CARDIOVASCULAR SAFETY FOR ROXADUSTAT

    May 10, 2019

    AstraZeneca has announced that pooled analyses of the phase III trials for its kidney disease drug roxadustat confirm the drug’s cardiovascular safety – a good sign for the potential blockbuster that hopes to compete with well-established treatments. Roxadustat, co-developed with FibroGe...


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    https://Pharmaceutical.report/news-article.aspx?ID=30763076

    POTENTIAL FIRST EVER TARGETED THERAPY DESIGNED FOR ‘UNTREATABLE’ CHILDHOOD BRAIN CANCER

    May 10, 2019

    Scientists at The Institute of Cancer Research, London have discovered a new type of drug that targets a genetic weakness in ‘diffuse intrinsic pontine glioma’ (DIPG), an untreatable childhood brain cancer, which could become the first ever treatment designed to target the disease. The i...


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    https://Pharmaceutical.report/news-article.aspx?ID=30773077

    TAKEDA DIVESTS EYE DRUG TO NOVARTIS FOR $5.3 BILLION

    May 09, 2019

    In January, Takeda Pharmaceutical announced plans to sell about $10 billion worth of assets to offset some of the debt the company garnered in its $62 billion acquisition of Shire. On Wednesday, the Osaka, Japan company announced divestitures worth about $5.7 billion. Takeda entered into agreements ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30713071

    BRISTOL-MYERS SQUIBB’S OPDIVO FAILS IN BRAIN CANCER TRIAL

    May 09, 2019

    It feels sometimes as if Bristol-Myers Squibb’s checkpoint inhibitor Opdivo (nivolumab) is a miraculous cancer drug, given the number of indications it has been approved for. And in many ways it is. However, it apparently can’t do everything, and the company announced today that the drug...


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    https://Pharmaceutical.report/news-article.aspx?ID=30723072

    MERCK TO INVEST $1 BILLION IN VIRGINIA FACILITY, ADD 100 JOBS

    May 09, 2019

    Merck & Company is planning a $1 billion expansion to its manufacturing facility in Elkton, Va. over the course of the next three years that will include the addition of approximately 100 new jobs, the office of the governor of Virginia announced Wednesday. Merck will add 120,000 square feet to ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30733073

    PFIZER ACQUIRES THERACHON AND ITS DWARFISM DRUG

    May 08, 2019

    Pfizer has announced it will pay $340 million upfront to snap up rare disease biotech Therachon, which is developing treatments for a form of dwarfism and short bowel syndrome (SBS). There’s also an additional $470 million worth of payments on the table contingent on Therachon achieving certai...


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    https://Pharmaceutical.report/news-article.aspx?ID=30623062

    PFIZER AGREES ON $340M UPFRONT TO BUY THERACHON FOR DWARFISM DRUG

    May 08, 2019

    Pfizer is set to pay $340 million (€304 million) upfront to buy Therachon for its treatment for a form of short-limbed dwarfism. The deal commits Pfizer to up to $470 million in additional milestones tied to the advance of the early-phase rare disease drug. Therachon has emerged as one of the b...


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    https://Pharmaceutical.report/news-article.aspx?ID=30633063

    AMARIN DEFENDS VASCEPA'S CV-PREVENTION DATA AGAINST SUPPLEMENT MAKERS EAGER TO CASH IN

    May 08, 2019

    Amarin spent years, millions of dollars and a lot of willpower proving its fish oil-based drug Vascepa really could cut the risk of heart attacks, strokes and other cardiovascular problems. To make that effort pay off, it needs to keep that proof to itself. That's just what the drugmaker did in ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30643064

    TEA LEAF PARTICLES COULD DESTROY LUNG CANCER CELLS – SCIENTISTS

    May 07, 2019

    British scientists in a breakthrough study, have found a natural replacement for chemotherapy in lung cancer patients, as they have demonstrated how tiny particles derived from tea leaves can restrain the growth of lung cancer cells, destroying up to 80 percent of them. The researchers from Swansea ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30563056

    INTENSIVE HYPERTENSION TREATMENT MAY LOWER DEATH RISK

    May 07, 2019

    A new research published in the American Heart Association’s (AHA) journal Hypertension,has shown that people with type 2 diabetes who received intensive treatment to keep blood pressure levels at or below 130/80 mmHg may reduce the risk of death from any cause. Diabetes is one of the most com...


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    https://Pharmaceutical.report/news-article.aspx?ID=30573057

    PROSTATE CANCER MUTATION FOUND TO TRIPLE RISK OF DEATH

    May 07, 2019

    The largest ever study of advanced prostate cancer genomics has revealed that men with mutations in the retinoblastoma gene in their tumours were more than three times as likely to die and nearly seven times as likely to relapse on standard treatments as those without the gene. Scientists identified...


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    https://Pharmaceutical.report/news-article.aspx?ID=30613061

    STUDY PRESENTS DRUG CANDIDATE FOR REVERSING MUCOSAL BARRIER DAMAGE BY HIV

    May 06, 2019

    A vaginal microbicide that could prevent sexual transmission of HIV-1 in women has tremendous potential for saving lives and helping staunch an epidemic. But the delicate milieu of microbes that naturally colonize the vagina and maintain a healthy mucosal barrier have made the search for such a micr...


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    https://Pharmaceutical.report/news-article.aspx?ID=30533053

    RHEUMATOID ARTHRITIS DRUG DIMINISHES ZIKA BIRTH DEFECTS IN MICE

    May 06, 2019

    In experiments with pregnant mice infected with the Zika virus, Johns Hopkins Medicine researchers report they have successfully used a long-standing immunosuppressive drug to diminish the rate of fetal deaths and birth defects in the mice's offspring. The U.S. Food and Drug Administration-appro...


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    https://Pharmaceutical.report/news-article.aspx?ID=30543054

    AWAITING FDA NOD, NOVARTIS TOUTS LATEST DATA ON GENE THERAPY ZOLGENSMA

    May 06, 2019

    As Novartis waits for FDA action on its gene therapy Zolgensma, expected this month, the company has rolled out yet another round of data on the spinal muscular atrophy treatment. Novartis’ AveXis, which developed the gene therapy, touted interim data through March 8 from a phase 1 study in Ty...


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    https://Pharmaceutical.report/news-article.aspx?ID=30553055

    NICE RECOMMENDS ROCHE’S TECENTRIQ COMBO FOR CERTAIN LUNG CANCER PATIENTS

    May 03, 2019

    Certain patients with untreated lung cancer in England have a new treatment option after cost-effectiveness body NICE made a draft recommendation that the NHS should fund Roche’s cocktail involving its immunotherapy Tecentriq. The combination of Tecentriq (atezolizumab), Avastin (bevacizumab),...


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    https://Pharmaceutical.report/news-article.aspx?ID=30473047

    TRIAL COULD UNLOCK ASTHMA USE FOR GSK’S TRELEGY

    May 03, 2019

    GlaxoSmithKline CEO Emma Walmsley has been predicting big things for respiratory triple therapy Trelegy in the next couple of years and has new data that could open up a new market.

    Top-line results from the CAPTAIN study have shown that Trelegy (fluticasone furoate/umeclidinium/vilan...


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    https://Pharmaceutical.report/news-article.aspx?ID=30483048

    AVOIDING EXCIPIENT VARIABILITY

    May 02, 2019

    Excipients are essential components in drug products. Although sometimes defined as “functional” or “inert,” each has a specific role within the formulation that is necessary for the overall function of the medicine. Variability in the properties and performance of excipients...


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    https://Pharmaceutical.report/news-article.aspx?ID=30413041

    EMA UPDATES PRESCRIBING INFORMATION OF BREAST CANCER MEDICINE WHILE DATA ARE RE-ANALYZED

    May 01, 2019

    The European Medicines Agency (EMA) has revealed in an April 30, 2019 press release that it is updating the prescribing information of Tyverb (lapatinib) as a result of the detection of errors in study results. In a study, which involved postmenopausal women who had HR+/HER2+ breast cancer and whose...


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    https://Pharmaceutical.report/news-article.aspx?ID=30423042

    INTERTEK EXPANDS PHARMA SERVICES FACILITY

    May 01, 2019

    Intertek, a provider of total quality assurance, has announced the expansion of its pharmaceutical services laboratory in Melbourn, near Cambridge, United Kingdom, through the acquisition of a new 20,000 sq. ft facility. The new facility doubles the current footprint of the company’s laborator...


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    https://Pharmaceutical.report/news-article.aspx?ID=30433043

    NHS, MSD COLLABORATE TO HELP ELIMINATE HEP C

    Apr 30, 2019

    The NHS has announced plans to collaborate with American Pharma giant MSD in a deal that could help England become the first country in the world to eliminate hepatitis C. MSD has already announced a commitment to help see hepatitis C eliminated in the UK by 2025, and over 30,000 people have already...


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    https://Pharmaceutical.report/news-article.aspx?ID=30353035

    AZ TO ACCELERATE DRUG DISCOVERY WITH BENEVOLENTAI PARTNERSHIP

    Apr 30, 2019

    AstraZeneca has announced a collaboration with Benevolent AI in order to use machine learning and artificial intelligence (AI) to discover potential new drugs for chronic kidney disease and idiopathic pulmonary fibrosis.The two companies will create a team of scientists that will work side-by-side t...


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    https://Pharmaceutical.report/news-article.aspx?ID=30363036

    GLAXOSMITHKLINE WINS BENLYSTA US LABEL EXPANSION FOR CHILDREN

    Apr 30, 2019

    GlaxoSmithKline has announced the US Food and Drug Administration expansion of its intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age. The approval, which marks the first medicine in the...


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    https://Pharmaceutical.report/news-article.aspx?ID=30373037

    ASEMBIA LAUNCHES A NETWORK OF RETAIL PHARMACIES FOR SPECIALTY DRUG SERVICES

    Apr 29, 2019

    As it kicks off its annual Specialty Pharmacy Summit (Las Vegas, Apr. 29-May 2), Asembia has announced a new offering that provides a level of patient support to drugs that typically are not budgeted for the high-touch, high-cost services of hub providers. The Asembia Managed Retail Network combines...


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    https://Pharmaceutical.report/news-article.aspx?ID=30233023

    CHP SET TO BRIDGE ADVOCACY GAP WITH US

    Apr 29, 2019

    At a time when world's largest market for pharmaceuticals, the US is sparing no words to accuse India as a source of counterfeit medicines, and complaining about India's intellectual property protection policies and drugs and medical device pricing regulatory systems, an industry veteran - G...


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    https://Pharmaceutical.report/news-article.aspx?ID=30243024

    PHARMACEUTICAL COMPANY RECALLS BLOOD PRESSURE DRUG OVER CANCER CONCERNS

    Apr 29, 2019

    A popular blood pressure medicine is under recall for possible carcinogens. Teva Pharmaceuticals is recalling 35 lots of bulk Losartan Potassium US tablets in 25 and 100 milligram strengths. The company says the pills may have been contaminated with an impurity that may cause cancer


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    https://Pharmaceutical.report/news-article.aspx?ID=30253025

    HEMOGENYX PHARMACEUTICALS PLC ANNOUNCES FINAL RESULTS FOR THE YEAR ENDED 31 DECEMBER 2018 - 29/04/2019

    Apr 29, 2019

    Hemogenyx Pharmaceuticals plc ("Hemogenyx" or the "Company")(HEMO.L), the biopharmaceutical group developing new therapies and treatments designed to transform bone marrow transplantation for the treatment of blood diseases, announces its Final Results for the year ended 31 Decem...


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    https://Pharmaceutical.report/news-article.aspx?ID=30263026

    MEAG MUNICH ERGO KAPITALANLAGEGESELLSCHAFT MBH PURCHASES SHARES OF 97,965 TAKEDA PHARMACEUTICAL CO LTD (TAK)

    Apr 29, 2019

    Meag Munich Ergo Kapitalanlagegesellschaft MBH purchased a new position in shares of Takeda Pharmaceutical Co Ltd (NYSE:TAK) during the 1st quarter, according to the company in its most recent 13F filing with the Securities and Exchange Commission. The institutional investor purchased 97,965 shares ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30273027

    POLICE MAKE ARREST IN FATAL DRUG OVERDOSES ON WEST SIDE

    Apr 26, 2019

    Chicago police have arrested a man in connection with a batch of drugs laced with the potent painkiller fentanyl that was distributed on the West Side this week, resulting in at least 17 overdoses, four of them fatal. The man was taken into custody Friday morning, but no charges have been announced....


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    https://Pharmaceutical.report/news-article.aspx?ID=30173017

    COPS BUST SYNTHETIC DRUG OPERATION IN PORTER COUNTY, SEIZE CHEMICALS, GUNS, CASH, POLICE SAY

    Apr 26, 2019

    Officers found inside of Portage residence 64 pounds of synthetic drugs; 940 grams of synthetic chemical compound used to manufacture the substance commonly referred to as Spice; evidence of several gallons of acetone, which also is used to manufacture the substance; $2,955 from the illicit sales of...


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    https://Pharmaceutical.report/news-article.aspx?ID=30183018

    POLL TAKERS PLACE OPIOID CRISIS BLAME AT THE FEET OF THE PHARMACEUTICAL INDUSTRY

    Apr 26, 2019

    It is estimated that more than 130 people in the United States die every day from an opioid-related overdose and the general public vastly lays the blame for these deaths at the feet of the pharmaceutical industry. A poll conducted by the Associated Press-NORC Center for Public Affairs Research reve...


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    https://Pharmaceutical.report/news-article.aspx?ID=30193019

    PFIZER TAKES TOP SPOT IN PHARMA MARKET CAP FOR 2018, ANALYSIS SHOWS

    Apr 26, 2019

    In the battle of titans, Pfizer has emerged on top as the most valuable pharma company by market cap for 2018. According to an analysis conducted by GlobalData, Pfizer replaced Swiss-based pharma giant Roche at the top of the mountain with a market cap of $253.2 billion. Roche, which came in at numb...


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    https://Pharmaceutical.report/news-article.aspx?ID=30203020

    LONDON DRUGS AUGMENTS LOCAL RECYCLING OPTIONS WITH SATURDAY SPECIAL

    Apr 26, 2019

    London Drugs hosts a recycling day for Victoria residents on April 27. The event encourages residents to responsibly recycle old household goods at the end of their usable life, including electronics and packaging to assist with reducing the amount of waste going to the landfill. “It is a grea...


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    https://Pharmaceutical.report/news-article.aspx?ID=30213021

    RAPID, AI-POWERED GENETIC DISEASE DIAGNOSIS FOR CRITICALLY ILL INFANTS

    Apr 25, 2019

    The researchers at Rady Children’s Institute for Genomic Medicine (RCIGM) are known for working quickly. In February of last year, they broke the Guinness World Record for the fastest diagnosis through whole genome sequencing, with an average of 19 hours. Continuing that work, they have built ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30063006

    DRUGS FOR TREATMENT OF STROKE, VASCULAR DEMENTIA SHOW PROMISING RESULTS IN EARLY TRIAL

    Apr 25, 2019

    Treatments that prevent recurrence of types of stroke and dementia caused by damage to small blood vessels in the brain have moved a step closer, following a small study. The drugs - called cilostazol and isosorbide mononitrate - are already used to treat other conditions, such as heart disease and ...


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    https://Pharmaceutical.report/news-article.aspx?ID=30073007

    OBESITY AND DIABETES RISK LINKED TO COMMON FOOD INGREDIENT

    Apr 25, 2019

    The combined results from a small-scale randomized human trial and studies in mice suggest that consuming propionate, a common food ingredient that is used widely to prevent mold, increases levels of hormones that are linked with diabetes and obesity. The research, headed by a team at the Harvard T....


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    https://Pharmaceutical.report/news-article.aspx?ID=30083008

    SIX FACTORS ASSOCIATED WITH INVASIVE BREAST CANCER RECURRENCE AFTER DCIS DIAGNOSIS

    Apr 25, 2019

    Current guidelines recommend surgical excision of DCIS, often followed by radiotherapy and sometimes endocrine therapy, yet most cases will likely not progress or become life-threatening. As a result, many women are overtreated. "There is a large unmet need to distinguish harmless from potentia...


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    https://Pharmaceutical.report/news-article.aspx?ID=30093009

    PREDICTING WHETHER A PATIENT WILL BENEFIT FROM CHEMOTHERAPY

    Apr 25, 2019

    Case Western Reserve University researchers and partners, including a collaborator at Cleveland Clinic, are pushing the boundaries of how "smart" diagnostic-imaging machines identify cancers--and uncovering clues outside the tumor to tell whether a patient will respond well to chemotherapy...


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    https://Pharmaceutical.report/news-article.aspx?ID=30103010

    STUDY REVEALS HOW GENERAL ANESTHETICS AFFECT THE BRAIN

    Apr 24, 2019

    New research reveals for the first time that diverse drugs that induce general anesthesia activate a brain circuit that brings on sleep. The scientists at Duke University in Durham, NC who carried out the study, suggest that the findings will help to develop better drugs that can induce sleep with f...


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    https://Pharmaceutical.report/news-article.aspx?ID=29972997

    HOW KETAMINE CAN CHANGE THE BRAIN TO FIGHT DEPRESSION

    Apr 24, 2019

    New research in mice, which the National Institutes of Health supported, shows how ketamine can alter brain circuits, quickly redressing depression-like symptoms. Previous studies have shown that ketamine — an anesthetic — can rapidly reduce severe symptoms of major depressive disorder, ...


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    https://Pharmaceutical.report/news-article.aspx?ID=29982998

    USING SMALL MOLECULES TO REGENERATE HEART TISSUE

    Apr 24, 2019

    New research, which appears in the journal Nature Communications, shows that delivering two small molecules to mice helps their hearts regenerate after a heart attack. Heart disease is the leading cause of death in the United States and responsible for almost 1 in 4 deaths in the country. An adverse...


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    https://Pharmaceutical.report/news-article.aspx?ID=29992999

    PSORIASIS AND CARDIO DRUGS DRIVE NOVARTIS’ Q1 SALES

    Apr 24, 2019

    Novartis has begun 2019 at a sprint, upgrading its sales forecasts for the year after strong performances from psoriasis drug Cosentyx and cardiology medicine Entresto. The company’s revolutionary CAR-T cancer cell therapy Kymriah has also begun to gain traction after a slow launch, according ...


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    https://Pharmaceutical.report/news-article.aspx?ID=29932993

    FULCRUM REPURPOSES FAILED GSK DRUG FOR RARE DISEASE

    Apr 24, 2019

    GSK’s failed cardiovascular drug losmapimod looks like it might get a new lease of life after being picked up by biotech Fulcrum Therapeutics, who want to repurpose the drug to treat the rare genetic disease facioscapulohumeral muscular dystrophy (FSHD). Fulcrum had identified inhibitors of p3...


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    https://Pharmaceutical.report/news-article.aspx?ID=29942994

    USING STEM CELLS TO COMBAT OSTEOARTHRITIS

    Apr 23, 2019

    In a recent preliminary study, scientists used stem cells to ease osteoarthritis. Although the trial was small-scale, the results are promising and will pave the way for larger studies. Osteoarthritis of the knee (KOA) occurs when the cartilage — the joint's natural cushioning system &mdas...


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    https://Pharmaceutical.report/news-article.aspx?ID=29952995

    STUDY IDENTIFIES A HORMONE THAT MAY HINDER WEIGHT LOSS

    Apr 23, 2019

    A series of experiments in mice demonstrates that a well-known hormone might have a previously unidentified role in the metabolic response to energy restriction during weight loss. Scientists have known about growth hormone (GH) for several decades. It plays a role in bone growth and is particularly...


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    https://Pharmaceutical.report/news-article.aspx?ID=29962996

    HEALTH INDUSTRY LOBBYISTS PUMP MORE MONEY INTO DEMOCRATS’ CONGRESSIONAL CAMPAIGN ARM

    Apr 23, 2019

    Corporate lobbyists collected almost $1 million for the Democratic Congressional Campaign Committee (DCCC) during the first quarter of 2019, according to an analysis by MapLight and Sludge. The amounts have been rising gradually since the first of the year, with lobbyists bundling almost $515,000 fo...


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    https://Pharmaceutical.report/news-article.aspx?ID=29832983

    HOUSE DEMOCRATS’ CAMPAIGN ARM ON PACE TO DOUBLE DONATIONS FROM CORPORATE LOBBYISTS

    Apr 23, 2019

    Corporate lobbyists collected almost $1 million for the Democratic Congressional Campaign Committee (DCCC) during the first quarter of 2019, according to an analysis by MapLight and Sludge. The amounts have been rising gradually since the first of the year, with lobbyists bundling almost $515,000for...


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    https://Pharmaceutical.report/news-article.aspx?ID=29842984

    DRUG PRICES COME UNDER FIRE AS US PHARMA LOBBY NEARS SPENDING RECORDS

    Apr 23, 2019

    More ambitious changes may be needed to lower pharmaceutical prices as the Trump administration proposes new rules and approves a slew of new generic drugs. Large drug makers and the pharmaceutical industry’s primary trade group neared previous spending records on lobbying in the first three m...


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    https://Pharmaceutical.report/news-article.aspx?ID=29852985

    DR REDDY'S GETS CHINESE REGULATOR NOD FOR ANTI-BLOOD CLOTTING DRUG

    Apr 23, 2019

    Sources said the company got approval earlier this month for generic Clopidogrel, which is used primarily to prevent blood clotting and acts against cardiovascular problems. Hyderabad-based Dr Reddy’s Laboratories (DRL), which is betting big on the Chinese drug market, recently got an approval...


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    https://Pharmaceutical.report/news-article.aspx?ID=29862986

    PROJECT AIMS TO REVIVE NATURAL PRODUCT DISCOVERY

    Apr 23, 2019

    The mid-20th century was the golden age of natural product discovery. Scientists discovered ground-breaking drugs, like penicillin and tetracycline, from sources in nature. But as the search for natural products continued, pharmaceutical companies kept finding the same products over and over again. ...


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    https://Pharmaceutical.report/news-article.aspx?ID=29872987

    CAN A BLOOD PRESSURE DRUG PROTECT THE BRAIN FROM PARKINSON'S?

    Apr 23, 2019

    A prescription drug already in use for the treatment of high blood pressure could be effective against conditions such as Parkinson's, Alzheimer's, and Huntington's, in which toxic proteins build up in brain cells. Scientists at the University of Cambridge in the United Kingdom and the G...


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    https://Pharmaceutical.report/news-article.aspx?ID=30003000

    PERKINS CAPITAL MANAGEMENT INC. CUTS POSITION IN ANI PHARMACEUTICALS INC (ANIP)

    Apr 22, 2019

    Perkins Capital Management Inc. trimmed its position in ANI Pharmaceuticals Inc (NASDAQ:ANIP) by 0.5% during the 1st quarter, according to the company in its most recent filing with the Securities and Exchange Commission (SEC). The firm owned 32,550 shares of the specialty pharmaceutical company&rsq...


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    https://Pharmaceutical.report/news-article.aspx?ID=29732973

    PHARMABOARDROOM RELEASES 'HEALTHCARE AND LIFE SCIENCES REVIEW CHINA' APRIL 2019 PHARMA REPORT

    Apr 22, 2019

    From the world’s ninth largest pharma market in 2007 to its second-biggest merely 12 years later, China and its growth story are impossible to ignore. China now accounts for a significant share of revenues for most major multinational pharmaceutical companies and almost 40 percent of total glo...


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    https://Pharmaceutical.report/news-article.aspx?ID=29742974

    GOODWIN BIOTECHNOLOGY SECURES SIGNIFICANT INSTITUTIONAL INVESTMENT IN NEW ROUND OF GROWTH CAPITAL FINANCING

    Apr 22, 2019

    Goodwin Biotechnology, Inc. ("Goodwin") announced that it has completed its largest ever round of financing with growth capital which will help fund its next stage of expansion.  Goodwin is a full GMP, FDA-registered biopharmaceuticals Contract Development and Manufacturing Organizati...


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    https://Pharmaceutical.report/news-article.aspx?ID=29752975

    MONARCH BECOMES THE 1ST FDA-CLEARED DEVICE FOR ADHD

    Apr 22, 2019

    NeuroSigma’s Monarch eTNS might be the first device to treat ADHD, but it is one of a growing number of technologies that occupy the burgeoning bioelectronic medicine space. The Monarch external Trigeminal Nerve Stimulation (eTNS) System made history last week after it became the first device ...


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    https://Pharmaceutical.report/news-article.aspx?ID=29762976

    FSD PHARMA RECEIVES CANNABIS SALES LICENSE FROM HEALTH CANADA

    Apr 22, 2019

    FSD Pharma Inc. (CSE:HUGE) (OTCQB:FSDDF) (FRA:0K9) (“FSD” or the Company”), announced today that its wholly-owned subsidiary FV Pharma Inc. has received its Sale for Medical Purposes license to sell cannabis under the Cannabis Act (Canada). The license went into effect on April 18,...


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    https://Pharmaceutical.report/news-article.aspx?ID=29772977

    THE SUPERBUG IS RISING: WHERE ARE THE NEW ANTIBIOTICS?

    Apr 19, 2019

    According to Alan Westwood, chief executive of Matoke, a company hoping to develop a new form of antibiotic, the issue of antibiotic resistance is one of the most troubling issues of our times. It is one of the biggest threats to human health. In 30 years, it’s estimated 10 million people will...


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    https://Pharmaceutical.report/news-article.aspx?ID=29672967

    DRUGMAKERS REVEAL LIST PRICES ONLINE AFTER PRESSURE FROM TRUMP

    Apr 19, 2019

    The world's biggest pharmaceutical companies are revealing prices of their prescription drugs on websites for the first time in a bid to stave off pressure from the Trump administration to make even more public disclosures. The move by companies ranging from pharma giant Pfizer to biotechnology ...


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    https://Pharmaceutical.report/news-article.aspx?ID=29682968

    PFIZER AND LILLY'S NON-OPIOID PAINKILLER SHOWS MIXED RESULTS IN PHASE III

    Apr 19, 2019

    Pfizer and Eli Lilly and Company announced top-line results from a Phase III clinical trial of two doses of tanezumab in moderate-to-severe osteoarthritis (OA) of the hip or knee. The results were mixed, with the 5 mg dose meeting two of the three co-primary efficacy endpoints but missing on the pat...


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    https://Pharmaceutical.report/news-article.aspx?ID=29692969

    DISPENSED: INTRODUCING BUSINESS INSIDER'S 10 PEOPLE TRANSFORMING HEALTHCARE

    Apr 19, 2019

    Welcome to another dose of Dispensed, Business Insider's weekly healthcare newsletter! Before heading out for the holiday weekend, I wanted to highlight some of the great work the healthcare team here has been pulling together. The entire Business Insider newsroom got together to compile a list ...


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    https://Pharmaceutical.report/news-article.aspx?ID=29702970

    POT STOCKS SOARING, CANNABIS INDUSTRY POISED FOR 'TONS OF GROWTH'

    Apr 19, 2019

    (CNN) - For decades, though nobody was really sure why, April 20 has been the unofficial holiday for marijuana users and a joke by and about them. Now, though, it's also a reminder of how quickly marijuana is moving from illegal and a joke to a multi-billion-dollar legal business and a good time...


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    https://Pharmaceutical.report/news-article.aspx?ID=29712971

    HEALTHCARE COMPANIES SEARCH FOR NEW WAYS TO OPPOSE THE SPREAD OF CANCER

    Apr 17, 2019

    Cancer is among one of the leading causes of death in the world since many countries are burdened by the lack of access to adequate healthcare, which results in the high number of deaths. In 2018, the World Cancer Research Fund (WCRF) estimated that there were 18 million new cancer cases worldwide. ...

    PTCOMMUNITY
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    https://Pharmaceutical.report/news-article.aspx?ID=29562956

    WIDESPREAD CLINICAL STUDIES CAN REINVIGORATE THE LEGALIZATION MOVEMENT FOR CANNABIS

    Apr 17, 2019

    Researchers and scientists are constantly developing new, innovative medicines to effectively treat patients. However, the cost to conduct clinical trials and then receive approval to commercialize a drug is absurdly expensive. The Tufts Center for the Study of Drug Development estimated that in 201...

    PTCOMMUNITY
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    https://Pharmaceutical.report/news-article.aspx?ID=29572957

    RESEARCHERS USE GENE EDITING WITH CRISPR TO TREAT LETHAL LUNG DISEASES BEFORE BIRTH

    Apr 17, 2019

    Using CRISPR gene editing, a team from Children's Hospital of Philadelphia (CHOP) and Penn Medicine have thwarted a lethal lung disease in an animal model in which a harmful mutation causes death within hours after birth. This proof-of-concept study, published today in Science Translational Medi...

    MEDICALXPRESS
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    https://Pharmaceutical.report/news-article.aspx?ID=29582958

    RESEARCHERS PINPOINT TUMOR-RELATED PROTEIN, SLOW PROGRESSION OF CANCERS

    Apr 17, 2019

    Locking a biochemical gate that admits fuel into immune-suppressing cells could slow tumor progression and assist the treatment of multiple cancers, says new research from the Wistar Institute, the University of Nebraska-Lincoln and others. Published April 17 in the journal Nature, the study found e...

    MEDICALXPRESS
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    https://Pharmaceutical.report/news-article.aspx?ID=29592959

    NEW STUDY TARGETS ACHILLES' HEEL OF PANCREATIC CANCER, WITH PROMISING RESULTS

    Apr 17, 2019

    Advanced pancreatic cancer is often symptomless, leading to late diagnosis only after metastases have spread throughout the body. Additionally, tumor cells are encased in a "protective shield," a microenvironment conferring resistance to many cancer treatment drugs. Now, Salk Institute res...

    MEDICALXPRESS
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    https://Pharmaceutical.report/news-article.aspx?ID=29602960

    ICC MAKES STRATEGIC INVESTMENT IN DISRUPTIVE BIOSYNTHESIS RESEARCH -- CFN MEDIA

    Apr 16, 2019

    He leading agency and financial media network dedicated to the North American cannabis industry, announces the publication of an article covering biosynthesis and International Cannabis Corp.’s recent biotechnology investment. Biosynthesis is the process of manipulating simple substances to pr...

    CFN MEDIA
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    https://Pharmaceutical.report/news-article.aspx?ID=29462946

    DNDI AND ATOMWISE COLLABORATE TO ADVANCE DRUG DEVELOPMENT USING AI FOR NEGLECTED DISEASES

    Apr 16, 2019

    A biotech company using artificial intelligence (AI) for drug discovery, and the Drugs for Neglected Diseases initiative (DND i ), a not-for-profit research and development organization working to deliver new treatments for neglected diseases, today announced that promising drug-like compounds have ...

    ATOMWISE, INC.
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    https://Pharmaceutical.report/news-article.aspx?ID=29482948

    FLAGSHIP PIONEERING UNVEILS KINTAI THERAPEUTICS AND APPOINTS PHARMACEUTICAL DRUG DEVELOPER PAUL-PETER TAK, M.D., PH.D., AS CHIEF EXECUTIVE OFFICER

    Apr 16, 2019

    A unique life science innovation enterprise, today unveiled Kintai Therapeutics and named Paul-Peter Tak, M.D., Ph.D., as president, chief executive officer, and member of the board of directors. Kintai is focused on leveraging the body's diverse signaling networks to pioneer a new class of Prec...

    FLAGSHIP PIONEERING
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    https://Pharmaceutical.report/news-article.aspx?ID=29492949

    FRENCH BIOTECH CELLVAX IS NOW ABLE TO PROPOSE PRECLINICAL STUDIES IN LARGE ANIMALS

    Apr 16, 2019

    CellVax can now respond to the strong demand for optimal selection of models that represent the human disease best and is able to offer preclinical studies in large nonrodent species as well as diversified preclinical models or clinical trials. Large animal models are essential for the development o...

    BUSINESSWIRE
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    https://Pharmaceutical.report/news-article.aspx?ID=29502950

    BOOZ ALLEN HAMILTON AWARDED THE 2019 INFORMS PRIZE FOR OPERATIONS RESEARCH

    Apr 15, 2019

    The leading international association for operations research and analytics professionals, announced that Booz Allen Hamilton has been awarded the 2019 INFORMS Prize for their pioneering and enduring integration of operations research (O.R.) and analytics programs into their organization. Recognizin...

    EUREKALERT
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    https://Pharmaceutical.report/news-article.aspx?ID=29472947

    ALCHEM INTERNATIONAL SOLVES STABILITY DILEMMA FOR MICRONIZED DIGOXIN

    Apr 15, 2019

    Alchem's molecule is the sole micronized digoxin available globally that resolves the challenge of micro dosage formulation and the long-term stability and impurity issues with this specialist heart drug.  Digoxin is commonly administered to treat various heart conditions including atrial f...

    ALCHEM INTERNATIONAL
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    https://Pharmaceutical.report/news-article.aspx?ID=29392939

    DEMOCRATS FEUD OVER DRUG PRICING POLICY, AS PROGRESSIVES PUSH PRAGMATISTS TO BE BOLDER

    Apr 15, 2019

    In recent weeks, tensions between the two camps have escalated, and some fights have even spilled into public view. In a high-profile tug of war, lawmakers hoping to strike an accord with the Trump administration have been forced to confront a faction pressing Democrats to instead pursue a bolder pr...

    STATNEWS
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    https://Pharmaceutical.report/news-article.aspx?ID=29402940

    THE ZUR ROSE GROUP NOMINATES THREE NEW BOARD MEMBERS

    Apr 15, 2019

    The Zur Rose Group is nominating Tobias Hartmann, Dr. Christian Mielsch and Florian Seubert as new members of the Board of Directors and proposing them for election at the General Meeting of Shareholders to be held on 23 May 2019. The nomination is intended to add proven expertise in technology, tra...

    PHARMIWEB
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    https://Pharmaceutical.report/news-article.aspx?ID=29352935

    SCIBITE LAUNCHES CENTREE TO REVOLUTIONISE ONTOLOGY MANAGEMENT FOR LIFE SCIENCES ORGANISATIONS

    Apr 15, 2019

    The award-winning semantic technology company, today announced the launch of CENtree, an innovative, collaborative platform which revolutionises the way Life Sciences organisations manage and release ontologies. Ontologies play a critical role in semantic enrichment, enabling unstructured scientific...

    PHARMIWEB
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    https://Pharmaceutical.report/news-article.aspx?ID=29362936

    DIPLOMAT PHARMACY INC. (DPLO) AND THE MEDICINES COMPANY (NASDAQ:MDCO) COMPARING SIDE BY SIDE

    Apr 14, 2019

    Both Diplomat Pharmacy Inc. (NYSE:DPLO) and The Medicines Company (NASDAQ:MDCO) are Drugs – Generic companies, competing one another. We will contrast their risk, analyst recommendations, profitability, dividends, institutional ownership, earnings and valuation. Diplomat Pharmacy, Inc. operate...

    MCMONITOR
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    https://Pharmaceutical.report/news-article.aspx?ID=29372937

    CANNABIS TRADE BODY WILL ALSO FOCUS ON CLINICAL TRIALS

    Apr 12, 2019

    The Centre for Medicinal Cannabis (CMC) has announced plans to extend its remit to focus on clinical trials. The CMC, which describes itself as an industry advocacy group and think tank, said its plans to “actively engage industry players” in clinical trials focusing on childhood epileps...

    THE CENTRE FOR MEDICINAL CANNABIS
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    https://Pharmaceutical.report/news-article.aspx?ID=29262926

    WASHINGTON WEEK: DRUGMAKERS, PBMS HAMMERED OVER HIGH DRUG PRICES

    Apr 12, 2019

    WASHINGTON -- Members of Congress blamed and shamed key players in the pharmaceutical market for high drug prices, while also asking for their help; and the Trump administration quietly advanced its block grant strategy for Medicaid. Drugmakers, PBMs Run the Gauntlet at House Hearing No punches were...

    MEDPAGETODAY
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    https://Pharmaceutical.report/news-article.aspx?ID=29282928

    STUDENTS AT WELSH ANNUAL PROFESSIONAL DEBATE VOTE AGAINST OTC SALE OF MEDICAL CANNABIS PRODUCTS

    Apr 11, 2019

    Pharmacists should not sell cannabis-derived medical products over the counter (OTC), according to pharmacy students at the 2019 Annual Professional Debate. Co-hosted by the Royal Pharmaceutical Society (RPS) in Wales and Healthcare Education and Improvement Wales (HEIW) Pharmacy  eanery, this ...

    THE PHARMACEUTICAL JOURNAL
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    https://Pharmaceutical.report/news-article.aspx?ID=29272927

    PROTAGEN PROTEIN SERVICES AND BIO ANALYTIX MERGE TO CREATE GLOBAL ANALYTIC SERVICE PARTNER FOR BIO PHARMACEUTICALS

    Apr 11, 2019

    HEILBRONN, Germany and BOSTON, April 11, 2019 (GLOBE NEWSWIRE) -- Protagen Protein Services GmbH (PPS), a full-service contract research organization (CRO) in protein analytics and BioAnalytix Inc., a Cambridge (MA)-based specialized provider of advanced analytics in biopharmaceutical development an...

    BIOANALYTIX
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    https://Pharmaceutical.report/news-article.aspx?ID=29162916

    JANSSEN PRESENTS NEW DATA FROM FIRST PHASE 3 TRIAL OF A SINGLE-TABLET

    Apr 11, 2019

    MIAMI, April 11, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson unveiled new 48-week data for SYMTUZA® (darunavir 800 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg D/C/F/TAF) showing that a high proportion of HIV patients achieved...

    JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON
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    https://Pharmaceutical.report/news-article.aspx?ID=29172917

    AS SANDERS OFFICIALLY REVIVES MEDICARE-FOR-ALL, PLAN B FOR DEMOCRATS GAINS TRACTION

    Apr 11, 2019

    As Democratic presidential primary candidates try to walk a political tightrope between the party’s progressive and center-left wings, they face increasing pressure to outline the details of their health reform proposals. On Wednesday, Sen. Bernie Sanders (I-Vt.) reaffirmed his stance by reint...

    KHN
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    https://Pharmaceutical.report/news-article.aspx?ID=29182918

    FDA ORDERS IMPORTANT SAFETY LABELING CHANGES FOR ADDYI

    Apr 11, 2019

    The U.S. Food and Drug Administration today issued a safety labeling change orderto Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their health care professionals need to have when considering use of the dru...

    U.S. FOOD AND DRUG ADMINISTRATION
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    https://Pharmaceutical.report/news-article.aspx?ID=29202920

    HORIZON PHARMA PLC NAMED ONE OF THE 2019 BEST WORKPLACES IN HEALTH CARE AND BIOPHARMA BY FORTUNE AND GREAT PLACE TO WORK.

    Apr 11, 2019

    Horizon Pharma plc (NASDAQ:HZNP) today announced it has been selected as one of the 2019 Best Workplaces in Health Care and Biopharma by Great Place to Work® and FORTUNE Magazine. The company has also been awarded a 2019 Best Places to work in Chicago designation by Crain's Chicago Business....

    HORIZON PHARMA PLC
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    https://Pharmaceutical.report/news-article.aspx?ID=29222922

    FDA REJECTS REGULATORY FILING FOR ZOGENIX EPILEPSY DRUG; GW PHARMA MOVES IN SYMPATHY

    Apr 09, 2019

    Zogenix, Inc.,which develops therapies for rare diseases, said Monday afternoon the FDA issued a refusal to file letter regarding its NDA for Fintepla, chemically fenfluramine hydrochloride, which is being evaluated for the treatment of seizures associated with Dravet syndrome. The FDA determined th...


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    https://Pharmaceutical.report/news-article.aspx?ID=29052905

    OUT FROM UNDER NOVARTIS, ALCON IS ITS OWN COMPANY NOW

    Apr 09, 2019

    Alcon is officially a standalone company. The eye care specialist has officially spun out from Swiss pharma giant Novartis. Alcon began trading today on the SIX Swiss Exchange and New York Stock Exchange under the symbol “ALC.” David Endicott, Alcon’s chief executive officer, said ...


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    https://Pharmaceutical.report/news-article.aspx?ID=29092909

    SCOTLAND BACKS AIMOVIG FOR MIGRAINE AFTER NICE SAYS NO

    Apr 09, 2019

    People suffering from severe migraines in Scotland will be able to get treatment with Amgen and Novartis’ Aimovig if they fail other therapies, according to the country’s cost-effectiveness agency for medicines. The Scottish Medicines Consortium (SMC) has given its backing to routine use...


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    https://Pharmaceutical.report/news-article.aspx?ID=29102910

    TRIFECTA PHARMACEUTICALS USA AND WALMART LAUNCH DISTRIBUTION PARTNERSHIP

    Apr 08, 2019

    FORT LAUDERDALE, FL, UNITED STATES, April 8, 2019 /EINPresswire.com/ -- TRIFECTAPHARMACEUTICALS USA, a leading developer, manufacturer and distributor of specialty OTC topical ointments, creams and gels, today announces its inaugural distribution partnership with Walmart. Mayinglong hemorrhoid ointm...


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    https://Pharmaceutical.report/news-article.aspx?ID=29062906

    AMAZON ALEXA'S FIRST HIPAA-SANCTIONED SKILLS OPEN NEW DOORS FOR PHARMA

    Apr 08, 2019

    Amazon's new Alexa upgrade offers some HIPAA-compliant skills—and some potential new opportunities for drugmakers that want to jump on the voice-activated AI platform. Amazon announced six partners last week in its first HIPAA-compliant nod for the voice apps it calls "skills." T...


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    https://Pharmaceutical.report/news-article.aspx?ID=29022902

    PFIZER USES REAL-WORLD DATA TO SCORE IBRANCE BREAST CANCER NOD IN MALES

    Apr 05, 2019

    Breast cancer is a rare disease in men, making it tough for drugmakers to conduct clinical trials. But Pfizer came up with a solution. The pharma giant scored a new nod Thursday for big-seller Ibrance in males, based largely on real-world evidence. Along the way, regulators studied data from electro...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28962896

    JAZZ, LUNDBECK AND ALEXION SETTLE WITH FEDS FOR $122M-PLUS OVER CHARITY CONTRIBUTIONS

    Apr 05, 2019

    The federal government’s probe into pharma’s co-pay assistance charities has snared some of the biggest names in the business, and Thursday the Department of Justice said three drugmakers have inked settlements totaling $122.6 million. Jazz, Lundbeck and Alexion each struck deals with th...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28972897

    CHINA-US FEUD FORCES PATIENTSLIKEME TO FIND NEW INVESTOR – PRESS

    Apr 05, 2019

    Increasingly fraught Sino-American relations are beginning to have a real impact on the health sector, after it emerged that the health networking startup PatientsLikeMe is being forced to find a buyer after the Trump administration ordered its Chinese majority owner to divest its stake. According t...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=29002900

    CHINA-US FEUD FORCES PATIENTSLIKEME TO FIND NEW INVESTOR – PRESS

    Apr 05, 2019

    Increasingly fraught Sino-American relations are beginning to have a real impact on the health sector, after it emerged that the health networking startup PatientsLikeMe is being forced to find a buyer after the Trump administration ordered its Chinese majority owner to divest its stake. According t...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=29012901

    NOVARTIS' SMA GENE THERAPY WOULD NOT BE COST-EFFECTIVE IF PRICED OVER $1.5M: ICER

    Apr 04, 2019

    The pricing analysis done by the Institute for Clinical and Economic Research (ICER) on new therapies for spinal muscular atrophy (SMA) has been no small undertaking. One of the therapies ICER reviewed—Zolgensma from Novartis’ AveXis unit—isn't yet FDA-approved or priced, forci...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28922892

    EU REGULATORS TO FAST-TRACK JANSSEN’S MULTIPLE MYELOMA CAR-T

    Apr 04, 2019

    European regulators are to hasten development of Janssen’s CAR-T therapy for patients with multiple myeloma, after promising early-stage trial results. Janssen, the pharma arm of Johnson & Johnson, said the European Medicines Agency has granted a PRIME (PRIority MEdicines) designation for ...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=28932893

    PBM CUTS INSULIN CO-PAY AS LAWMAKER CONFRONTATIONS LOOM

    Apr 04, 2019

    Express Scripts has announced a plan to cut patient co-pays for insulin products at $25 a month ahead of a pricing showdown with US politicians next week. The cap is part of a “patient assurance programme” that the pharmacy benefit manager (PBM) is launching for members of participating ...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=28942894

    FORMER INSYS SALES EXEC TO SHELL OUT $9.5M IN OPIOID SPRAY KICKBACK SCHEME

    Apr 03, 2019

    Insys’ former VP of sales has settled and turned state's evidence in an Arizona kickback suit alleging an executive-driven scheme to buy scripts for the company’s powerful opioid spray, Subsys. Alec Burkaloff, who pleaded guilty in a Boston courthouse in November on federal racketeer...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28852885

    ROCHE FORCED TO EXTEND SPARK TENDER OFFER AS INVESTORS SUE OVER $4.3B MERGER

    Apr 03, 2019

    Roche’s $114.50-per-share offer for Spark Therapeutics represents a whopping 122% premium to the gene specialist’s closing price on the last trading day before the acquisition announcement. But some Spark investors still think the price is too low. So far, Spark investors have tendered o...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28862886

    FUSION RAISES $105M FOR RADIOPHARMACEUTICAL TRIALS

    Apr 03, 2019

    Bayer’s Xofigo (radium 223) was a trailblazer in this field following FDA approval in 2013 – a calcium mimic, the drug selectively binds to bone metastases in prostate cancer to deliver a localised dose of radiation. Novartis has placed its big bet in therapeutic radiopharmaceuticals wit...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=28882888

    TEVA’S MIGRAINE DRUG AJOVY APPROVED IN EUROPE

    Apr 02, 2019

    Teva’s migraine drug Ajovy (fremanezumab) has been approved in Europe, taking on rivals from the same class from Novartis and Eli Lilly. Novartis already has Aimovig (erenumab) approved in Europe, along with Eli Lilly’s Emgality (galcanezumab), with both drugs available as monthly inject...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=28802880

    NOVARTIS’ COSENTYX BEATS J&J, LILLY TO LAND FIRST-IN-CLASS CHINESE PSORIASIS NOD

    Apr 02, 2019

    Novartis’ psoriasis blockbuster Cosentyx has beaten out rivals from Eli Lilly and Johnson & Johnson as the first interleukin inhibitor approved in China. China’s National Medical Product Administration has approved Cosentyx to treat moderate-to-severe plaque psoriasis in adult patien...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28812881

    ABBVIE INVESTORS AGITATE FOR CHAIR-CEO SPLIT, FLAGGING BONUS PAY AND HUMIRA HIKES

    Apr 02, 2019

    AbbVie investors are calling for a separation of powers in the C-suite, citing Chairman and CEO Richard Gonzalez's outsized pay package and the company's "thicket" of Humira patents. In an SEC filing Monday, AbbVie investor and Rhode Island General Treasurer Seth Magaziner threw hi...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28822882

    BETTER 8 YEARS LATE THAN NEVER: MERCK KGAA NABS FDA NOD FOR MS DRUG MAVENCLAD

    Apr 01, 2019

    Up to 10 years of safety data has paid off for Merck KGaA’s oral multiple sclerosis treatment Mavenclad. The drug has returned from the dead, eight years after an FDA rejection dashed its dream of challenging Novartis’ then-newly-minted Gilenya—and according to one analyst, it migh...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28732873

    HERITAGE PHARMA SUES OVER CONTAINER OF REFRIGERATED DRUGS KNOCKED INTO RIVER

    Apr 01, 2019

    A refrigerated container of drugs was rolling on the river last year when a supply chain mishap resulted in eight shipping containers falling like dominoes from a ship into the Elizabeth River in Virginia. Now Heritage Pharmaceuticals wants reimbursement. The Eatontown, New Jersey-based drugmaker ha...

    FIERCEPHARMA
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    https://Pharmaceutical.report/news-article.aspx?ID=28742874

    BLUEBIRD BIO GETS CHMP NOD FOR GENE THERAPY ZYNTEGLO

    Apr 01, 2019

    A European Medicines Agency advisory panel has recommended a conditional approval for Zynteglo, bluebird bio’s lead gene therapy for thalassemia, a rare blood disorder. The Committee for Medicinal Products for Human Use (CHMP) confirmed on Friday that it had issued a positive opinion for the t...

    PHARMAPHORUM
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    https://Pharmaceutical.report/news-article.aspx?ID=28762876

    PLATELET BIOGENESIS EYES ENTERING THE CLINIC, DOUBLING EMPLOYMENT THIS YEAR

    Mar 28, 2019

    The polar vortex that brought bone-chilling temperatures to much of the United States earlier this winter highlighted a near constant concern – an inadequate supply of platelets at blood centers across the country. Platelets are essential for helping the body stop bleeds and are also excellent...


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    https://Pharmaceutical.report/news-article.aspx?ID=28672867

    SEATTLE GENETICS & ASTELLAS REPORT POSITIVE UROTHELIAL CANCER STUDY

    Mar 28, 2019

    Seattle Genetics and Tokyo-based Astellas Pharma announced positive topline data from the first cohort of its Phase II EV-201 trial. The trial is evaluating enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who had previously received both platinum-based chemothera...


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    https://Pharmaceutical.report/news-article.aspx?ID=28682868

    NEARLY 8,000 PACKETS OF ORKAMBI DESTROYED AS THE U.K. AND VERTEX HASH OUT PRICING CONCERNS

    Mar 28, 2019

    Cystic fibrosis drugmaker Vertex Pharmaceuticals was forced to destroy nearly 8,000 packs of its drug Orkambi after the medication had expired before they could be shipped to the United Kingdom due to a contentious pricing fight. Boston-based Vertex and the National Health Service in England have be...


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    https://Pharmaceutical.report/news-article.aspx?ID=28692869

    NHS DIGITAL TRANSFORMATION TEAM TO BEGIN WORK NEXT MONTH

    Mar 28, 2019

    England’s NHS is gearing up towards the ‘go live’ of a new digital transformation team that aims to drive service improvement using health data and technology. The government announced the creation of NHSX last month and there are now 11 days to go before the official launch said h...


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    https://Pharmaceutical.report/news-article.aspx?ID=28702870

    HEARTLIGHT X3 SYSTEM FOR RAPID AND ACCURATE CARDIAC ABLATION PROCEDURES CLEARED IN EUROPE

    Mar 27, 2019

    Ablation of cardiac tissue is one of the most common ways of treating atrial fibrillation. Interventional cardiologists have to work quite a bit to make sure the energy they’re delivering hits the correct areas. The HeartLight X3 System from CardioFocus is designed to make this process much fa...


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    https://Pharmaceutical.report/news-article.aspx?ID=28592859

    CELGENE REFILES POTENTIAL MS BLOCKBUSTER OZANIMOD WITH FDA

    Mar 27, 2019

    Celgene has filed its highly anticipated oral MS drug ozanimod with the US regulator, more than a year after the FDA rejected it because of a bureaucratic foul-up. Last February Celgene received a “Refuse to File” notice from the FDA after finding issues with the dossier submitted by the...


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    https://Pharmaceutical.report/news-article.aspx?ID=28602860

    HEALTH SECRETARY HINTS AT ‘CONSTRUCTIVE’ TALKS OVER CF DRUGS

    Mar 27, 2019

    Health secretary Matt Hancock has offered hope to thousands of people in the UK who have been denied access to powerful cystic fibrosis drugs because of a row over pricing with manufacturer Vertex, saying that fresh discussions with the firm have been “constructive”. Around three years a...


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    https://Pharmaceutical.report/news-article.aspx?ID=28622862

    IMPLANT ATTACHED TO HEART GENERATES ELECTRICITY TO POWER PACEMAKER

    Mar 26, 2019

    Pacemakers, defibrillators and other cardiac implants are life-saving devices, but the batteries inside of them remain their Achilles’ heel. Every five to ten years they have to be replaced in another invasive surgery that patients abhor and that put a high cost on the healthcare system. Harve...


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    https://Pharmaceutical.report/news-article.aspx?ID=28522852

    FOX FOUNDATION BACKS INFLAZOME PARKINSON’S PROJECT

    Mar 26, 2019

    Irish start-up Inflazome has won $1 million in funding from the Michael J. Fox Foundation (MJFF) to help it develop a brain imaging probe for Parkinson’s, as well as a new drug class for the disease. The cash injection will be used to support a positron emission tomography (PET) imaging techni...


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    https://Pharmaceutical.report/news-article.aspx?ID=28532853

    ALDEYRA’S CONJUNCTIVITIS DRUG IN PHASE III IS A SIGHT FOR SORE EYES

    Mar 26, 2019

    Aldeyra Therapeutics, headquartered in Lexington, Mass., announced positive results from its Phase III ALLEVIATE trial of reproxalap for allergic conjunctivitis. The trial evaluated reproxalap topical ophthalmic solution in two different concentrations, 0.25%, and 0.5%. The trial met the primary end...


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    https://Pharmaceutical.report/news-article.aspx?ID=28542854

    AIMMUNE'S PEANUT ALLERGY PRODUCT HITS PRIMARY ENDPOINTS IN EUROPEAN PHASE III TRIAL

    Mar 25, 2019

    Brisbane, Calif.-based Aimmune Therapeutics announced that its Phase III European clinical trial of AR101 for treatment of peanut allergy met its primary efficacy endpoint. In November 2018, the company had announced the publication of its successful Phase III PALISADE clinical trial of AR101 in the...


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    https://Pharmaceutical.report/news-article.aspx?ID=28442844

    THERMO FISHER SCIENTIFIC TO BUY BRAMMER BIO FOR $1.7 BILLION

    Mar 25, 2019

    Thermo Fisher Scientific, based in Waltham, Mass., is buying gene and cell therapy manufacturer Brammer Bio, located in Cambridge, Mass. for $1.7 billion in cash. Brammer Bio is a contract development and manufacturing organization (CDMO) focusing on manufacturing viral vectors for gene and cell the...


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    https://Pharmaceutical.report/news-article.aspx?ID=28452845

    FDA UNCONVINCED BY SANOFI’S ZYNQUISTA IN TYPE 1 DIABETES

    Mar 25, 2019

    Sanofi’s hopes of getting its dual SGLT inhibitor sotagliflozin approved alongside insulin for type 1 diabetes in the US have been dashed by the FDA. The US regulator has issued a complete response letter (CRL) for Lexicon Pharma-partnered sotagliflozin, a dual SGLT1 and SGLT2 inhibitor that h...


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    https://Pharmaceutical.report/news-article.aspx?ID=28462846

    UNDERSTANDING GENE INTERACTIONS HOLDS KEY TO PERSONALIZED MEDICINE, SCIENTISTS SAY

    Mar 25, 2019

    When the Human Genome Project was completed, in 2003, it opened the door to a radically new idea of health—that of personalized medicine, in which disease risk and appropriate treatment would be gleaned from one's genetic makeup. As more people had their genomes sequenced, disease-related ...


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    https://Pharmaceutical.report/news-article.aspx?ID=28472847

    NOVARTIS CONFIRMS ALCON EYE CARE UNIT SPIN OFF NEXT MONTH

    Mar 22, 2019

    Novartis has finalized plans for the long-awaited spin-off of its Alcon eye care business, announcing that the new company will list on April 9. The Swiss pharma has approval for listing on the SIX Swiss Exchange and the New York Stock Exchange, adding that Alcon is expected to list on Switzerland&r...


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    https://Pharmaceutical.report/news-article.aspx?ID=28362836

    FIRST CARDIAC CONTRACTILITY MODULATION DEVICE APPROVED BY FDA

    Mar 22, 2019

    Most cardiac implants, such as pacemakers and AICDs, are designed to correct the underlying heart’s rhythm and synchronize atrial and ventricular contractions. That’s how these devices can improve cardiac performance in people with heart failure. They don’t do anything to boost the...


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    https://Pharmaceutical.report/news-article.aspx?ID=28372837

    AI DRUG R&D FIRM EXSCIENTIA EXPANDS INTO JAPAN

    Mar 22, 2019

    AI drug R&D firm Ex Scientia has announced it has expanded into Japan, after clinching a major research deal with Celgene. Based in Oxford, UK, Ex Scientia said it has established a subsidiary, Ex Scientia K.K. which is to spearhead its pharmaceutical interests across Asia. Exscientia K.K. is he...


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    https://Pharmaceutical.report/news-article.aspx?ID=28382838

    ADVOCACY GROUP AND FDA ADVISOR CALL FOR A MORATORIUM ON OPIOID APPROVALS

    Mar 22, 2019

    As America continues to grapple with the opioid crisis, nonprofit advocacy group Public Citizen is calling for the U.S. Food and Drug Administration (FDA) to place a moratorium on the approval of any new opioid medications. Raeford Brown, chair of the FDA’s Anesthetic and Analgesic Drug Produc...


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    https://Pharmaceutical.report/news-article.aspx?ID=28392839

    FRANCE’S DOCTOLIB IS NEW DIGITAL HEALTH UNICORN

    Mar 20, 2019

    Doctolib, the largest digital health service in Europe, has raised 150 million euros in a funding round, valuing it at over a billion euros. Thanks to the funding round led by growth equity firm General Atlantic, France’s Doctolib has become a privately-owned digital health “unicorn&rdqu...


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    https://Pharmaceutical.report/news-article.aspx?ID=28282828

    SEVEN FUTURE BLOCKBUSTER DRUGS TO LOOK OUT FOR IN 2019

    Mar 20, 2019

    AbbVie’s rheumatoid arthritis drug upadacitinib is at the top of a new list of drugs due to launch this year that are expected to make blockbuster sales by 2023. JAK1 inhibitor upadacitinib for rheumatoid arthritis will be a $2.2 billion product by that time, predicts Clarivate Analytics, desp...


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    https://Pharmaceutical.report/news-article.aspx?ID=28292829

    MORE OVARIAN CANCER WOES FOR MERCK KGAA AND PFIZER AS THEY HALT LATE-STAGE TRIAL

    Mar 20, 2019

    Merck KGaA, Darmstadt, Germany, and Pfizer discontinued a Phase III ovarian cancer drug trial after determining that the degree of benefit observed in the treatment during an interim analysis does not support the continuation of the trial. It was the second ovarian cancer trial the two companies col...


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    https://Pharmaceutical.report/news-article.aspx?ID=28302830

    NEW CLASS OF DRUGS COULD TREAT OVARIAN CANCER

    Mar 20, 2019

    A team of researchers across The University of Manchester have shown that a new class of drugs are able to stop ovarian cancer cells growing. The Cancer Research UK and Wellcome Trust-funded study, published in the journal Cancer Cell, showed that the drugs, called PARG inhibitors, can kill ovarian ...


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    https://Pharmaceutical.report/news-article.aspx?ID=28312831

    AZ BACKS DIABETES DRUG FARXIGA WITH NEW CARDIO ANALYSIS

    Mar 19, 2019

    AstraZeneca continues to make the case for its Farxiga diabetes drug, highlighting a cardiology analysis that it hopes will convince more doctors to prescribe it in a highly competitive market. Farxiga (dapagliflozin) is AZ’s fifth biggest-selling drug, making up around 7% of product sales. La...


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    https://Pharmaceutical.report/news-article.aspx?ID=28202820

    CELL MOGRIFY GETS £420K FUNDING FOR REGENERATIVE CELL THERAPIES

    Mar 19, 2019

    UK cell therapy company Cell Mogrify has been awarded £420,000 funding from Innovate UK to accelerate its data-driven cell conversion programmes. The funding from the UK’s innovation agency will be used to transition three products to the preclinical stage, with potential application in ...


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    https://Pharmaceutical.report/news-article.aspx?ID=28212821

    LIXIANA HITS THE MARK IN CATHETER ABLATION TRIAL

    Mar 19, 2019

    Daiichi Sankyo’s Lixiana was a late entrant to the novel oral anticoagulant (NOAC) category, but the Japanese drugmaker hopes new data in atrial fibrillation (AFib) could accelerate its growth. The ELIMINATE-AF trial compared uninterrupted treatment with Factor Xa inhibitor Lixiana (edoxaban) ...


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    https://Pharmaceutical.report/news-article.aspx?ID=28222822

    DR. REDDY'S LAB LAUNCHES CUSTOMER SERVICE PORTAL TO INCREASE OPERATIONAL EFFICIENCY FOR US CUSTOMERS

    Mar 18, 2019

    Hyderabad, India and Princeton, NJ, USA. March 18, 2019 - Dr. Reddy’s Laboratories Ltd. announces the launch of its advanced B2B Customer Service Portal “XCEED.” Fully focused on meeting the growing demand for Dr. Reddy’s portfolio of generic active pharmaceutical ingredients...


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    https://Pharmaceutical.report/news-article.aspx?ID=28142814

    PRALUENT APPROVED TO REDUCE CV RISK IN EUROPE

    Mar 18, 2019

    The European Commission has approved Sanofi and Regeneron’s Praluent for reducing cardiovascular risk in adults with established atherosclerotic CV disease (ASCVD), giving the drug another advantage in its battle against Amgen’s Repatha. The approval is based on results from the phase II...


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    https://Pharmaceutical.report/news-article.aspx?ID=28152815

    FIBROMYALGIA ACCURATELY SPOTTED IN AN EXPERIMENTAL BLOOD TEST: STUDY

    Mar 18, 2019

    Washington D.C.: In a first, researchers have found that fibromyalgia can reliably be detected in blood samples which could possibly lead to a simple and fast diagnosis. In the study that appears in the Journal of Biological Chemistry, researchers from The Ohio State University report success in ide...


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    https://Pharmaceutical.report/news-article.aspx?ID=28162816

    MERCK KGAA SIGNS ANOTHER AI DEAL

    Mar 15, 2019

    Merck KGaA is doubling down on AI through a new collaboration agreement with tech firm Iktos, using its generative modeling technology to speed up the discovery and design of promising new compounds. Iktos’ AI tech, which is based on deep generative models, automatically designs virtual n...


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    https://Pharmaceutical.report/news-article.aspx?ID=28052805

    TINY ROBOTIC TOOL TO DETECT, KILL CANCER CELLS

    Mar 15, 2019

    Toronto: Canadian scientists have developed a kind of magnetic tweezer that can precisely insert a minuscule bead robot into a live human cancer cell, pointing to a new option for diagnosing and killing cancer. The study, published in the journal Science Robotics, described the design in which a mag...


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    https://Pharmaceutical.report/news-article.aspx?ID=28062806

    TIP THAT LAUNCHED COLLEGE BRIBERY SCANDAL CASE CAME FROM PHARMA PUMP-AND-DUMP INVESTIGATION

    Mar 15, 2019

    The college bribery scandal that is currently lighting up the media was brought to light by a Securities and Exchange Commission (SEC) investigation into a pharmaceutical pump-and-dump case. The scandal, dubbed Operation Varsity Blues, revolves around dozens of wealthy parents paying a college consu...


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    https://Pharmaceutical.report/news-article.aspx?ID=28072807

    PRICES OF SELECT INSULIN SHOOTS UP TO 20% IN ONE YR

    Mar 15, 2019

    Chennai: Fluctuating US Dollar has pushed prices of insulin pens, cartridges, and basal insulin by up to 20% over the last few months, thereby pushing up medical bills of diabetics in India. Diabetologists say nearly a third of-of their insulin dependent patients are now paying more for their daily ...


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    https://Pharmaceutical.report/news-article.aspx?ID=28082808

    UK GETS EARLY ACCESS TO ROCHE’S BREAST CANCER IMMUNOTHERAPY

    Mar 14, 2019

    Hard on the heels of an FDA approval for Roche’s Tecentriq and Celgene’s Abraxane for triple-negative breast cancer (TNBC), the regimen has been cleared for early access in the UK. The green light means adult patients with PD-L1 positive, unresectable locally advanced or metastatic TNBC ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27982798

    JUBILANT PHARMA'S RATINGS UNAFFECTED BY USFDA WARNING, FITCH SAYS

    Mar 14, 2019

    Jubilant Pharma’s credit profile remains unaffected by the US Food and Drug Administration's (USFDA) recent regulatory action at its Roorkee facility in India, Fitch Ratings has said. “The plant makes generic solid-dosage products and has limited contribution to JPL's revenue and...


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    https://Pharmaceutical.report/news-article.aspx?ID=27992799

    INDIANA UNIVERSITY RESEARCHERS DEVELOP BLOOD TEST FOR PTSD

    Mar 14, 2019

    Researchers at Indiana University have developed a blood test that could help more accurately diagnose post-traumatic stress disorder, or PTSD. The study tracked more than 250 veterans in over 600 visits at the Richard L. Roudebush VA Medical Center in Indianapolis, attempting to identify a molecule...


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    https://Pharmaceutical.report/news-article.aspx?ID=28002800

    CEO OF NOVARTIS’ GENERICS UNIT QUITS, SPARKING SALE SPECULATION

    Mar 14, 2019

    Richard Francis is stepping down as CEO of Novartis’ generics and biosimilars division Sandoz at the end of March, sparking further speculation about the unit’s future. The Swiss drugmaker said that current region head for Europe, Francesco Balestrieri, has been appointed ad-interim CEO ...


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    https://Pharmaceutical.report/news-article.aspx?ID=28012801

    CANCER DOCTOR SHARPLESS TO TAKE REINS AT FDA NEXT MONTH

    Mar 13, 2019

    The director of the US National Cancer Institute, Norman “Ned” Sharpless has been announced as the acting FDA commissioner, following the shock resignation of incumbent Scott Gottlieb. Health and Human Services Secretary Alex Azar made the announcement in a hearing before a House committ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27902790

    ZYDUS CADILA GETS USFDA NOD TO MARKET POTASSIUM CHLORIDE CAPSULES

    Mar 13, 2019

    New Delhi: Drug firm Zydus Cadila Wednesday said it has received final approval from the US health regulator to market Potassium Chloride extended-release capsules, used to treat or prevent low amounts of potassium in the blood. Zydus Cadila said the newly-approved product will be manufactured at th...


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    https://Pharmaceutical.report/news-article.aspx?ID=27912791

    SMITH & NEPHEW BUYS OSIRIS IN REGENERATIVE MEDICINE PUSH

    Mar 13, 2019

    Medical equipment company Smith & Nephew has agreed a $660 million deal to buy US biotech Osiris Therapeutics that expands its business into regenerative medicine. Osiris makes medical products used to treat skin, bone and cartilage damage, with the bulk of its revenues coming from Grafix and St...


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    https://Pharmaceutical.report/news-article.aspx?ID=27922792

    FDA APPROVES GENERIC VALSARTAN AMID DRUG SHORTAGE

    Mar 13, 2019

    The U.S. Food and Drug Administration on Tuesday approved a new generic of heart medicine Valsartan and said it prioritized the drug's review to help relieve recent shortage as manufacturers around the world have pulled the treatment from the market. Several drugmakers, including Teva Pharmaceut...


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    https://Pharmaceutical.report/news-article.aspx?ID=27932793

    CITY OF MEMPHIS SUES PHARMACEUTICAL COMPANIES FOR OPIOID CRISIS

    Mar 12, 2019

    The City of Memphis has filed a federal lawsuit against a group of more than 20 opioid drug manufacturers and distributors, accusing them of fueling the addiction crisis plaguing the community, according to court records. The lawsuit was filed in U.S. District Court for the Western District of Tenne...


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    https://Pharmaceutical.report/news-article.aspx?ID=27822782

    OPIOID LITIGATION CONCERNS WEIGH ON PHARMACEUTICAL LOAN BORROWERS

    Mar 12, 2019

    The opioid crisis came to the loan market last week, as the potential fallout from lawsuits weighed on manufacturers of the drugs cited as a root cause of the epidemic. Pharmaceutical company Endo International's US$ 3.4 billion term loan was quoted at 97.75-98.5 on Monday, unchanged from Friday...


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    https://Pharmaceutical.report/news-article.aspx?ID=27832783

    PHARMACEUTICALS IN THE ENVIRONMENT: COMMISSION TO ACT

    Mar 12, 2019

    The European Commission has adopted a Communication detailing actions to be taken to avoid the proliferation of pharmaceutical substances into the environment. The Strategic Approach to Pharmaceuticals in the Environment report covers every stage of the “pharmaceutical life cycle” in bot...


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    https://Pharmaceutical.report/news-article.aspx?ID=27842784

    AZ JOINS WITH SERES TO RESEARCH ROLE OF GUT MICROBIOME IN CANCER

    Mar 12, 2019

    AstraZeneca has announced an immuno-oncology collaboration with US biotech Seres Therapeutics, which will focus on increasing understanding of the gut microbiome in order to increase the efficacy of cancer immunotherapy. The tie-up is based on preclinical and clinical evidence suggesting that the co...


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    https://Pharmaceutical.report/news-article.aspx?ID=27852785

    ROCHE GETS FIRST CHECKPOINT INHIBITOR OK IN BREAST CANCER

    Mar 11, 2019

    Roche’s Tecentriq was the third PD-1/PD-L1 inhibitor to reach the market but is the first in class to be approved for any form of breast cancer. PD-L1 inhibitor Tecentriq (atezolizumab) has been cleared by the FDA for advanced triple-negative breast cancer (TNBC), in combination with Celgene&r...


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    https://Pharmaceutical.report/news-article.aspx?ID=27742774

    MERCK & CO PENS $340M PAIN DRUG DEAL WITH KCL AND WELLCOME

    Mar 11, 2019

    Merck & Co has announced a deal with King’s College London (KCL) and Wellcome to investigate a new class of painkillers that could provide an alternative to opioids and their dangerous side-effects. Known as MSD outside of the US, the big pharma has signed a collaborative license deal with...


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    https://Pharmaceutical.report/news-article.aspx?ID=27752775

    SMOKING DURING PREGNANCY DOUBLES THE RISK OF SUDDEN UNEXPECTED INFANT DEATH, STUDY WARNS

    Mar 11, 2019

    The first findings to result from a collaboration between Seattle Children's Research Institute and Microsoft data scientists provide expecting mothers new information about how smoking before and during pregnancy contributes to the risk of an infant dying suddenly and unexpectedly before their ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27762776

    NEW DIAGNOSTIC CLUES FOUND FOR LIFE LIMITING LUNG CONDITION

    Mar 11, 2019

    A new biomarker that could be used to provide an earlier diagnosis for a life-limiting lung condition has been identified by researchers at the University of Bradford. Pulmonary arterial hypertension (PAH) affects around 6,500 people in the UK and is caused by a narrowing of the arteries supplying b...


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    https://Pharmaceutical.report/news-article.aspx?ID=27772777

    FDA ADVISORY PANEL GIVES MIXED REVIEW TO SANOFI’S DENGUE VACCINE

    Mar 08, 2019

    Sanofi has been hoping to secure approval from the U.S. Food and Drug Administration (FDA) for its dengue vaccine, but a mixed review from a panel of experts could sink the chances of a green light for the medication. The FDA is expected to rule on Sanofi’s Biologics License Application by May...


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    https://Pharmaceutical.report/news-article.aspx?ID=27652765

    NEW SOFTWARE AIMS TO REPLACE HANDWRITTEN EXPERIMENT METHODS

    Mar 08, 2019

    The not-for-profit organization, the Pistoia Alliance, has announced new software that aims to make pharma labs work more efficiently, replacing handwritten experiment methods with digital documents. The MethodDB project has been launched in conjunction with pharma companies including Bristol-Myers ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27662766

    BEDROCK APPOINTS EMILY HOWMAN TO LEAD SCIENTIFIC SERVICES TEAM

    Mar 08, 2019

    Bedrock Healthcare Communications has appointed Emily Howman to lead its scientific services team in a move designed to reinforce its core medical communications offering. In taking up the newly-created position of head of scientific services Howman will also join the med comms agency’s senior...


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    https://Pharmaceutical.report/news-article.aspx?ID=27672767

    INVESTMENT FIRM APPALOOSA AGAIN CALLS FOR LEADERSHIP CHANGES AT ALLERGAN

    Mar 08, 2019

    After Allergan reported that its late-stage adjunctive treatment for major depressive disorder failed to distinguish itself against placebo, hedge fund investor Appaloosa LP is again calling on the Ireland-based company to make some changes to its board of directors, including tapping a new chairman...


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    https://Pharmaceutical.report/news-article.aspx?ID=27682768

    IN AN ATTEMPT AT CLARITY, FDA MAKES THE BIOSIMILAR NAMING CONVENTION EVEN MORE CONFUSING

    Mar 08, 2019

    The U.S. Food and Drug Administration (FDA) and some biosimilar and generic drug advocates were concerned that the naming for biosimilars the branded drug’s name and a unique, four-letter suffix made the drugs sound inferior to consumers than their branded counterparts. So in January 2017, the...


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    https://Pharmaceutical.report/news-article.aspx?ID=27692769

    IPSEN LAUNCHES NEW SYRINGE FOR RARE DISEASE BLOCKBUSTER

    Mar 07, 2019

    Ipsen will be launching a new pre-filled syringe for its blockbuster rare disease drug Somatuline (lanreotide) in the EU. The new design was based on several studies, involving patients, their caregivers, nurses and other healthcare professionals that aimed to inform and test enhancements to the exi...


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    https://Pharmaceutical.report/news-article.aspx?ID=27552755

    TREATING TRIPLE-NEGATIVE BREAST CANCER BY REPURPOSING OLD DRUGS FOR DIABETES AND RARE BLOOD DISORDER

    Mar 07, 2019

    Triple-negative breast cancer patients lack three common markers estrogen, progesterone, and HER2 making them unresponsive to targeted therapies. A team led by University of Chicago scientists may have found a new option for these patients, and it's one that involves combining two old FDA-approv...


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    https://Pharmaceutical.report/news-article.aspx?ID=27562756

    ALNYLAM TO SEEK APPROVAL FOR SECOND RNAI DRUG

    Mar 07, 2019

    Alnylam thinks it has strong enough clinical data for its gene-silencing drug for rare disease acute hepatic porphyria (AHP), and plans to move ahead with regulatory filings in the US and Europe. The US biotech made a bit of biotech history last August after getting the first-ever FDA approval for a...


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    https://Pharmaceutical.report/news-article.aspx?ID=27572757

    ROCHE STUDY SHOWS AI CAN DETECT SEVERITY OF DIABETIC MACULAR EDEMA

    Mar 07, 2019

    A new study conducted by researchers from Genentech and Roche shows first-time proof that artificial intelligence can detect the severity of diabetic macular edema, which is a leading cause of blindness. On Monday, researchers from Genentech and its parent company Roche published the study, Deep Lea...


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    https://Pharmaceutical.report/news-article.aspx?ID=27582758

    MERCK KGAA ADMITS TO ‘CHALLENGING’ 2018, AS CURRENCIES HIT SALES

    Mar 07, 2019

    Germany’s Merck KGaA has described 2018 as a “challenging” year, which saw profits hit by currency headwinds and the company struggling to convince shareholders at semiconductor Versum firm to allow a merger. In its full-year results for 2018, Merck KGaA said sales rose in 2018 by ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27592759

    GENE-EDITING STARTUP BEAM BAGS $135M IN SERIES B TOP-UP

    Mar 06, 2019

    Beam Therapeutics has raised a healthy $135 million in second-round financing that will be used to advance its single-base approach to gene editing. The Cambridge, Massachusetts, biotech—which was one of our Fierce 15 winners last year—says the new funding will be used to expand its pipe...


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    https://Pharmaceutical.report/news-article.aspx?ID=27452745

    ALNYLAM'S GIVOSIRAN LOOKS POSITIVE OVERALL IN PHASE III TRIAL FOR RARE DISEASE

    Mar 06, 2019

    Despite releasing positive data on its Phase III ENVISION trial, Alnylam Pharmaceuticals stock dropped 7.5 percent. Although not completely clear why the drop may be related to a high percentage of serious adverse events observed in the trial. The ENVISION Phase III trial evaluated givosiran, an inv...


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    https://Pharmaceutical.report/news-article.aspx?ID=27462746

    MEDITERRANEAN DIET BOOSTS ENDURANCE EXERCISE WITHIN DAYS

    Mar 06, 2019

    Researchers at Saint Louis University have found that eating a Mediterranean diet can improve athletes' endurance exercise performance after just four days. In a small study published in the Journal of the American College of Nutrition, investigators found that participants ran a 5K six percent ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27472747

    VERTEX TRIPLE COMBINATION CF DRUGS HIT THE MARK IN PHASE III TRIALS

    Mar 06, 2019

    A Vertex triple-combination treatment for cystic fibrosis hit the mark in two Phase III trials, setting the stage for the company to secure approval for another treatment for the life-shortening genetic disease that affects approximately 75,000 people in North America, Europe, and Australia. This mo...


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    https://Pharmaceutical.report/news-article.aspx?ID=27482748

    BRISTOL-MYERS SQUIBB STRIKES BACK! RESPONSE TO CRITICS OF CELGENE DEAL

    Mar 06, 2019

    Bristol-Myers Squibb announced its bid to acquire Celgene on January 3, 2019. However, the deal hit a snag. One of its biggest shareholders, Wellington Management Company LLP, has objected to the acquisition. Wellington owns about an 8 percent stake in Bristol-Myers. Another BMS shareholder, Starboa...


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    https://Pharmaceutical.report/news-article.aspx?ID=27492749

    STEM CELL TRANSPLANT POTENTIALLY "CURES" SECOND HIV PATIENT

    Mar 05, 2019

    Although cautious about using the word “cure,” researchers have described a second person globally to be cleared of HIV, the virus that causes AIDS. The first patient was Timothy Ray Brown, also dubbed the “Berlin Patient,” who was cured of HIV in 2007. The new study was publ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27352735

    FOCUSED ULTRASOUND AND MICROBUBBLES PUSH DRUGS ACROSS BLOOD-BRAIN BARRIER

    Mar 05, 2019

    The blood-brain barrier is an important defense mechanism that prevents infections and contamination within the brain. It is also responsible for making it extremely difficult to get therapeutic drugs, including chemo agents, into the brain. Now researchers at Washington University in St. Louis have...


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    https://Pharmaceutical.report/news-article.aspx?ID=27362736

    KEYTRUDA COULD GET PATIENT-FRIENDLY 6 WEEK DOSING SCHEDULE IN EU

    Mar 05, 2019

    US-based Merck & Co is putting further pressure on its arch-rival Bristol-Myers Squibb with a potential new six-week dosing schedule for some European patients taking its Keytruda (pembrolizumab) cancer immunotherapy. Late last week the European Medicines Agency’s Committee for Medicinal P...


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    https://Pharmaceutical.report/news-article.aspx?ID=27372737

    GILEAD EXPANDS CAR-T DEAL WITH MAXCYTE, PRECISION FILES FOR $100M IPO

    Mar 05, 2019

    It has been a busy month already in the field of CAR-T therapy, with Gilead expanding a partnership with MaxCyte, and Precision BioSciences filing for a $100 million IPO for its ‘off-the-shelf’ cancer cell therapies. Gilead’s subsidiary Kite Pharma has revised a deal with London-li...


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    https://Pharmaceutical.report/news-article.aspx?ID=27382738

    FORMER AGIOS EXECUTIVE TO TAKE OVER DECIPHERA AFTER CEO STEPS DOWN

    Mar 05, 2019

    After five years at the reins, Mike Taylor will step down from his role as president and chief executive officer of Waltham, Mass.-based Deciphera Pharmaceuticals. Taylor’s last day in the role will by March 18, the company announced late Monday. Steve Hoerter, the chief commercial officer of ...


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    https://Pharmaceutical.report/news-article.aspx?ID=27392739

    PRECISION BIOSCIENCES FILES FOR $100 MILLION IPO TO FUND OFF-THE-SHELF CAR-T TRIALS

    Mar 04, 2019

    Durham, NC-based Precision BioSciences filed on Friday with the U.S. Securities Exchange Commission for an initial public offering (IPO). The company, which focuses on gene-edited CAR-T cell therapies for cancer, plans to raise $100 million. Precision’s technology is based on its ARCUS tech pl...


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    https://Pharmaceutical.report/news-article.aspx?ID=27232723

    CHMP OKAYS SANOFI’S ZYNQUISTA IN TYPE 1 DIABETES

    Mar 04, 2019

    Sanofi has moved a step closer to getting its new diabetes therapy Zynquista approved in Europe, with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The European Medicines Agency (EMA) drugs advisory panel has recommended the oral SGLT1/2 inhibitor as an adjunct t...


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    https://Pharmaceutical.report/news-article.aspx?ID=27242724

    NEW CARCINOGENS FOUND IN BLOOD PRESSURE MEDICATIONS, RECALL ISSUED

    Mar 04, 2019

    More carcinogens have been discovered in blood pressure medications, which has prompted another recall by the U.S. Food and Drug Administration (FDA). On Friday, the FDA raised concerns about losartan potassium tablets sold by India-based Hetero Labs Ltd. and distributed by Camber Pharmaceuticals. T...


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    https://Pharmaceutical.report/news-article.aspx?ID=27252725

    ERGOJACK SMART VEST PREVENTS INJURIES AT WORK

    Mar 04, 2019

    Construction, factory, and farm workers, among others, tend to put a lot of strain on their backs. It’s no surprise that back problems are common in such professions. Paying attention to one’s posture and being careful to avoid putting too much demand on the bones and muscles of the back...


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    https://Pharmaceutical.report/news-article.aspx?ID=27262726

    ASCENDIS PHARMA’S TRANSCON GROWTH HORMONE PASSES PHASE III WITH FLYING COLORS

    Mar 04, 2019

    Ascendis Pharma, based in Copenhagen, Denmark, announced that its once-weekly TransCon Growth Hormone (HGH) hit its primary endpoints in its Phase III height Trial in children with pediatric growth hormone deficiency (GHD). The trial compared Ascendis’ TransCon hGH to a daily growth hormone, G...


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    https://Pharmaceutical.report/news-article.aspx?ID=27272727

    NAPP LAUNCHES NEULASTA BIOSIMILAR IN UK

    Mar 04, 2019

    Napp’s Pelmeg, a biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), has been launched in the UK following approval late last year. This is Napp’s first launch of a product developed by Cinfa Biotech, which was acquired by its parent network Mundipharma in October. Aside fr...


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    https://Pharmaceutical.report/news-article.aspx?ID=27282728

    NAPP LAUNCHES NEULASTA BIOSIMILAR IN UK

    Mar 04, 2019

    Napp’s Pelmeg, a biosimilar of Amgen’s cancer drug Neulasta (pegfilgrastim), has been launched in the UK following approval late last year. This is Napp’s first launch of a product developed by Cinfa Biotech, which was acquired by its parent network Mundipharma in October. Aside fr...


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    https://Pharmaceutical.report/news-article.aspx?ID=27292729

    LUCID GROUP ACQUIRES CREATIVE AND DIGITAL CONSULTANCY BLUEDOG

    Mar 01, 2019

    UK-based medical communications group Lucid has made its first acquisition, adding creative and digital consultancy Bluedog to the fold. The consultancy was set up over 23 years ago and counts UCB Pharma, Reckitt Benckiser, Estée Lauder and Visa among its clients. Bluedog’s managing dir...


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    https://Pharmaceutical.report/news-article.aspx?ID=27082708

    INDIANA UNIVERSITY RESEARCH ADVANCES SEARCH FOR NEW ANTIBIOTICS

    Mar 01, 2019

    Indiana University researchers are advancing knowledge about how bacteria build their cell walls that could contribute to the search for new antibacterial drugs. They have created a new tool to observe living cells in real time under a microscope. "If you look at the history, no one's reall...


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    https://Pharmaceutical.report/news-article.aspx?ID=27092709

    RANI COMPLETES FIRST TRIAL OF CAPSULE THAT COULD REPLACE INJECTIONS

    Mar 01, 2019

    Results of the first human study of a capsule designed to replace injections of biologics have been announced, using an automatic pill designed by Silicon Valley-based Rani Therapeutics. Backed by Google’s parent company Alphabet, Rani has begun clinical trials of the RaniPill, which is capabl...


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    https://Pharmaceutical.report/news-article.aspx?ID=27102710

    PFIZER IS TARGET OF FEDERAL CIVIL PROBE INTO EPIPEN MALFUNCTIONS

    Mar 01, 2019

    Problems for the troubled Pfizer unit that makes EpiPen injectors for Mylan have opened on a new front. The U.S. Attorney for the Southern District of New York is now digging into the issues of why Pfizer continued to produce pens after receiving dozens of complaints that many were failing during li...


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    https://Pharmaceutical.report/news-article.aspx?ID=27112711

    IMMUNOGEN PLUNGES AFTER PHASE III OVARIAN CANCER TREATMENT FAILS TO HIT PFS ENDPOINT

    Mar 01, 2019

    Shares of Waltham, Mass.-based ImmunoGen, Inc. have plunged nearly 50 percent in premarket trading after the company’s Phase III ovarian cancer treatment failed to meet the primary endpoint of progression-free survival. ImmunoGen’s FORWARD I trial was testing the safety and efficacy of m...


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    https://Pharmaceutical.report/news-article.aspx?ID=27122712

    TOWARDS A BLOOD TEST FOR EARLY-STAGE LIVER DISEASE

    Mar 01, 2019

    One in four people in Western and Asian societies develop a build-up of fat in the liver as a result of an unhealthy diet. This disease - referred to as non-alcoholic fatty liver disease (NAFLD) - causes no symptoms initially but can develop into end-stage liver cirrhosis with limited treatment opti...


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    https://Pharmaceutical.report/news-article.aspx?ID=27132713

    LARGEST BMS SHAREHOLDER OPPOSES CELGENE DEAL

    Mar 01, 2019

    Bristol-Myers Squibb’s (BMS) largest shareholder has come out against the company’s planned merger with Celgene, putting the future of the deal in doubt. The $74 billion deal, announced in January, would be one of the largest ever pharma mergers, and the combined company would be the wor...


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    https://Pharmaceutical.report/news-article.aspx?ID=27142714

    GENE THERAPY FOR DEAFNESS, AUTISM GENES, BREAKTHROUGHS IN PARKINSON’S AND ALS, AND MORE

    Mar 01, 2019

    Researchers with the Institut Pasteur and several other institutions restored the hearing in adult mice with a specific congenital form of deafness using gene therapy. Researchers with Institut Pasteur, University of Florida, University of California, San Francisco (UCSF), Columbia University Medica...


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    https://Pharmaceutical.report/news-article.aspx?ID=27152715

    BACTERIOPHAGES TO THE RESCUE: A POSSIBLE APPROACH TO ANTIBIOTIC RESISTANCE

    Feb 27, 2019

    Ella Balasa, a 26-year-old from Richmond, Virginia, recently made the news when she was apparently successfully treated for a lung infection using a kind of virus called a bacteriophage. The word “apparently” is important in terms of determining exactly how effective the treatment was, i...


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    https://Pharmaceutical.report/news-article.aspx?ID=26802680

    ADVISERS URGE FDA TO DELAY DECISION ON KARYOPHARM CANCER DRUG

    Feb 27, 2019

    Advisers to the US drugs regulator have said a decision on whether to approve Karyopharm’s multiple myeloma combination should be delayed until the results of a phase 3 trial, due late this year or in 2020. The FDA’s Oncologic Drugs Advisory Committee (ODAC) was discussing Massachusetts-...


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    https://Pharmaceutical.report/news-article.aspx?ID=26812681

    A NEW METHOD FOR PRECISION DRUG DELIVERY: PAINTING

    Feb 27, 2019

    If traditional drug delivery were a type of painting, it might be akin to paintball. With good aim, a majority of the paint ends on the bullseye, but it also drips and splashes, carrying streams of paint across the target. If the drug needs to enter the bloodstream and circulate throughout your body...


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    https://Pharmaceutical.report/news-article.aspx?ID=26822682

    APPLYING ANTIMALARIAL DRUGS TO BED NETS COULD LEAD TO DROP IN MALARIA TRANSMISSION

    Feb 27, 2019

    Mosquitoes that landed on surfaces coated with the anti-malarial compound atovaquone were completely blocked from developing Plasmodium falciparum (P. falciparum), the parasite that causes malaria, according to new research led by Harvard T.H. Chan School of Public Health. The study showed that atov...


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    https://Pharmaceutical.report/news-article.aspx?ID=26832683

    MYLAN REPORTS LOWER THAN EXPECTED EARNINGS

    Feb 27, 2019

    Mylan has reported lower than expected full-year earnings and 2019 forecasts, thanks partly to delays in its generic Advair approval and continuing problems at its US manufacturing plant. Total revenues were $11.43 billion, down 4% compared to the prior year. North America segment net sales were dow...


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    https://Pharmaceutical.report/news-article.aspx?ID=26842684

    DR. REDDY'S SOLID DOSE PLANT PINCHED BY FDA FOR MISSTEPS

    Feb 27, 2019

    The FDA keeps rolling through the Indian manufacturing plants of Dr. Reddy’s Laboratories and the Form 483s keep falling out. The FDA this week posted a Form 483 (PDF) for Dr. Reddy’s solid dose plant in Pradesh that was issued after an inspection in January. There were only four observa...


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    https://Pharmaceutical.report/news-article.aspx?ID=26852685

    COHEN DROPS TESTIMONY ON NOVARTIS DEAL: THEY WANTED ‘ACCESS’ TO TRUMP

    Feb 27, 2019

    As much as Novartis might want the issue to go away, the company’s questionable $1.2 million consulting contracts with President Donald Trump’s former attorney Michael Cohen caught the spotlight again Wednesday as Cohen testified to Congress. Pressed by lawmakers in the House of Represen...


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    https://Pharmaceutical.report/news-article.aspx?ID=26862686

    EU STEPS CLOSER TO GENERICS AND BIOSIMILARS MANUFACTURING WAIVER

    Feb 27, 2019

    A change to European rules on drug manufacturing that could benefit makers of generics and biosimilars is edging closer after lawmakers agreed on draft legislation that tweaks rules on export and manufacture of drugs that are off-patent outside the EU. The draft of the so-called supplementary protec...


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    https://Pharmaceutical.report/news-article.aspx?ID=26882688

    MICROFLUIDIC DEVICE PULLS EXOSOMES FROM BLOOD TO TEST FOR CANCER

    Feb 27, 2019

    Exosomes are tiny vesicles that seemingly all the cells in our bodies produce. Initially, exosomes were thought to be a way for cells to expunge built-up trash, but over the past decade or so scientists have discovered that they seem to play an important role in regulating a variety of biochemical p...


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    https://Pharmaceutical.report/news-article.aspx?ID=26952695

    NOVARTIS' SHIFT TO SUPERPRICEY CELL AND GENE THERAPIES DRAWS INVESTOR IRE

    Feb 27, 2019

    It's not unusual for critics to challenge top drugmakers for price hikes on old drugs, but Novartis is contending with a different kind of pricing pressure from a Swiss shareholder activist group. In this case, it's the company's move into ultra-expensive, one-time treatments that has cr...


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    https://Pharmaceutical.report/news-article.aspx?ID=26962696

    LUNDBECK JOINS WITH ELSEVIER TO HELP MANAGE R&D DATA

    Feb 27, 2019

    Denmark’s Lundbeck has signed an agreement with information business Elsevier, that aims to help organize the masses of scientific data it has available, and make drug research more productive and efficient. The companies have created a big data project that creates a comprehensive database of...


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    https://Pharmaceutical.report/news-article.aspx?ID=26972697

    SANDERS ESCALATES FIGHT WITH CATALYST, ASKING FDA TO ALLOW UNBRANDED COPIES OF $375K FIRDAPSE: REPORT

    Feb 27, 2019

    After a seemingly vain attempt to appeal to Catalyst Pharmaceuticals’ conscience, Sen. Bernie Sanders, I-Vt., has turned to the FDA, asking the agency to allow cheaper, unapproved versions of Catalyst’ Firdapse to be distributed as they had been over the past three decades. In a bid to c...


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    https://Pharmaceutical.report/news-article.aspx?ID=26982698

    FORMER TRUMP LAWYER COHEN SAYS NOVARTIS ‘WANTED HIM TO BE LOBBYIST’

    Feb 27, 2019

    Novartis’ dodgy dealings with the Trump administration have come under fresh scrutiny, as his former personal lawyer Michael Cohen told politicians that the pharma company had wanted to use him to lobby the government and president. Cohen was testifying against the president in a much-anticipa...


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    https://Pharmaceutical.report/news-article.aspx?ID=26992699

    NEW INSIGHT INTO HOW BIOGEN'S TECFIDERA WORKS MAY LEAD TO BETTER MS THERAPIES

    Feb 27, 2019

    Biogen’s top-selling Tecfidera (dimethyl fumarate) has proven to be an effective treatment for multiple sclerosis, bringing in $4.27 billion in sales in 2018, but its exact mechanism of action remains a mystery. Now scientists from the City University of New York and the Icahn School of Medici...


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    https://Pharmaceutical.report/news-article.aspx?ID=27002700

    FDA FINDS AUROBINDO STERILE DRUG PLANT CONTINUES TO HAVE PROBLEMS

    Feb 26, 2019

    Aurobindo pledged to resolve issues at a sterile manufacturing plant in India last year after an FDA inspection cited it for problems that could lead to contamination. It didn’t do enough. The FDA has made another trip to the key Aurobindo facility and once again found it lacking. The agency h...


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    https://Pharmaceutical.report/news-article.aspx?ID=26662666

    AZ/MERCK & CO’S LYNPARZA DELAYS SPREAD OF PANCREATIC CANCER

    Feb 26, 2019

    AstraZeneca and Merck & Co’s Lynparza could offer a new option for certain patients with pancreatic cancer after a trial showed it slowed progression of the disease. Lynparza (olaparib) is a poly (ADP-ribose) polymerase, or PARP inhibitor class drug and is already established as a therapy ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26672667

    AMGEN PERSUADES JURY TO BACK PCSK9 PATENTS, PUTTING SANOFI AND REGENERON BACK ON DEFENSE

    Feb 26, 2019

    Give the latest round of the PCSK9 patent fight to Amgen. A California jury decided Monday that two key patents protecting its Repatha cholesterol drug are indeed valid—and that puts Sanofi and Regeneron in a tough spot. The partners, which sell a rival PCSK9 inhibitor called Praluent, previou...


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    https://Pharmaceutical.report/news-article.aspx?ID=26682668

    IVASCULAR’S NAVITIAN CORONARY MICROCATHETERS FOR CHRONIC TOTAL OCCLUSIONS CLEARED IN EU

    Feb 26, 2019

    iVascular, a Spanish company that makes catheter-based devices, won the European CE Mark for its new Navigation coronary microcatheter. The device is indicated as support for guidewires, helping to exchange guidewires, and for injection of radiopaque contrast agents, as well as the saline solution. ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26692669

    SENSOR DETECTS SEPSIS BIOMARKER IN LESS THAN THREE MINUTES

    Feb 26, 2019

    Fulminate sepsis is a dangerous condition, usually caused by a bacterial infection. The runaway behavior of the immune system in sepsis is still poorly understood. The trick is to diagnose it early and to use antibiotics to fight it off. These days it can take up to three days to diagnose sepsis, us...


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    https://Pharmaceutical.report/news-article.aspx?ID=26702670

    M&A FLURRY CONTINUES WITH $21BN DANAHER BID FOR GE UNIT

    Feb 26, 2019

    GE Healthcare was supposed to be heading for an initial public offering (IPO) this year, but that looks less likely after a $21.4 billion buyout offer for its biopharma unit from medtech company Danaher. The business, which makes equipment for researching, developing and manufacturing biopharmaceuti...


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    https://Pharmaceutical.report/news-article.aspx?ID=26712671

    NOTABLE LABS BRINGS ON 2 DEVELOPMENT EXECUTIVES AHEAD OF ITS FIRST BLOOD CANCER TRIALS

    Feb 26, 2019

    After launching its first in-house R&D program last month, cancer drug-testing startup Notable Labs has brought on two biopharma executives to take charge of its clinical operations and drug development work. Incyte’s Hiroomi Tada joined as a chief medical officer, while Aquinox’s Ll...


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    https://Pharmaceutical.report/news-article.aspx?ID=26722672

    NOVARTIS PAYS $150M TO LICENSE AKCEA-IONIS CARDIAC DISEASE DRUG

    Feb 25, 2019

    Novartis has taken up its option to license antisense oligonucleotide TQJ230, triggering a $150 million payout that Akcea Therapeutics will share with Ionis Pharmaceuticals. The decision sets Novartis up to test the RNA-targeting drug in phase 3 cardiovascular outcomes trial. TQJ230, formerly known ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26522652

    ROCHE TO BUY GENE THERAPY FIRM SPARK FOR $4.8 BILLION

    Feb 25, 2019

    Roche is to buy gene therapy firm Spark Therapeutics for $4.8 billion, adding an already-approved treatment for inherited blindness to its portfolio, and boosting its pipeline with a series of potential rare disease drugs. The Swiss pharma has reached a deal to buy Spark in an all-cash transaction a...


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    https://Pharmaceutical.report/news-article.aspx?ID=26532653

    DOES VACCINATING AGAINST ROTAVIRUS ALSO PROTECT AGAINST TYPE 1 DIABETES?

    Feb 25, 2019

    The rotavirus vaccine may be pulling double duty; it not only protects young children against a potentially life-threatening rotavirus infection but may also reduce their likelihood of developing type 1 diabetes. A study published in JAMA Pediatrics in late January noted a decrease in the prevalence...


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    https://Pharmaceutical.report/news-article.aspx?ID=26542654

    PRICE HEARING CHEAT SHEET: CEOS PREP FOR GRILLING, HISTORY REPEATS ITSELF AND MORE

    Feb 25, 2019

    The nation's capital is abuzz as Big Pharma CEOs rehearse their testimony for Tuesday's big drug-pricing hearing. What to expect? High political theater, for one thing, as Republicans and Democrats both take their shots. But don't dismiss the event as mere grandstanding, analysts say. Se...


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    https://Pharmaceutical.report/news-article.aspx?ID=26552655

    ABBVIE UPSCALES VOYAGER ALLIANCE WITH NEW TARGET, MORE CASH

    Feb 25, 2019

    AbbVie has extended its collaboration with gene therapy specialist Voyager Therapeutics, adding a new programme in Parkinson’s disease and another $1.5 billion in potential fees. The two started working together on “vectorized” antibodies targeting tau protein for Alzheimer’s...


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    https://Pharmaceutical.report/news-article.aspx?ID=26562656

    DANAHER PLUNKS DOWN $21.4 BILLION TO ACQUIRE GENERAL ELECTRIC’S BIOPHARMA BUSINESS

    Feb 25, 2019

    Shares of General Electric jumped as much as 13 percent in trading this morning after Danaher announced it was acquiring the conglomerate’s biopharma business, GE Biopharma, for $21.4 billion. GE Biopharma includes a wide-range of dealings, including the development and sale of medical instrum...


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    https://Pharmaceutical.report/news-article.aspx?ID=26572657

    FDA DRAFTS ‘LEAPFROG’ GUIDANCE ON BRAIN-COMPUTER INTERFACE TECH

    Feb 25, 2019

    The FDA is hoping to help the industry take a leap toward what was once pure science fiction: interfaces that link brains and computers, allowing a person to directly control devices with their thoughts. To promote the development of a new generation of fully integrated implants, the agency publishe...


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    https://Pharmaceutical.report/news-article.aspx?ID=26582658

    OPIANT’S MID-STAGE TREATMENT FOR A SEVERE EATING DISORDER FAILS TO REACH ENDPOINTS

    Feb 22, 2019

    Shares of Opiant Pharmaceuticals fell in trading Thursday and continue to slide in premarket trading this morning after the company announced its Phase II trial evaluating a naloxone nasal spray for the treatment of bulimia nervosa failed to meet primary endpoints and will discontinue the program. S...


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    https://Pharmaceutical.report/news-article.aspx?ID=26382638

    BAYER PAIRS ITS PRODUCTS IN FIRST-EVER TV AD FOR HORMONE-RELEASING IUDS

    Feb 22, 2019

    Bayer is taking on myths about intrauterine devices (IUDs) in a new two-product ad campaign. The first-ever campaign featuring both the Mirena and Kyleena branded IUDs recently began as Bayer looks to not only explain what the levonorgestrel-releasing IUDs do but also impart basic knowledge about IU...


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    https://Pharmaceutical.report/news-article.aspx?ID=26392639

    HEALTH POLICY ANALYSTS CALL FOR MORE STRINGENT RULES FOR AI MEDICAL APPLICATIONS

    Feb 22, 2019

    A trio of health policy analysts from the University of Pennsylvania and the University of California has published a Policy Forum piece in the journal Science calling for more stringent rules for the introduction of AI medical applications. In their paper, Ravi Parikh, Ziad Obermeyer and Amol Navat...


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    https://Pharmaceutical.report/news-article.aspx?ID=26402640

    ABBVIE’S CANCER DRUG VENCLEXTA BLOCKS DIABETES IN MICE BY TARGETING BETA CELL ‘SENESCENCE’

    Feb 22, 2019

    Diabetes researchers have long believed that the disease starts when the immune system attacks insulin-producing beta cells in the pancreas. But that theory never made much sense to Anil Bhushan, Ph.D., a professor at the University of California, San Francisco, Diabetes Center. So he and a team of ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26412641

    PORTABLE, BATTERY POWERED VIRAL DETECTOR TAKES ONLY A DROP OF BLOOD

    Feb 22, 2019

    Performing a lab-quality test for many infectious diseases, particularly viral ones, is difficult in remote regions. Much lab equipment requires some kind of infrastructure, including clean rooms, trained staff, and money. Researchers at Purdue University have developed a device that can perform RNA...


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    https://Pharmaceutical.report/news-article.aspx?ID=26422642

    MENDELIAN GETS £500,000 FOR RARE DISEASE SCREENING TECH

    Feb 22, 2019

    UK health technology startup Mendelian has received a £500,000 grant from a government agency to build products that will help GPs identify patients with rare or hard to diagnose conditions and diseases. Mendelian will use the grant from Innovate UK to get a specialized screening system for ra...


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    https://Pharmaceutical.report/news-article.aspx?ID=26432643

    MARKET ACCESS ROUNDUP: UK HTA SHAKEUPS AS BREXIT FEARS DEEPEN

    Feb 22, 2019

    With a Brexit deal still out of sight, there have been intensified warnings in the UK about potential disruptions to medical supplies that could follow a no-deal scenario. One government minister has said that a no-deal Brexit could disrupt medicines supplies to the UK for at least six months becaus...


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    https://Pharmaceutical.report/news-article.aspx?ID=26442644

    FDA ADVANCES NEW PROPOSED REGULATION TO MAKE SURE THAT SUNSCREENS ARE SAFE AND EFFECTIVE

    Feb 21, 2019

    This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among its provisions, the...


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    https://Pharmaceutical.report/news-article.aspx?ID=26262626

    PATIENTS SWITCH TO LOWER DOSE OF PFIZER’S RA PILL AFTER SAFETY SIGNAL

    Feb 21, 2019

    Pfizer is moving rheumatoid arthritis patients to a lower dose of its blockbuster inflammatory diseases pill Xeljanz in a clinical study after a safety signal emerged in the trial of patients at high risk of cardiovascular events. A Janus kinase inhibitor class drug, Pfizer has produced Xeljanz as a...


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    https://Pharmaceutical.report/news-article.aspx?ID=26272627

    CONGRESSMAN AIMS TO BREAK PHARMA’S INSULIN ‘PRICING MONOPOLY’ BY LEGALIZING CANADIAN IMPORTS

    Feb 21, 2019

    U.S. legislators have been introducing bills left and right proposing a variety of methods for bringing down drug prices. Now, Vermont's congressman is zeroing in on a specific class of diabetes medicines that he says have become far too expensive: insulin. Rep. Peter Welch introduced a bill on ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26282628

    NEXUS PHARMACEUTICALS RECEIVES FDA APPROVAL FOR PROCHLORPERAZINE EDISYLATE INJECTION, USP

    Feb 21, 2019

    Nexus Pharmaceuticals, Inc. announced today it has received U.S. Food and Drug Administration (FDA) approval for Prochlorperazine Edisylate Injection, USP in 10mg/2mL vial. “The launch further expands our generic injectable portfolio but more importantly, it shows our commitment to meeting the...


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    https://Pharmaceutical.report/news-article.aspx?ID=26292629

    VICAL SLASHES STAFF AFTER CULLING PHASE II ANTIFUNGAL

    Feb 21, 2019

    US biotech Vical is planning another round of job cuts after deciding to abandon its antifungal drug VL-2397, its last remaining clinical-stage asset. The San Diego company only started the phase II trial of VL-2397 last year but says a slow uptake of patients into the trial, coupled with a need to ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26302630

    MERCK’S KEYTRUDA FAILS IN LATE-STAGE HCC TRIAL

    Feb 20, 2019

    Merck’s vaunted PD-1 inhibitor Keytruda took a stumble in a late-stage trial as a treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy. In the pivotal Phase, III KEYNOTE-240 trial, Keytruda plus best supportive care failed to hit ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26162616

    RESEARCH SHOWS MANY PATIENTS WERE IMPROPERLY PRESCRIBED FENTANYL

    Feb 20, 2019

    Fentanyl is a powerful form of opioid given to patients who are suffering from severe pain. The medication is about 100 times more powerful than morphine. A new study shows that a large number of patients who should not have received something so powerful were still prescribed the drug. Researchers ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26172617

    ABBVIE’S JAK INHIBITOR UPADACITINIB GETS PRIORITY REVIEW

    Feb 20, 2019

    AbbVie’s attempts to diversify beyond Humira have been boosted as its investigational drug upadacitinib has been granted Priority Review by the FDA for moderate to severe rheumatoid arthritis (RA). Trial data has suggested that upadacitinib, a JAK1-selective inhibitor, is more effective at tre...


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    https://Pharmaceutical.report/news-article.aspx?ID=26182618

    FDA CRACKS DOWN ON UNAUTHORIZED USE OF PLASMA TREATMENTS FOR AGING, OTHER ILLNESSES

    Feb 20, 2019

    In the seventeenth century, Hungarian Countess Elizabeth Bathory bathed in the blood of young women she murdered in order to sustain her beauty. Blood, albeit more freely given, continues to be an attractive tool for some who want to stave off the effects of age. Individuals have been using plasma i...


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    https://Pharmaceutical.report/news-article.aspx?ID=26192619

    KEYTRUDA GETS OKAY FROM FDA FOR ADJUVANT MELANOMA

    Feb 20, 2019

    The US FDA has approved Merck & Co’s Keytruda as an adjuvant treatment for patients with melanoma who have had surgery but still show some evidence of cancer in their lymph nodes. It’s the first time that PD-1 inhibitor Keytruda (pembrolizumab) has been approved in the US for adjuvan...


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    https://Pharmaceutical.report/news-article.aspx?ID=26202620

    INTERCEPT PHARMA IS ONE STEP CLOSER TO FILING FOR APPROVAL OF FIRST NASH TREATMENT

    Feb 19, 2019

    Shares of Intercept Pharmaceuticals have exploded this morning after the company announced positive news from its Phase III nonalcoholic steatohepatitis (NASH) trial. The stock has shot up more than 20 percent in premarket trading to $133 per share as investors see the potential for the first approv...


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    https://Pharmaceutical.report/news-article.aspx?ID=26072607

    CIPLA TAPS WELLTHY FOR DIGITAL THERAPEUTICS EXPERTISE

    Feb 19, 2019

    Indian pharma company Cipla has made another play in the digital medicine category by taking a near-12% stake in start-up Wellthy Therapeutics. Under the terms of their agreement Wellthy and Cipla – which is India’s third-biggest pharma company – will work together on combined drug...


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    https://Pharmaceutical.report/news-article.aspx?ID=26082608

    TAPEWORM DRUG COULD BE AN EFFECTIVE TREATMENT FOR CERTAIN CANCERS

    Feb 19, 2019

    Could a drug used to treat tapeworms be effective at treating a type of cancer? Researchers in Singapore think they are on the right track in demonstrating just that. Scientists from A*STAR’s Institute of Molecular and Cell Biology (IMCB) recently discovered that the use of niclosamide, which ...


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    https://Pharmaceutical.report/news-article.aspx?ID=26092609

    INVENTIVA DISCONTINUES SYSTEMIC SCLEROSIS DRUG AFTER MID-STAGE FLOP

    Feb 19, 2019

    Shares of France-based Inventiva have plunged more than 45 percent after the company reported that its experimental treatment for a rare autoimmune disease failed to hit primary and secondary endpoints in a mid-stage trial. Inventiva said its FASST (For A Systemic Sclerosis Treatment) clinical trial...


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    https://Pharmaceutical.report/news-article.aspx?ID=26102610

    KEYTRUDA COMBO SET TO BECOME “STANDARD OF CARE” IN KIDNEY CANCER

    Feb 18, 2019

    Analysts are predicting that a combination of Merck’s Keytruda and Pfizer’s Inlyta will become the standard of care in renal cell carcinoma (RCC) thanks to impressive trial results and a price advantage over BMS’ rival drug. The combination of anti-PD-1 therapy Keytruda with tyrosi...


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    https://Pharmaceutical.report/news-article.aspx?ID=25992599

    CHOLESTEROL CAN BE A PROBLEM FOR SOME CANCER CELLS, RESEARCHERS REVEAL

    Feb 18, 2019

    For millions of people across the globe, cholesterol has become a significant health issue. It also turns out that cholesterol can be a problem for some cancer cells. New research coming from Rockefeller University reveals that a rare tumor type is unable to synthesize cholesterol, which is somethin...


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    https://Pharmaceutical.report/news-article.aspx?ID=26002600

    TRIAL COULD UNLOCK NEW PROSTATE CANCER SALES FOR PFIZER/ASTELLAS’ XTANDI

    Feb 18, 2019

    Pfizer and Astellas’ Xtandi has shown it is effective in men with prostate cancer that has spread but has not yet become hormone resistant, stepping up pressure on rival therapy Zytiga from Johnson & Johnson. The results of the ARCHES trial show that giving androgen receptor antagonist Xta...


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    https://Pharmaceutical.report/news-article.aspx?ID=26012601

    MAPPING BRAIN CIRCUITS IN NEWBORNS MAY AID EARLY DETECTION OF AUTISM

    Feb 18, 2019

    A new map of newborn babies' brains offers details of structure that will provide a new reference for researchers studying both typical brain development and neurological disorders. Using noninvasive, 20-minute magnetic resonance imaging (MRI) scans, researchers have revealed some of the complex...


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    https://Pharmaceutical.report/news-article.aspx?ID=26022602

    LUNDBECK AND OTSUKA'S ANTIPSYCHOTIC DRUG REXULTI FAILS TWO BIPOLAR PHASE III TRIALS

    Feb 15, 2019

    Denmark’s H. Lundbeck A/S and Japan’s Otsuka Pharmaceutical announced that their brexpiprazole failed to meet its primary endpoint in two Phase III clinical trials to treat manic episodes in patients with bipolar I disorder. The drug was approved by the U.S. Food and Drug Administration ...


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    https://Pharmaceutical.report/news-article.aspx?ID=25912591

    PRICE CUT UNLOCKS NICE NOD FOR PERJETA IN POST-SURGERY BREAST CANCER

    Feb 15, 2019

    Roche has finally won NICE backing for the use of Perjeta (pertuzumab) to prevent early-stage HER2-positive breast cancer from recurring after surgery, at the third attempt. The new draft guidance means that the HER2 inhibitor can be given as an adjuvant therapy to people with early-stage HER2-posit...


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    https://Pharmaceutical.report/news-article.aspx?ID=25922592

    WHO PLANS TO DEVELOP OVERSIGHT STANDARDS FOR GENE EDITING FOLLOWING CHINESE RESEARCHER’S EXPERIMENT

    Feb 15, 2019

    Following international concern and outrage over a gene-editing treatment of human embryos in China, the World Health Organization (WHO) is taking action. On Thursday, WHO announced it was assembling a panel of experts to form an advisory committee to develop global standards for the governance and ...


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    https://Pharmaceutical.report/news-article.aspx?ID=25932593

    STATINS COULD PROTECT AGAINST MOTOR NEURONE DISEASE, SCIENTISTS SUGGEST

    Feb 15, 2019

    High cholesterol could be a risk factor in the development of motor neuron disease, according to a study of genetic data by UK scientists. A team led by the Queen Mary University of London, in collaboration with the National Institutes of Health in the US, said that cholesterol-lowering drugs such a...


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    https://Pharmaceutical.report/news-article.aspx?ID=25942594

    BIOGEN FACES MULTIBILLION-DOLLAR TECFIDERA LOSS IF MYLAN WINS LATEST PATENT THREAT

    Feb 07, 2019

    Cash cow Tecfidera has been pumping out blockbuster sales as Biogen plows ahead with pricey Alzheimer's trials and scouts for new pipeline assets. But what if those sales took a big hit early next year, instead of eight years later? That's the threat from a Mylan challenge at the U.S. Patent...


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    https://Pharmaceutical.report/news-article.aspx?ID=25832583

    HIBERCELL LAUNCHES WITH $60.75 MILLION SERIES A TO TARGET DORMANT METASTATIC CANCER CELLS

    Feb 07, 2019

    HiberCell, based in New York City, launched with a $60.75 million Series A funding. The funding was led by ARCH Venture Partners. Additional investors included Hillhouse Capital, 6 Dimensions Capital, Celgene Corporation, the NYC Life Sciences Fund, and other undisclosed investors. HiberCell focuses...


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    https://Pharmaceutical.report/news-article.aspx?ID=25842584

    AN ORAL INSULIN DELIVERY SYSTEM INSPIRED BY TORTOISES

    Feb 07, 2019

    Despite nearly a century of research, researchers have so far failed to develop an oral form of insulin that would allow patients with diabetes to avoid multiple daily injections. Now researchers from the Massachusetts Institute of Technology, Brigham and Women’s Hospital, and Novo Nordisk say...


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    https://Pharmaceutical.report/news-article.aspx?ID=25852585

    FDA PUBLISHES PREMARKET GUIDANCE ON COMBINATION PRODUCTS

    Feb 07, 2019

    The FDA has published new premarket guidance on efficient development and review of combination products, which often combine drugs or biologic medicines with a device. In a statement, the FDA referred to the technologies such as digital pills from Proteus Digital Health, which track when patients t...


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    https://Pharmaceutical.report/news-article.aspx?ID=25862586

    GSK CUTS SIX RESPIRATORY ASSETS AS IT CONTINUES TO FOCUS ON ONCOLOGY TREATMENTS

    Feb 06, 2019

    GlaxoSmithKline has been in the midst of a significant reshaping to focus on pharmaceuticals, particularly a renewed interest in oncology treatments. As a result, the company has made some cuts to its pipeline, including six quietly announced this morning in the company’s year-end report.

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    https://Pharmaceutical.report/news-article.aspx?ID=25752575

    CALL FOR BETTER REGULATION OF AI-BASED MEDICAL PRODUCTS

    Feb 06, 2019

    Products based on artificial intelligence should be regulated like drugs, and those that are deemed unsafe should be removed from the market, according to a new report. The report commissioned by NHS Digital noted that AI-based products are likely to fall under the remit of the UK’s regulator,...


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    https://Pharmaceutical.report/news-article.aspx?ID=25762576

    AMPROLOGIX SECURES FUNDING TO DEVELOP NEW ANTIBIOTIC WITH INGENZA

    Feb 06, 2019

    Ingenza is pleased to announce that University of Plymouth spin-out Amprologix, in which it has a stake, has been awarded a £1.2 million contract from the UK Department of Health and Social Care to accelerate the development and scale up its lead antibiotic candidate, Epidermicin NI01. The fun...


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    https://Pharmaceutical.report/news-article.aspx?ID=25772577

    TAKEDA ORDERED TO PAY BAYER $155M FOR HEMOPHILIA PATENT INFRINGEMENT

    Feb 06, 2019

    It may not be what Takeda bargained for with its massive Shire buyout, but early into its ownership of the rare disease specialist, a jury ordered the Japanese drugmaker to pay hemophilia rival Bayer $155 million for patent infringement. The case dates back to a December 2016 lawsuit Bayer filed aga...


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    https://Pharmaceutical.report/news-article.aspx?ID=25782578

    ROCHE SEEKS KADCYLA BOOST TO FEND OFF HERCEPTIN BIOSIMILARS

    Feb 05, 2019

    As biosimilar competition to Herceptin ramps up, Roche is looking to bolster its position in HER2-positive breast cancer with a new indication for Kadcyla. The Swiss pharma firm has announced that it has submitted a supplemental Biologics License Application to the US FDA that could broaden the drug...


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    https://Pharmaceutical.report/news-article.aspx?ID=25662566

    ALLERGAN TRIES TO BLUNT IMPACT OF BOTOX COMPETITOR WITH COMPLAINT OF PILFERED MANUFACTURING SECRETS

    Feb 05, 2019

    It may not be a trend as yet, but for the second time recently, drugmakers have tried to put the kibosh on a competitor’s launch by alleging their product was made using stolen manufacturing secrets. The most recent is a complaint filed Jan. 30 by Allergan and its Botox partner Medytox against...


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    https://Pharmaceutical.report/news-article.aspx?ID=25672567

    IN-HOUSE DEVELOPED MULTIPLE MYELOMA DRUG LEADS THE WAY FOR SANOFI

    Feb 05, 2019

    Paris-based Sanofi announced positive results from its pivotal Phase III trial of isatuximab in patients with relapsed/refractory multiple myeloma. The drug, in combination with Celgene’s Pomalyst/Imnovid (pomalidomide) and low-dose dexamethasone, met the primary endpoint of prolonging progres...


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    https://Pharmaceutical.report/news-article.aspx?ID=25682568

    LESS ANESTHESIA DURING SURGERY DOESN'T PREVENT POST-OP DELIRIUM

    Feb 05, 2019

    Many older adults who have major surgery experience postoperative delirium in the days after their operations. Previous research has suggested that closely monitoring the brain during surgery and making adjustments to protect the brain from too much anesthesia could reduce the risk of postoperative ...


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    https://Pharmaceutical.report/news-article.aspx?ID=25692569

    DRUG TARGET IDENTIFIED FOR CHEMOTHERAPY-RESISTANT OVARIAN, BREAST CANCER

    Feb 04, 2019

    People who inherit a faulty copy of the so-called "breast cancer genes" BRCA1 and BRCA2 are at high risk of cancer. About 10 percent of breast cancer cases and 15 percent of ovarian cancers can be traced back to a flaw in one of these genes. A class of drugs known as PARP inhibitors was de...


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    https://Pharmaceutical.report/news-article.aspx?ID=25572557

    TEVA’S MIGRAINE DRUG AJOVY LOOKS SET FOR EU APPROVAL

    Feb 04, 2019

    Teva’s migraine drug Ajovy (fremanezumab) has moved closer to the EU market after the influential CHMP regulatory committee gave it the green light. The decision paves the way for European approval, which usually follows a positive opinion from the CHMP within a few months. Ajovy is one of a g...


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    https://Pharmaceutical.report/news-article.aspx?ID=25582558

    INSIGHT INTO PROTEIN FORMATION COULD AID UNDERSTANDING OF DISEASES

    Feb 04, 2019

    Scientists have shed light on a biological process that helps the production of healthy cells, which may aid the understanding of neurological diseases and other conditions. Researchers examined a housekeeping mechanism which removes faulty proteins as they form. This process, which is common to man...


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    https://Pharmaceutical.report/news-article.aspx?ID=25592559

    FUNCTIONAL INSULIN-PRODUCING CELLS GROWN IN LAB

    Feb 04, 2019

    UC San Francisco researchers have for the first time transformed human stem cells into mature insulin-producing cells, a major breakthrough in the effort to develop a cure for type 1 (T1) diabetes. Replacing these cells, which are lost in patients with T1 diabetes, has long been a dream of regenerat...


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    https://Pharmaceutical.report/news-article.aspx?ID=25602560

    NOVO ACCELERATES LAUNCH PLANS FOR ORAL SEMAGLUTIDE

    Feb 01, 2019

    Novo Nordisk has said it is accelerating launch preparations for its new diabetes pill semaglutide, after investing in a voucher that will allow a fast review of the drug in the US. The FDA grants priority reviews for drugs that it considers to be a significant improvement over available therapies f...


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    https://Pharmaceutical.report/news-article.aspx?ID=25492549

    HHS SECRETARY AZAR FLOATS PLAN TO LOWER PRESCRIPTION DRUG COSTS

    Feb 01, 2019

    As lawmakers in Congress are exploring potential price-lowering options for prescription drugs, Department of Health and Human Services Secretary Alex Azar is floating a proposed rule to lower the prices and out-of-pocket expenses by encouraging manufacturers to pass discounts to patients instead of...


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    https://Pharmaceutical.report/news-article.aspx?ID=25502550

    A DEEPER LOOK AT DRUG SHORTAGES IN THE U.S.

    Feb 01, 2019

    Drug shortages can occur for a number of reasons. The Pharmaceutical Research and Manufacturers of America (PhRMA) lists the most common as changes in clinical practices, inventory practices of wholesalers and pharmacies, raw material shortages, changes in hospital and pharmacy contractual relations...


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    https://Pharmaceutical.report/news-article.aspx?ID=25512551

    BD UNVEILS NANO PEN NEEDLE FOR ACCURATE SUBCUTANEOUS INSULIN INJECTIONS

    Jan 31, 2019

    BD is releasing its new Nano pen needle designed for achieving consistent depth during subcutaneous injections, particularly for diabetic patients on insulin. Intramuscular injections can occur when a patient applies too much force too many of the existing injection devices. The new BD Nano compensa...


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    https://Pharmaceutical.report/news-article.aspx?ID=25392539

    SYLENTIS' DRY EYE DRUG MISSES PRIMARY GOALS IN PHASE 3

    Jan 31, 2019

    A phase 3 trial of Sylentis’ dry eye disease candidate tivanisiran has missed (PDF) its primary endpoints. The PharmaMar subsidiary failed to link the siRNA eye drops to improved scores on scales of ocular pain and corneal staining compared to artificial tears. Sylentis advanced tivanisiran in...


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    https://Pharmaceutical.report/news-article.aspx?ID=25402540

    ADURO CUTS 37% OF EMPLOYEES AS IT REFOCUSES ON CANCER PIPELINE

    Jan 31, 2019

    Aduro Biotech has hit the reset button, laying off about 37% of its workforce to throw all of its resources behind a handful of lead programs: assets that target the STING and APRIL pathways for the treatment of cancer. “Over the years, Aduro has demonstrated a proven track record in the disco...


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    https://Pharmaceutical.report/news-article.aspx?ID=25412541

    ON HEELS OF DRUG PRICING HEARINGS, DEMOCRATIC LAWMAKERS KICK OFF INSULIN PROBE

    Jan 31, 2019

    Sanofi, Novo Nordisk, and Eli Lilly have faced years of scrutiny over insulin prices, but their responses haven't satisfied two Democratic lawmakers who this week kicked off a fresh investigation into pricing for the products. The probe comes as drug pricing creates daily headlines in Washington...


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    https://Pharmaceutical.report/news-article.aspx?ID=25422542

    ALLERGAN ABANDONS WOMEN’S HEALTH SALE PLAN AS PROFIT SLUMPS

    Jan 30, 2019

    Shares in Allergan fell after the company said it had swung to a loss in the last quarter of 2018 and forecast 2019 revenues below analyst expectations. The Ireland-headquartered specialty drugmaker, best known for its Botox wrinkle treatment, reported a loss of $4.3 billion that reversed a profit o...


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    https://Pharmaceutical.report/news-article.aspx?ID=25302530

    READY FOR BOTOX, MILLENNIALS? ALLERGAN HAS LAUNCHED ITS FIRST CAMPAIGN TARGETING YOU

    Jan 30, 2019

    Allergan’s latest target for Botox Cosmetic is millennials. If there's any doubt, just look at the crowd of 20-somethings in its newly launched TV ad: Young people exaggerate their facial expressions surprised, embarrassed or laughing with no noticeable frown lines or forehead wrinkles. Th...


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    https://Pharmaceutical.report/news-article.aspx?ID=25312531

    SENATE FINANCE COMMITTEE AND HOUSE OVERSIGHT COMMITTEE TAKE AIM AT DRUG PRICING

    Jan 30, 2019

    The U.S. Senate Finance Committee and the House Oversight Committee started hearings on Tuesday, January 29, focused on dealing with high drug prices. In the Finance Committee hearing, chair of the committee, Sen. Chuck Grassley, (R-IA), began by saying tackling high prescription drug prices was a p...


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    https://Pharmaceutical.report/news-article.aspx?ID=25322532

    IS BIOGEN’S ADUCANUMAB FOR ALZHEIMER’S THE HOLY GRAIL OR COLD FUSION?

    Jan 30, 2019

    Whenever a drug fails an Alzheimer’s clinical trial, analysts, investors, and industry watchers immediately turn to look at Biogen. Will the company’s aducanumab be the one? Will it be the drug that will actually break the string of more than 150 drug failures? Today, Roche announced tha...


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    https://Pharmaceutical.report/news-article.aspx?ID=25332533

    GATES FOUNDATION, GILEAD AND OTHERS DROP $55 MILLION ON SERIES B FOR LYNDRA THERAPEUTICS

    Jan 29, 2019

    Lyndra Therapeutics, based in Watertown, Mass., announced the closing of a Series B financing round worth $55 million. All original investors from the $23 million Series A round led by Polaris Partners were involved. New investors include HOPU Investments, Gilead Sciences, Invus, the Bill & Meli...


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    https://Pharmaceutical.report/news-article.aspx?ID=25202520

    CELGENE STRIKES DEAL WORTH NEARLY $1 BILLION FOR BLOOD CANCER TREATMENT

    Jan 29, 2019

    Celgene has struck another collaborative deal, even as the large pharmaceutical company is in the process of being folded into the operations of its new owner, Bristol-Myers Squibb. This morning, privately-owned drug developer Triphase Accelerator, along with its majority shareholder FACIT, announce...


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    https://Pharmaceutical.report/news-article.aspx?ID=25212521

    TAKEDA'S PHASE III DENGUE VACCINE RESULTS BRING THEM "ONE STEP CLOSER" TO STOPPING TROPICAL DISEASE

    Jan 29, 2019

    Takeda Pharmaceutical announced that its vaccine for dengue fever hit its primary efficacy endpoint in its Phase III clinical trial. Dengue fever affects as many as 400 million people annually, according to the U.S. Centers for Disease Control and Prevention (CDC). It is caused by one of four relate...


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    https://Pharmaceutical.report/news-article.aspx?ID=25222522

    ABBVIE AND J&J CLAIM NEW IMBRUVICA OKAY IN US

    Jan 29, 2019

    AbbVie and Johnson & Johnson’s Imbruvica has become the first chemo-free treatment for first-line chronic lymphocytic leukemia (CLL) to be approved by the FDA, its tenth indication. The green light from the US regulator is for a regimen based on BTK inhibitor Imbruvica (ibrutinib) and Roch...


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    https://Pharmaceutical.report/news-article.aspx?ID=25232523

    ABBVIE AND J&J CLAIM NEW IMBRUVICA OKAY IN US

    Jan 29, 2019

    AbbVie and Johnson & Johnson’s Imbruvica has become the first chemo-free treatment for first-line chronic lymphocytic leukemia (CLL) to be approved by the FDA, its tenth indication. The green light from the US regulator is for a regimen based on BTK inhibitor Imbruvica (ibrutinib) and Roch...


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    https://Pharmaceutical.report/news-article.aspx?ID=25242524

    FDA GIVES GREENLIGHT TO JANSSEN AND ABBVIE'S IMBRUVICA FOR THE 10TH TIME

    Jan 28, 2019

    Leukemia drug Imbruvica snagged another approval from the U.S. Food and Drug Administration (FDA). The regulatory agency gave the green light for Imbruvica combined with Gazyva for adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma. The approval of the c...


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    https://Pharmaceutical.report/news-article.aspx?ID=25112511

    NO NEW PATIENTS SHOULD TAKE LILLY’S CANCER DRUG LARTRUVO, SAY REGULATORS

    Jan 28, 2019

    Regulators on both sides of the Atlantic have ruled that no new patients should start treatment with Eli Lilly’s Lartruvo (olaratumab) for soft tissue sarcoma, after a study that was supposed to confirm its efficacy failed. Late last week the FDA joined the European Medicines Agency by ruling ...


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    https://Pharmaceutical.report/news-article.aspx?ID=25122512

    ALEXION'S ULTRA-RARE KIDNEY DISEASE DRUG PASSES PHASE III WITH FLYING COLORS

    Jan 28, 2019

    Boston-based Alexion’s Ultomiris (ravulizumab-cwvz) hit its primary objective in its Phase III study of complement inhibitor-naïve patients with the atypical hemolytic uremic syndrome (aHUS). aHUS is a chronic, progressive and debilitating ultra-rare disease. It affects children and adult...


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    https://Pharmaceutical.report/news-article.aspx?ID=25132513

    PFIZER’S CANCER PORTFOLIO EXPECTED TO RAKE IN $8.3 BILLION IN 2019

    Jan 28, 2019

    Pfizer is a big company with a diverse portfolio, but it hasn’t really been noted for its presence in the oncology market. The majority of its successful drugs are in primary care and heart medicine, like Lipitor (atorvastatin) for cholesterol, Lyrica (pregabalin) for neuropathic pain and fibr...


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    https://Pharmaceutical.report/news-article.aspx?ID=25142514

    OPTIMAL-G PRO ROBOTIC GAIT REHAB SYSTEM UNVEILED

    Jan 24, 2019

    Motorika, a company out of Mount Laurel, New Jersey, is introducing its Optimal-G Pro robotic walking rehabilitation system at the  American Physical Therapy Association’s Combined Sessions Meeting this week in Washington DC. The device helps to train the walking gait of people who have s...


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    https://Pharmaceutical.report/news-article.aspx?ID=25032503

    UEXPLORER WHOLE BODY PET-CT CLEARED BY FDA FOR CLINICAL AND RESEARCH USE

    Jan 24, 2019

    United Imaging Healthcare, a company out of Shanghai, China, won FDA clearance for its uEXPLORER combined Positron Emission Tomography (PET) and Computed Tomography (CT) scanner. The device can perform whole-body scans using both imaging modalities at the same time. The system is expected to be used...


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    https://Pharmaceutical.report/news-article.aspx?ID=25042504

    FDA APPROVES CONSUMER COLORECTAL CANCER TEST

    Jan 24, 2019

    The FDA will allow consumer DNA testing company 23andMe to give customers reports on their risk of hereditary colorectal cancer. The California-based company, which allows customers to test their own DNA via mail, will now be able to tell its users whether they have the two most common genetic varia...


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    https://Pharmaceutical.report/news-article.aspx?ID=25052505

    NICE BACKS DIGITAL CBT FOR YOUNGSTERS WITH DEPRESSION

    Jan 23, 2019

    NICE has recommended digital cognitive behavioural therapy (CBT) should be used as a first-line treatment for children and young people with mild depression. The draft guideline is an overarching document that paves the way for more use of this technology and is part of NICE’s drive to encoura...


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    https://Pharmaceutical.report/news-article.aspx?ID=24962496

    FDA PUTS TRANSLATE BIO’S RARE DISEASE MRNA DRUG ON HOLD

    Jan 23, 2019

    The FDA has placed a clinical hold on the IND for Translate Bio’s mRNA treatment for ornithine transcarbamylase (OTC) deficiency, a genetic disease that causes too much ammonia to build up in the blood. The hold comes just nine months after the agency lifted a clinical hold on a different prog...


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    https://Pharmaceutical.report/news-article.aspx?ID=24972497

    NEW REPORT SHOWS PRICE OF INSULIN DOUBLED FROM 2012 TO 2016

    Jan 23, 2019

    In October, Minnesota Attorney General Lori Swanson filed a lawsuit against three of the biggest insulin manufacturers over price gouging claims. In the lawsuit, Swanson said Eli Lilly, Sanofi and Novo Nordisk “deceptively raise the list price of insulin” and that the hikes have made the...


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    https://Pharmaceutical.report/news-article.aspx?ID=24982498

    VERTEX’S CF DRUG GETS LABEL EXTENSION AS PRICING ROW CONTINUES

    Jan 23, 2019

    While UK cystic fibrosis patients continue their long wait for access to Vertex’s Orkambi, the drug has received a label extension from the European Commission allowing it to be used in younger children. The Commission has approved the drug for the treatment of children with cystic fibrosis (C...


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    https://Pharmaceutical.report/news-article.aspx?ID=24992499

    FDA SLAPS CLINICAL HOLD ON TRANSLATE BIO’S MRNA THERAPY FOR RARE LIVER DISEASE

    Jan 22, 2019

    Translate Bio had been hoping that it would initiate clinical trials for its rare liver disease treatment asset MRT5201 this year. However, that hope has been delayed after the U.S. Food and Drug Administration (FDA) placed a hold on the trial. This morning, Lexington, Mass.-based Translate Bio anno...


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    https://Pharmaceutical.report/news-article.aspx?ID=24872487

    A BLOOD TEST THAT CAN ID ALZHEIMER'S RISK UP TO 16 YEARS BEFORE SYMPTOMS

    Jan 22, 2019

    As researchers struggle to find a treatment for Alzheimer’s disease, the field struggles with the difficulties of early diagnosis. There are a number of biomarkers identified that show a tendency toward the disease, such as ApoE, but not definitive tests. Researchers with the German Center for...


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    https://Pharmaceutical.report/news-article.aspx?ID=24882488

    NOVO HOLDINGS INVESTS IN THREE MORE AMR BIOTECHS

    Jan 22, 2019

    Novo Holdings’ REPAIR Impact Fund, which helps fund companies tackling antimicrobial resistance (AMR), has announced three new investments. The first beneficiary is AstraZeneca spin-off Entasis Therapeutics, whose programmes include a new class of non-β-lactam PBP inhibitors (NBP) targeti...


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    https://Pharmaceutical.report/news-article.aspx?ID=24892489

    TAKEDA MULLING SALE OF EMERGING MARKET DRUGS – REPORT

    Jan 22, 2019

    Takeda could be considering selling some emerging-market drugs in a bid to cut debts following its merger with the Shire that completed earlier this month, according to a press report. In order to finance the $62 billion takeovers, Takeda had to take out bank loans of around $31 billion and needs to...


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    https://Pharmaceutical.report/news-article.aspx?ID=24902490

    NEW NANOPARTICLE TARGETS TUMOR-INFILTRATING IMMUNE CELLS, FLIPS SWITCH

    Jan 21, 2019

    Immunotherapy's promise in the fight against cancer drew international attention after two scientists won a Nobel Prize this year for unleashing the ability of the immune system to eliminate tumor cells. But their approach, which keeps cancer cells from shutting off the immune system's power...


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    https://Pharmaceutical.report/news-article.aspx?ID=24772477

    HOW GUT BACTERIA AFFECT THE TREATMENT OF PARKINSON'S DISEASE

    Jan 21, 2019

    Patients with Parkinson's disease are treated with levodopa, which is converted into dopamine, a neurotransmitter in the brain. In a study published on 18 January in the journal Nature Communications, scientists from the University of Groningen show that gut bacteria can metabolize levodopa into...


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    https://Pharmaceutical.report/news-article.aspx?ID=24782478

    NHS FACES UPHILL BATTLE IN PREVENTION – SURVEY

    Jan 21, 2019

    A new survey has revealed confusion amongst the UK public on how to maintain a healthy lifestyle, suggesting the NHS has a long way to go to meet its goal of more disease prevention. The survey, commissioned by Sanofi, reveals that while just over half (52%) of people think they lead a healthy lifes...


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    https://Pharmaceutical.report/news-article.aspx?ID=24792479

    RESEARCH INTO OPIOID PAINKILLERS COULD PROVIDE CLUES FOR SAFER DRUG DEVELOPMENT

    Jan 21, 2019

    Researchers have taken a step closer to understanding the body's response to opioid painkillers such as morphine and fentanyl, which could lead to the development of safer opioid drugs. Opioids are a class of powerful painkillers used to treat moderate to severe pain. They act on the nervous sys...


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    https://Pharmaceutical.report/news-article.aspx?ID=24802480

    RESEARCH INTO OPIOID PAINKILLERS COULD PROVIDE CLUES FOR SAFER DRUG DEVELOPMENT

    Jan 21, 2019

    Researchers have taken a step closer to understanding the body's response to opioid painkillers such as morphine and fentanyl, which could lead to the development of safer opioid drugs. Opioids are a class of powerful painkillers used to treat moderate to severe pain. They act on the nervous sys...


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    https://Pharmaceutical.report/news-article.aspx?ID=24812481

    BRAIN-EATING AMOEBA INFECTIONS ARE RARE, BUT DEADLY—RESEARCH IS WORKING ON A CURE

    Jan 18, 2019

    The rate of incidence of infection by Naegleria fowleri in the U.S. is very, very low. But there’s something about picking up an incurable, brain-eating amoeba by swimming in freshwater lakes and rivers that understandably freaks people out. N. fowleri causes primary amebic meningoencephalitis...


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    https://Pharmaceutical.report/news-article.aspx?ID=24672467

    J&J PARTNERS WITH APPLE FOR ECG MONITORING PROJECT

    Jan 18, 2019

    Apple has a new big pharma partner to help put its new Apple Watch with the built-in electrocardiogram (ECG) through its paces, signing an alliance with Johnson & Johnson. The collaboration centers on seeing if the Apple Watch’s heart rate monitoring ECG functions can be used for earlier d...


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    https://Pharmaceutical.report/news-article.aspx?ID=24682468

    NOVARTIS AND OXFORD UNIVERSITY BEGIN R&D TIE-UP

    Jan 18, 2019

    Novartis and Oxford University have begun a partnership that will attempt to use artificial intelligence to predict how patients will respond to new and existing treatments for inflammatory diseases such as multiple sclerosis (MS) and psoriasis. The Swiss pharma has joined with the university’...


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    https://Pharmaceutical.report/news-article.aspx?ID=24692469

    JANUARY 18 RESEARCH ROUNDUP: SKIN CANCER, TURNING CANCER CELLS INTO FAT CELLS, AND A LONGEVITY TEST

    Jan 18, 2019

    Researchers with American University have identified genetic factors that lead to squamous cell carcinoma, a form of skin cancer. They published their work in the journal Oncogenesis. Squamous cell carcinoma is the second most common form of cancer in the U.S. and has the highest mortality rate of n...


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    https://Pharmaceutical.report/news-article.aspx?ID=24702470

    SUN PHARMA DROPS TO 6-YEAR LOW ON REPORT OF ANOTHER WHISTLEBLOWER COMPLAINT

    Jan 18, 2019

    Just weeks after Sun Pharma’s stock was hit by whistleblower allegations of insider trading, a second complaint reportedly filed to Indian regulators sent the drugmaker’s shares tumbling to a new six-year low. A whistleblower alleged in a 172-page complaint that dubious transactions amou...


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    https://Pharmaceutical.report/news-article.aspx?ID=24712471

    UK RESEARCHERS INVESTIGATE ALTERNATIVES TO LONG-TERM OPIOID USE

    Jan 17, 2019

    A UK university has been awarded £2.4 million to research overprescribing of opioids, and how to improve treatment of patients with persistent pain without long-term use of these morphine-like drugs. The government-backed National Institute of Health Research (NIHR) awarded the money to resear...


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    https://Pharmaceutical.report/news-article.aspx?ID=24582458

    TELEHEALTH FIRM SECURES MORE CASH TO EXPAND IN CHINA, JAPAN AND US

    Jan 17, 2019

    Telehealth firm Tyto Care has secured additional funding to help with the launch of its technology allowing for remote medical examinations. This latest $9 million funding round is an extension of an oversubscribed Series C round last year and brings the total funds raised to $33.5 million. Strategi...


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    https://Pharmaceutical.report/news-article.aspx?ID=24592459

    UNITED NEUROSCIENCE INCHES CLOSER TO ALZHEIMER’S VACCINE PRIZE

    Jan 17, 2019

    A vaccine for Alzheimer’s disease developed by United Neuroscience has cleared a phase IIa trial and seems to be free of the toxicity that has scuppered earlier candidates. To be clear, there’s no solid evidence yet that United’s UB-311 candidate has an impact on cognition and memo...


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    https://Pharmaceutical.report/news-article.aspx?ID=24602460

    FDA COMMITTEE VOTES 18-1 FOR AMGEN'S OSTEOPOROSIS DRUG

    Jan 17, 2019

    The U.S. Food and Drug Administration (FDA)’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 18 to 1 to recommend Amgen and UCB’s Evenity (romosozumab) to treat postmenopausal women with osteoporosis. This follows a 2017 rejection by the agency, requesting more d...


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    https://Pharmaceutical.report/news-article.aspx?ID=24612461

    LILLY’S VERZENIOS APPROVED BY NICE

    Jan 17, 2019

    NICE has published draft guidance that now recommends Eli Lilly’s breast cancer drug Verzenios for use on the NHS. The guidance concludes that Verzenios (abemaciclib) is as effective as its rivals, Pfizer’s Ibrance (palbociclib) and Novartis’ Kisqali (ribociclib), which NICE approv...


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    https://Pharmaceutical.report/news-article.aspx?ID=24622462

    APTINYX’S MID-STAGE NMDA RECEPTOR FAILS TO HIT ENDPOINTS IN NEUROPATHIC PAIN STUDY

    Jan 16, 2019

    Shares of Illinois-based Aptinyx have plunged more than 67 percent in premarket trading after the company announced its mid-stage treatment for painful diabetic peripheral neuropathy failed to show statistical significance. Aptinyx’s NYX-2925 is a novel NMDA receptor, which earned Fast Track d...


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    https://Pharmaceutical.report/news-article.aspx?ID=24492449

    DIFFICULTIES WITH AUDIOVISUAL PROCESSING CONTRIBUTES TO DYSLEXIA IN CHILDREN

    Jan 16, 2019

    A University at Buffalo psychologist has published a neuroimaging study that could help develop tests for early identification of dyslexia, a disorder that affects 80 percent of those diagnosed with difficulties reading, writing and spelling. Tasks which require audiovisual processing are especially...


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    https://Pharmaceutical.report/news-article.aspx?ID=24502450

    MERCK BUMPS KEYTRUDA CREDIBILITY WITH REAL DOCTOR APPEARANCE IN LATEST ‘TRU’ PATIENT ADS

    Jan 16, 2019

    Merck & Co. is changing the game again in oncology ads, this time putting a real doctor to work in its Keytruda patient campaign. The latest additions to the multichannel "It's Tru" work include two TV ads, one with oncologist Goetz Kloecker, M.D., alone and a second where he appea...


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    https://Pharmaceutical.report/news-article.aspx?ID=24512451

    OXYCONTIN MAKER SOUGHT 'BLIZZARD OF PRESCRIPTIONS’, COURT DOCUMENTS SHOW

    Jan 16, 2019

    The notorious legacy of OxyContin continues to be a major black mark against Purdue Pharma. And that mark is only getting worse as a court case against the opioid manufacturer has revealed company officials used deceptive marketing practices to boost sales of the drug. Documents in a Massachusetts c...


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    https://Pharmaceutical.report/news-article.aspx?ID=24522452

    PFIZER SET FOR JULY FDA VERDICT ON RARE HEART DISEASE DRUG

    Jan 15, 2019

    Pfizer is finally closing on approval of its rare disease therapy tafamidis in the US, several years after it first reached the market in Europe. The FDA has accepted two separate marketing applications for the drug – both for cardiomyopathy associated with the rare disease ATTR amyloidosis &n...


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    https://Pharmaceutical.report/news-article.aspx?ID=24392439

    DESPITE GOVERNMENT SHUTDOWN, EXELIXIS SNAGS FDA APPROVAL FOR HCC DRUG CABOMETYX

    Jan 15, 2019

    Shares of Alameda, Calif.-based Exelixis are climbing after the U.S. Food and Drug Administration (FDA) approved its hepatocellular carcinoma (HCC) treatment Cabometyx (cabozantinib). It was previously approved for the treatment of patients with advanced renal cell carcinoma. The approval came despi...


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    https://Pharmaceutical.report/news-article.aspx?ID=24402440

    AHA SAYS PENALTIES AS WELL AS INCENTIVES ARE NEEDED TO FACE DOWN 'PERSISTENT' DRUG SHORTAGES

    Jan 15, 2019

    Persistent drug shortages have become dangerous and costly, the American Hospital Association says, forcing staff to use drugs with which they have less experience and that are sometimes more expensive. Responding to an FDA request for comment, the AHA, which represents 5,000 hospitals and 270,000 p...


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    https://Pharmaceutical.report/news-article.aspx?ID=24412441

    FDA APPROVES RECORD-BREAKING 59 NOVEL DRUGS IN 2018

    Jan 15, 2019

    The past year proved to be a big one for the U.S. Food and Drug Administration (FDA) and the approval of novel drugs. Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s dia...


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    https://Pharmaceutical.report/news-article.aspx?ID=24422442

    AIMMUNE’S PEANUT ALLERGY TREATMENT DELAYED AS GOVERNMENT SHUTDOWN CONTINUES

    Jan 15, 2019

    The partial government shutdown has entered day 24 and the pharma and medtech industry is beginning to feel the impact even more, particularly as the U.S. Food and Drug Administration (FDA) grows more incapable of reviewing some medications for approval. On Monday, California-based Aimmune Therapeut...


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    https://Pharmaceutical.report/news-article.aspx?ID=24432443

    SMARTPHONE APP DETECTS OPIOID OVERDOSE

    Jan 14, 2019

    Researchers at the University of Washington have developed a smartphone app that can detect if someone is experiencing an opioid overdose. The app uses sonar to monitor the breathing rate of a user, which it can do from up to three feet away, to assess if someone is experiencing an overdose. So far,...


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    https://Pharmaceutical.report/news-article.aspx?ID=24292429

    BRAINCARTA MAPS CREATES MAPS FOR BRAIN SURGERIES: CES 2019

    Jan 14, 2019

    Brain surgery is a complicated business, requiring utmost precision when excising tumors and other maladies. BrainCarta, a Dutch firm, is showing off its Elonav technology that uses functional magnetic resonance imaging (fMRI) scans to create maps of lesions and provide helpful analysis about the ne...


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    https://Pharmaceutical.report/news-article.aspx?ID=24302430

    FDA GIVES AMNEAL'S GENERIC ALZHEIMER’S & PARKINSON’S PATCH A THUMBS-UP

    Jan 14, 2019

    The U.S. Food and Drug Administration (FDA) approved Bridgewater, NJ-based Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases. The two companies were involved in pate...


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    https://Pharmaceutical.report/news-article.aspx?ID=24312431

    FOR THE FIRST TIME, WE'RE MORE LIKELY TO DIE FROM ACCIDENTAL OPIOID OVERDOSE THAN MOTOR VEHICLE CRASH

    Jan 14, 2019

    National Safety Council analysis reveals trends that worsen the odds of dying accidentally. For the first time in U.S. history, a person is more likely to die from an accidental opioid overdose than from a motor vehicle crash, according to National Safety Council analysis. The odds of dying accident...


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    https://Pharmaceutical.report/news-article.aspx?ID=24322432

    MORE ACCURATE LEUKEMIA DIAGNOSIS EXPECTED AS RESEARCHERS REFINE LEUKEMIA CLASSIFICATION

    Jan 14, 2019

    Like cartographers completing a map, investigators have identified multiple new subtypes of the most common childhood cancer research that will likely improve the diagnosis and treatment of high-risk patients. St. Jude Children's Research Hospital scientists led the study, which appears as an ad...


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    https://Pharmaceutical.report/news-article.aspx?ID=24332433

    PHARMA FEELS IMPACT OF GOVERNMENT SHUTDOWN AS FDA DRUG REVIEW WORK SLOWS

    Jan 11, 2019

    As the partial government shutdown enters its 21st day, tying it for the longest U.S. shutdown in history, the impact is becoming more and more realized within the pharmaceutical industry. Most noticeably for pharma and biotech, the partial shutdown has brought a halt to some of the operations of th...


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    https://Pharmaceutical.report/news-article.aspx?ID=24192419

    KYOWA HAKKO KIRIN SIGNS AI DRUG R&D DEAL WITH INVENIAI

    Jan 11, 2019

    Artificial intelligence and machine learning company InveniAI has joined with Kyowa Hakko Kirin to harness the power of technology for drug discovery. The companies are the latest to use AI and machine learning to make the drug development process more effective. In this case, Kyowa Hakko Kirin will...


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    https://Pharmaceutical.report/news-article.aspx?ID=24202420

    NEOLEUKIN THERAPEUTICS HOPES TO IMPROVE ON NATURE'S APPROACH TO BATTLING CANCER

    Jan 11, 2019

    One of the key immune regulatory proteins is interleukin 2 (IL-2). It has used in treating cancer and autoimmune disease but has toxic side effects that limit its use. Researchers at the University of Washington Medicine’s Institute for Protein Design recently created a protein that mimics the...


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    https://Pharmaceutical.report/news-article.aspx?ID=24212421

    DOES OPIOID USE IN PETS CREATE HIGHER RISK FOR ABUSE IN HUMANS?

    Jan 11, 2019

    The increase in opioid prescriptions for people over the past decade may have been paralleled by an increase in opioid prescriptions for pets, according to a study from researchers at the University of Pennsylvania's Perelman School of Medicine and the School of Veterinary Medicine. The findings...


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    https://Pharmaceutical.report/news-article.aspx?ID=24222422

    RESEARCHERS ANSWER DECADES-OLD QUESTION ABOUT PROTEIN FOUND IN ALZHEIMER'S BRAIN PLAQUES

    Jan 11, 2019

    Alzheimer's-affected brains are riddled with amyloid plaques, protein aggregates consisting mainly of amyloid-β. However, amyloid-β is a fragment produced from a precursor protein whose normal function has remained enigmatic for decades. A team of scientists at VIB and KU Leuven led by...


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    https://Pharmaceutical.report/news-article.aspx?ID=24232423

    EUSA PHARMA BUYS RIGHTS TO JANSSEN RARE DISEASE DRUG

    Jan 10, 2019

    UK-based EUSA Pharma has bought worldwide rights to Janssen’s rare diseases drug Sylvant (siltuximab) for $115 million. EUSA already markets two oncology drugs and is seeking to build its presence in the rare disease market with Sylvant, which has been approved in the US since 2014 to treat mu...


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    https://Pharmaceutical.report/news-article.aspx?ID=24092409

    NICE REJECTS NOVARTIS’ MIGRAINE PREVENTION DRUG AIMOVIG

    Jan 10, 2019

    Some migraine sufferers in the UK hoping to get access to Novartis’ new migraine prevention drug Aimovig are facing disappointment after NICE rejected it in the draft guidance. The cost-effectiveness watchdog says that it can’t recommend routine NHS use of Aimovig (erenumab) for people s...


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    https://Pharmaceutical.report/news-article.aspx?ID=24102410

    ALZHEIMER’S: NEW APPROACHES AND NEW HOPE

    Jan 10, 2019

    Unfortunately, 2018 marked yet another bad year for Alzheimer’s disease drug development. There were easily half-a-dozen major clinical drug trial failures, leading one analyst to call Alzheimer’s drug development “an unrelenting disaster zone.” These failures included: Taked...


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    https://Pharmaceutical.report/news-article.aspx?ID=24112411

    HRT TABLETS LINKED TO HIGHER BLOOD CLOT RISK: STUDY

    Jan 10, 2019

    Certain types of hormone replacement therapy (HRT) could lead to an increased risk of venous thromboembolism (VTE), a new study has suggested. HRT is used to prevent a range of symptoms experienced by many women during the menopause, such as hot flushes and night sweats. The study, by researchers fr...


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    https://Pharmaceutical.report/news-article.aspx?ID=24122412

    NOVARTIS DEFENDS ITSELF AGAINST KICKBACK ALLEGATIONS FROM FORMER EMPLOYEE

    Jan 10, 2019

    Swiss pharma giant Novartis has found itself at the center of a legal battle that could determine if the company engaged in a research project that was a kickback in disguise. Former Novartis executive Min Amy Guo has alleged that in 2012, the company initiated a study of breast cancer drug Afinitor...


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    https://Pharmaceutical.report/news-article.aspx?ID=24132413

    GREEN ALTERNATIVE FOR DRUG PRODUCTION

    Jan 09, 2019

    For the production of drugs, pesticides, and smartphone displays, most of the processes are cost-intensive and generate a large amount of waste. Scientists at the University of Göttingen have now succeeded in developing a resource-saving "green" alternative. The results were published...


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    https://Pharmaceutical.report/news-article.aspx?ID=23992399

    UNDERSTANDING INFECTIOUS DISEASE BY STUDYING BACTERIAL IMMUNITY

    Jan 09, 2019

    Patients with cystic fibrosis are often infected by Pseudomonas aeruginosa, a bacterium that infects the lungs and prevents breathing, often causing death. P. aeruginosa itself can also be infected by viruses, which can affect the clinical outcomes of cystic fibrosis patients. “Just like human...


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    https://Pharmaceutical.report/news-article.aspx?ID=24002400

    NEAR INFRARED FOOD SHELF LIFE SCANNER

    Jan 09, 2019

    Spoiled food is a global problem and people end up sick all the time. Modern methods of detecting spoiled food include smelling it, looking for moldy spots, and arguing with your spouse whether a given item is ready to be thrown in the trash. Researchers at Fraunhofer Institute for Optronics, System...


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    https://Pharmaceutical.report/news-article.aspx?ID=24012401

    NOVARTIS’ SICKLE CELL DRUG GETS BREAKTHROUGH THERAPY DESIGNATION

    Jan 09, 2019

    The FDA has granted Breakthrough Therapy designation to Novartis’ crizanlizumab for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease. Also known as sickle cell pain crises, VOCs are unpredictable and extremely painful events that can lead to ...


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    https://Pharmaceutical.report/news-article.aspx?ID=24022402

    TAKEDA’S SHIRE TAKEOVER COULD HERALD NEW ERA OF PHARMA M&A

    Jan 09, 2019

    Takeda has officially taken over the Shire in a deal that could re-establish the trend for mega-mergers in big pharma. The merger was approved yesterday in a court hearing in Jersey, where the Shire was officially based, although it was listed on the London Stock Exchange and domiciled in Ireland fo...


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    https://Pharmaceutical.report/news-article.aspx?ID=24032403

    IT’S A WRAP! TAKEDA-SHIRE MERGER IS A DONE DEAL, MAKING TAKEDA THE LARGEST MASS. BIOTECH EMPLOYER

    Jan 08, 2019

    Last year’s sole mega-deal, the acquisition of Dublin-based Shire by Japan-based Takeda Pharmaceutical is finally closed. Takeda, 237 years old, is now a top 10 international drug company. The entire deal began in March 2018, with Takeda expressing an interest in buying the Shire. Once it was ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23892389

    NOVARTIS TALKS MOVE TO CELL AND GENE THERAPIES AT JPM

    Jan 08, 2019

    Following a strong post-hoc analysis of mid-stage data in the fall of 2018, Novartis announced this morning the company’s experimental humanized anti-P-selectin monoclonal antibody was crizanlizumab granted Breakthrough Therapy Status by the U.S. Food and Drug Administration (FDA). Crizanlizum...


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    https://Pharmaceutical.report/news-article.aspx?ID=23902390

    UROGEN APPOINTS FORMER NOVARTIS CANCER CHIEF BARRETT AS CEO

    Jan 08, 2019

    Novartis’ former oncology CEO Liz Barrett has left to join little-known biotech, UroGen, to help bring its potential urothelial cancer drug to market. Barrett raised eyebrows last month when she announced her decision to leave Novartis after less than a year in charge of its oncology unit, but...


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    https://Pharmaceutical.report/news-article.aspx?ID=23912391

    2018 SET BENCHMARK FOR DIGITAL HEALTH INVESTMENT – REPORT

    Jan 08, 2019

    Last year was the biggest ever for digital health investment, according to a report that has been tracking the market since the beginning of the decade. According to the report by Startup Health Insights, investment in digital health has increased 14-fold since 2010. In 2018, funding for digital hea...


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    https://Pharmaceutical.report/news-article.aspx?ID=23922392

    AFTER ANNOUNCING A NEW CEO, UROGEN TOUTS POSITIVE PHASE III DATA FOR UROTHELIAL CANCER

    Jan 08, 2019

    UroGen Pharma, based in New York, announced positive topline results from its Phase III OLYMPUS clinical trial. The trial evaluated UGN-101 (mitomycin gel) for installation for the non-surgical treatment of low-grade upper tract urothelial cancer (UTUC). Of the 71 patients in the trial, 61 have been...


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    https://Pharmaceutical.report/news-article.aspx?ID=23932393

    SANOFI AND REGENERON RESTRUCTURE IMMUNO-ONCOLOGY COLLABORATION TO ADD TWO NEW PRODUCTS

    Jan 07, 2019

    Tarrytown, NY-based Regeneron Pharmaceuticals and Paris-based Sanofi restructured a 2015 agreement to develop immuno-oncology (I/O) treatments. That deal was scheduled to wrap in 2020, but the revision adds two clinical-stage bispecific antibodies to the collaboration. The revision lets Regeneron ho...


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    https://Pharmaceutical.report/news-article.aspx?ID=23792379

    NHS LOOKS TO DIGITAL AND GENOMICS TO SECURE ITS FUTURE

    Jan 07, 2019

    Genomics, digital tech, and artificial intelligence are at the forefront of the government’s long-term plan for the NHS, unveiled today. In a statement, the health service said it believed the plans would save almost half a million more lives and would make the NHS ‘fit for the future&rs...


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    https://Pharmaceutical.report/news-article.aspx?ID=23802380

    PAIR OF DEALS BOOSTS BIOGEN’S EARLY-STAGE CNS PIPELINE

    Jan 07, 2019

    Biogen has signed a brace of collaborations to expand its central nervous system (CNS) pipeline, adding new candidates for Alzheimer’s, multiple sclerosis and other neurological diseases. The first of the new deals is a $415 million collaboration with protein degradation specialist C4 Therapeu...


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    https://Pharmaceutical.report/news-article.aspx?ID=23812381

    TAKEDA UNLIKELY TO SELL OTC UNIT TO PAY SHIRE MERGER DEBTS

    Jan 07, 2019

    Takeda’s $59 billion takeover of Shire is due to close tomorrow (Tuesday) and the company’s CEO Christophe Weber has already given some strong clues about the company’s strategy once the deal completes. Last week Takeda announced three new research collaborations in immuno-oncology...


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    https://Pharmaceutical.report/news-article.aspx?ID=23822382

    OBSESSIVE-COMPULSIVE SYMPTOMS IN YOUTH: A PSYCHOLOGICAL RED FLAG?

    Jan 07, 2019

    Engaging in repetitive and ritualistic behaviors is part of typical child development. However, behaviors that develop into obsessive and compulsive symptoms (OCS) may represent a red flag for serious psychiatric conditions. Researchers at the Lifespan Brain Institute (LiBI) of Children’s Hosp...


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    https://Pharmaceutical.report/news-article.aspx?ID=23832383

    SELECTA BIOSCIENCES' NEW CEO RESTRUCTURES, CUTS 36% OF STAFF

    Jan 04, 2019

    Selecta Biosciences, based in Watertown, Mass., announced that as part of restructuring efforts it is cutting its current workforce by 36 percent. The company believes that the cuts, along with a reprioritization of its pipeline, will decrease its yearly cash burn by 19 percent. At its third-quarter...


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    https://Pharmaceutical.report/news-article.aspx?ID=23692369

    AMPLIPHI BIOSCIENCES AND C3J THERAPEUTICS AGREE TO MERGE

    Jan 04, 2019

    AmpliPhi Biosciences  Corporation (“AmpliPhi”) (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, and C3J Therapeutics, Inc. (“C3J”), a private cli...


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    https://Pharmaceutical.report/news-article.aspx?ID=23702370

    X-CHEM AND VERTEX EXPAND EXISTING PARTNERSHIP

    Jan 04, 2019

    X-Chem Inc., a privately held biotechnology company focused on applying its industry-leading DNA-encoded (DEX™) drug discovery engine to the generation of novel small molecule therapeutics, today announced the expansion of its collaboration with Vertex Pharmaceuticals Incorporated (NASDAQ: VRT...


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    https://Pharmaceutical.report/news-article.aspx?ID=23712371

    BIONTECH TEAMS UP WITH SANOFI TO TARGET SOLID TUMORS IN $91.5 MILLION DEAL

    Jan 04, 2019

    Days ahead of the J.P. Morgan Healthcare Conference, Germany-based BioNTech extended its three-year-old collaboration with Sanofi as the companies look to co-develop the first cancer immunotherapy candidate for solid tumors. As part of the deal, the French pharma giant will invest about $91.5 millio...


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    https://Pharmaceutical.report/news-article.aspx?ID=23722372

    ABBVIE FORGES $105 MILLION+ CD39 INHIBITOR ALLIANCE WITH TIZONA

    Jan 04, 2019

    Privately-held Tizona Therapeutics snagged $105 million in upfront cash as its cancer antibody TTX-030 is the centerpiece of a collaborative effort with Illinois-based AbbVie. The two companies intend to combine their R&D capabilities with a focus on CD39-targeted therapeutics. CD39 is the enzym...


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    https://Pharmaceutical.report/news-article.aspx?ID=23732373

    AMRA PROFILER CLEARED BY FDA FOR BODY COMPOSITION ANALYSIS FROM MRI SCANS

    Jan 03, 2019

    AMRA Medical, a company based in Linköping, Sweden, won FDA clearance to introduce its AMRA Profiler technology for fat and muscle composition analysis. The product relies on a six-minute MRI scan, performed using a compatible scanner, with the imaging data being sent to AMRA’s servers. A...


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    https://Pharmaceutical.report/news-article.aspx?ID=23592359

    SANOFI PALMS OFF MYOKARDIA HEART DISEASE PACT

    Jan 03, 2019

    Sanofi has walked away from a four-year-old alliance with US biotech MyoKardia, handing back rights to three drugs for heart disease. The decision comes ahead of data readouts for two of the clinical candidates – mavacamten and MYK-491 – within the next 12 to 24 months and comes as Sanof...


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    https://Pharmaceutical.report/news-article.aspx?ID=23602360

    GIVE IT TO US STRAIGHT, DOCTORS TELL PHARMA ADVERTISERS—BUT BEING FUNNY IS OK, TOO

    Jan 03, 2019

    Want to catch doctors’ attention with flashy advertising and intellectual jargon? Don’t bother. A new study finds that physicians prefer simple and clear messages, with more than half (51%) admitting they don’t always understand what’s being communicated in pharma advertising...


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    https://Pharmaceutical.report/news-article.aspx?ID=23612361

    GLASSY CARBON MICRONEEDLES: A NEW TRANSDERMAL DRUG DELIVERY DEVICE

    Jan 03, 2019

    Microneedles are designed to infuse medications transdermally (through the skin) and relatively painlessly during clinical applications. In a recent study, Richa Mishra and her colleagues developed a new technique to convert polymer films into a fracture-resistant glassy form of carbon to develop mi...


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    https://Pharmaceutical.report/news-article.aspx?ID=23622362

    SURPRISE DISCOVERY REVEALS SECOND VISUAL SYSTEM IN MOUSE CEREBRAL CORTEX

    Jan 03, 2019

    The visual system is probably the best-understood part of the brain. Over the past 75 years, neuroscientists have assembled a detailed account of how light waves entering your eyes allow you to recognize your grandmother's face, to track a hawk in flight, or to read this sentence. But a new stud...


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    https://Pharmaceutical.report/news-article.aspx?ID=23632363

    BIOXCEL’S AGITATION DRUG GETS FDA FAST TRACK

    Jan 02, 2019

    The FDA has granted Fast Track Designation to BioXcel Therapeutics’ BXCL501 for the treatment of acute agitation resulting from neurological and psychiatric disorders like Alzheimer’s and schizophrenia. BioXcel is a clinical-stage biopharmaceutical development company utilizing novel art...


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    https://Pharmaceutical.report/news-article.aspx?ID=23492349

    PROMETHERA LOOKS TO ASIA WITH €10M INVESTMENT

    Jan 02, 2019

    Belgium-based liver disease specialists Promethera Biosciences have received a leg-up for the Asian market in the form of a €10 million investment from Japanese business conglomerate ITOCHU Corporation. ITOCHU is the first lead investor in Promethera’s Series D round, which the company ex...


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    https://Pharmaceutical.report/news-article.aspx?ID=23512351

    MSD AND PFIZER TOP DOW FOR 2018

    Jan 02, 2019

    MSD and Pfizer were 2018’s top gainers on the Dow Jones Industrial Average for the calendar year, with both companies bucking the trend of an otherwise lacklustre year for the index. MSD was the biggest Dow winner, with shares of the company surging more than 30%, with a dividend yield of 2.9%...


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    https://Pharmaceutical.report/news-article.aspx?ID=23522352

    TEVA AND NEOS SETTLE OVER COTEMPLA PATENT DISPUTE

    Jan 02, 2019

    Teva and Neos Therapeutics have reached a confidential settlement and licensing agreement that resolves a patent dispute over the Israeli firm’s generic version of Neos’ ADHD drug Cotempla XR-ODT (methylphenidate). Under the settlement and license agreement, Neos has granted Teva the rig...


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    https://Pharmaceutical.report/news-article.aspx?ID=23532353

    MYCENAX’S ACTEMRA BIOSIMILAR EDGES CLOSER TO APPROVAL

    Dec 31, 2018

    Mycenax’s biosimilar of Roche’s Actemra (tocilizumab), LusiNEX, has been shown to match its originator’s profile in a phase I PK trial, meaning it is on track to become the first approved biosimilar for the drug. Actemra, marketed as RoActemra in the EU, is approved for immunology ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23502350

    NUCLEUS-SPECIFIC X-RAY STAIN FOR 3-D VIRTUAL HISTOLOGY

    Dec 27, 2018

    Histology is used to identify structural details of tissue at the microscale in the pathology lab, but analyses remain two-dimensional (2D) as they are limited to the same plane. Nondestructive 3D technologies including X-ray micro and nano-computed tomography (nanoCT) have proven validity to unders...


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    https://Pharmaceutical.report/news-article.aspx?ID=23392339

    PROPORTION OF CANCERS ASSOCIATED WITH EXCESS BODY WEIGHT VARIES CONSIDERABLY BY STATE

    Dec 27, 2018

    A new study looking at the share of cancers related to obesity finds an at least 1.5-fold difference between states with the highest and lowest proportions. The proportion of cancer cases that could be attributable to excess body weight ranged from a high of 8.3% in the District of Columbia to a low...


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    https://Pharmaceutical.report/news-article.aspx?ID=23412341

    YOUR BRAIN REWARDS YOU TWICE PER MEAL: WHEN YOU EAT AND WHEN FOOD REACHES YOUR STOMACH

    Dec 27, 2018

    We know a good meal can stimulate the release of the feel-good hormone dopamine, and now a study in humans from the Max Planck Institute for Metabolism Research in Germany suggests that dopamine release in the brain occurs at two different times: at the time the food is first ingested and another on...


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    https://Pharmaceutical.report/news-article.aspx?ID=23422342

    SLEEPING SICKNESS PARASITE USES MULTIPLE METABOLIC PATHWAYS

    Dec 27, 2018

    Parasitic protozoa called trypanosomes synthesize sugars using an unexpected metabolic pathway called gluconeogenesis, according to a study published December 27 in the open-access journal PLOS Pathogens by David Horn of the University of Dundee in the UK, and colleagues. The authors note that this ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23432343

    ACORDA SNAGS APPROVAL FOR NEW TREATMENT OF OFF EPISODES OF PARKINSON’S DISEASE

    Dec 26, 2018

    Acorda Therapeutics can breathe a bit easier. The U.S. Food and Drug Administration (FDA) approved Inbrija, the first inhaled formula of levodopa (L-dopa) for the intermittent treatment of OFF episodes in Parkinson’s disease patients. The approval came about two weeks before its PUDFA date. Th...

    ACORDA THERAPEUTICS
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    https://Pharmaceutical.report/news-article.aspx?ID=23292329

    POINT-COUNTERPOINT: SENATOR WARREN'S GENERIC DRUG PROPOSAL

    Dec 26, 2018

    Senator Elizabeth Warren (D-MA), proposed The Affordable Drug Manufacturing Act, which would allow the Department of Health and Human Services (HHS) to manufacture or contract out the manufacture of generic drugs. Warren argues that the generic drug system was designed to promote competition, which ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23302330

    THE FDA APPROVES TWO ORPHAN BLOOD DISORDER DRUGS

    Dec 26, 2018

    The U.S.Food and Drug Administration (FDA) approved two drugs for separate blood disorders, Alexion Pharmaceuticals’ Ultomiris for the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), and Stemline Therapeutics’ Elzonris for blastic plasmacytoid dendritic cell neoplasm (BPDC...


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    https://Pharmaceutical.report/news-article.aspx?ID=23312331

    FDA ACTION ALERT: WRAPPING UP 2018 AND HEADING INTO 2019

    Dec 26, 2018

    With the holidays upon us, along with the end of 2018 and the beginning of 2019, the U.S. Food and Drug Administration (FDA) squeezed some target action dates into the last weeks and beginning of the new year. As it turned out, these appear to be a mixed bag of extensions, resubmissions and suppleme...


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    https://Pharmaceutical.report/news-article.aspx?ID=23322332

    DUSA PHARMACEUTICALS, INC. AWARDED PRELIMINARY INJUNCTIVE RELIEF PROHIBITING BIOFRONTERA FROM USING ITS TRADE SECRETS

    Dec 26, 2018

    MUMBAI, India and PRINCETON, New Jersey, December 26, 2018 /PRNewswire/ -- DUSA Pharmaceuticals, Inc., ("DUSA"), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO) (Bloomberg: SUNP IN) (NSE: SUNPHARMA) (BSE: 524715) announced that DUSA has been granted prelim...


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    https://Pharmaceutical.report/news-article.aspx?ID=23332333

    FRAMINGHAM SUES DRUG MAKERS, DISTRIBUTORS OVER OPIOID EPIDEMIC

    Dec 24, 2018

    City officials are pressing their case against drug makers and distributors for what they describe as reckless conduct that fueled the nation’s opioid epidemic. A pair of law firms representing the city recently filed a lawsuit in Middlesex Superior Court seeking damages from a range of major ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23202320

    IBM RESEARCH SHOWS HOW HEALTH INSIGHTS MAY COME FROM FINGERNAIL WEARABLE

    Dec 24, 2018

    A tiny fingernail sensor has been worked up that monitors diseases and movement disorders. IBM Research tells their prototype story in a December video. The IBM team designed the tiny fingernail sensors to help clinicians detect and monitor the progression of disease via AI analysis and grip strengt...


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    https://Pharmaceutical.report/news-article.aspx?ID=23212321

    CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY TREATMENT MARKET IS EXPECTED TO EXPERIENCE A RAPID GROWTH BY 2025

    Dec 24, 2018

    Global and China Chemotherapy Induced Peripheral Neuropathy Treatment Market Research by Company, Type & Application 2013-2025 is latest research study released by HTF MI evaluating the market, highlighting opportunities, risk side analysis, and leveraged with strategic and tactical decision-mak...


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    https://Pharmaceutical.report/news-article.aspx?ID=23222322

    PARAMEDICS CAN SAFELY EVALUATE PSYCHIATRIC PATIENTS' MEDICAL CONDITION IN THE FIELD

    Dec 24, 2018

    Emergency medical personnel in Alameda County, California, use a screening process for determining whether to "medically clear" patients experiencing psychiatric emergencies before transporting them. They identify patients who are at low risk for medical emergencies and take them directly ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23232323

    CHOLESTEROL-LOWERING DRUGS REDUCE BROWN ADIPOSE TISSUE

    Dec 21, 2018

    ETH Zurich scientists have shown that statins, one of the most commonly prescribed classes of pharmaceuticals, reduce beneficial brown adipose tissue. But this is no reason to demonize these drugs, the researchers insist. A certain proportion of the adult population has not only white adipose (or fa...


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    https://Pharmaceutical.report/news-article.aspx?ID=23092309

    TOWARD VACCINATION AGAINST THE CHIKUNGUNYA VIRUS

    Dec 21, 2018

    A live vaccine genetically engineered from a common measles vaccine promises to be effective against the chikungunya virus. Such is the central finding of a recently completed Phase II trial now published in the prestigious journal The Lancet. Two MedUni Vienna departments were also involved in the ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23102310

    NOVARTIS OFFERS TO BUY KYMRIAH MANUFACTURER

    Dec 21, 2018

    Following its success in the burgeoning area of CAR-T therapies, Novartis is looking to strengthen its cell and gene manufacturing capabilities by offering to acquire CDMO CellforCure, manufacturers of its CAR-T drug Kymriah. Under the proposed agreement, Novartis would acquire the share capital of ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23112311

    GENE DISCOVERY REVEALS NEW TARGETS FOR TREATING ATHEROSCLEROSIS, INFLAMMATORY DISEASES

    Dec 21, 2018

    A group of genes that have been largely ignored by scientists could play critical roles in atherosclerosis (hardening of the arteries), inflammation, and likely obesity and other metabolic diseases, new research suggests. The discovery was made by researchers at the University of Virginia School of ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23122312

    RESEARCHERS DEVELOP SIGHT-SAVING TREATMENT FOR EYE INFECTION OR TRAUMA

    Dec 21, 2018

    Scientists at the University of Birmingham have developed a novel eye drop that rapidly reduces sight-threatening scarring to the surface of the eye. The surface of the eye (the cornea) is usually transparent, but scars resulting from eye infection or trauma make it opaque causing blurred vision or ...


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    https://Pharmaceutical.report/news-article.aspx?ID=23132313

    AZ/MERCK & CO GET NEW US USE FOR OVARIAN CANCER DRUG

    Dec 20, 2018

    After several disappointments this year AstraZeneca has ended 2018 on a positive note, gaining a new use for its ovarian cancer drug Lynparza in the US and the first approval in China for its new anemia drug. While AZ’s immunotherapy drug Imfinzi has made some missteps recently, most notably i...


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    https://Pharmaceutical.report/news-article.aspx?ID=22992299

    AS IMMUNO-ONCOLOGY HEADS INTO 2019, ONE THING IS CLEAR: IT’S GOOD TO BE MERCK

    Dec 20, 2018

    When 2018 began, there was still plenty of uncertainty surrounding the previously untreated lung cancer market—the holy grail for immuno-oncology drugmakers, thanks to its sheer size. Merck had the lead with two approvals for Keytruda, but three other companies were awaiting combo data and aim...


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    https://Pharmaceutical.report/news-article.aspx?ID=23002300

    AFTER NEW YEAR'S, EXPECT MORE DRUG PRICING FIREWORKS IN 2019

    Dec 20, 2018

    For several years, pharma watchers have witnessed drug pricing grow into a top issue facing the industry, dominating discussion almost daily. The conversation isn’t likely to subside next year, either. Lawmakers on both sides of the aisle including the newly Democratic House—and the Trum...


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    https://Pharmaceutical.report/news-article.aspx?ID=23012301

    SCOTLAND’S NHS COULD REIMBURSE VERTEX CF DRUGS, PRICE ROW ONGOING IN ENGLAND

    Dec 20, 2018

    Vertex is to file its two latest cystic fibrosis drugs with Scotland’s drug cost watchdog in a bid for NHS reimbursement – but an ongoing row over price in England is still unresolved. The US pharma said it will submit files for Orkambi (lumacaftor+ivacaftor), and Symkevi (tezacaftor+iva...


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    https://Pharmaceutical.report/news-article.aspx?ID=23022302

    SCIENTISTS ADVISE CAUTION IN IMMUNOTHERAPY RESEARCH

    Dec 20, 2018

    In a new study, Yale Cancer Center (YCC) scientists suggest that as the number of clinical trials in cancer immunotherapy grows exponentially, some caution should be exercised as we continue to better understand the biology of these new therapeutic targets. The findings are published today in the jo...


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    https://Pharmaceutical.report/news-article.aspx?ID=23032303

    PATIENT-SPECIFIC ORGANOID MODELS APPENDIX CANCER TREATMENT

    Dec 19, 2018

    Scientists at the Wake Forest Institute for Regenerative Medicine (WFIRM) have recently developed a process that may change the way cancer of the appendix is treated in the future. Researchers at WFIRM, in collaboration with the Department of Surgery – Surgical Oncology at Wake Forest Baptist ...


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    https://Pharmaceutical.report/news-article.aspx?ID=22892289

    DETECTING LUNG CANCER – THINKING OUTSIDE THE TUMOR

    Dec 19, 2018

    Scientists in Anant Madabhushi's computational imaging lab at Case Western Reserve University have started thinking outside the box--or in their case, looking outside the tumor. They're hoping that this novel computerized approach represents a historic leap in diagnosing cancer using just ro...


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    https://Pharmaceutical.report/news-article.aspx?ID=22902290

    ZIKA VACCINE PROTECTS MOUSE FETUSES AGAINST BRAIN INFECTIONS AND MALFORMATIONS

    Dec 19, 2018

    In 2015 and 2016, the world was shocked by the sudden and massive outbreak of the Zika virus in Latin America. “The Zika virus is transmitted by the tiger mosquito and, in most cases, the patient experiences no or only mild symptoms,” says Professor Johan Neyts. “But when a pregnan...


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    https://Pharmaceutical.report/news-article.aspx?ID=22912291

    PREGNANT WOMEN AND EXTREMELY OBESE PEOPLE AT HIGH RISK OF FLU COMPLICATIONS

    Dec 19, 2018

    Pregnant women and the extremely obese are among those at high risk for complications from the flu – including death – and should be tested and begin antiviral treatment promptly if they are sick enough to be hospitalized with flu symptoms, according to updated guidelines released by the...


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    https://Pharmaceutical.report/news-article.aspx?ID=22922292

    TETRA, SHIONOGI INK $40M PACT ON PDE4 DRUG FOR ALZHEIMER’S, FRAGILE X

    Dec 19, 2018

    Tetra Discovery Partners is teaming up with Shionogi to advance its PDE4-targeting drug in Alzheimer’s disease and fragile X syndrome. In return for the rights to the drug in three Asian countries, Shionogi will hand over a $5 million upfront payment and $35 million in equity. If all goes well...


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    https://Pharmaceutical.report/news-article.aspx?ID=22932293

    AXOVANT BUYS MORE GENE THERAPIES, SETTING IT UP FOR A BUSY 2019

    Dec 14, 2018

    Axovant has licensed two gene therapies from the University of Massachusetts Medical School (UMMS). The deal accelerates Axovant’s evolution into a gene therapy specialist by giving it control of two assets that are in or near the clinic. Following the failures of intepirdine and nelotanserin,...


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    https://Pharmaceutical.report/news-article.aspx?ID=22792279

    WUXI APPTEC EYES ACQUISITIONS AFTER $1BN HONG KONG IPO

    Dec 14, 2018

    Chinese biotech WuXi AppTec has completed its listing on Hong Kong’s HKEX, raising $967m just months after making its debut on the Shanghai exchange. The company which provides contract research, development, and manufacturing services to pharma, medical device and biotech firms – said t...


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    https://Pharmaceutical.report/news-article.aspx?ID=22802280

    IPSEN WARNS OVER MEDICINE SUPPLIES AMID BREXIT UNCERTAINTY

    Dec 14, 2018

    France’s Ipsen has become the latest pharma company to warn about the impact of Brexit on the pharma industry and patients’ access to medicines. As Theresa May attempts to drum up support for her Brexit deal, the French pharma said it was taking steps to minimize disruption to supplies o...


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    https://Pharmaceutical.report/news-article.aspx?ID=22812281

    RESEARCHERS ZERO IN ON POTENTIAL THERAPEUTIC TARGET FOR DIABETES, ASSOCIATED DISEASES

    Dec 14, 2018

    A recent study led by researchers in Texas A&M University's department of nutrition and food science shows how a novel regulatory mechanism serves as an important biomarker for the development of diabetes, as well as a potential therapeutic target for its prevention. The study can be found o...


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    https://Pharmaceutical.report/news-article.aspx?ID=22822282

    EARLY PHYSICAL THERAPY CAN REDUCE RISK, AMOUNT OF LONG-TERM OPIOID USE, STUDY FINDS

    Dec 14, 2018

    Patients who underwent physical therapy soon after being diagnosed with pain in the shoulder, neck, low back or knee were approximately 7 to 16 percent less likely to use opioids in the subsequent months, according to a new study by researchers at the Stanford University School of Medicine and the D...


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    https://Pharmaceutical.report/news-article.aspx?ID=22832283

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

    Dec 13, 2018

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


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

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

    Dec 13, 2018

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


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

    GARMIN TO DEVELOP WEARABLES FOR CLINICAL TRIALS WITH ACTIGRAPH

    Dec 13, 2018

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


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

    FDA HAILS 2018 AS BUMPER YEAR FOR DRUG DEVELOPMENT SUCCESSES

    Dec 13, 2018

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


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

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

    Dec 13, 2018

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


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

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

    Dec 11, 2018

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


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

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

    Dec 11, 2018

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


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

    NICE REVEALS NEW STANDARDS FOR DIGITAL TECH

    Dec 11, 2018

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


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

    AKORN SEARCHES FOR NEW CEO AFTER FAILED FRESENIUS MERGER

    Dec 11, 2018

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


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

    BOEHRINGER FOLLOWS SANOFI WITH JOB CUTS IN FRANCE

    Dec 11, 2018

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


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

    AXOVANT ABANDONS ANOTHER DEMENTIA DRUG AFTER FAILED TRIAL

    Dec 10, 2018

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


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

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

    Dec 10, 2018

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


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

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

    Dec 10, 2018

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


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

    PHARMA COMPANIES WARNED OVER ‘NO DEAL’ BREXIT DISRUPTION

    Dec 10, 2018

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


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

    MACROGENICS HALTS TRIALS OF CANCER DRUG AFTER FDA PARTIAL HOLD

    Dec 10, 2018

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


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

    SUPERNUS SAYS ADHD DRUG TROUNCES RIVALS, BUT SHARES SLIDE

    Dec 07, 2018

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


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

    CANCER VACCINE VALIDATED IN MICE

    Dec 07, 2018

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


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

    ELIMINATING HIV'S LATENT RESERVOIR

    Dec 07, 2018

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


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

    SEEING STRESS WITH SUPERCOMPUTERS

    Dec 07, 2018

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


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

    VITAMIN D DEFICIENCY INCREASES SCHIZOPHRENIA RISK

    Dec 07, 2018

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


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

    SHAREHOLDERS APPROVE TAKEDA’S $59BN TAKEOVER OF SHIRE

    Dec 06, 2018

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


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

    AFTER DELAYED IPO, MEREO GETS US LISTING VIA ONCOMED MERGER

    Dec 06, 2018

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


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

    HOW PERCEPTIONS OF HIGH DRUG PRICES DO NOT NECESSARILY MATCH REALITY

    Dec 06, 2018

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


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

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

    Dec 06, 2018

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


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

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

    Dec 05, 2018

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


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

    NOVARTIS TAKES XOLAIR FOLLOW-UP INTO PHASE III HIVES TRIAL

    Dec 05, 2018

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


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

    OPEN HEALTH MERGES WITH MED COMMS SERVICES PROVIDER PELOTON

    Dec 05, 2018

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


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

    NEW DRUG TARGET DISCOVERED FOR POTENTIAL BLOOD PRESSURE TREATMENT

    Dec 05, 2018

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


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

    GENES LINKED TO DEMENTIA IDENTIFIED

    Dec 04, 2018

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


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

    URINE TEST TO IMPROVE BLADDER CANCER DETECTION

    Dec 04, 2018

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


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

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

    Dec 04, 2018

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


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

    ASURAGEN LAUNCHES ASSAY TO HELP DIAGNOSE STEINERT’S DISEASE

    Dec 04, 2018

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


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

    CELGENE SCORES AT ASH18 WITH DOUBLE LUSPATERCEPT DATA

    Dec 03, 2018

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


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

    REGENERON RECORDS 80% COMPLETE RESPONSE RATE IN LYMPHOMA TRIAL

    Dec 03, 2018

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


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

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

    Dec 03, 2018

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


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

    STENTRODE DEVELOPED FOR BRAIN TREATMENTS WITHOUT MAJOR SURGERY

    Dec 03, 2018

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


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

    VIACYTE BAGS $80M TO TRIAL DIABETES STEM CELL THERAPIES

    Nov 29, 2018

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


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

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

    Nov 29, 2018

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


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

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

    Nov 29, 2018

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


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

    THE TOP 3 HOUSE DEMOCRAT LEADERS HAVE POCKETED MILLIONS FROM PHARMA

    Nov 29, 2018

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


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

    HEALIOS BEGINS TRIALS OF MENTAL HEALTH APP FOR SCHOOLCHILDREN

    Nov 28, 2018

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


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

    BAYER/LOXO DRUG APPROVED IN CANCERS WITH CERTAIN MUTATION

    Nov 28, 2018

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


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

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

    Nov 28, 2018

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


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

    ANTIBIOTIC COULD PROTECT AGAINST NEURODEGENERATIVE DISEASES DURING AGING

    Nov 28, 2018

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


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

    NHS SAVING £300M WITH HUMIRA BIOSIMILAR DEAL

    Nov 27, 2018

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


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

    SIEMENS HEALTHINEERS UNVEILS MAGNETOM ALTEA 1.5 TESLA MRI SCANNER

    Nov 27, 2018

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


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

    LUNG DISEASE MAY INCREASE DEMENTIA RISK

    Nov 27, 2018

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


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

    COPD AND ANXIETY: RESEARCHERS TEST PROMISING APPROACH

    Nov 27, 2018

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


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

    SLUGGISH BRAINWAVE ACTIVITY IN DEMENTIA PREDICTS SEVERITY OF COGNITIVE IMPAIRMENT

    Nov 26, 2018

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


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

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

    Nov 26, 2018

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


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

    MINIMAL RESIDUAL DISEASE: APPLICATION IN BLOOD CANCERS

    Nov 26, 2018

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


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

    ‘GENERATION Z’ HAPPY TO BE DIAGNOSED BY CHATBOTS

    Nov 26, 2018

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


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

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

    Nov 23, 2018

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


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

    CELLULAR MECHANOSENSING KEY FOR 3D FORMATION

    Nov 23, 2018

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


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

    THE SURPRISING CULPRIT FOR HIV PERSISTENCE DURING THERAPY

    Nov 23, 2018

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


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

    BREAST CANCERS ENHANCE THEIR GROWTH BY RECRUITING CELLS FROM BONE MARROW

    Nov 23, 2018

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


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

    THOUSANDS TO BENEFIT AS NHS FUNDS KEYTRUDA LUNG CANCER COMBO

    Nov 22, 2018

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


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

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

    Nov 22, 2018

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


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

    SONS OF FATHERS WHO SMOKE HAVE 51% LOWER SPERM COUNT

    Nov 22, 2018

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


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

    CEO OF UK DRUGS REGULATOR QUITS, AS BREXIT NEARS

    Nov 21, 2018

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


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

    MACHINE LEARNING MODELS HELP PREDICT WHICH PATIENTS NEED A&E

    Nov 21, 2018

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


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

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

    Nov 21, 2018

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


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

    HOW ASPIRIN AND OMEGA-3 MAY REDUCE CANCER RISK

    Nov 20, 2018

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


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

    MERCK AND PFIZER CHALK UP ANOTHER FAIL FOR BAVENCIO

    Nov 20, 2018

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


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

    NEJM PAPER BUOYS AIMMUNE’S PEANUT ALLERGY DRUG PROSPECTS

    Nov 19, 2018

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


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

    INFLAZOME RAISES €40M TO GET NLRP3 DRUG INTO HUMANS

    Nov 19, 2018

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


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

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

    Nov 16, 2018

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


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

    BLUEPRINT EYES QUICK FILING FOR GIST DRUG AVAPRITINIB

    Nov 16, 2018

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


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

    DEFINED HEALTH BECOMES CELLO HEALTH BIOCONSULTING

    Nov 15, 2018

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


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

    LITMUS HEALTH PUBLISHES CENSUS OF WEARABLE DEVICES FOR CLINICAL RESEARCH

    Nov 15, 2018

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


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

    AI DEVICE COULD BE CHEAPER AND MORE ACCURATE THAN SMEAR TESTS

    Nov 14, 2018

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


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

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

    Nov 14, 2018

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


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

    EYEING NOVARTIS DEAL, AKCEA TRUMPETS LIPOPROTEIN DRUG DATA

    Nov 14, 2018

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


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

    GOOGLE HIRES GEISINGER CEO AS NEW HEALTH STRATEGY LEADER

    Nov 13, 2018

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


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

    NANONEEDLE SKIN PATCH TO INJECT DRUGS INTO CELLS

    Nov 13, 2018

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


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

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

    Nov 13, 2018

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


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

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

    Nov 12, 2018

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


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

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

    Nov 12, 2018

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


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

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

    Nov 12, 2018

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

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

    VERTEX WINS EUROPEAN APPROVAL FOR NEW CYSTIC FIBROSIS COMBINATION

    Nov 02, 2018

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


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

    SINGLE-CELL ANALYSIS REVEALS HOW MELANOMA CELLS RESIST IMMUNOTHERAPY

    Nov 02, 2018

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


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

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

    Nov 02, 2018

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

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

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

    Nov 01, 2018

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


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

    UK OPENS DOORS TO CANNABIS-BASED THERAPIES VIA NHS

    Nov 01, 2018

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


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

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

    Oct 31, 2018

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


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

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

    Oct 31, 2018

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


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

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

    Oct 31, 2018

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


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

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

    Oct 30, 2018

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


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

    AUGMENTED REALITY PRE-SURGERY TECH APPROVED BY US REGULATOR

    Oct 30, 2018

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


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

    LEO PHARMA TEAMS UP WITH WEARIFI FOR DERMATOLOGY RESEARCH WEARABLE

    Oct 29, 2018

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


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

    BIOLOGISTS DISCOVER SOURCE FOR BOOSTING TUMOR CELL DRUG SENSITIVITY

    Oct 29, 2018

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


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

    NOVIOSENSE ANNOUNCES POSITIVE CLINICAL TRIAL RESULTS OF TEAR GLUCOSE MEASUREMENT TECHNOLOGY

    Oct 25, 2018

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


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

    OPTOACOUSTIC GUIDEWIRE SYSTEM FOR BREAST CANCER LOCALIZATION

    Oct 25, 2018

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


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

    BAYER PLANS FILINGS FOR PROSTATE CANCER DRUG DAROLUTAMIDE

    Oct 24, 2018

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


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

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

    Oct 24, 2018

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


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

    NEW COMBINATION TREATMENT FLIPS THE SWITCH ON MELANOMA CELLS

    Oct 23, 2018

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


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

    WEEK 34 OF PREGNANCY REDUCES BREAST CANCER RISK: STUDY

    Oct 23, 2018

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


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

    SANGAMO VET GARY LEE JOINS SYNTHETIC BIOLOGY OUTFIT SENTI AS CSO

    Oct 23, 2018

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


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

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

    Oct 22, 2018

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


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

    NEW AT-HOME FETAL HEART RATE MONITOR WITH CLINICAL ACCURACY

    Oct 22, 2018

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

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

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

    Oct 22, 2018

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


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

    GILEAD, AELIX ALLY TO TRIAL HIV-SUPPRESSING COMBINATION

    Oct 18, 2018

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


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

    IMPROVING CANCER IMMUNOTHERAPY BY CONTROLLING RNA EXPRESSION

    Oct 18, 2018

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


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

    PFIZER’S TALZENNA PARP BREAST CANCER DRUG APPROVED IN US

    Oct 17, 2018

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


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

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

    Oct 17, 2018

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


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

    NEW TEST RAPIDLY IDENTIFIES ANTIBIOTIC-RESISTANT SUPERBUGS

    Oct 16, 2018

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

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

    MICROLAPAROSCOPIC ROBOTIC SURGERIES NOW CLEARED ON TRANSENTERIX SENHANCE SYSTEM

    Oct 16, 2018

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

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

    ANTIDEPRESSANTS COULD STAVE OFF DEMENTIA

    Oct 15, 2018

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

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

    ASPIRIN MAY REDUCE LIVER CANCER RISK

    Oct 15, 2018

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


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

    CANCER STEM CELLS USE 'NORMAL' GENES IN ABNORMAL WAYS

    Oct 12, 2018

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


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

    NUMBER OF UK CLINICAL TRIALS IN DECLINE SINCE BREXIT VOTE

    Oct 12, 2018

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

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

    BIODEGRADABLE IMPLANT STIMULATES INJURED NERVES TO SPEED UP HEALING

    Oct 11, 2018

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


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

    NEUROCRINE, JNANA TEAM UP TO DISCOVER CNS DRUGS

    Oct 11, 2018

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


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

    ANTI-PSYCHOTIC DRUG COULD TREAT AGGRESSIVE BREAST CANCER

    Oct 09, 2018

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


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

    GENE THERAPY BREAKTHROUGH IN TREATING RARE FORM OF BLINDNESS

    Oct 09, 2018

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


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

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

    Oct 08, 2018

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


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

    NERVE DAMAGE: USING ELECTRONIC IMPLANTS TO HASTEN HEALING

    Oct 08, 2018

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


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

    SANDOZ ENCOURAGES DIGITAL HEALTH INNOVATION IN SECOND COMPETITION

    Oct 05, 2018

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


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

    DNA SEQUENCING AND PATIENT DATA USED TO HALT INFECTION OUTBREAK

    Oct 05, 2018

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


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

    PERSONALIZING CROHN’S DISEASE THERAPIES WITH MICRORNA AS INDICATOR

    Oct 04, 2018

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


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

    SAREPTA SEES MUSCLE FUNCTION GAINS WITH DMD GENE THERAPY

    Oct 04, 2018

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


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

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

    Oct 02, 2018

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

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

    POWERFUL NEW X-RAY LASER IMAGES BIOMOLECULES LIKE NEVER BEFORE

    Oct 02, 2018

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

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

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

    Oct 01, 2018

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

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

    INEXPENSIVE TB TEST HOLDS PROMISE FOR LOW-INCOME COUNTRIES

    Oct 01, 2018

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


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

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

    Sep 27, 2018

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


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

    ALEXION PREPARES FILINGS FOR NEW RARE DISEASE USE FOR SOLIRIS

    Sep 27, 2018

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


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

    ZIKA AND YELLOW FEVER—VACCINES WITHOUT EGGS

    Sep 26, 2018

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


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

    MICROBIAL DARK MATTER DOMINATES EARTH'S ENVIRONMENTS

    Sep 26, 2018

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

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

    DEEP CONVOLUTIONAL NEURAL NETWORK IDENTIFIES LUNG CANCER TYPES FROM BIOPSY SLICES

    Sep 24, 2018

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


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

    SPINAL CORD EPIDURAL STIMULATION LETS PARALYZED WALK AGAIN

    Sep 24, 2018

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

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

    PEROVSKITE SEMICONDUCTORS SEEING RIGHT THROUGH NEXT GENERATION X-RAY DETECTORS

    Sep 21, 2018

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

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

    EARLY WARNING SIGN OF PSYCHOSIS DETECTED

    Sep 21, 2018

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


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

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

    Sep 20, 2018

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

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

    EXICURE PLANS CHECKPOINT COMBO AFTER TLR9 DRUG CLEARS EARLY TEST

    Sep 20, 2018

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


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

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

    Sep 18, 2018

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


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

    SCIENTISTS SEE AT-HOME BIOHACKING AS FUTURE OF MEDICINE

    Sep 17, 2018

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

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

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

    Sep 17, 2018

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

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

    FDA APPROVES TEVA’S HIGHER-DOSE OPIOID DEPENDENCE THERAPY

    Sep 10, 2018

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


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

    IS REGULAR SCREENING FOR PROSTATE CANCER REALLY NECESSARY?

    Sep 07, 2018

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


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

    ELECTRON MICROSCOPY PROVIDES NEW VIEW OF TINY VIRUS WITH THERAPEUTIC POTENTIAL

    Sep 07, 2018

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


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

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

    Sep 06, 2018

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

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

    HISTORIC FLUORINE DISCOVERY

    Sep 06, 2018

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


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

    DEMENTIA: 10-YEAR RISK ESTIMATES MAY INFORM PREVENTION

    Sep 05, 2018

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


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

    NEW SMALLER FLEXIBLE ROBOTIC SURGICAL SYSTEM FROM SOUTH KOREA

    Sep 05, 2018

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


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

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

    Sep 04, 2018

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


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

    REGULATOR PROTEIN KEY TO MALARIA PARASITE'S LIFECYCLE

    Sep 04, 2018

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

    New experimental re...

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

    MORE US ADOLESCENTS UP TO DATE ON HPV VACCINATION

    Sep 03, 2018

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


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

    CHAOS-INDUCING GENETIC APPROACH STYMIES ANTIBIOTIC-RESISTANT SUPERBUGS

    Sep 03, 2018

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


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

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

    Aug 31, 2018

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


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

    ASTRAZENECA IMPROVES DIABETES PEN TO MAINTAIN ITS MARKET SHARE

    Aug 31, 2018

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


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

    PFIZER DRUG REDUCES MORTALITY IN PATIENTS WITH FATAL HEART DISEASE

    Aug 30, 2018

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

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

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

    Aug 30, 2018

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


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

    DIGITAL HEALTH TECHNOLOGY HAS POTENTIAL TO TRANSFORM CANCER CARE

    Aug 29, 2018

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


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

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

    Aug 29, 2018

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


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

    LIVIO AI HEARING AIDS WITH PHYSICAL AND COGNITIVE HEALTH MONITORING

    Aug 28, 2018

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

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

    SECOND TIME LUCKY? ALZHEON TRIES FOR MUCH-REDUCED IPO

    Aug 28, 2018

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

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

    FIRMS URGED TO STOCKPILE DRUGS TO PREVENT BREXIT SHORTAGES

    Aug 27, 2018

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


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

    EBOLA SPECIES FOUND IN BATS AHEAD OF ANY POTENTIAL OUTBREAK

    Aug 27, 2018

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


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

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

    Aug 24, 2018

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


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

    TRACKING THE EVOLUTION AND TRANSMISSION OF YELLOW FEVER

    Aug 23, 2018

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


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

    KEEPING CANCER OUT OF BREATH BLOCKS DRUG RESISTANCE

    Aug 23, 2018

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


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

    CELLULAR CHANGES LEAD TO CHRONIC ALLERGIC INFLAMMATION IN THE SINUS

    Aug 22, 2018

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

    MASSACHUSETTS INSTITUTE OF TECHNOLOGY