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French drug trial disaster leaves one brain dead, five injured

One person has been left brain dead and five others are in a serious condition after taking part in a clinical trial in France of an experimental medicine from an unnamed drug company, the French Health Ministry said on Friday. The ministry did not say what the medicine was intended to be used for. A […]

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FDA clears Olympus duodenoscope with design modifications

The U.S. Food and Drug Administration on Friday cleared Japan’s Olympus Corp’s duodenoscope with changes to the device’s design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model being used in health care facilities to fix them as quickly as possible, the regulator said. (1.usa.gov/1Smn8p8) The […]

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Drug shortages in U.S. emergency rooms on the rise

(Reuters Health) – U.S. emergency rooms are increasingly running short on medications, including many that are needed for life-threatening conditions, a recent study documents. Since 2008, the number of shortages has risen by more than 400 percent, researchers found. Half of all emergency room shortages were for life-saving drugs, and for one in 10 there […]

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Theracos Snags $25 Million for Diabetes Drug

MARLBOROUGH, Mass. – Privately-held Theracos, Inc. raised $25 million to fund development of bexagliflozin, an experimental SGLT-2 inhibitor for the treatment of Type 2 diabetes, MedCityNews reported this morning. SGLT2 is an acronym for sodium-glucose linked transporter 2, a membrane protein that acts as a portal for glucose into the cell. SGLT2 inhibitors have been […]

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Merck Resolves Previously Disclosed Securities Class Action Lawsuit Related to Vioxx

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that it has reached an agreement with plaintiffs to resolve In re Merck & Co., Inc. Securities Litigation, a multi-district class action lawsuit pending in New Jersey federal court. The settlement class consists of persons who purchased Merck securities during […]

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Heron Therapeutics Notified by FDA That It Will Not Take Action on SUSTOL New Drug Application by the PDUFA Date

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Heron Therapeutics, Inc. (NASDAQ:HRTX), announced today that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of the New Drug Application (NDA) of SUSTOL® (granisetron) Injection, extended release and would not be taking action by the Prescription Drug User Fee Act (PDUFA) […]

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Sanofi Pasteur Provides Key Support to the Human Vaccines Project

The research program is designed to accelerate the development of vaccines by decoding the human immune system

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Liberia declared Ebola-free, signaling end to West African epidemic

Liberia was declared free of the Ebola virus by global health experts on Thursday, a milestone that signaled an end to an epidemic in West Africa that has killed more than 11,300 people. But the World Health Organisation (WHO) warned there could still be flare-ups of the disease in the region, which has suffered the […]

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FDA rejects BioMarin’s DMD drug

BioMarin Pharmaceutical Inc said on Thursday the U.S. Food and Drug Administration had rejected the company’s drug to treat a rare muscle-wasting disorder. The rejection caps months of uncertainty surrounding the drug, Kyndrisa, which was billed to be the first treatment in the United States for Duchenne muscular dystrophy. DMD, which affects one in 3,600 […]

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Apple Ramps Up its Medtech Workforce

SAN FRANCISCO – Apple (AAPL) is continuing to make moves in its healthcare division, developing wearable gear and hiring four new positions in its health technology division, including listings for biomedical engineers and a lab technician, BuzzFeed reported on Tuesday. The new positions are likely to support Apple’s continued foray into developing wearable medical devices. […]

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Biogen CMO Says Company Plans To Hire 150 For Neuroscience Development

Now that Pfizer (PFE) and Allergan (AGN) are going to merge, the two companies’ leaders are trying to explain, or perhaps justify, the rationale behind the merger. Cambridge, Mass.-based Biogen, Inc. (BIIB) indicated at the J.P. Morgan Healthcare Conference in San Francisco that it plans to hire 150 new employees. This is something of a […]

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Johnson & Johnson’s Cash Pile and Its CEO are Fueling Speculation of a Major Acquisition

Johnson & Johnson’s expanding cash hoard is fueling speculation of a major acquisition, but Chief Executive Officer Alex Gorsky isn’t talking like someone with a big deal in the offing. In an interview, Gorsky said he’s more partial to small deals for treatments in the early stage of development, not the kind of cost-saving megamergers […]

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Pfizer says its CAR T cancer therapy could outshine rivals

Pfizer Inc aims to drive profits in coming years with more-responsive and easier-to-manufacture new cancer treatments. With its French partner Cellectis, Pfizer is in the early stages of developing new cancer treatments called CAR T cells it says has major medical and manufacturing advantages over similar cell therapies being developed by others. The treatments are […]

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Dr. John Hixson Brings Clinical Neurology Expertise To FreshBlood

Hixson Named Sr. Medical Director/Neurologist for FreshBlood’s Consortium San Francisco, CA, Jan 13, 2016 — FreshBlood Health Market Consultants, a unique, on-demand creative consultancy comprised of senior-level management consultants and communications specialists in the healthcare industry, has continued to expand its clinical capabilities and scientific expertise with the addition of highly regarded neurologist, John Hixson, […]

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Controversial ‘pay-for-delay’ deals drop after FTC’s win in top court

Branded drug companies hammered out far fewer deals with generic drug makers to delay sales of cheaper medicines in the year after the Supreme Court ruled the Federal Trade Commission could legally pursue such agreements as potentially illegal. The FTC, which has fought the practice for years, said that pharmaceutical companies reached 21 of the […]

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Preparing for pandemics could cost less than $1 each a year, review says

Investing less then $0.72 a year for each person would make the world far more resilient to potentially devastating infectious disease pandemics, according to a global health expert group convened in the wake of the Ebola crisis.   A report by the Commission on Creating a Global Health Risk Framework for the Future, published on […]

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Catalent Biologics Announces Research Collaboration with Roche on SMARTag Technology

SOMERSET, N.J.–(BUSINESS WIRE)–Catalent, Inc. (NYSE:CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products today announced, through its wholly owned subsidiary, Redwood Bioscience, Inc., a research collaboration with Roche to develop next-generation molecules coupling different therapeutic modalities using Catalent’s proprietary SMARTag™ technology. Roche will gain non-exclusive […]

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Spark Therapeutics’ Ambitious Goals Include 10 Gene Therapy Programs by 2018

Spark Therapeutics Inc. said its expects to be advancing 10 clinical-stage gene therapy programs by 2018, all fully funded with existing financial resources. The plan, according to Spark CEO and co-founder Jeffrey D. Marrazzo, includes having its first commercial product in the market in 2017 and having two other new gene therapy candidates in late-stage […]

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Ex-GlaxoSmithKline Biostatistician Sues, Claims He was Let Go Over Nicoderm Studies

Alexandre Selmani, a former biostatistics manager for London-based GlaxoSmithKline (GSK), recently filed a whistleblower lawsuit against the company regarding his firing for questioning statistical data for its clinical trials for its smoking-cessation products. Selmani filed the lawsuit over his subsequent termination in Morris County Superior Court in New Jersey. The suit argues that he received […]

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GlaxoSmithKline CEO Might Consider Breakup After Novartis AG Deal Completion

January 13, 2016By Mark Terry, BioSpace.com Breaking News Staff   After several months of encouragement by super investor Neil Woodford for UK-based GlaxoSmithKline (GSK) to break up, GSK’s Andrew Witty says he’d consider it … eventually. Neil Woodford, of Woodford Investment Management, met in October 2015 with Sir Philip Hampton, the chairman of the board […]

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