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Merck Announces Top-Line Results Of TRA-2P Study Of Vorapaxar
2/7/2012
Merck, known outside the United States and Canada as MSD, recently announced the top-line results of the TRA-2P (Thrombin Receptor Antagonist in Secondary Prevention of atherothrombotic ischemic events) study of vorapaxar.
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China Emerging As An Innovation Hub For Formulation And Delivery
2/7/2012
A clutch of promising Chinese companies in the formulation and delivery (F/D) market underlines the emergence of the Asian giant as a center for biopharma innovation and entrepreneurship, even as Western pharmaceutical companies continue to enjoy technological and business advantages, according to a Lux Research report titled, "The Expanding Formulation and Delivery Market in China."
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FDA Approves KALYDECO (Ivacaftor), The First Medicine To Treat The Underlying Cause Of Cystic Fibrosis
1/31/2012
Vertex Pharmaceuticals Incorporated announced recently that the U.S. Food and Drug Administration (FDA) has approved KALYDECOTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease.
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NPS Pharmaceuticals Announces FDA Acceptance Of New Drug Application For GATTEX (teduglutide) For The Treatment Of Adult Short Bowel Syndrome (SBS)
1/31/2012
NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, recently announced the U.S. Food and Drug Administration (FDA) has accepted and filed for review the company's New Drug Application (NDA) for GATTEX (teduglutide) for the treatment of adults with short bowel syndrome or SBS.
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Bionest And PMC Address Optimization Of Personalized Medicine Strategies
1/31/2012
Bionest Partners, a premier strategy and management consulting firm for life science industries, and a recognized leader in personalized medicine strategy consulting, announces the publication of an article in a supplement to the Dec. 23, 2011 issue of Science.
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Alkermes Initiates Open-Label Pilot Study Of VIVITROL To Evaluate Impact On Re-Arrest And Re-Incarceration In Offenders With History Of Opioid Dependence
1/31/2012
Alkermes plc recently announced the initiation of a pilot study of VIVITROL (naltrexone for extended-release injectable suspension) in prisoners with a pre-incarceration history of opioid dependence.
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BioLineRx Signs Exclusive License Agreement For BL-8020, An Oral Treatment For Hepatitis C
1/24/2012
BioLineRx, a biopharmaceutical development company, announced recently it has signed a worldwide, exclusive license agreement with Genoscience, a French company focused on viral disease therapeutics, to develop and commercialize BL-8020, an orally available treatment for Hepatitis C. BL-8020 has been developed for anti-viral therapy by Professor Philippe Halfon, Co-Founder and President of Genoscience.
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Pernix Therapeutics Announces Agreement To License A New FDA-Approved Product To Treat Gastroenterology Disease
1/23/2012
Pernix Therapeutics Holdings, Inc., a specialty pharmaceutical company, recently announced it has entered into a license and supply agreement with a private company for a new FDA-approved prescription product to treat gastroenterology disease.
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APP Pharmaceuticals Settles With The Medicines Company On Angiomax (Bivalirudin) Patent Litigation
1/23/2012
APP Pharmaceuticals, Inc., a Fresenius Kabi Company, announced recently that it has settled its litigation with The Medicines Company relating to APP's Abbreviated New Drug Application for a generic version of the anti-clotting drug Angiomax (bivalirudin for injection).
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FDA Updates TYSABRI (Natalizumab) Label To Include Anti-JC Virus Antibody Status As A PML Risk Factor
1/20/2012
Recently Biogen Idec and Elan Corporation, plc announced that the U.S. Food and Drug Administration (FDA) has approved a product label change for TYSABRI that will help enable individual benefit risk assessment for patients with multiple sclerosis (MS).