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Achillion Pharmaceuticals Inc. (NASDAQ:ACHN), New Haven, Conn. Product: ACH-3102 Business: Infectious FDA granted Fast Track designation for Achillion's ACH-3102 as part of an interferon-free regimen to treat chronic …
Published on 5/21/2012
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Vectura Group plc (LSE:VEC), Chippenham, U.K. Baxter International Inc. (NYSE:BAX), Deerfield, Ill. Product: Advate octocog alfa Business: Hematology Baxter said China's State Food and Drug Administration (SFDA) …
Published on 5/21/2012
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Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Androxal enclomiphene Business: Endocrine/Metabolic Repros said FDA received the company's submission of required documentation for an SPA for 2 …
Published on 5/21/2012
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Arno Therapeutics Inc. (OTCBB:ARNI), Parsippany, N.J. Product: AR-42 Business: Cancer Arno said the European Commission granted Orphan Drug designation for AR-42 to treat neurofibromatosis type 2. The compound is in …
Published on 5/21/2012
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Cytomedix Inc. (OTCBB:CMXI), Gaithersburg, Md. Product: AutoloGel System Business: Dermatology The Centers for Medicare & Medicaid Services (CMS) issued a proposed decision memo supporting coverage of autologous …
Published on 5/21/2012
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BG Medicine Inc. (NASDAQ:BGMD), Waltham, Mass. Product: BGM Galectin-3 heart failure risk test Business: Diagnostic BG Medicine received CE Mark approval to expand the indication for its BGM Galectin-3 heart failure …
Published on 5/21/2012
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Idaho Technology Inc., Salt Lake City, Utah Product: FilmArray Respiratory Panel Business: Diagnostic FDA granted Idaho Technology 510(k) clearance for its FilmArray Respiratory Panel to include the diagnosis of 5 viral…
Published on 5/21/2012
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Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508), Osaka, Japan Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Gilenya (Imusera) fingolimod (FTY720) Business: Autoimmune FDA completed its safety …
Published on 5/21/2012
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Pharmacyclics Inc. (NASDAQ:PCYC), Sunnyvale, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Ibrutinib (formerly PCI-32765) Business: Cancer Pharmacyclics disclosed in its 3Q12 earnings that FDA …
Published on 5/21/2012
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Intelligent Medical Devices Inc., Cambridge, Mass. Abbott Laboratories (NYSE:ABT), Abbott Park, Ill. Product: IMDx GBS for Abbott m2000 Business: Diagnostic Intelligent Medical Devices received CE Mark approval for its …
Published on 5/21/2012
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Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Kiklin bixalomer (AMG 223, ASP1585) (formerly ILY101) Business: Endocrine/Metabolic In March, Astellas said Japan'…
Published on 5/21/2012
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Rosetta Genomics Ltd. (NASDAQ:ROSG), Rehovot, Israel Product: MiRview mets2 Business: Diagnostic Rosetta said Medicare administrative contractor Novitas Solutions Inc. informed the company it would cover the company's …
Published on 5/21/2012
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OraSure Technologies Inc. (NASDAQ:OSUR), Bethlehem, Pa. Product: OraQuick In-Home HIV test (formerly OraQuick Rapid HIV-1/2 test) Business: Diagnostic FDA's Blood Products Advisory Committee voted 17-0 that data show …
Published on 5/21/2012
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Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Plavix clopidogrel Business: Cardiovascular FDA approved generic versions of cardiovascular drug Plavix …
Published on 5/21/2012
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Osiris Therapeutics Inc. (NASDAQ:OSIR), Columbia, Md. JCR Pharmaceuticals Co. Ltd. (Osaka:4552; Tokyo:4552), Ashiya, Japan Product: Prochymal remestemcel-L Business: Transplant Health Canada granted conditional approval…
Published on 5/21/2012
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Ohr Pharmaceutical Inc. (OTCBB:OHRP), Salt Lake City, Utah Product: Squalamine eye drops Business: Ophthalmic FDA granted Fast Track designation for Ohr's squalamine eye drops to treat wet age-related macular …
Published on 5/21/2012
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Allergan Inc. (NYSE:AGN), Irvine, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Tazarotene Business: Dermatology FDA approved an NDA from GlaxoSmithKline's Stiefel Laboratories Inc. subsidiary …
Published on 5/21/2012
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Curetis AG, Holzgerlingen, Germany Product: Unyvero P50 Cartridge Business: Diagnostic Curetis received CE mark approval for the Unyvero System and the Unyvero P50 Pneumonia Cartridge for diagnosing pneumonia infection …
Published on 5/21/2012
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Abbott Laboratories (NYSE:ABT), Abbott Park, Ill. Product: Xience Prime, Xience V (Promus) Business: Cardiovascular Abbott said the Xience Prime and Xience V everolimus-eluting coronary stent systems received CE Mark …
Published on 5/21/2012
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BTG plc (LSE:BGC), London, U.K. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Zytiga abiraterone acetate (CB7630) Business: Cancer The U.K.'s NICE issued draft guidance recommending Zytiga abiraterone from …
Published on 5/21/2012
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Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Androxal enclomiphene Business: Endocrine/Metabolic Repros said it reached an agreement with FDA on the design of 2 Phase III trials for oral …
Published on 5/14/2012
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Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Product: Arcalyst rilonacept (formerly IL-1 Trap) Business: Endocrine/Metabolic FDA's Arthritis Advisory Committee voted 11-0 that efficacy and safety data …
Published on 5/14/2012
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Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Product: BG-12 Business: Autoimmune FDA and EMA accepted for review regulatory applications from Biogen Idec for BG-12 to treat multiple sclerosis (MS). The compound is an …
Published on 5/14/2012
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Allergan Inc. (NYSE:AGN), Irvine, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Botox onabotulinumtoxinA (formerly botulinum toxin) Business: Neurology The U.K.'s NICE issued a final appraisal …
Published on 5/14/2012
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Gentium S.p.A. (NASDAQ:GENT), Como, Italy Sigma-Tau Group, Pomezia, Italy Product: Defibrotide Business: Hepatic Gentium said it received Day 180 questions from EMA's CHMP related to the review of an MAA for defibrotide…
Published on 5/14/2012