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AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) fell $2.68 (11%) to $22.40 on Wednesday after disclosing in an SEC filing that partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) is recalling a batch of anemia drug Rienso …
Published on 5/22/2013
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HHS's Biomedical Advanced Research and Development Authority (BARDA) awarded GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) $40 million for an initial 18-month period to develop GSK's portfolio of antibacterial candidates to …
Published on 5/22/2013
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FDA's Drug Safety and Risk Management Advisory Committee will meet on July 10 to discuss the REMS with elements of safe use (ETASU) for Lotronex alosetron from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner …
Published on 5/22/2013
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Biogen Idec Inc. (NASDAQ:BIIB) submitted a BLA to FDA for Plegridy peginterferon beta-1a (BIIB017) to treat relapsing forms of multiple sclerosis (MS). The company said it expects to submit MAA to EMA "in the coming …
Published on 5/21/2013
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The European Commission approved an MAA from Baxter International Inc. (NYSE:BAX) for HyQvia as replacement therapy for adults with primary immunodeficiencies. The product is also approved as replacement therapy in …
Published on 5/21/2013
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Veloxis Pharmaceuticals A/S (CSE:VELO) said EMA accepted for review an MAA for LCP-Tacro tacrolimus to prevent organ rejection in kidney transplant patients. The company said it expects a decision on the application …
Published on 5/21/2013
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Gilead Sciences Inc. (NASDAQ:GILD) said EMA accepted for accelerated assessment an MAA for sofosbuvir to treat chronic HCV infection. An accelerated assessment shortens the review period to 150 days from 210. Gilead …
Published on 5/21/2013
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Novo A/S (Hellerup, Denmark) will acquire infectious disease company Xellia Pharmaceuticals A/S (Oslo, Norway) from private equity firm 3i Group for about $700 million. In 2008, 3i acquired Xellia, which develops and …
Published on 5/21/2013
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Roche (SIX:ROG; OTCQX:RHHBY) said it declined to exercise its option to license STX209 from Seaside Therapeutics Inc. (Cambridge, Mass.) for autism after Seaside reported earlier this month that the compound missed the …
Published on 5/21/2013
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Generics company Actavis Inc. (NYSE:ACT) will acquire specialty pharma Warner Chilcott plc (NASDAQ:WCRX) in a stock deal that values Warner Chilcott at about $5 billion. Warner Chilcott shareholders will receive 0.16 …
Published on 5/20/2013
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Elan Corp. plc (NYSE:ELN) announced two proposed acquisitions on Monday, including a proposal to buy rare disease company AOP Orphan Pharmaceuticals AG (Vienna, Austria) for EUR 175.7 million ($225.5 million) in cash …
Published on 5/20/2013
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FDA reviewers said insomnia candidate suvorexant from Merck & Co. Inc. (NYSE:MRK) is effective at promoting sleep, but questioned the product's safety profile as well as the pharma's proposed dosing levels. In briefing …
Published on 5/20/2013
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Bayer AG (Xetra:BAYN) submitted a regulatory application in Japan for riociguat to treat chronic thromboembolic pulmonary hypertension (CTEPH). The oral soluble guanylyl cyclase (sGC) stimulator is under Priority Review…
Published on 5/17/2013
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Germany's Federal Joint Committee (G-BA) issued a final benefit assessment rebuffing diabetes drug Trajenta linagliptin from Boehringer Ingelheim GmbH (Ingelheim, Germany) as add-on therapy to insulin with or without …
Published on 5/17/2013
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TaiGen Biotechnology Co. Ltd. (Taipei, Taiwan) submitted a pair of NDAs in Taiwan and China for oral nemonoxacin to treat community-acquired pneumonia (CAP). The company, which said these are the first applications …
Published on 5/17/2013
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Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) jumped $14.73 (31%) to $61.70 on Thursday after the company said late Wednesday that the "launch metrics" for Juxtapid lomitapide are ahead of the company's internal plan and …
Published on 5/16/2013
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Evotec AG (Xetra:EVT) and Harvard University partnered to discover and develop small molecule inhibitors of peptidoglycan biosynthesis. Harvard will contribute research on proprietary assays, chemical starting points …
Published on 5/16/2013
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FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet on July 17 to discuss an NDA from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. …
Published on 5/16/2013
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Germany's Federal Joint Committee (G-BA) said in a final assessment that lymphoma drug Adcetris brentuximab vedotin from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) has an "unquantifiable" degree of additional benefit. …
Published on 5/16/2013
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IBM Corp. (NYSE:IBM) and UCB Group (Euronext:UCB) partnered to develop a point-of-care analytics system to predict the probability of success of epilepsy treatments to inform treatment decisions. The partners said they …
Published on 5/16/2013
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Neurology company Intra-Cellular Therapies Inc. (New York, N.Y.) appointed Sir Michael Rawlins, former chairman of the U.K.'s NICE, as a director. Rawlins' term ended on March 31, 2013; he had been chairman since the …
Published on 5/16/2013
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Roche (SIX:ROG; OTCQX:RHHBY) partnered with the California Institute for Quantitative Biosciences (QB3) to launch the Collaborative Startups program to identify, fund and support early life science startups in the San …
Published on 5/16/2013
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India's Association of Biotechnology Led Enterprises sent a letter to the Drug Controller General of India (DCGI) asking whether the approval of biosimilar Etacept from Cipla Ltd. (Mumbai, India) was based on India's …
Published on 5/15/2013
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The Bayer Healthcare LLC subsidiary of Bayer AG (Xetra:BAYN) partnered with the California Institute for Quantitative Biosciences (QB3) under a three-year deal to evaluate and support life science startups from QB3. The…
Published on 5/15/2013
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FDA approved an NDA from Bayer AG (Xetra:BAYN) for Xofigo radium-223 dichloride to treat castration-resistant prostate cancer (CRPC) in patients with symptomatic bone metastases. Xofigo is indicated for men whose cancer…
Published on 5/15/2013