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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
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A German court on Wednesday dismissed a suit from Novartis AG (NYSE:NVS; SIX:NOVN) seeking to block the assessment of the pharma's Type II diabetes drugs in the dipeptidyl peptidase-4 (DPP-4) inhibitor (gliptin) class. …
Published on 5/15/2013
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Alvine Pharmaceuticals Inc. (San Carlos, Calif.) granted AbbVie Inc. (NYSE:ABBV) an exclusive option to acquire the company or its ALV003, which is in Phase II testing to treat celiac disease, under undisclosed terms. …
Published on 5/14/2013
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FDA approved an sNDA from Astellas Pharma Inc. (Tokyo:4503) on Tuesday to expand the label for Tarceva erlotinib and also approved the cobas EGFR Mutation Test from partner Roche (SIX:ROG; OTCQX:RHHBY) as a companion …
Published on 5/14/2013
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Seattle Genetics Inc. (NASDAQ:SGEN) said FDA accepted for review an sBLA to expand the label of Adcetris brentuximab vedotin to include retreatment and an extended duration of treatment beyond 16 cycles in relapsed …
Published on 5/14/2013
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AbbVie Inc. (NYSE:ABBV) disclosed in an SEC filing that SVP and CSO John Leonard will retire in the "next few months." AbbVie said Leonard will be involved in the transition process for naming his successor. Leonard was…
Published on 5/13/2013
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Cempra Inc. (NASDAQ:CEMP) granted Toyama Chemical Co. Ltd. exclusive rights to develop and commercialize solithromycin in Japan. The fluoroketolide/macrolide antibiotic is in Phase III testing to treat moderate to …
Published on 5/13/2013
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Biogen Idec Inc. (NASDAQ:BIIB) said FDA accepted for review a BLA for Eloctate rFVIIIFc to treat hemophilia A. The company submitted the application in March; a standard review would place the PDUFA date in March 2014, …
Published on 5/13/2013
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FDA accepted and granted Priority Review to an NDA from the Janssen Research & Development LLC unit of Johnson & Johnson (NYSE:JNJ) for simeprevir to treat HCV genotype 1 infection in adult patients with compensated …
Published on 5/13/2013
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Vectura Group plc (LSE:VEC) partnered with Tianjin KingYork Group Co. Ltd. and private equity investor Zendex Bio Strategy to form a JV -- Tianjin Kinnovata Pharmaceutical Co. Ltd. -- to develop and commercialize …
Published on 5/13/2013
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Shares of generics company Actavis Inc. (NYSE:ACT) and specialty pharma Warner Chilcott plc (NASDAQ:WCRX) jumped on Friday after the companies disclosed before market close they are in "early stage" discussions to merge…
Published on 5/10/2013
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Shares of Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics Inc. (NASDAQ:PTIE) slid on Friday after partner Pfizer Inc. (NYSE:PFE) disclosed in an SEC filing that if it "elect[s] to continue development" of Remoxy …
Published on 5/10/2013
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FDA denied a 2012 Citizen Petition from Endo Health Solutions Inc. (NASDAQ:ENDP) asking the agency to determine that the original formulation of the company's pain drug Opana ER oxymorphone had been withdrawn due to …
Published on 5/10/2013