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FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended approval of once-daily suvorexant from Merck & Co. Inc. (NYSE:MRK) to treat insomnia. The panel concluded suvorexant is an effective sleep…
Published on 5/22/2013
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Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and partner Sanofi (Euronext:SAN; NYSE:SNY) said once-weekly subcutaneous dupilumab met the primary endpoint of reducing the proportion of patients who experienced an asthma …
Published on 5/21/2013
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Royalty Pharma (New York, N.Y.) raised its offer to acquire Elan Corp. plc (NYSE:ELN) on Monday shortly after Elan announced a flurry of proposed moves, including two proposed acquisitions, a spinout, a share buyback …
Published on 5/20/2013
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Sanofi (Euronext:SAN; NYSE:SNY) said once-daily 400 and 500 mg doses of oral SAR302503 each met the primary endpoint in the Phase III JAKARTA trial to treat primary myelofibrosis (PMF), post-polycythemia vera …
Published on 5/17/2013
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Gilead Sciences Inc. (NASDAQ:GILD) said twice-daily oral idelalisib plus rituximab led to an overall response rate (ORR) of 97% in the 64-patient Phase II Study 101-08 to treat previously untreated chronic lymphocytic …
Published on 5/16/2013
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Roche (SIX:ROG; OTCQX:RHHBY) and its Genentech Inc. unit submitted regulatory applications to FDA and EMA for obinutuzumab (GA101) to treat chronic lymphocytic leukemia (CLL). The submissions were based on data from the…
Published on 5/15/2013
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Astellas Pharma Inc. (Tokyo:4503) said it will close its OSI Pharmaceuticals LLC and Perseid Therapeutics LLC units and scale back its Astellas Research Institute of America LLC unit to focus on CNS therapies as part of…
Published on 5/14/2013
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Theravance Inc. (NASDAQ:THRX) gained $6.26 (18%) to $41.20 on Monday after Elan Corp. plc (NYSE:ELN) said it will pay $1 billion in cash in exchange for a 21% interest in the royalties Theravance is eligible to receive …
Published on 5/13/2013
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Theravance Inc. (NASDAQ:THRX) gained $3.63 (12%) to $34.94 on Friday after FDA approved an NDA from partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for Breo Ellipta fluticasone furoate/vilanterol as maintenance therapy …
Published on 5/10/2013
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Trevena Inc. (King of Prussia, Pa.) granted Forest Laboratories Inc. (NYSE:FRX) an exclusive option to license worldwide development and commercialization rights to Trevena's TRV027, which has completed a Phase IIa …
Published on 5/9/2013
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Nimbus Discovery LLC (Cambridge, Mass.) and Shire plc (LSE:SHP; NASDAQ:SHPG) partnered to discover and develop oral small molecules against an undisclosed target to treat lysosomal storage disorders. Nimbus will use its…
Published on 5/8/2013
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Isis Pharmaceuticals Inc. (NASDAQ:ISIS) released 1Q13 earnings late Tuesday and also said it plans to sell 9 million shares in a follow-on underwritten by Goldman Sachs; JPMorgan; Stifel Nicolaus Weisel; BMO Capital …
Published on 5/7/2013
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Celgene Corp. (NASDAQ:CELG) partnered with Concert Pharmaceuticals Inc. (Lexington, Mass.) to develop deuterium-modified compounds for cancer and inflammation. The deal will initially focus on one jointly selected …
Published on 5/6/2013
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Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) gained $17.53 to $266.16 on Friday after reporting 1Q13 revenues that beat the Street and announcing it acquired full rights from Sanofi (Euronext:SAN; NYSE:SNY) to two …
Published on 5/3/2013
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EMA said biosimilar sponsors who use a reference product approved outside the EU must provide data from analytical studies showing an "acceptable bridge" between the biosimilar, the non-EU reference product and the EU-…
Published on 5/2/2013
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The U.S. Department of Justice on Wednesday filed an appeal in the U.S. District Court for the Eastern District of New York of an April order compelling FDA to make emergency contraceptives containing levonorgestrel …
Published on 5/1/2013
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Aveo Pharmaceuticals Inc. (NASDAQ:AVEO) fell $2.33 (31%) to $5.11 on Tuesday after FDA reviewers questioned whether a single Phase III trial is sufficient to support approval of tivozanib to treat renal cell carcinoma (…
Published on 4/30/2013
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Celgene Corp. (NASDAQ:CELG) partnered with Forma Therapeutics Holdings LLC (Watertown, Mass.) to discover, develop and commercialize compounds that regulate protein homeostasis for multiple disease areas with an …
Published on 4/29/2013
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EMA's CHMP issued a number of positive recommendations on Friday, including a recommendation to approve an MAA from Astellas Pharma Inc. (Tokyo:4503) for Xtandi enzalutamide to treat metastatic castration-resistant …
Published on 4/26/2013
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Even under a "best case" scenario, a vaccine to protect against the new H7N9 avian influenza virus will not be available in the U.S. until the fall, Robin Robinson, director of HHS's Biomedical Advanced Research and …
Published on 4/25/2013
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Galapagos N.V. (Euronext:GLPG; Pink:GLPYY) said late Wednesday that it raised EUR 53.9 million ($70.5 million) through the sale of 2.7 million shares at EUR 20 in a private placement to institutional investors. …
Published on 4/24/2013
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AbbVie Inc. (NYSE:ABBV) reported additional data from the Phase IIb Aviator (Study M11-652) trial of an interferon-free regimen that includes three of Abbott's antivirals to treat HCV genotype 1 infection in non-…
Published on 4/23/2013
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AstraZeneca plc (LSE:AZN; NYSE:AZN) announced two early stage cancer deals on Monday, including a deal with Bind Therapeutics Inc. (Cambridge, Mass.) to develop and commercialize an Accurin based on an undisclosed …
Published on 4/22/2013
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FDA Commissioner Margaret Hamburg said on Thursday that she supports exempting user fees from sequestration. She said sequestering fees would hurt FDA's ability to meet negotiated performance goals. Hamburg also said …
Published on 4/19/2013
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Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) jumped $28.58 (54%) in early after-hours trading after reporting data from a Phase II trial of VX-661 to treat cystic fibrosis (CF). All VX-661 monotherapy and combination arms …
Published on 4/18/2013