FDA approves Amgen's XGEVA® (denosumab) for the treatment of giant cell tumor of bone
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- Category: Amgen
Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for XGEVA® (denosumab) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.
Bristol-Myers Squibb and Simcere enter partnership to co-develop and co-commercialize Orencia® SC (abatacept) in China
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE: BMY) and Simcere Pharmaceutical Group (NYSE: SCR), a leading pharmaceutical company in China, today announced that the companies have expanded their strategic relationship formed in 2010. The companies have agreed to collaborate in China on the development and commercialization of the subcutaneous (SC) formulation of Bristol-Myers Squibb's biologic medicine, Orencia® (abatacept), for the treatment of rheumatoid arthritis.
Pfizer obtains $2.15 billion settlement from Teva and Sun for infringement of Protonix® patent
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- Category: Pfizer
Pfizer Inc. announced today a $2.15 billion settlement reached with Teva Pharmaceuticals Industries, Limited and Sun Pharmaceutical Industries, Limited for patent-infringement damages resulting from their "at-risk" launches of generic Protonix® in the United States.
New four-strain influenza vaccine from Sanofi Pasteur now licensed by FDA
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- Category: Sanofi
Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for licensure of its four-strain influenza vaccine, Fluzone Quadrivalent vaccine. Fluzone Quadrivalent vaccine is the newest addition to the Fluzone family of influenza vaccines.
AstraZeneca to acquire Pearl Therapeutics to strengthen respiratory portfolio
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- Category: AstraZeneca
AstraZeneca announced today that it has entered into a definitive agreement to acquire Pearl Therapeutics, a privately held company based in Redwood City, California, focused on the development of inhaled small-molecule therapeutics for respiratory disease.
Boehringer Ingelheim pioneers biopharmaceuticals move to China
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- Category: Boehringer Ingelheim
Boehringer Ingelheim has signed with Zhangjiang Biotech & Pharmaceutical Base Development Company in Pudong, Shanghai a strategic alliance agreement and contract to build a cGMP biopharmaceuticals facility. The new site will provide full range of development and clinical services to Chinese and multi-national customers.
FDA grants Priority Review to Bristol-Myers Squibb and AstraZeneca's Metreleptin
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- Category: Bristol-Myers Squibb
Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted a Priority Review designation for the Biologics License Application (BLA) for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy (LD), a rare disease estimated to affect a few thousand people around the world, often with an early age of onset.
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