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News Breaks
August 7, 2014
09:03 EDTBAXBaxter opens biologics facility in Singapore
Baxter International announced the formal opening of its first advanced recombinant biologic facility in Singapore, and expansion plans for a new recombinant protein processing suite. The current suite supports the processing of ADVATE.The second suite will initially process RIXUBIS, a recombinant factor IX protein for the treatment of adults with hemophilia B and, when operational, will be the primary global commercial processing facility. It will also support production of the company’s investigational extended half-life recombinant FVIII treatment BAX 855 upon regulatory approval. The Singapore facility received regulatory approval from the European Medicines Agency in January 2014 for the production of ADVATE2. This allows the facility to process and supply ADVATE to the European Union, Iceland and Norway. The biologics facility in Singapore currently employs more than 400 production staff and expects to reach 450 by 2015 to support the second processing suite.
News For BAX From The Last 14 Days
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September 17, 2014
08:44 EDTBAXJPMorgan biotech analysts hold an analyst/industry conference call
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September 15, 2014
09:16 EDTBAXOn The Fly: Pre-market Movers
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09:01 EDTBAXBaxter announces FDA approval for RIXUBIS
(BAX) announced that the U.S. Food and Drug Administration has approved RIXUBIS for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX approved for routine prophylaxis and control of bleeding episodes in the U.S. for adults living with this chronic condition. The approval is based on the results of a clinical trial investigating the efficacy and safety of RIXUBIS among 23 previously-treated male patients less than 12 years of age with severe or moderately severe hemophilia B. There were no reports of inhibitor development, no severe allergic reactions, and no thrombotic or treatment-related adverse events among the study participants. Baxter’s application for marketing approval for RIXUBIS for adults and pediatric patients is currently under review in the EU, with a regulatory decision expected later this year. The treatment also recently gained regulatory approval in Australia.
September 12, 2014
20:32 EDTBAXFDA approves Baxter's HYQVIA for treatment of primary immunodeficiency
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September 11, 2014
08:15 EDTBAXBaxter says separation on track for mid-2015, new company to be called 'Baxalta'
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September 8, 2014
05:47 EDTBAXBaxter price target raised to $96 from $85 at Piper Jaffray
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