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News Breaks
January 23, 2014
08:45 EDTBAXBaxter says recently received FDA warning letter on manufacturing
Baxter said it recently received an FDA warning letter primarily directed to its quality systems in Round Lake, Illinois for certain medical devices. Baxter says it is working with FDA on issues noted in the warning letter and that the company does not expect an impact on product availability based on the letter. The company also said, that while "it took longer than we expected" to complete the regulatory process, the company is "pleased" with the progress it is making on the integration of Gambro. Comments made during Q4 earnings conference call.
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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