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News Breaks
January 30, 2014
07:18 EDTBAXBaxter restructures agreement with Xenetic Biosciences
Baxter International announced it has restructured its ongoing agreement with Xenetic Biosciences for the development of BAX 826, a recombinant Factor VIII treatment for hemophilia A under investigation to assess its potential to extend the half-life and duration of effectiveness. This program complements the company’s current development programs, which are focused on improving the pharmacokinetic profile and extending the half-life of blood coagulation factors, including Factor VIII. Xenetic and Baxter previously established an exclusive worldwide agreement to develop novel forms of polysialylated blood coagulation factors, including Factor VIII, using Xenetic’s proprietary polysialic acid technology. Under the terms of the restructured arrangement, Baxter will make an equity investment in the common stock of Xenetic and has agreed to make contingent milestone payments as well as pay royalties on future sales. Baxter recently announced the completion of enrollment in a Phase III clinical trial of BAX 855, its investigational, extended half-life, recombinant Factor VIII treatment for hemophilia A. The company continues to expect to file for regulatory approval for BAX 855 in the United States by the end of 2014. The company also said a Phase I/II open-label clinical trial to assess the safety and optimal dosing schedule of BAX 335, an investigational Factor IX gene therapy treatment for hemophilia B, is underway and the first patients have been dosed.
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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