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April 16, 2014
08:48 EDTBAXBaxter says meets primary endpoint in Phase 3 BAX 111 trial
Baxter International announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics of BAX 111. BAX 111 is a recombinant von Willebrand factor under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder. The study of BAX 111, the first recombinant treatment in clinical development for this condition, met its primary efficacy endpoint, as all patients achieved pre-specified success in the on-demand treatment of bleeding events. The Phase 3 multicenter, open-label clinical trial assessed the safety, efficacy and pharmacokinetics of BAX 111 administered together with ADVATE or as a stand-alone therapeutic agent in the on-demand treatment of 37 patients with severe von Willebrand disease at trial sites in the United States, Europe, Australia, Japan, Russia and India. The primary endpoint was the number of patients experiencing successful treatment for bleeding episodes. Secondary endpoints included additional efficacy and safety measures, pharmacokinetics and health-related quality of life. There were no reports of inhibitor development or thrombotic events in the study participants. The most common adverse events in the study were headache, vomiting/nausea and anemia (iron deficiency anemia), which were not considered to be related to treatment. There was one serious adverse event related to treatment, characterized by chest discomfort and increased heart rate during infusion, which rapidly resolved without further complication. The investigational treatment was developed using a plasma- and albumin-free manufacturing method.
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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