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News Breaks
July 31, 2014
14:00 EDTHALO, BAXBaxter, Halozyme announce favorable FDA panel recommendation on HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that the Blood Products Advisory Committee of the FDA voted 15-1 that HyQvia, Baxter’s investigational subcutaneous treatment for patients with primary immunodeficiency, has a favorable risk/benefit profile. ''We are hopeful that the positive support for HyQvia is the next step toward providing a new treatment option for patients with primary immunodeficiency in the United States. We look forward to working closely with the FDA as it completes its review,'' said Ludwig Hantson, Ph.D., president of Baxter BioScience. HyQvia was approved in Europe in 2013 for adults with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections. HyQvia is a product consisting of human normal immunoglobulin and recombinant human hyaluronidase, licensed from Halozyme.
News For BAX;HALO 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 EDTBAX, HALOOn 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 EDTBAX, HALOFDA 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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September 3, 2014
08:31 EDTHALOHalozyme's PEGPH20 program receives fast track designation
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