Provider: Wright Reports
Swedish Orphan Biovitrum AB: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
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Biogen Idec Inc and Swedish Orphan Biovitrum AB Announce Positive Results from Phase 3 Study Investigating Long-Lasting Recombinant Factor VIII FC Fusin Protein in Hemophilia A
Biogen Idec Inc and Swedish Orphan Biovitrum AB announced positive results from A-LONG, a clinical study that evaluated a new long-lasting clotting factor candidate in people with hemophilia A. Hemophilia A is a rare inherited disorder that impairs blood coagulation. Top-line results from A-LONG, a global, multi-center, Phase 3 clinical study of the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc), showed that rFVIIIFc was effective in the control and prevention of bleeding, routine prophylaxis and perioperative management. Recombinant FVIIIFc was generally well-tolerated. Additional analyses of the A-LONG study are ongoing, and the companies anticipate presenting detailed results at a future scientific meeting. Biogen Idec plans to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013. Consistent with guidelines published by the European Medicines Agency (EMA) that require a study in children less than 12 years of age prior to filing, Biogen Idec and Swedish Orphan Biovitrum expect to file a Marketing Authorization Application with the EMA upon completion of the ongoing Kids A-LONG study.
Latest Developments for Swedish Orphan Biovitrum publ AB
- Swedish Orphan Biovitrum publ AB Receives Approval for Kineret for Treatment of CAPS
- Swedish Orphan Biovitrum publ AB Maintains FY 2013 Revenue Guidance
- Swedish Orphan Biovitrum publ AB Submits Application for Orfadin Oral Suspension to FDA
- Swedish Orphan Biovitrum publ AB Receives Positive CHMP Opinion for Kineret for Treatment of Rare Disease CAPS
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