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January 4, 2013
07:34 EDTBIIBBiogen submits application to FDA for factor IX therapy for Hemophilia B
Biogen Idec says it recently submitted a Biologics License Application to the U.S. Food and Drug Administration for the marketing approval of recombinant factor IX Fc fusion protein for the treatment of hemophilia B. rFIXFc is the first product candidate in a new class of long-lasting clotting factor therapies that are being developed with the goals of reducing the burden of treatment for this condition and enhancing protection from bleeding. The regulatory submission was based on results from B-LONG, the largest registrational phase 3 clinical study in hemophilia B to date. Biogen Idecís BLA submission to the U.S. FDA for rFVIIIFc for use in patients with hemophilia A is on track for filing in 1H 2013.
News For BIIB From The Last 14 Days
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October 1, 2014
07:39 EDTBIIBBiogen reinstated with a Neutral at BofA/Merrill
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September 29, 2014
07:26 EDTBIIBInforma Business Information to hold a conference
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September 22, 2014
07:21 EDTBIIBEBD Group to hold a conference
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