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News Breaks
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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November 25, 2014
11:08 EDTBIIBBiogen to add PML info on Tecfidera label after patient dies
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11:04 EDTBIIBFDA says Biogen adding PML information on Tecfidera label
November 24, 2014
07:59 EDTBIIBBiogen resumed with an Outperform at Leerink
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November 19, 2014
07:52 EDTBIIBInforma Business Information to hold a conference
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07:21 EDTBIIBBiogen price target lowered to $400 from $425 at Credit Suisse
Credit Suisse lowered Biogen's price target to $400 from $425 based on Gilenya PPMS risk but retains its Outperform rating based on the quality of earnings growth and pipeline.

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