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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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April 15, 2015
07:14 EDTBIIBBiogen volatility flat into new drug data
Biogen overall option implied volatility of 35 compares to its 26-week average of 34 according to Track Data, suggesting non-directional into results as shares rally in the preopen on Phase 2 RENEW study of anti-LINGO-1 in acute optic neuritis clinical data.
April 14, 2015
18:30 EDTBIIBOn The Fly: After Hours Movers
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16:12 EDTBIIBBiogen presents new Anti-LINGO-1 Phase 2 AON data
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11:25 EDTBIIBPTAB declares interference between Forward Pharma and Biogen regarding treatment
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April 9, 2015
09:25 EDTBIIBPiper Jaffray pharmaceuticals analysts hold an analyst/industry conference call
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07:27 EDTBIIBBiogen PML death case previously reported, says Deutsche Bank
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07:23 EDTBIIBDoctors report case of fatal PML in patient treated with Tecfidera to NEJM
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April 8, 2015
07:24 EDTBIIBNeurotechnology Industry Organization to hold a conference
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April 7, 2015
07:31 EDTBIIBBiogen to present data on neurological disease therapies at AAN meeting
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07:14 EDTBIIBEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.

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