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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.
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June 26, 2015
05:21 EDTBIIBBiogen, Sobi announce EMA validates MAA for Alprolix
Biogen and Swedish Orphan Biovitrum AB, or Sobi, announced that the European Medicines Agency, or EMA, has accepted the Marketing Authorization Application, or MAA, of Alprolix, a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. This validation signifies the initiation of the EMAís review process. The MAA includes results from two global, Phase 3 clinical trials examining the efficacy, safety and pharmacokinetics of ALPROLIX for hemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and Kids B-LONG study for previously treated children under age 12.
June 25, 2015
12:59 EDTBIIBOptions with increasing implied volatility
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June 24, 2015
11:16 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility: WMB AMZN CMG BIIB VMW QLIK ISRG FB UA FFIV
June 23, 2015
11:00 EDTBIIBOptions with increasing implied volatility
Options with increasing implied volatility:TRIP WPZ CMG BIIB WMB AMZN ISRG VMW
07:55 EDTBIIBBiogen's Tysabri in SPMS a $1B-$2B opportunity, says Morgan Stanley
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June 18, 2015
07:36 EDTBIIBReceptos remains an attractive takeover candidate, says Leerink
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07:31 EDTBIIBBiogen to present new hemophilia data at ISTH Congress
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