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News Breaks
March 28, 2014
18:28 EDTBIIBBiogen announces FDA approval for Alprolix
Biogen Idec announced that the U.S. FDA has approved Alprolix, the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative management and routine prophylaxis in adults and children with hemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic infusions starting at least a week apart. Alprolix was recently approved by Health Canada for the treatment of hemophilia B and is currently under review by regulatory authorities in several other countries, including Australia and Japan. Biogen Idec plans to make Alprolix commercially available to people with hemophilia B in the United States in early May.
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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 EMA’s 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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