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News Breaks
April 30, 2014
07:41 EDTBIIBBiogen says TECFIDERA effective in MS patients with high disease activity
New data reinforce the efficacy of TECFIDERA in a wide range of patients with relapsing-remitting multiple sclerosis, as well as support its favorable safety and tolerability profile in the real-world setting. These data were presented by Biogen Idec at the 66th American Academy of Neurology annual meeting in Philadelphia. A new post-hoc analysis from the Phase 3 studies, DEFINE and CONFIRM, reinforce that TECFIDERA can be effective in RRMS patients with high disease activity. In addition, new data from the Phase 4 MANAGE study show that gastrointestinal events experienced by patients in the clinical practice setting were mostly mild to moderate and generally manageable, and significantly decreased in prevalence within the first two months of TECFIDERA treatment. A post-hoc analysis of pooled data from the Phase 3 DEFINE and CONFIRM studies evaluated the efficacy of TECFIDERA in RRMS patients with highly active disease. The findings are consistent with the data from the overall intent-to-treat patient populations in DEFINE and CONFIRM, which supported the regulatory submissions for TECFIDERA globally. Results show that at two years, TECFIDERA taken twice daily significantly reduced annualized relapse rate by 60 percent and the proportion of patients who relapsed by 63 percent. There was no significant effect of TECFIDERA on 12-week confirmed disability progression.
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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
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June 23, 2015
11:00 EDTBIIBOptions with increasing implied volatility
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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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