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News Breaks
January 16, 2013
05:23 EDTELN, BIIBBiogen Idec, Elan submit applications for first-line use of Tysabri
Biogen Idec (BIIB) and Elan Corporation (ELN) announced that they have submitted applications to the FDA and European Medicines Agency, or EMA, requesting updates to the Tysabri labels. The applications request an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis, or MS, who have tested negative for antibodies to the JC virus, or JCV. A formal assessment of both applications is ongoing. These submissions are supported by risk stratification data and a risk algorithm that enables physicians and individuals living with MS to make informed decisions when considering treatment with Tysabri. If approved, a first-line label will allow all appropriate anti-JCV antibody negative patients to consider Tysabri early in the course of treatment, regardless of the level of disease activity or prior treatment history. Tysabri is a highly efficacious treatment that has been shown to slow disability progression by 42%-54% and reduce annualized relapse rates by 68%.
News For BIIB;ELN 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.
November 13, 2014
10:42 EDTBIIBSummer Street chief scientific officer holds an analyst/industry conference call
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November 12, 2014
08:13 EDTBIIBBoston Biotech to hold a conference
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