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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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February 27, 2015
07:37 EDTBIIBBiogen removed from the short-term buy list at Deutsche Bank
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07:19 EDTBIIBBiogen, Sobi report Phase 3 Alprolix paediatric study meets primary endpoint
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07:10 EDTBIIBBiogen Idec, Swedish Orphan Biovitrum AB announce positive Alprolix results
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February 26, 2015
08:15 EDTBIIBBiogen shares likely to continue to advance, says RBC Capital
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February 25, 2015
06:14 EDTBIIBPTC Therapeutics takeout price likely tops $100/share, said Credit Suisse
Credit Suisse yesterday raised its price target for PTC Therapeutics (PTCT) shares to $100 from $66 after Reuters reported the drug market is starting a sale process with Shire (SHPG) and Biomarin (BMRN) as possible suitors. The firm believes a takeout is a likely outcome before or after data the Phase III data expected to be announced in October. PTC has Translarna Phase III trials ongoing in Duchenne muscular dystrophy and cystic fibrosis to support full approval in the U.S. Credit Suisse said yesterday in a note to investors that a takeout value for the company likely exceeds $100 per share. It believes PTC would be a good fit for Vertex (VRTX), Biogen (BIIB), Roche (RHHBY) and others. The firm kept an Outperform rating on the stock. PTC Therapeutics shares closed yesterday up $6.20 to $71.16.
February 19, 2015
18:25 EDTBIIBPiper Jaffray biotech analyst to hold analyst/industry conference call
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14:08 EDTBIIBBiogen consortium identifies new ALS gene and signaling pathways
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February 13, 2015
08:19 EDTBIIBAckman noncommittal on McDonald's rumors, Bloomberg reports
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