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Stock Market & Financial Investment News

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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August 15, 2014
18:35 EDTBIIBBiogen PLEGRIDY approved in U.S. for treatment of multiple sclerosis
Biogen Idec announced that the FDA has approved PLEGRIDY, a new treatment for people with relapsing forms of multiple sclerosis, or RMS. PLEGRIDY is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe. The FDA approval of PLEGRIDY is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients.
07:01 EDTBIIBIsis Pharmaceuticals earns $2M from advancement of ISIS-SMN from Biogen
Isis Pharmaceuticals (ISIS) announced that it has earned a $2M milestone payment from Biogen (BIIB) related to the advancement of the ongoing open-label extension study of ISIS-SMNRx in children with spinal muscular atrophy.
August 11, 2014
10:50 EDTBIIBBiogen weakness attributed to Forward Pharma IPO filing
Shares of Biogen Idec (BIIB) came off their earlier highs and moved into negative ground in early trading, with some attributing the move lower to another pharmaceutical company, Forward Pharma (FWP), filing its registration statement with the SEC relating to a proposed initial public offering and reporting that Joel Sendek has been appointed CFO. WHAT'S NOTABLE: Forward Pharma focuses on a proprietary formulation of dimethyl fumarate, or DMF, for the treatment of multiple sclerosis. DMF is the Active Pharmaceutical Ingredient, or API, found in Tecfidera, which Biogen Idec began selling for the treatment of RRMS following approval by the FDA in March 2013 and approval by the European Commission in February 2014, Forward Pharma indicated in its IPO filing. In addition to its filing, Forward Pharma announced this morning that it has hired Joel Sendek from Stifel Financial, where he served as Managing Director, Biotechnology and led the firm's healthcare equity research group. PRICE ACTION: Shares of Biogen are down fractionally in mid-morning trading after being up over 1% soon after today's opening bell.

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