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April 29, 2014
07:41 EDTBIIBBiogen to present two-year data from Plegridy Phase 3 study at AAN meeting
Biogen Idec announced two-year data from its Phase 3 ADVANCE clinical trial for PLEGRIDY in people with relapsing forms of multiple sclerosis. These data, which will be presented at the 66th American Academy of Neurology annual meeting, indicate PLEGRIDY dosed once every two weeks demonstrated favorable results on relapse rates, magnetic resonance imaging findings and disease progression. Over two years, the safety profile of PLEGRIDY was consistent with other multiple sclerosis interferon therapies. “The two-year data from ADVANCE further establish the efficacy and safety profile of PLEGRIDY demonstrated in the first year of the pivotal trial,” said Gilmore O’Neill, vice president, Global Neurology Clinical Development at Biogen Idec. “If approved, we believe that PLEGRIDY dosed once every two weeks will provide MS patients with one of the most significant developments in the interferon class in over a decade.” ADVANCE was a two-year, Phase 3, placebo-controlled study that evaluated the efficacy and safety of PLEGRIDY administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received PLEGRIDY for the duration of the study.
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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.
August 7, 2014
10:51 EDTBIIBOptions with increasing implied volatility
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