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January 16, 2013
05:23 EDTBIIB, ELNBiogen 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%.
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September 15, 2014
08:01 EDTBIIBAlnylam names Karen Anderson as SVP, Chief Human Resources Officer
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September 12, 2014
07:32 EDTBIIBBiogen, AbbVie announce ZINBRYTA DECIDE Phase 3 study results
Biogen (BIIB) and AbbVie (ABBV) announced the full results from the Phase 3 DECIDE clinical trial, which show ZINBRYTA, dosed subcutaneously once a month, demonstrated a statistically significant improvement in reducing disease activity in people with relapsing-remitting multiple sclerosis compared to AVONEX. These results are being presented at the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis. Patients on ZINBRYTA demonstrated a statistically significant 45% reduction in annualized relapse rate compared to patients treated with AVONEX. Based on the efficacy and safety data from the ZINBRYTA clinical development program, Biogen Idec and AbbVie plan to file marketing applications for ZINBRYTA with regulatory authorities during 1H15.
September 11, 2014
07:31 EDTBIIBBiogen announces 5-year results from TECFIDERA ENDORSE Phase 3 study
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07:31 EDTBIIBBiogen announces new data from Plegridy Phase 3 ADVANCE trial
Biogen Idec announced new data from the second year of its Phase 3 ADVANCE clinical trial that show the positive treatment effects of PLEGRIDY were maintained in people with relapsing forms of multiple sclerosis beyond the first year of the study. These results were presented at the sixth Triennial Joint Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis in Boston. Post-hoc analyses from the two-year, Phase 3 ADVANCE clinical trial confirm that PLEGRIDY’s positive effects on reducing disease activity and disability progression were maintained in year two of the study. A significantly higher proportion of patients taking PLEGRIDY during both years of the study experienced no evidence of disease activity – defined as the absence of clinical and MRI disease activity over two years of treatment – compared to those who switched to PLEGRIDY from placebo. Also, those treated with PLEGRIDY for both years of the study had significant reductions in the risk of 24-week confirmed disability progression compared to patients treated with placebo during the first year. In addition, new data from the second year of ADVANCE show that patients who took PLEGRIDY throughout the study experienced statistically significant improvements in clinical and MRI outcomes – including annualized relapse rate, risk of relapse, risk of 24-week confirmed disability progression, and number of brain lesions – when compared to those who switched to PLEGRIDY after taking placebo for the first year. This new data also showed that the safety profile of PLEGRIDY was consistent between years one and two of the study.
September 8, 2014
09:27 EDTBIIBLeerink biotech analyst holds a luncheon meeting with a conference call
Biotech Analyst Schwartz provides an update on key trends and controversies for marketed MS therapies and discusses new data presented at ACTRIMS-ECTRIMS at a Luncheon Meeting with an Analyst/Industry conference call to be held in Boston on September 11 at 12:15 pm.
07:15 EDTBIIBIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.

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