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August 5, 2014
08:09 EDTRGLS, BIIBRegulus Therapeutics and Biogen enter into new collaboration agreement
Regulus Therapeutics (RGLS) announced that it has entered into a new collaboration agreement with Biogen (BIIB) to expand its research focused on identifying microRNAs as biomarkers for multiple sclerosis, or MS, under its Regulus microMarkers division. The new research will focus on profiling a large number of whole blood samples from a cohort of MS patients who have been treated with a Biogen MS therapy to identify potential microRNA signatures. Regulus will receive $2M upfront and is eligible for future payments upon achievement of certain milestones related to the identification of potential microRNA signatures.
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September 18, 2014
08:07 EDTRGLSRegulus Therapeutics initiates ATHENA study in Alport syndrome patients
Regulus Therapeutics has initiated its ATHENA natural history of disease study in patients with Alport syndrome, a life-threatening genetic kidney disease with no approved therapy. The ATHENA study is designed to characterize the natural decline of renal function markers such as Glomerular Filtration Rate, creatinine, proteinuria and beta-2 microglobulin, in Alport syndrome patients over time. The data collected from the ATHENA study will provide information about the changes in renal function over time in Alport syndrome patients, which will inform future clinical development plans of Regulus' RG-012, a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21, currently in development to treat renal dysfunction in Alport syndrome patients.
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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