The abstracts of the CTAD are available in PDF format, you can download them on

this link

The abstracts of the ICFSR are available in PDF format, you can download them on this link

this link

The abstracts of the ICFSR are available in PDF format, you can download them on this link

this link

News

Utilization of Observational Data as a Proxy Cohort for Comparison Purposes with Open-Label Study Results: An Example from Alzheimer’s Disease

Randomized placebo-controlled trials in the development of disease-modifying treatments for Alzheimer’s disease are typically of short duration (12–18 months), and health economic modeling requires extrapolation of treatment effects beyond the trial period. (1) Reed, C., Happich, M., Raskin, J. et al…. Continue Reading →

Aducanumab Phase 3 studies results to be presented on December 5 at 8 am

Following the press release issued by Biogen regarding their plans on regulatory filing for Aducanumab in Alzheimer’s disease based on new analysis of larger dataset from Phase 3 studies, we are pleased to announce that these results will be presented… Continue Reading →

Biogen plans regulatory filing for Aducanumab in Alzheimer’s Disease based on new analysis of larger dataset from phase 3 studies October 22, 2019 at 6:30 am

New analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer’s disease as measured by the pre-specified primary and secondary endpoints Based on discussions with the FDA, the Company plans to submit a Biologics License… Continue Reading →

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