Biogen
NEWS
As the therapy “did not achieve proof-of-concept” and failed to provide benefit in this study, the development of the drug has been discontinued.
The decision by the FDA on the drug application was expected on March 7, but is now delayed until June 7, 2021.
The new year began with a fairly low level of clinical trial news. Here’s a look.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for December 15, 2020.
A Biogen corporate conference held in February at the Boston Marriott Long Wharf Hotel was initially traced to about 100 cases of COVID-19 that spread across the country. That number has grown exponentially.
The consumer’s group Public Citizen demanded the Office of the Inspector General (OIG) for the U.S. Department of Health and Human (HHS) conduct an investigation.
Sage and Biogen forged the deal to jointly develop and commercialize zuranolone (SAGE-217) for major depressive disorder, postpartum depression and other psychiatric disorders and SAGE-324 for essential tremor and other neurological disorders.
With the opinions that were expressed by the advisory committee, along with the data presented, the FDA will continue onward with its review process. It is expected to determine whether to approve the aducanumab Biologics License Application by March 7, 2021.
Biogen and Tokyo-based development partner Eisai are embroiled in controversy surrounding their investigational Alzheimer’s drug, aducanumab.
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