Biogen
NEWS
It was a particularly busy week for clinical trial news, in part because of several big medical conferences. Here’s a look.
Recently announced topline results from a Phase II study show SAGE-324, Sage Therapeutics’ investigational oral neuroactive steroid GABAA receptor positive allosteric modulator, significantly reduced tremor score in adult patients with essential tremor.
Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to the drug in a JAMA article.
One of the big drugs investors, analysts and pretty much everyone else in the biopharma industry is keeping an eye on is Biogen and Eisai’s aducanumab for Alzheimer’s disease.
Clarivate published its annual “Drugs to Watch” list, and cited four drugs that it expects to be blockbusters—projected to bring in $1 billion in sales annually.
One of the key drivers of a shift in CNS drugs hinges on the success or failure of Biogen’s aducanumab for Alzheimer’s disease.
Biogen plans to build a new gene therapy manufacturing plant in Research Triangle Park, North Carolina. The site is on the company’s manufacturing campus.
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.
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