Biogen
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In phase one of the two-part program, access to tofersen will be granted on an individual basis to SOD1-ALS patients with an ALS Functional Rating Scale - Revised (ALSFRS-R) slope decline greater than or equal to 2 points per month.
The long and strange journey of Biogen’s Alzheimer’s drug aducanumab is coming to an end. Whether it will be a complete ending—with the U.S. FDA rejecting it—or a new chapter, with an approval, remains to be seen.
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.
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