Biogen
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With Biogen’s potential treatment for Alzheimer’s, aducanumab, coming in weeks before a U.S. FDA decision, ICER wrote a punishing report slamming the drug for insufficient efficacy and recommending a low price point if approved.
BioSpace takes an in-depth look at the Top 25 of Q1. You should be aware of these biopharma companies as they hold a great future ahead. So, check them out.
The U.S. FDA says it is unable to approve Biogen supplemental Biologic License Application (sBLA) for subcutaneously delivered TYSABRI® for the treatment of relapsing multiple sclerosis (MS), at least while the sBLA remains in its present form.
A multi-day conference hosted by Biogen during the early days of the COVID-19 pandemic has been determined to be a super-spreader event, with more than 300,000 infections linked to the conference.
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.
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