Biogen

NEWS
The drug was approved on June 7 under the agency’s accelerated approval pathway, despite the agency’s Peripheral and Central Nervous System Drugs Advisory Committee voting against the drug in November 2020 and having been assured at that time the agency was not considering an accelerated approval.
It’s been a bumpy ride for Biogen as news swirls around its overall Alzheimer’s program… but not for its competitors with investigational therapies for that disease.
The Third Rock Ventures-backed startup has a pipeline of Treg therapeutics aimed at multiple sclerosis, type 1 diabetes and inclusion body myositis.
It was another busy week of clinical trial announcements. Here’s a look.
FDA
Three other drug contenders that work similarly to Biogen’s drug are currently in clinical trials and expecting data relatively soon.
Biogen’s quest to develop additional medicines for Alzheimer’s disease beyond its newly-approved aducanumab has hit a clinical snag after gosuranemab failed.
Biotech companies are dominating Nasdaq’s IPO scheduled this week. Here’s who is making their big public debut.
FDA
In an eight page letter to U.S. DOH and Human Services Secretary Xavier Becerra, Public Citizen said Woodcock and other FDA officials should resign.
The study drug is a once-daily, two-week therapy developed by Sage Therapeutics and Biogen for major depressive disorder (MDD) and postpartum depression (PPD).
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