Biogen

NEWS
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).
The company noted it would continue to assess the STAR study’s complete data set before confirming its future plans for clinical development of timrepigene emparvovec.
This is the first confirmation of elemental metals in human brain tissue. Researchers hope it can contribute to the ongoing Herculean task of finding a cure for Parkinson’s and Alzheimer’s.
FDA
Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.
David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.
In a conference call on Wednesday, Biogen CEO Michel Vounatsos outlined the company’s plans for commercial distribution of Aduhelm.
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