Keyword: Sage Therapeutics
The trial linked the drug, SAGE-217, to sustained, statistically significant improvements on a depression score and saw no cases of fainting.
The FDA, which expected to approve or deny Sage Therapeutics’ brexanolone next month, has pushed that decision off to March 19.
An FDA advisory committee voted 17-1 on Friday to recommend the approval of Sage Therapeutics’ postpartum depression drug, brexanolone.
There’s no one-size-fits-all solution when it comes to academic partnerships, but successful ones have one thing in common: communication.
Martin Shkreli, infamous for his combative tweets and general "insolent" demeanor, may be blogging biopharma tips from prison.
Securing the status positions Sage to receive a decision from the FDA by the end of the year.
In response to declining venture investment in some disease areas, BIO is releasing reports to identify barriers to innovation.
SAGE-217 triggered near-immediate, fairly durable improvements in patients with major depressive disorder.
The trials linked the drug to improvements on a depression scale, teeing Sage up to file for approval next year and sending its stock up 44%.
Kerrisdale Capital Management, known for its activist short positions, has given Prothena the unwanted title of the “next big biotech blowup.”