Keyword: Sage Therapeutics
Steven Paul, M.D., left Eli Lilly after 17 years to “do something a bit more entrepreneurial." He went on to work on CNS disorders in small biotechs.
Two weeks after an FDA panel recommended Zulresso for approval in a near-unanimous vote, the agency put off its decision on the drug so it could work on a risk evaluation and mitigation strategy.
The failure of SAGE-217 to beat placebo wiped more than 50% off Sage’s share price as investors digested the implications of the data.
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.