The latest, 60% hit to AcelRx’s stock price followed another run-in with the FDA, which knocked back a filing for approval of pain drug Dsuvia.
Around a third of Trevena’s workforce are facing the ax as the biotech throws all its weight behind soon-to-be-filed injectable pain therapy Olinvo.
Elligo Health Research will test a harmonized real-word data model built by the FDA.
The FDA agreed with the efficacy conclusion Aerie reached to support its bid for approval of glaucoma and ocular hypertension hopeful Rhopressa.
Spark Therapeutics’ inherited eye disorder treatment voretigene neparvovec faces an FDA advisory committee this week.
China has said it will accept data from clinical trials run overseas in a bid to shorten the time it takes to approve new drugs and medical devices.
The EMA’s call for extra staff comes as it is bracing itself for the likely loss of employees when it moves from its current home in London.
The data tee Motif Bio up to file for approval of a drug that was knocked back by the FDA in 2009 and almost sunk the biotech 12 months ago.
Catabasis is looking to test its experimental Duchenne drug edasalonexent in a late-stage trial.
A panel of experts convened by the FDA has overwhelmingly knocked back PTC Therapeutics’ filing for approval of ataluren.