Latest from Alaric DeArment
The Phase III study’s principal investigator said that if Xpovio doesn’t win approval, NCCN Guidelines could enable off-label use, as has occurred with BMS’s Reblozyl.
Deal Snapshot: The French drugmaker gains rights to the anti-CD19xBCMAxCD3 candidate, which is designed to have the benign safety profile considered especially important in immunology.
Scrip spoke with Debiopharm’s Luke Piggott about the Swiss biotech’s interest in synthetic lethality and strategy around development and partnering.
The approval of Wegovy HD brings a more effective version to the lower-dose version and the oral formulation, but the company has struggled to compete with obesity rival Eli Lilly.
The drug is the first oral IL-23 receptor antagonist to clear the US FDA. Johnson & Johnson and partner Protagonist Therapeutics are banking on its convenience as well as efficacy and safety to make the drug competitive.
A series of surprise rejections has made for an FDA that drug and vaccine manufacturers are finding much harder to read than in years past.
