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Robert Califf has, at long last, been confirmed as the new commissioner of the FDA, in a close 50-to-46 Senate vote that contrasted with his easy 89-to-4 confirmation vote to the leadership role in 2016. Read More
In a cloture vote late Monday, the Senate voted 49 to 45 to limit floor debate on the nomination of Robert Califf to the role of Commissioner of the FDA. However, the Senate delayed the full-chamber vote on Califf’s possible confirmation until today at noon. Read More
The FDA doesn’t want any part of regulating the “sanitation tunnels” that have popped up in certain commercial settings as a response to the COVID-19 pandemic. Read More
The Federal Trade Commission (FTC) is likely to soon begin an examination into pharmacy benefit managers (PBMs), which could impact drugmakers. Read More
Eli Lilly and Roche/Genentech — both developers of antiamyloid antibodies for Alzheimer’s — have charged into the Aduhelm coverage war in defense of their own products. Read More
The Senate is scheduled to hold a cloture vote on the nomination of Robert Califf for the position of FDA commissioner today at 5:30 pm, which indicates that Senate Majority Leader Chuck Schumer (D-N.Y.) believes he has the votes needed to get Califf confirmed in a floor vote of the evenly divided Senate. Read More
The European Medicines Agency’s (EMA) safety committee has recommended that the EU suspend authorizations for hydroxyethyl-starch (HES) solutions for infusion after concluding that the products are being administered in a potentially harmful manner. Read More
Amid accusations of manipulating data associated with trials for its Alzheimer’s drug candidate simufilam, Cassava Sciences had a bit of good news when the FDA denied a citizen petition pressing the agency to investigate claims that Cassava changed trial data. Read More