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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
Sen. Wyden had expressed his concerns over the potential misuse of the accelerated approval pathway and asked Califf to answer how he would reform the program if confirmed as FDA commissioner. Read More
A foundation representing German vaccine maker BioNTech has been accused of trying to undermine the World Health Organization’s (WHO) initiative to bring COVID-19 vaccine manufacturing to the African continent. Read More
Democrats in the U.S. House of Representatives and eight advocacy groups are pressing Department of Health and Human Services (HHS) head Xavier Becerra to use either “march-in” or government use rights for the prostate cancer drug Xtandi, which is marketed by Pfizer and Japanese company Astellas but was developed using grant funding from the U.S. Army and the National Institutes of Health (NIH). Read More
President Biden sought yesterday to revive his massive spending package lying dormant in the Senate by highlighting a popular component of the bill — prescription drug pricing reform. Read More
Members of FDA’s Oncologic Drugs Advisory Committee voted 14-1 yesterday to require a U.S. study for sintilimab, Lilly’s investigational lung cancer drug that — so far — only has Chinese trial data. Read More
Seventy-eight Republicans have thrown down the gauntlet in front of the Centers for Medicare & Medicaid Services (CMS), charging that limiting payments for Biogen’s Aduhelm pressures people with Alzheimer’s disease — especially minorities, the poor and the disabled — to participate in clinical trials if they want the drug. Read More