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In early October, a federal appeals court ruled that the FDA incorrectly approved Ruzurgi because Catalyst Pharmaceuticals already owned the rights to the drug. Read More
Medicare will only cover Aduhelm, the controversial Alzheimer’s disease antibody, for people who are enrolled in qualifying clinical trials, the Centers for Medicare and Medicaid Services (CMS) proposed today. Read More
The FDA has lifted its clinical hold on Allogene Therapeutics’ five early-stage clinical trials of its chimeric antigen receptor T (CAR-T) therapy. Read More
Pfizer is eying March as a potential roll-out date for a hybrid COVID-19 vaccine that would cover both the original Wuhan strain and the highly vaccine-resistant Omicron strain. Read More
Drugmakers are not pleased with the FDA’s draft guidance on microbiological contamination, published in September to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Read More
In overturning the settlement on Dec. 16, McMahon ruled that the federal bankruptcy judge who approved the Sacklers’ settlement plan in September had ruled incorrectly. Read More
A federal judge has thrown out Amarin’s complaint against Hikma Pharmaceuticals over the latter’s alleged patent infringement by its generic version of Vascepa (icosapent ethyl). Read More
A federal judge in Texas has ruled that the FDA must by the end of this month make public 12,000 pages of the data it used to make decisions about approvals for Pfizer/BioNTech’s COVID-19 vaccine — and then release 55,000 pages every 30 days after that until all 450,000 requested pages are public. Read More