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Could Biogen sidestep the Centers for Medicare and Medicaid Services (CMS) coverage decision that threatens to topple its longed-for Alzheimer’s treatment franchise? Read More
In a 13-to-8 vote yesterday, the Senate Health and Education, Labor and Pensions (HELP) Committee signed off on Robert Califf as the next FDA commissioner, paving the way for a full chamber vote on his nomination. Read More
In October, the European Medicines Agency recommended that the condition be added as an adverse reaction with an unknown frequency to the J&J vaccine product information. Read More
CMS’ proposal to only cover Aduhelm in clinical trials has put a big hole in Biogen’s plan to create a global Alzheimer’s disease therapy franchise. Read More
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Drugmakers are not pleased with the FDA’s draft guidance on microbiological contamination, published in September to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs).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