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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
The FDA issued a warning letter to Hubei Kangzheng Pharmaceutical detailing significant violations observed during an inspection of the company’s facility in Hubei Province, China. Read More
Amgen and Arrakis Therapeutics have teamed up to develop targeted RNA degraders, an entirely new class of therapeutic molecules designed to destroy disease-causing RNA. Read More
Results seen across multiple trials bolster Sarepta’s “confidence in the potential disease-modifying benefits of this therapy,” said the company’s CEO, Doug Ingram. 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