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The European Medicines Agency’s (EMA) safety committee said it found no evidence for a causal link between the Pfizer/BioNTech and Moderna COVID-19 vaccines and very rare cases of autoimmune hepatitis (AIH). Read More
The European Medicines Agency (EMA) has issued draft guidance on redacting commercially confidential information (CCI) in trial data and documents filed to the Clinical Trials Information System (CTIS). Read More
Dropping from a high of 47 requests for Regenerative Medicine Advanced Therapy (RMAT) designations in 2018, the FDA has received, so far, just 14 requests this year, according to new data from the FDA’s Center for Biologics Evaluation and Research (CBER). Read More
Claims by CofixRX for its iodine-containing nasal spray render it an unapproved new drug that is misbranded and adulterated, the FDA said, in a warning letter to the company in Rochester Hills, Mich. Read More
Last week’s Aduhelm coverage decision by the Centers for Medicare and Medicaid Services (CMS) raises the bar for three other antiamyloid antibodies in late-stage development: Eisai’s and Biogen’s lecanemab, Eli Lilly’s donanemab and Roche’s gantenerumab. It all depends on the evidence that the drugmakers provide in their submissions to the FDA. Read More