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Members of an FDA advisory committee agreed in a 5-3 vote yesterday that clinical data on Biogen’s tofersen — a first-in-class drug candidate for a rare type of amyotrophic lateral sclerosis (ALS) — didn’t support a full approval, but said it might pass muster for an Accelerated Approval. Read More
Dunagin Pharmaceuticals of Rogers, Ark., received an FDA warning letter for manufacturing drugs on the same equipment used to manufacture non-drug products and failing to test samples of product components for its pharmaceutical and nonpharmaceutical dental care products, among other lapses. Read More
In response to a request for information from the White House, PhRMA has offered recommendations for improving clinical trial infrastructure to enable effective responses to public health emergencies, including advice on trial diversity and participation in general. Read More
In light of Moderna’s plan to price its COVID-19 vaccine and booster from $110 to $130 per dose — up from the $26.36 the U.S. government pays now — CEO Stéphane Bancel faced some heavy questioning from the Senate health committee Wednesday. Read More
The Pharmaceutical Research and Manufacturers of America (PhRMA) is asking for several changes to the FDA’s January draft guidance on the dosage and administration section of labeling for drugs and biologics. Read More
The FDA has accused Procter & Gamble (P&G) of submitting one ingredient list for Nyquil to the agency and using a different one for the over-the-counter product’s physical labeling. Read More
Insurers need more evidence of long-term safety and efficacy to make the best decisions about whether — and how — to cover Eisai’s Leqembi (lecanemab) for early Alzheimer’s disease, according to experts who participated in a policy discussion with the Institute for Clinical and Evidence Review (ICER). Read More