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 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The Pharmaceutical Research and Manufacturers of America (PhRMA) is asking for several changes to the FDA’s January draft guidance on the dosage and administration section of labeling for drugs and biologics.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

The FDA appears to be casting a favorable eye on Biogen’s SOD1-amyotrophic lateral sclerosis drug tofersen, suggesting that reductions in neurofilament light, a protein associated with neuronal damage, could support an Accelerated Approval. Read More

CDER’s Office of Compliance issued 101 warning letters in fiscal 2022 — about two-thirds of them related to COVID-19 products, according to the office’s latest annual report. Read More

The FDA outlined its current thinking on submitting pharmacogenomic data in new drug applications in a draft guidance released Friday. Read More

The Institute for Clinical and Economic Review (ICER) plans to take health equity into account in its product value assessments and has come up with some ideas for how to do that. Read More