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The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has proposed major reforms to its clinical trial regulations — including a 30-day maximum for reviewing new trial applications and a 10-day maximum for granting a decision after receiving requested follow-up information. Read More
The Federal Trade Commission (FTC) has filed an amicus brief urging the U.S. District Court for the District of Delaware not to dismiss the suit brought by Sage Chemical and its marketing partner TruPharma against Supernus Pharmaceuticals over alleged blocking of generic competition. Read More
The FDA is standing up a new program to provide a framework for regulators, researchers and the public to explore how digital health technologies (DHT) — such as mobile medical apps and wearable devices — can advance drug development. Read More
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The Pharmaceutical Research and Manufacturers of America (PhRMA) is asking for several changes to the FDA’s January draft guidance on the dosage and administration section of labeling for drugs and biologics.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