Trump administration revises rebate pilot for 340B drug discount program
Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter. The Trump administration has revised the terms of a pilot effort that will allow some drugmakers to offer rebates to certain hospitals and […]
Pharmalittle: Novo discloses setback, Replimune drug endorsed
And so, another working week will soon come to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still taking shape, but we plan on promenading with the official mascots, catching up on our reading, and manicuring the Pharmalot campus. […]
Pharmalittle: How did a fugitive working in biotech escape scrutiny?
Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the not-so-appetizing possibilities, we invite you to join us for a needed […]
FDA questions the efficacy of Capricor’s Duchenne drug
The Food and Drug Administration said Monday that Capricor Therapeutics’ stem cell treatment for Duchenne muscular dystrophy did not meet the objectives of Phase 3 trial — contrary to the company’s claims last year. Capricor said in December that the drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized […]
Cyclospora wake-up call: ‘Eat Real Food’ relies on robust food safety
I spent nearly a decade leading FDA’s Center for Food Safety and Applied Nutrition. That role convinced me that food safety and nutrition are interdependent in so many ways, and if we want to make our population healthier, we need to support both. Over the past few weeks, record numbers of cases of cyclosporiasis have driven […]
HHS to convene experts on standards for clinical AI
Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13. You’re reading the […]
Nabla’s new CEO outlines how to gain market share in a AI scribe environment
Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01. Nabla, the Paris-based maker of ambient scribes used to automate clinical documentation, says it’s […]
U.S. military testosterone screening is an unprecedented experiment
When I first heard the announcement on Wednesday that the Department of Defense will begin a mandatory testosterone screening program for service members, my mind naturally leapt to a series of questions derived from my career studying men’s health and population-level screening in men’s health. In particular, I fear that the widespread rollout of testosterone […]
Testosterone therapy, wildfire smoke, Duchenne: Morning Rounds
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Greetings from Brooklyn, where the wildfire smoke is so thick you can chew it. Stay safe, everyone. A new idea for treating Duchenne muscular dystrophy divides experts Take a hike, viral vectors. A small California startup has […]
FDA CBER, ACA subsidy fallout, cyclosporiasis: Morning Rounds
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning. I dedicate the first item in today’s newsletter to a friend who is suffering from what she suspects to be cyclosporiasis. Feel free to forward this email to your friends who need information but are […]