In an unusual move, Sandoz is no longer cooperating with a U.K. industry trade group following a dispute over allegations that the company inappropriately marketed a biosimilar medicine. At issue was an anonymous complaint filed in May 2023 by a physician who contended that Sandoz unfairly attempted to promote a biosimilar version of Tysabri for treating...

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday. We did something a little different for this issue: We wanted to share some of the stories that explain the machinations of the U.S. health care system — stories that really influenced how...

Late-stage results of Cytokinetics’ drug for a rare heart disease suggest it can compete with a similar treatment sold by Bristol Myers Squibb on efficacy and safety, and can also be dosed more conveniently, potentially making it a more attractive option for doctors if approved. The 24-week Phase 3 trial tested the drug, a daily pill called aficamten,...

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the...

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hello! Today we learn whether AI might help hasten the development of n-of-1 therapies (hint: not yet), explore why the FDA hasn’t offered Orange Book guidance on drug-device combinations, and talk about CRISPR. A lot.Read the...

When it comes to a crucial controversy over pharmaceutical patents, the FDA has been MIA. For nearly 20 years, drug companies have asked the Food and Drug Administration for guidance on listing patents for drug-and-device combination products, such as asthma inhalers and auto-injectors for diabetes treatments, in an obscure, but highly important agency...