Hello, everyone, and how are you today? The skies over the Pharmalot campus are soggy this morning, but our spirits are sunny, nonetheless. After all, as the Morning Mayor liked to say: Every new day should be unwrapped like a precious gift. So while you tug on the ribbon, we will get busy gathering interesting items for you to peruse. So time to get started. The coffee kettle is boiling, which allows us to pour a delicious cup of stimulation. Our choice today is coconut hazelnut, one of the newer choices in our pantry. Meanwhile, we hope that you have a smashing day and stay in touch. We are always happy to have new pen pals. …
Within the next two weeks, Novo Nordisk is expected to announce results of perhaps the most ambitious studies yet of its blockbuster GLP-1 drug semaglutide — whether the medicine can help slow the progression of Alzheimer’s disease, STAT tells us. The company has repeatedly stressed these are risky studies, since there has not yet been definitive proof this class of drugs, which has transformed the treatment of obesity and diabetes, can also help patients with the devastating neurological disease. But Novo still appears to be quietly preparing for the possibility that it may soon be able to add Alzheimer’s to the list of approved indications for semaglutide, marketed as Ozempic and Wegovy. Novo posted job openings just a few days ago for at least four positions around the world focused on Alzheimer’s consumer marketing and medical affairs, roles that involve communicating the scientific data behind commercial products to doctors and patients.
New warnings and restrictions placed on a Sarepta Therapeutics gene therapy last week by the U.S. Food and Drug Administration have cast a spotlight on an important but overlooked heart-safety risk, STAT tells us. “Acute, serious, and life-threatening” cases of heart inflammation called myocarditis and elevations of troponin-I, a protein released by dying heart-muscle cells, have been reported in patients treated with Elevidys, a gene therapy for Duchenne muscular dystrophy, according to its prescribing label updated on Friday. A previous version of the Elevidys label noted only that “acute and serious” myocarditis and troponin-I elevations had been observed. Elevated heart warnings are part of a broader Elevidys safety crackdown implemented by the FDA following the deaths of two teenage boys from liver failure this summer.
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