And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda: promenading with the official mascots, manicuring the Pharmalot grounds, and escorting Mrs. Pharmalot to a supper club. We also hope to find time for yet another listening party, where the rotation will likely include this, this, this, this, this. And what about you? As we like to remind folks, this is a fine time to enjoy the great outdoors. Hiking, strolling, dipping your toe in the water — take your pick. Of course, if the weather fails to cooperate, you could catch up on your reading, binge-watch on the telly, or tidy up around the castle. The possibilities are endless, yes? Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon….
The U.S. Food and Drug Administration proposed excluding the active ingredients in wildly popular obesity and diabetes drugs from a list of substances that can be used for making certain compounded versions, STAT writes. The agency determined there is no “clinical need” to allow large compounding facilities to make large quantities of medicines from semaglutide, the ingredient in Novo Nordisk’s Wegovy weight loss and Ozempic diabetes treatments, as well as tirzepatide, the ingredient in Eli Lilly’s Mounjaro diabetes drug and Zepbound obesity medicine. The decision singled out these compounders after growing controversy over their role in making weight loss treatments available over the past few years. In explaining its decision — which is a victory for Novo and Lilly and will rework choices for consumers — the FDA explained these compounders no longer meet the legal requirements to market their products.
The FDA named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply, STAT notes. She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California, San Francisco. Szarama joined the FDA at the end of last year to serve as Prasad’s deputy. It is not clear whether Szarama will serve permanently in the role. Government and industry sources previously indicated that Houman Hemmati, an ophthalmologist, biopharma executive, and frequent Fox News contributor, was a top candidate for the role.
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