FDA panel backs peptides, Merck licenses HIV pill
An FDA advisory panel recommended in favour of peptides, a win for Health and Human Services Secretary Robert F. Kennedy Jr. Merck has also licensed its HIV pill to another party. These are among the key pharmaceutical developments highlighted in the weekly Pharmalittle industry briefing.
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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 is still in the works, but we do plan to promenade extensively with the official mascots, stroll the supermarket aisles, and spend time with the Pharmalot ancestor. We also hope to hold yet another listening party, where the rotation will likely include this , this , this , this and this . And what about you? The possibilities are endless — you could stop by your favorite restaurant, curl up with a good book, hang with your best friend, or take a long drive to nowhere. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …
In a win for peptide proponents and for U.S. Health and Human Services Secretary Robert F. Kennedy Jr., an advisory panel to the U.S. Food and Drug Administration recommended compounding pharmacies be allowed to make the drugs BPC-157, KPV, TB-500, and MOTS-c. , STAT says The FDA panel will vote on additional compounds on Friday. The votes are not binding, so the FDA will decide whether to lift restrictions and make them more accessible to people who have been turning to the little-researched but popular drugs. The vote reflects tensions between FDA staff, who recommended against lifting restrictions on the peptides because of safety and efficacy concerns, and the panel, which critics have said was “stacked” by Kennedy with people who stand to benefit from broader peptide access.
People with diabetes who use a popular long-acting insulin pen made by Sanofi have had to become pharmacy scouts in recent weeks as they encounter supply issues , STAT explains. The Lantus Solostar pen containing 3 milliliters of insulin glargine has been running low for several weeks because of increased demand “driven by broader market dynamics,” according to Sanofi. The issue is not technically considered a shortage by the FDA, but patients are having trouble finding the medication. While some diabetes patients have had luck finding the medication at small independent pharmacies or their hospital pharmacy, large pharmacies like CVS and Walgreens are coming up dry.
Continue to STAT+ to read the full story…
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