Hello, everyone, and welcome to the middle of the week. Congratulations on making it this far. It is an accomplishment, after all. The next step is to … keep going. And why not? Just consider the alternatives. On that optimistic note, please join us for a needed cup of stimulation. Our choice today is maple bourbon. Meanwhile, here are some items of interest to get you going. Have a wonderful day, and do drop us a line when you hear something juicy. …
The U.S. Food and Drug Administration is moving toward allowing compounding pharmacies to produce more than a dozen injectable peptides that were banned because of potentially significant safety risks, The New York Times reports. In 2023, 14 peptides were removed from a list of products that the agency allows compounding pharmacies to produce. The peptides had not been approved by the FDA as safe or effective and, in recent years, the agency had noted that they were increasingly being marketed with unproved claims that they had cosmetic, anti-aging, and disease-fighting benefits. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. has said in recent podcast appearances that he is pushing for the FDA to reverse the prohibition on the peptides, which include some that act as growth-hormone stimulators. On Joe Rogan’s podcast last month, Kennedy said he has personally used the products to heal injuries “with really good effect.”
The scientists behind treating Baby KJ say they have hit a stumbling block in their efforts to create more custom gene editing treatments for children with rare diseases, STAT explains. They maintain that FDA reviewers are imposing high manufacturing and quality control standards that could make it too expensive and complicated for them — or any academics — to bring such bespoke therapies to approval. Instead, they warned, such efforts could require the resources of industry. The researchers received the feedback in a meeting with FDA reviewers to discuss a potential study of custom treatments using prime editors, a more complex and cumbersome gene editing technology that can treat a much wider range of genetic misspellings.Continue to STAT+ to read the full story…