FDA panel backs compounding of epitalon and semax, votes against emideltide

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Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on a cuppa stimulation. Our choice today is Earl Grey, an old standby. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some items of interest to help you on your journey today, which we hope will be productive and meaningful. Best of luck and, of course, do keep in touch. …

A U.S. Food and Drug Administration advisory panel on Friday recommended that compounding pharmacies be allowed to manufacture the peptides epitalon and semax, but narrowly voted to recommend against manufacturing emideltide , STAT writes. The votes, which followed the panel’s decision on Thursday to recommend allowing pharmacies to make four other peptides, bring U.S. Health and Human Services secretary Robert F. Kennedy Jr. one step closer to his mission of making these unapproved compounds more available for Americans. Peptides have become increasingly popular in the U.S., driven by endorsements from social media influencers.

Amgen submitted new evidence to the FDA ​as it seeks a hearing to challenge the proposed ‌withdrawal of its rare disease drug Tavneos from the U.S. market , Reuters says. In April, the agency proposed withdrawing the drug, which treats a rare autoimmune ​disease that damages blood vessels, citing a lack of proven effectiveness ​and false statements in its original marketing application. Amgen strongly disagrees with the FDA and noted its submission includes more than 70 real-world studies involving over ​2,200 patients supporting the drug’s effectiveness and safety.

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