Peptides

• An FDA advisory committee voted to expand access to four peptides, including KPV, despite the agency's warnings regarding a lack of clinical evidence for their efficacy. • The FDA specifically noted that there is no human clinical data to support using KPV for wound healing or inflammatory conditions like psoriasis, eczema, and ulcerative colitis. • This decision is significant as peptides have become a major wellness trend, though the FDA maintains that multiple approved drugs already exist for these conditions.

• An FDA advisory panel narrowly voted to recommend allowing compounding pharmacies to produce BPC-157 and KPV, two popular but unproven peptides. • The decision follows advocacy from Robert F. Kennedy Jr., who pushed for increased access to these substances despite their lack of formal FDA approval. • This move is significant as it challenges standard regulatory hurdles for unapproved drugs, potentially expanding patient access to experimental treatments.

• An FDA advisory panel began a two-day meeting on Thursday to review more than six types of peptides currently used in wellness trends. • These substances are under scrutiny because there is little scientific evidence to prove they are safe or effective for human use. • The review is critical as these unproven peptides have gained popularity despite a lack of formal regulatory approval.

• An FDA advisory committee is set to review evidence regarding peptides to determine if they should be approved for legal compounding. • Experts have expressed concern over a lack of sufficient evidence to support the safety and efficacy of compounding these substances. • While FDA-approved peptide drugs like semaglutide and tirzepatide have undergone rigorous clinical trials for obesity, compounded versions may lack such validation.

Vote from advisory group – whose members include people linked to peptides industry – likely to embolden RFK JrA panel of federal health advisers on Thursday narrowly recommended easing access to several peptides popular with wellness influencers and celebrities, despite warnings from government scientists that the chemicals have not been shown to be safe or effective.In a series of votes, outside experts to the Food and Drug Administration advised the agency to drop current restrictions barring pharmacies from producing injectable peptides with names like BPC-157, TB-500 and KPV. Continue reading...

• The FDA is currently reviewing the regulatory status and future of peptides, while companies like RevMed and GSK have received new approvals. • Repligen has expanded its cell therapy capabilities through a $1.5 billion acquisition deal for BioLife. • A new study has provided support for testing Merck’s Ebola vaccine during the current outbreak in the Democratic Republic of the Congo.

Prof Channa Jayasena says growing online sales of unregulated drugs risk fatalities as responsibility falls between regulatorsFitness influencers linked to wellness brand helping run illegal steroid market on TelegramThe UK has become a “wild west” for people peddling experimental peptides, steroids and other substances, a leading expert has said, warning action must be taken to avoid fatalities.Prof Channa Jayasena of Imperial College London, a consultant in reproductive endocrinology and andrology at Hammersmith and St Mary’s hospitals, said he is now encountering patients “day in, day out” who are taking experimental peptides. Continue reading...

Committee will meet in July to discuss peptides now sold in gray market despite limited evidence of safety and efficacyAdvisers to the Food and Drug Administration (FDA) will soon hold a meeting about whether to ease restrictions on access to some research peptides, a group of drugs with a zealous following and thin evidence to support them.If restrictions are eased, US compounding pharmacies would be able to produce and fill prescriptions for Americans – a change that would effectively legalize a thriving gray market. Continue reading...

Peptides join melatonin, cannabis and weight loss medications as priority concerns. Follow today’s news liveGet our breaking news email, free app or daily news podcastGood morning and welcome to our live news blog. I’m Martin Farrer with the top overnight stories and then it will be Nick Visser with the main action.A non-profit organisation that runs a helpline for young people says there is little sign of a dip in cyberbullying or image-based abuse in the six months since teenagers under 16 have been banned from social media. More coming up. Continue reading...

Influencers and athletes are among those claiming substances can help with injury repair, weight loss and angi-ageingMedicines watchdog to investigate UK peptide clinics over health claims From influencers to athletes, high-profile figures are hailing peptides as the route to wellness, claiming they help with injury repair, weight loss, anti-ageing and mood. We take a look at what these substances are, and the murky industry surrounding them. Continue reading...