Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Panel Gives Thumbs Up To Some Peptide Compounding
In a win for peptide proponents and for health secretary Robert F. Kennedy Jr., an advisory panel to the Food and Drug Administration recommended on Thursday that compounding pharmacies be allowed to manufacture the drugs BPC-157, KPV, TB-500, and MOTS-c. The FDA panel will vote on additional compounds on Friday. (Todd and Lawrence, 7/23)
Your favorite local restaurant or hair salon is subject to more inspections and oversight than the medspa down the street selling peptide injections. (Weber, 7/24)
An advisory committee to the Food and Drug Administration convened Thursday to evaluate whether compounding pharmacies should be allowed to produce seven peptides that were previously banned over safety concerns. (Smith, 7/23)
On genetic testing for trans athletes 鈥
The Women鈥檚 Tennis Association (WTA) has taken a step beyond most other women鈥檚 sports leagues by requiring genetic sex testing for female athletes. (Rummler, 7/22)
In other pharmaceutical industry news 鈥
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. (Cueto, 7/23)
As the fungus that causes valley fever expands across the western United States and cases skyrocket in California, researchers say they may have found a new drug that can help those suffering from the most advanced form of the disease. And they鈥檙e hoping that someday the antifungal drug known as olorofim can be given to patients in earlier stages of the illness 鈥 before the fungal infection becomes too perilous. (Rust, 7/23)
Ipsen said its Bylvay drug didn鈥檛 meet the main objective in a late-stage clinical trial that tested the medicine in biliary atresia, a rare and serious liver disease that affects babies. The French drugmaker said Friday that Bylvay missed the study鈥檚 primary objective of showing an improvement in native liver survival rates compared to placebo. The drug鈥檚 safety profile was consistent with that shown in other indications for which it is approved, the company said. (Calatayud, 7/24)
In a boost for greater clinical trial transparency, the European Medicines Agency is taking what consumer advocacy groups are calling unexpectedly 鈥渞apid action鈥 to ensure that study results are made public as required by law. (Silverman, 7/23)
