Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Panel Gives Thumbs Up To Some Peptide Compounding
Stat: FDA Panel Backs Compounded BPC-157, KPV Peptides In Win For RFK Jr.
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)
The Washington Post: Peptide Boom Has States Scrambling To Protect Consumers, Post Investigation Finds
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)
The New York Times: What To Know About Peptides The FDA Is Considering For Use
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 —
The 19th: Tennis Is The First Major Women’s Sports League To Require Genetic Testing
The Women’s Tennis Association (WTA) has taken a step beyond most other women’s sports leagues by requiring genetic sex testing for female athletes. (Rummler, 7/22)
In other pharmaceutical industry news —
Stat: Sanofi Insulin Product, Lantus Solostar Pen, Reported In Short Supply
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)
Los Angeles Times: New Drug Could Help People Stricken With Valley Fever
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’re hoping that someday the antifungal drug known as olorofim can be given to patients in earlier stages of the illness — before the fungal infection becomes too perilous. (Rust, 7/23)
The Wall Street Journal: Ipsen Drug Misses Goal In Late-Stage Trial For Rare Liver Disease
Ipsen said its Bylvay drug didn’t 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’s primary objective of showing an improvement in native liver survival rates compared to placebo. The drug’s safety profile was consistent with that shown in other indications for which it is approved, the company said. (Calatayud, 7/24)
Stat: European Medicines Agency Looks To Bolster Clinical Trial Transparency
In a boost for greater clinical trial transparency, the European Medicines Agency is taking what consumer advocacy groups are calling unexpectedly “rapid action” to ensure that study results are made public as required by law. (Silverman, 7/23)
