| |   | Happy Friday, Meghana here. We look today at more FDA ire, a clinical hold at an up-and-coming biotech, and wonder — what's next for Martin Shkreli? | | | What happens when the White House runs out of Covid-19 money? Why are kids suddenly getting mysterious infections? And who’s going to hire Martin Shkreli? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, STAT’s Helen Branswell joins us to explain the medical mystery of hepatitis appearing worldwide in young children, plus the sudden outbreak of monkeypox. Then, STAT Washington correspondent Rachel Cohrs calls in to discuss how Congress’ reluctance to pass a Covid funding bill might imperil the U.S. pandemic response just in time for a winter surge. We also chat about the latest news in the life sciences, including Clay Siegall’s resignation and Martin Shkreli’s release from federal prison. Listen here. | The FDA under scrutiny, and not just for drugs The FDA’s been under fire for a litany of reasons lately (aducanumab, among them) but the ire typically seems to be directed at the “D” portion of the agency. Now, however, the FDA is under fire for its slow response to the ongoing baby formula shortages — and a recent Politico investigation revealed flaws in how the agency oversees food safety in general. A whistleblower complaint last year called to investigate formula production at an Abbott facility, but some say regulators didn’t take it seriously enough. “Why did the FDA not spring into action?” one congresswoman said, per the Washington Post. “How many illnesses and deaths were due to the FDA’s slow response? This makes me question which side FDA is on, on the side of Abbott or the American public?” | Sign up for our free pop-up newsletter: ADA in 30 seconds Get insightful analysis of the data presented at the conference of the American Diabetes Association with this newsletter. STAT will be on top of all the news out of the event and will recap the most important advances in research and care for you from June 4-6. Sign up now. | Foghorn trial on partial hold after patient death The FDA has placed Foghorn Therapeutics’ Phase 1 dose escalation study on a partial clinical hold, after the company reported a participant’s death from a possible case of differentiation syndrome. The study was testing FHD-286, an experimental drug that modulates gene expression in the chromatin regulatory system, in patients with acute myelogenous leukemia and myelodysplastic syndrome. Differentiation syndrome involves a rapid release of cytokines after a leukemia patient is treated with certain cancer drugs. It can be life-threatening — and, according to a release, “an effect that is believed to be on-target for the proposed mechanism for FHD-286.” The FDA plans to review the company’s safety database, risk mitigation strategies, and examine clinical activity across dose levels. Foghorn is a spinout of Flagship Pioneering, and went public two years back after a major deal with Merck. The company was cofounded by Cigall Kaddoch, a rising star at Dana Farber and the Broad Institute. | Pfizer partnership aimed at improving trial diversity In an effort to diversify clinical study, Pfizer is teaming up with trial site network Headlands Research to launch several new research outposts in diversely populated areas, FierceBiotech writes. A new Headlands facility is set to open in Brownsville, Texas, which sits right on the border of Mexico. The partnership is meant to develop over the course of several years, with the aim of creating several diversity-focused trial sites. “Diversity is a key pillar of our commitment to ensure clinical trials represent broader populations,” Headlands CEO Mark Blumling said in a statement. | More reads - CDC advisory committee recommends Covid boosters for kids ages 5 to 11. (STAT)
- Not one, not two, but three — biotech claims it will pursue CARs T, M and NK all at once. (Endpoints)
- Amgen celebrates 25 years of deCODE Genetics as partnership evolves from discovery to development. (FierceBiotech)
| Thanks for reading! Until next week,  | | | |
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