The Readout Loud

How has the Food and Drug Administration's recent decisions on rare disease drugs affected investment trends? Why is Eli Lilly getting into sleep medicine? And where did Allison go on her vacation? We discuss all that and more on this week's episode of “The Readout LOUD,” STAT's weekly biotech podcast. Biotech investor Rod Wong joins us to talk about why an industry-patient coalition he's part of sent a letter to President Trump asking for more regulatory flexibility at the FDA. We also discuss the U.S. approval of Eli Lilly's obesity pill, recent deal-making by large pharma companies, a strange story about promotion of psychedelic drugs on YouTube, and more.

On this week’s episode of "The Readout LOUD": Allison DeAngelis is still away, leaving Elaine Chen and Adam Feuerstein to mind the podcasting store. You've been warned. Eli Lilly’s deal man Jake van Naarden is very, very busy, so what does that mean for biotech and pharma? Speaking of deals, Merck is buying Terns for nearly $7 billion. Why are some people mad about it? You might be surprised to hear this, but off-the-shelf CAR-T therapies for cancer are still a thing. We preview an interesting data readout coming soon from Allogene Therapeutics. And finally, someone forgot to tell Wave Life Sciences that weight loss drugs are supposed to help people lose weight.

On this week's episode of "The Readout LOUD," we bring you a special conversation with Stelios Papadapolous, also know as the "godfather" of biotech. He sat down for an on-stage chat with our colleague Damian Garde Thursday afternoon during STAT’s Breakthrough Summit East event in New York City. We also chat about the latest biotech news, including new weight loss data from Structure Therapeutics and Eli Lilly, plus recent staff departures from the Food and Drug Administration.

How was a known friend of Jeffrey Epstein able to raise $100 million, with the help of a prominent biotech VC? And will Vinay Prasad return to the Food and Drug Administration for a "three-peat"? Damian Garde joins Allison, Adam, and Elaine to discuss his article about Boris Nikolic, a well-connected biotech investor with deep ties to Jeffrey Epstein, who has raised a new biotech investment firm. The hosts also talk about Prasad's second exit from the FDA and a congressman's probing of the agency's rare disease drug denials. And they recap Novo Nordisk and Hims' detente and Xenon Pharmaceuticals' promising seizure data.

Will drugmakers finally be able to breach the efficacy ceiling in inflammatory bowel disease? And is the Food and Drug Administration being flexible enough with rare disease treatments? Spyre Therapeutics CEO Cameron Turtle joins the podcast to discuss his company's experimental IBD medications, and whether the drug industry is scraping the barrel in the search for better treatments. We also discuss the latest news in the life sciences, including the ongoing debate between the FDA and UniQure over its Huntington's disease therapy, as well as Moderna's mammoth patent settlement.

On "The Readout LOUD" this week: Adam Feuerstein, solo. His usual co-hosts Allison DeAngelis and Elaine Chen took some time off, so Adam manned the podcast mic himself. Adam thought, quite understandably, that our cherished listeners wouldn’t want to hear him drone on for 30 minutes, so he thankfully found some help. Jared Holz, health care sector specialist at Mizuho Securities, agreed to be Adam’s podcasting wingman for this week’s show.They ran through a menu of takes on biotech stock performance, M&A, Food and Drug Administration turmoil, election intrigue, and artificial intelligence.

Was Hims' Super Bowl ad the final straw for regulators? Is the bar being lowered for psychedelic medicines? And what's happening behind-the-scenes with Moderna and the Food and Drug Administration? We discuss all that on this week's episode of "The Readout LOUD." STAT's Katie Palmer joins Adam, Elaine, and Allison to discuss the Hims GLP-1 pill fallout. The hosts also discuss the latest on Moderna's influenza vaccine application and Compass Pathways' depression psychedelic data.

We’re devoting our entire episode this week to one controversial and impactful topic: the FDA’s decision to block the review of Moderna’s mRNA flu shot. STAT was the first to report that Vinay Prasad, the agency’s top regulator of vaccines, overruled the head of the FDA’s vaccine office and other staffers in making that decision. Prasad’s unilateral action has renewed concerns about the FDA’s regulatory posture under the Trump administration. To help us dig deeply into this important story and its ramifications, we bring on STAT reporters Lizzy Lawrence and Matthew Herper. We also chat with Moderna President Stephen Hoge and former FDA official Jesse Goodman.

On this week’s episode of The Readout LOUD: two starkly different financial outlooks from Novo Nordisk and Eli Lilly, a psychedelics drug from Compass Pathways encountered a roadblock with the Trump White House, and a closer look at why manufacturing problems have slowed the rollout of a crucial sickle cell treatment. It’s our pre-Super Bowl show, which triggered some co-host squabbling. Adam Feuerstein is all Patriots, Elaine Chen is Team Seahawks, while Allison DeAngelis, raised in Seattle but now a Boston denizen, struggles with dual loyalties. Our special guest this week is STAT reporter Jason Mast. And if you get a chance, wish Adam a happy birthday.

This is an episode of Drug Story, a podcast by Thomas Goetz. You can find the rest of the series at https://www.drugstory.co/podcast Once you turn 40, it seems like half the people you know are taking a statin drug. You know, because their cholesterol is high, and to prevent heart disease down the line. It makes sense: better safe than sorry. This is a huge triumph for preventive medicine. Statin drugs have saved (or improved) the lives of millions of people because they acted early. This is how medicine (and public health) is supposed to work. But the devil is in the details. Like all drugs, statins have side effects. And when they are prescribed for many millions of people, the math means that millions of people will not, in fact, get any benefit from the drug. It turns out that atorvastatin (and other statin drugs) may be the most over-prescribed drugs in the history of medicine. And therein lies a Drug Story. This episode includes perspective from Rita Redberg, MD, cardiologist and former editor in chief at JAMA Internal Medicine.

Biotech company UniQure is set to meet with the Food and Drug Administration to discuss the path forward for its gene therapy for Huntington's disease, and the outcome could be potentially devastating for patients. That's what patient advocate Lauren Holder says on the latest episode of “The Readout LOUD,” STAT’s weekly biotech podcast. Holder joins the podcast for an in-depth discussion of how the regulator's changing perspective on UniQure's trial affects patients, and patients' attempts to petition the agency to reverse course. Adam, Elaine, and Allison also chat about the latest news in the life sciences, including the new slate of drug prices negotiated by Medicare, a rise in pharmaceutical industry lobbying, and a halt on another gene therapy trial.