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12. FEB.

388: The FDA's refusal to review Moderna's mRNA flu vaccine

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.

12. feb.

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51 min
PRED 3 DNEVI

389: Hims' Super Bowl fallout, and the FDA reverses course

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.

pred 3 dnevi

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34 min
29. JAN.

386: The high stakes for Huntington's patients

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.

29. jan.

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42 min
5. FEB.

387: Challenges for a crucial sickle cell treatment and the latest outlook for GLP-1s

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.

5. feb.

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28 min
04. 12. 2025

380: A new top drug regulator and the future of psychedelics

On this week’s episode of "The Readout Loud": a look at an emerging class of psychedelic drugs that may treat depression, anxiety, and other psychiatric conditions without the hallucinogenic “trip.” Plus, a dash through the week’s biotech news. Our special guest this week is David Olson, director of the UC Davis Institute for Psychedelics and Neurotherapeutics and the co-founder of Delix Therapeutics, a startup that is developing a new class of neuropsychiatric medicines that are similar to psychedelics in that they can exert strong and rapid therapeutic benefits, but without the hallucinogenic effects.

04. 12. 2025

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33 min
03. 04. 2025

348: Cuts, ousters and drama at the FDA

STAT’s FDA reporter Lizzy Lawrence joins to discuss her inside-the-agency reporting on how Robert F. Kennedy Jr. forced top FDA officials to resign at a time when newly sworn-in FDA Commissioner Makary is still figuring out how to get around the agency’s White Oak campus in suburban Maryland. Then: AstraZeneca presented positive mid-stage results this week on a PCSK9 pill that dramatically lowered cholesterol levels on top of traditional statins. R&D executive Sharon Barr joins to talk about why AstraZeneca views this experimental cardiovascular medicine as a key part of its growth strategy.

03. 04. 2025

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31 min
20. 11. 2025

379: How Mark Cuban plans to ‘f— up’ health care

How much time does Mark Cuban spend thinking about health care? Why does he think TrumpRx, a direct drug purchasing platform that the Trump administration aims to launch, is “the most incredible program ever”? And what are his thoughts on sports betting? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast. Cuban comes on for an extensive chat about the latest biosimilar launch by his company, Cost Plus Drugs, as well his broader thoughts on the drug industry and how the direct-to-consumer field is changing.We also chat about the news this week, including more M&A deals and an upcoming Alzheimer’s readout from Novo Nordisk.

20. 11. 2025

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37 min
25. 09. 2025

371: A gene therapy success in Huntington's and Trump's autism announcement

We bring on UniQure CEO Matt Kapusta to discuss the company's announcement this week that its one-time treatment for Huntington’s disease significantly slowed down the neurological condition in a key study. We also chat about the Trump's administration initiatives on autism. Officials this week warned pregnant women not to take Tylenol, saying that it may cause autism, and they announced an FDA decision to make a decades-old drug called leucovorin available as a treatment for people with certain autism symptoms. To unpack the implications of these statements, we bring on by Ari Ne'eman, an assistant professor of health policy and management at Harvard’s school of public health who researches how policies affect people with disabilities.

25. 09. 2025

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43 min
18. 12. 2025

382: Biotech's year in review

Is the biotech industry truly out of its slump? Why are employers dropping coverage of weight loss drugs? And what will the hosts bake for the holidays? We discuss all that and more on this week's episode of "The Readout LOUD," the last episode of the year. We bring on Bruce Booth, partner at venture capital firm Atlas Venture, to reflect on everything that's happened in the biotech industry this year and to look ahead at the trends next year.We also chat about Adam's picks for best and worst biopharma CEOs in 2025, and why Eli Lilly and Novo Nordisk's direct-to-consumer offerings may be contributing to employers' decisions to drop coverage of weight loss drugs.

18. 12. 2025

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34 min
13. 11. 2025

378: Merck's heart disease win and the FDA's new drug regulator

What does Rick Pazdur's new role mean for the Food and Drug Administration? Has Merck solved the PCSK9 access issue? And how much credit can the president take for lowering GLP-1 drug prices? Dean Li, the head of R&D at Merck, joins us to discuss the long-awaited trial results for the company's oral medicine targeting PCSK9 to lower cholesterol. These types of treatments have proven effective at addressing heart disease, but making them into more accessible pills has proven tricky.We also discuss the latest news in the life sciences, including the resolution of Pfizer and Novo Nordisk's bidding war over Metsera, Pazdur's new role at the FDA, and the end of a decade-long longevity venture.

13. 11. 2025

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36 min

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