The Readout Loud

Latest Episodes:

365: Vinay Prasad’s return, animal testing alternatives, and mRNA upended Aug 14, 2025

Show notes

We discuss the sudden return of Prasad and the mixed prospects for mRNA. Then, we invite STAT fellow Marissa Russo on to discuss the alternatives to animal testing, and why they’re the subject of hot debate among scientists.

364: Closing a zombie biotech, and Lilly's disappointing obesity readout Aug 07, 2025

Show notes

We bring on Natalie Holles, who was the CEO of Third Harmonic Bio, which recently decided to dissolve and return cash to shareholders. She walks us through why the company has decided to do this and her advice for other biotech CEOs.

We also chat about a disappointing readout from Eli Lilly's key small molecule GLP-1 candidate, setbacks in Vertex's pain business, and the story behind Replimmune's recent FDA rejection.

363: What Vinay Prasad’s ouster means for biotech and the FDA Jul 31, 2025

Show notes

This week’s show is focused on a single topic — the ouster of Food and Drug Administration official Vinay Prasad from his job running the agency’s biologics division. This surprising development came after a series of controversial decisions he made on Sarepta’s gene therapy for Duchenne muscular dystrophy and a barrage of political attacks from conservative voices.

We bring on Brian Skorney, senior research analyst at Baird, to talk about the implications for the biotech industry. We then have on Robert Califf, former FDA commissioner, and Ned Sharpless, former acting FDA commissioner, to discuss the implications for the agency.

362: A mother’s perspective on Sarepta’s gene therapy halt Jul 24, 2025

Show notes

We bring on a mother whose 7-year-old has Duchenne muscular dystrophy, and hear her thoughts on Sarepta’s decision to pull its treatment Elevidys from the market, following a request from the Food and Drug Administration. We also talk about a rare mega-round for a new oncology biotech and an emerging class of drugs aimed at helping people stay awake.

361: Inside an FDA drug rejection, and layoffs at Sarepta Jul 17, 2025

Show notes

Just how many employees is Sarepta Therapeutics laying off? And why did the Food and Drug Administration reject Ultragenyx’s rare disease drug over manufacturing qualms?

Ultragenyx CEO Emil Kakkis joins us to discuss what was in the rejection letter his company received late last week, and whether he still has confidence in FDA Commissioner Marty Makary. We also discuss Capricor’s drug rejection, and Sarepta’s decision to lay off hundreds of staffers, but give raises to some executives.

360: NIH grant cuts, FDA transparency questions and biotech M&A Jul 10, 2025

Show notes

On this week’s episode of the Readout LOUD: A closer look at the NIH’s grant-cutting legal playbook, a not-so-transparent transparency push by the FDA commissioner, and another big biotech acquisition.

Our colleague Anil Oza joins us to unravel a previously unseen memo he obtained from HHS that lays out the legal framework being used to justify the termination of NIH grants. The disclosure comes as legal fights over the legitimacy of these funding cuts are being challenged in multiple courts.

359: Vaccine policy frays, CDC nominee in the hot seat, & obesity drug side effects Jun 26, 2025

Show notes

We invite STAT’s senior writer for infectious diseases, Helen Branswell, and Washington correspondent Chelsea Cirruzzo on to the podcast to discuss the latest news at the CDC. The agency is in the spotlight once again, after the Senate grilled the potential head of the agency at a confirmation hearing and its federal vaccine advisory committee met for the first time after Robert F. Kennedy Jr. fired its existing 17 members and installed a new, smaller panel.

We also discuss the latest news in the life sciences, including data presented at last weekend’s American Diabetes Association research meeting. We also squeeze in some conversation about summer blockbusters. (Check out Adam’s "Jaws" Lego set here).

358: FDA's gene therapy turmoil, and an alternative model for funding research Jun 19, 2025

Show notes

We discuss the tragic news that a second teenage boy with Duchenne muscular dystrophy died after taking Sarepta Therapeutics' gene therapy, raising renewed questions about the FDA's standards for approving drugs.
We look at the continued turmoil within the FDA, including the forced dismissal of top gene therapy regulator Nicole Verdun, as well as the announcement of a controversial drug-review voucher program that seems to be steering the agency into politics.
We also talk about a private equity firm's decision to fund a research lab at Harvard University, filling a void created by government spending cuts. And we look at the approval of a groundbreaking HIV prevention medicine from Gilead Sciences, as well as a recap of the big BIO convention this week and a preview of the upcoming American Diabetes Association meeting this weekend.

357: The upheaval of CDC's vaccine panel, and drug pricing confusion Jun 12, 2025

Show notes

First, we chat about how pharma companies still don’t have much clarity on Trump’s most-favored nation drug pricing policy, biotech’s next big takeout target, and more. Then we bring on Kathryn Edwards, a vaccine expert and a former member of the CDC advisory panel, to parse through the turmoil.

356: An AI experiment at the FDA & Novo trailing in the obesity drug race Jun 05, 2025

Show notes

The FDA has rolled out an internal AI tool called Elsa that, unlike its namesake Disney character, can’t seem to let go of mistakes. Our colleague Brittany Trang joins to explain. And it’s always a fun podcast when we can discuss a biotech acquisition. This week, we’ll chat about Sanofi’s $9 billion offer for Blueprint Medicines. But first, our cohost Elaine Chen has a new story published this week that examines the reasons behind Novo Nordisk’s fall and what it’s doing to catch up.

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