The Readout Loud

STAT's European correspondent Andrew Joseph calls in from the U.K. to the podcast to dissect why companies like Merck and GSK are putting their money elsewhere.

We also discuss the Advisory Committee on Immunization Practices, or ACIP, meeting and biotech M&A, including Roche's $3.5 billion acquisition of 89bio and its MASH drug, announced this week.

Listeners of this podcast probably know pharma consultant Mike Rea for his annual ranking of drug company R&D productivity. But this week, he penned a poignant personal essay explaining how some medical setbacks have impacted his professional life. He joins us to discuss.

But first, President Trump is considering a significant crackdown on drugs invented in China, according to a recent report in the New York Times. Industry support for the possible measures are mixed, however. While strengthening the U.S. biopharma industry garners wide support, so too does the freedom to source innovative drugs from Chinese biotechs.

Labor Day is in the rearview mirror, and that means Adam, Elaine, and Allison are all back to work. They take the pulse of the biotech market and discuss forthcoming data readouts at two sleep and lung disorder conferences. But first, they discuss the bubbling uncertainty in the vaccine field.

We bring on Washington correspondent Chelsea Cirruzzo to explain the ouster of CDC Cirector Susan Monarez and the resignations of other top officials.

We also chat about STAT's annual VC rankings report, as well as ongoing issues at a major drug manufacturing site that was owned by Catalent and now owned by Novo Nordisk.

On this week’s episode of “The Readout LOUD”: vikings. No, not the seafaring Norse people of the 10th century, or the Minnesota football team. The gang will discuss obesity drug developer Viking Therapeutics and the investor cult that embraces it, both of which performed a painful belly flop this week.

Then, we’ll dish on the growing “pharm to table” movement. That’s the clever buzzphrase bandied around by Big Pharma insiders to promote plans that sell drugs directly to consumers — supposedly at lower costs that will make President Trump happy. Except as our cohost Elaine Chen reported this week, these direct-to-consumer plans championed by Eli Lilly, Novo Nordisk, Bristol Myers Squibb, and others are unlikely to make drugs more affordable. We’ll dig into the details.

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.

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.

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.

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.

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.