The Readout Loud

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.

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.

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.

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).

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.

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.

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.

The American Society of Clinical Oncology, or ASCO, kicks off its annual meeting this weekend in Chicago. We discuss what to watch at the meeting. Then, STAT’s infectious disease reporter Helen Branswell joins us to discuss RFK Jr.’s unprecedented move to strike Covid shot recommendations, and the cancellation of a $600 million contract with Moderna to develop, test and license vaccines for subtypes of flu. We also welcome chronic disease reporter Isa Cueto to discuss the key takeaways from a closely watched report from Kennedy’s Make America Healthy Again Commission.

We chat about M&A deals picking up, leadership changes at Novo, and recent FDA advisory committee meetings for cancer drugs. We also bring on STAT reporter Jason Mast to talk about the latest research and sentiment at the annual American Society of Cell and Gene Therapy meeting.

We chat about the mixed sentiment in biotech markets these days and a new blood-testing company formed by Elizabeth Holmes' husband. We also bring on STAT's D.C. correspondent Daniel Payne to talk about President Trump's "most-favored nation" drug pricing policy and health secretary Robert F. Kennedy Jr.'s recent congressional hearing.

Matt Herper joins Adam and Allison to examine Prasad's appointment and the band of outsiders now in charge of U.S. health agencies. He and Adam debate just how disruptive Prasad's tenure could be.