The Readout Loud

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 Lizz...

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 Ma...

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 t...

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...

Why is the U.S. at risk of losing its measles elimination status? How are health officials reacting to the measles outbreak? And what did top Centers for Medicare and Medicaid Services official Mehmet Oz tell hospital executives at a fancy yacht party in San Francisco?

We discuss all that and more on this week's episode of "The Readout LOUD," STAT's weekly biotech podcast. We bring on our infectious disease reporter Helen Branswell to talk about the ongoing measles outbreak in South Carolina and what it means for the U.S. more broadly.

We also...

For this very special episode of The Readout LOUD Allison, Adam, and Elaine are live from the J.P. Morgan Healthcare Conference in San Francisco.

The hosts are joined by ARCH Venture Partners co-founder and managing director Bob Nelsen and new Novo Nordisk CEO Mike Doustdar joins the podcast hosts live to discuss his first few months on the job and the company's push to regain market share in the competitive obesity market.

What news happened over the holidays? Why will pharma CEOs be greeted warmly in San Francisco next week? And who will buy Revolution Medicines?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast. We bring on former co-host Damian Garde, who’s now a reporter at large at STAT, to preview the upcoming J.P. Morgan Healthcare Conference. We also discuss the approval of Novo Nordisk’s Wegovy pill, the federal government’s move to slash the number of recommended pediatric immunizations, and the resurgence of M&A deals.<

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...

How did Terns Pharmaceuticals and its “hodgepodge” pipeline grab attention at the American Society of Hematology conference? Is Eli Lilly’s new drug making people lose too much weight? And what, exactly, is the Trump administration’s plan for reforming the National Institutes of Health?

First, we discuss all things ASH, particularly Tern’s chronic myeloid leukemia data,  Johnson & Johnson’s multiple myeloma data, and Fulcrum Therapeutics’ pill for sickle cell disease. We also get into the latest news in — what else? — obesity drugs.

Then, STAT reporters Megan Molteni and Anil Oza join for a conversation on t...

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.

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...

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...

On a jam-packed show, your co-hosts, minus the vacationing Allison DeAngelis, chat with STAT’s D.C. correspondent Lizzy Lawrence about a slow-boiling feud between Vinay Prasad, the head of the FDA’s biologics and vaccine branch, and his staff that has triggered even more exits and plunging morale.

On the drug side of the agency, we dish on the shocking exit of director George Tidmarsh after he was accused of using his regulatory position to exact personal revenge against a former business partner. Bonus: Prasad and Tidmarsh hate each other.

Has BridgeBio’s business model worked? How are executives at Moderna dealing with the company’s slump? And who will the hosts dress up as for Halloween?

We discuss all that on this week’s episode of the “The Readout LOUD,” STAT’s biotech podcast. We bring on BridgeBio CEO Neil Kumar to discuss the company’s positive Phase 3 readouts and our colleague Jason Mast to discuss Moderna’s struggles following its Covid-19 vaccine boom.

Can Trump take credit for North Carolina's booming biopharma industry? Which drugs could get a shortcut to the market? And who wore a tuxedo to the STAT Summit?

We discuss all that and more in the latest episode of "The Readout LOUD."
Elaine is out this week, so Adam and Allison dive into the latest news in the life science industry together, including the two companies pushing the Food and Drug Administration, the first recipients of the Commissioner’s National Priority Review voucher, and why Flagship Pioneering founder Nobuar Afeyan thinks that mRNA vaccines are th...

On this week’s episode of “The Readout LOUD”: an interview with veteran biotech executive and company founder Clive Meanwell. Pfizer recently acquired one of Meanwell’s companies, the obesity drug developer Metsera, for just under $5 billion.

Meanwell offered his perspectives on the evolving obesity drug market, and continued need for drugs to treat diseases with large prevalence, which he’s doing with his latest venture, called Corsera Health. Meanwell also weighed in on drug pricing policies both in the U.S. and the U.K.

Your favorite podcast co-hosts have been extra busy this week moderat...

Where did former vaccine regulator Peter Marks find a new job? How did a math error cost AstraZeneca a rare disease candidate? And is biotech back?

We discuss all that on this week’s episode of the “The Readout LOUD,” STAT’s biotech podcast. We bring on Mizuho health care strategist Jared Holz to discuss the rebound in biotech stocks and sentiment.

We also talk about Marks’ new role at Eli Lilly after leaving the Food and Drug Administration, an attempt by a biotech to revive a rare disease drug shelved by AstraZeneca, and new funds rais...

How will we look back on Emma Walmsley's tenure as GSK's CEO? Why did one of the FDA's top drug officials call out an obscure lupus drug on LinkedIn? And will we ever stop talking about the pharma patent cliff?
Adam is out this week, so Allison and Elaine dive into the latest news, starting with another biotech acquisition and a new CEO at GSK. Then, they invite health policy researcher Stacie Dusetzina to break down President Trump's "most-favored nation" pricing deal with Pfizer.

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 pr...

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 Chin...

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...

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 implicat...

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 rese...

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...

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.

On this week’s episode of the Readout LOUD, we review President Trump’s first 100 days, the return of biotech M&A, strong drug launches, and Eli Lilly’s PBM problem. 

The first 100 days of the Trump administration have had a profound impact on federal health agencies, medical research, health policy and the biotech and pharmaceuticals industries. To help us make sense of all the cuts and policy shifts, we talk with STAT editors Gideon Gil and Zach Tracer for their perspective overseeing STAT’s reporting on science and politics. 

But first, your co-hosts Elaine, Allison an...