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 Lizzy Lawrence and Matthew Herper. We also chat with Moderna President Stephen Hoge and former FDA official Jesse Goodman.

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.

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 to work. But the devil is in the details. Like all drugs, statins have side effects. And when they are prescribed for many millions of people, the math means that millions of people will not, in fact, get any benefit from the drug. It turns out that atorvastatin (and other statin drugs) may be the most over-prescribed drugs in the history of medicine. And therein lies a Drug Story. This episode includes perspective from Rita Redberg, MD, cardiologist and former editor in chief at JAMA Internal Medicine.

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.

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 chat with our hospitals and insurance reporter Tara Bannow about the financial troubles afflicting nonprofit hospitals and how they spent their time at the J.P. Morgan Healthcare Conference.

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 Eli Lilly and Novo Nordisk's direct-to-consumer offerings may be contributing to employers' decisions to drop coverage of weight loss drugs.

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 the new series “American Science, Shattered,” which details this fissure and what it means for the future of the country’s scientific institutions.

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.We also chat about the news this week, including more M&A deals and an upcoming Alzheimer’s readout from Novo Nordisk.

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.

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 the canary in the coal mine that is the drug industry. Adam also asks Allison about her trip to North Carolina to check out the local biomanufacturing boom.

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 moderating panel discussions at the STAT Summit in Boston, so we prerecorded this interview with Meanwell on Oct. 8. A regular “Readout LOUD” episode will return next week.

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 raised by China-focused Expedition Therapeutics.

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?We discuss all that and more on this week's episode of "The Readout LOUD," a weekly biotech podcast from STAT. 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 professor of health policy and management at Harvard’s school of public health who researches how policies affect people with disabilities.