The Readout Loud

Dean Li, Head of R&D at Merck, discusses the groundbreaking results of Merck's oral PCSK9 candidate, enlicitide, which shows impressive LDL cholesterol reduction comparable to injectables. He explores the challenges of making effective heart disease treatments more accessible and the potential public health impact of wider adoption. The conversation also touches on FDA leadership changes and hopes for regulatory pathways that prioritize patient access while maintaining safety. Li emphasizes the importance of innovating beyond injectables and targeting new areas in cardiometabolic health.

Lizzy Lawrence, STAT's D.C. correspondent specializing in FDA and health policy, joins to discuss a brewing crisis within the FDA. She reveals leadership disputes between Vinay Prasad and his team, leading to declining morale and multiple staff exits. The shock departure of director George Tidmarsh for allegedly misusing his position adds to the turmoil. The conversation also touches on the heated bidding war between Pfizer and Novo Nordisk for the desirable MetSera assets, highlighting the competitive landscape in the obesity treatment market.

Neil Kumar, the CEO of BridgeBio, shares insights about the company's recent Phase 3 successes and discusses their innovative hub-and-spoke model. He reveals exciting news about the potential full approval for Ripetol and competitive strategies for Atrubi. Meanwhile, STAT reporter Jason Mast dives into Moderna's post-COVID turmoil, examining internal conflicts and the fallout from ambitious expansions. He highlights the challenges ahead for mRNA technology in therapeutics and the impact of political sentiment on the company’s future.

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. 

Jared Holz, a healthcare strategist at Mizuho, provides insights into the biotech rebound and investor sentiment, emphasizing the impact of fewer IPOs on market recovery. He shares that hedge funds are currently driving biotech investments. Meanwhile, Dietmar Berger, from Gilead Sciences, discusses innovative cell therapies in oncology. The conversation also explores AstraZeneca's surprising revival of a shelved rare disease candidate due to a calculation error, and Peter Marks’ transition to Eli Lilly adds a splash of controversy to the biotech landscape.

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 professor of health policy and management at Harvard’s school of public health who researches how policies affect people with disabilities.

Andrew Joseph, STAT's European correspondent, sheds light on significant pharma pullbacks from the U.K., revealing why giants like Merck and GSK are shifting their investments elsewhere. He analyzes the pricing tensions and the impact of U.S. investment strategies on the U.K. life sciences landscape. The discussion also covers Roche's bold $3.5 billion acquisition of 89bio, reflecting a trend of steady biotech M&A activity and improving market sentiment, providing listeners with a clear perspective on industry dynamics.

Mike Rea, a pharma consultant and head of Idea Pharma, shares insights from his personal journey through medical setbacks that reshaped his career. The conversation shifts to President Trump's proposed drug policies targeting China, stirring a debate on innovation versus protectionism. They also dive into the game-changing potential of the PD-1 VEGF inhibitor Ivanesimab, and discuss the leadership changes at Novo Nordisk, with implications for Alzheimer's research. Health challenges and the importance of patient advocacy in epilepsy treatment add a deeply personal touch.