Power struggles and exodus at Vinay Prasad's FDA center

Tumult inside the FDA's Center for Biologics Evaluation and Research is threatening the center's stability under its director, Vinay Prasad, STAT's Lizzy Lawrence reports exclusively. His tenure, more than a dozen insiders tell STAT, has been marked by fear, firings, and fierce micromanagement. Morale is cratering as Prasad, newly reinstated after a brief ouster this summer, consolidates power, overrules scientific staff, and removes veteran leaders without explanation, they say.

"He's wreaking havoc with the staff," one agency official said. "People are terrified."

Once a vocal critic of the FDA, Prasad now holds sweeping authority as both CBER director and the agency's chief medical officer — a dual role that insiders say he's wielding with vengeance, driving out senior scientists and threatening to undermine oversight of the nation's vaccines and blood safety.

podcast

BridgeBio's great week and Moderna's unraveling

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

We discuss all that on this week's episode of 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.

We also chat about the news this week, including Novo Nordisk's takeover bid for biotech company Metsera and troubles in the field of genetic medicines.

Listen here.

drug pricing

Opinion: Bausch's $800 drug exposes pharma's trust crisis

A $20 European over-the-counter eye drop now costs Americans $800 and a prescription — a glaring example of how pharma manipulates regulatory gaps for profit, opines pharmaceutical analyst David Maris. Bausch & Lomb repackaged EvoTears as Miebo, bypassing OTC approval to secure patents and monopoly pricing — a tactic that echoes its Valeant-era playbook of price gouging, Maris argues.

While the company blames FDA standards, Maris writes, its refusal to seek OTC status reveals a profit-first strategy that erodes public trust.

"Let's end the price-gouging practices of outliers and build a health care system that puts patients first," he writes. "Just as targeting criminal outliers fosters a law-abiding society, holding bad pharmaceutical actors accountable is crucial for restoring trust and integrity to our health care system."

glp-1 drugs

Lilly's tirzepatide topples Keytruda as global revenue leader

Eli Lilly has dethroned Merck as maker of the world's best-selling drug, with tirzepatide — sold as Mounjaro for diabetes and Zepbound for obesity — so far racking up $10.1 billion in third-quarter sales and $24.8 billion year-to-date, surpassing Keytruda's $23.3 billion.

Analysts now expect tirzepatide to hit $32.2 billion in full-year revenue, STAT's Elaine Chen writes, edging out Keytruda's projected $31.8 billion — and cementing Lilly's dominance in the booming GLP-1 market. The meteoric rise underscores the explosive demand for weight-loss drugs, and signals that the industry's center of gravity has officially shifted from oncology to obesity.