Prasad blames media as FDA turmoil deepens

At a closed-door investor conference in New York, FDA vaccines chief Vinay Prasad railed against “misleading media narratives” as backlash mounts over his push to require larger, longer studies for updated vaccines, STAT’s Damian Garde reports. His proposal has drawn an extraordinary public rebuke from 12 former FDA commissioners.

Prasad defended the policy shift and distanced himself from health secretary Robert F. Kennedy Jr.’s anti-vaccine rhetoric, even as he declined to address his own unsupported claim that Covid vaccines killed 10 children. His remarks came amid escalating internal chaos: staff describe a demoralized agency, biotech firms say he’s upending agreed-upon trial plans, and critics question the legality of a new fast-track voucher program tied to White House drug-pricing demands.

Prasad brushed off the criticism — even as the FDA’s approval rate has slipped and its leadership fractures spill into public view.

“I read in the newspaper I'm both micromanaging every single thing in the FDA and I'm never there,” Prasad said. “I'm like, ‘Who is this guy? He's never around and he's got his hand in everything.’”

american science, shattered

Harvard lab hollowed out by Trump cuts

John Quackenbush’s renowned computational biology lab at the Harvard T.H. Chan School of Public Health — once bustling with trainees developing tools that transformed genetics research — now sits nearly empty after sweeping Trump-era cuts gutted NIH programs and wiped out the grants that sustained his work.

Quackenbush lost multiple funding streams this year, STAT’s Angus Chen writes, including an Outstanding Investigator Award that covered half his salary. The cuts leave him unable to hire replacements as postdocs depart and threaten the future of the lab’s influential “Network Zoo” software suite, which is used worldwide to model gene regulation in cancer, autism, and other diseases.

With Harvard tightening budgets, morale plummeting, and roughly $1.2 million already gone — with far more at stake in future years — the 100,000-citation scientist is weighing whether he can keep the lab alive at all, even as he insists on fighting to the end.

“Every day we come in to fight through the current situation as much as possible,” he said. “We want to continue research. We want to continue to make advances.”

biosimilars

Streamlining biosimilars could finally cut costs

The global biosimilar landscape is on the brink of its first real overhaul in two decades, opines Claire D’Abreu-Hayling, chief scientific officer of Sandoz. Regulators, she writes, are rethinking legacy requirements that have slowed competition and kept prices high.

With advanced analytics now able to characterize biologics more precisely than ever, agencies like MHRA, Health Canada, FDA, and even EMA are moving to scrap routine comparative efficacy trials — long the most expensive, least informative step in biosimilar approval.

“We are on the cusp of a harmonized global regulatory environment — one that could unlock timely, affordable access to these essential treatments if regulators, industry, clinicians, and patient advocates come together and commit to a shared regulatory language rooted in the latest science,” she writes.

podcast

A new top drug regulator and the future of psychedelics

In 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.

The turmoil at the Food and Drug Administration continues: Richard Pazdur has announced his retirement from the agency, just a month after taking the job as top drug regulator. He's being replaced by Covid contrarian Tracy Beth Høeg. We also discuss a U.K.-U.S pharma trade agreement, a very large financing round for an AI-tinged longevity startup, and a big Phase 3 study win for Capricor Therapeutics and its Duchenne muscular dystrophy cell therapy.

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.

Listen here.

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