Matthew Herper

whoops

Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks In a closed meeting, Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his role in recent drug-approval turbulence.

Vinay Prasad, FDA’s vaccine regulator, waves off criticism in closed-door remarks www.statnews.com/2025/12/04/v...

CDC vaccine advisers appear likely to recommend delaying hepatitis B vaccine birth dose A panel that issues advice on U.S. vaccine policy appears prepared to vote Thursday to recommend a delay in when most babies begin to be vaccinated against hepatitis B.

CDC vaccine advisers appear likely to recommend delaying hepatitis B vaccine birth dose

Experts warn such a change will increase number of children

By @helenbranswell.bsky.social

www.statnews.com/2025/12/04/c...

This doesn't relate to the phases of trials; it relates to how many trials are included in phase 3. Traditionally it is two, although it is actually usually one these days. But this would make one the official norm, which is a big and potentially disruptive change.

Paradigm Health, seeking to use AI to enroll clinical trials, partners with Roche Paradigm Health, which is seeking to use AI to enroll clinical trials, has raised more funds and is acquiring a business from Flatiron Health.

Paradigm Health, seeking to use AI to enroll clinical trials, partners with Roche www.statnews.com/2025/12/04/p... via @statnews.com

FDA to lower number of trials required for approval of drugs, other medical products The FDA plans to begin requiring one clinical study, instead of the standard two, for medical products before consideration for approval.

FDA to lower number of trials required for approval of drugs, other medical products www.statnews.com/2025/12/04/f... via @statnews.com

Top drug regulator Richard Pazdur set to leave FDA Top drug regulator Richard Pazdur filed papers to retire from the Food and Drug Administration at the end of this month, but could withdraw them.

Three weeks ago @matthewherper.bsky.social described the appointment of Richard Pazdur as the FDA's top drug regulator as welcome news "for patients, drug companies, and anyone who cares about a rigorous" agency. Now he appears to be headed for the exits.

www.statnews.com/2025/12/02/r...

Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence The FDA’s top vaccine regulator asserted in a staff email that the Covid vaccine caused at least 10 kids' deaths, but experts told STAT they are skeptical of the “extraordinary” claim because it was n...

Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence; suggested reforms unclear, too. www.statnews.com/2025/11/29/c... via @statnews.com @matthewherper.bsky.social @helenbranswell.bsky.social

A dozen former FDA commissioners decry Prasad memo on vaccine regulation Changes to the ways in which the FDA plans to regulate vaccines represent a threat to effective vaccines and public health, 12 former commissioners say.

12 former FDA commissioners denounce Vinay Prasad's internal memo on vaccine regulation, from
@matthewherper.bsky.social: www.statnews.com/2025/12/03/f...

Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence The FDA’s top vaccine regulator asserted in a staff email that the Covid vaccine caused at least 10 kids' deaths, but experts told STAT they are skeptical of the “extraordinary” claim because it was n...

Experts say top FDA official’s claim that Covid vaccines caused kids’ deaths requires more evidence

Vinay Prasad ties 10 deaths to the shots, calls for stricter vaccine regulation, in leaked memo

www.statnews.com/2025/11/29/c...

Unfortunately, I can confirm that this is true.

I have known Carl for 2 decades and he is smart, dedicated, and quite apolitical, focused on science and getting stuff done on important problems.

Huge unnecessary loss of leadership and expertise.

What Pfizer’s Metsera deal means for biotech M&A What might Pfizer's Metsera deal mean for biotech M&A? Quite a lot.

What Pfizer’s Metsera deal means for biotech M&A www.statnews.com/2025/11/11/p... via @statnews.com

Yes

Arena BioWorks, an ambitious biomedical institute backed by billionaires, abruptly shuts down Exclusive: Arena Bioworks, the buzzy research institute that launched with $500 million to support a decade of scientific R&D, is abruptly shutting down, STAT has learned.

OMG.

Arena BioWorks, an ambitious biomedical institute backed by billionaires, abruptly shuts down www.statnews.com/2025/11/04/a... via @statnews.com

The news over the weekend shocked agency employees. “It is impossible for dedicated career FDA staff to responsibly regulate new products, conduct groundbreaking research, and manage FDA’s resources on behalf of the American public,” said one agency staffer. “The situation is not salvageable. We need our many stakeholders, legislators, and pharmaceutical companies to demand better and to insist on change now, from the top of FDA and HHS down.”

Important new analysis from @matthewherper.bsky.social and @lizzylawrence.bsky.social about the ongoing situation at FDA. This quote from an agency staffer sums up the potential concerns. www.statnews.com/2025/11/04/f...

Experts worry FDA’s credibility is being shredded by scandal and 'soap opera' Experts worry that the FDA’s credibility is being shredded by scandal and "soap opera."

Experts worry FDA’s credibility is being shredded by scandal and 'embarassing' ‘soap opera’ 'clown show' www.statnews.com/2025/11/04/f...

😔

I have worked directly with Adam and with Lizzy. They are diligent and smart and I trust them.

Lawsuit against top FDA drug regulator is packed with incendiary texts, emails A lawsuit filed against George Tidmarsh, who resigned from a top FDA post on Sunday, includes a series of incendiary texts and emails

Lawsuit against top FDA drug regulator is packed with incendiary texts, emails

Because of course it is.

www.statnews.com/2025/11/03/g... via @statnews.com

FDA’s top drug regulator placed on leave amid investigation George Tidmarsh, the FDA's top drug regulator, has been placed on leave after being accused of abusing his regulatory authority, STAT has learned.

FDA’s top drug regulator placed on leave amid investigation

CDER Director George Tidmarsh is accused of seeking to use authority to inflict financial harm on former associate

www.statnews.com/2025/11/02/f...

Below, GSK CEO Emma Walmsley meets Baby KJ, the child who was treated with CRISPR gene editing by researchers at Children's Hospital of Philadelphia.

It was one of the biggest moment from #STATSummit. You can read about that moment and more here: www.statnews.com/2025/10/24/p...

Insightful piece from @matthewherper.bsky.social that captures both the hopes being made possible by medical innovation and the concerns facing both drugmakers and the public.

It's also in front of the @statnews.com paywall.

The sci-fi films that physicists love to watch — from Interstellar to Spider-Man Nature surveyed scientists about their favourite cinematic moments to celebrate the International Year of Quantum Science and Technology.

The sci-fi films that physicists love to watch — from Interstellar to Spider-Man

Nature surveyed scientists about their favourite cinematic moments to celebrate the International Year of Quantum Science and Technology.

www.nature.com/articles/d41...

Moderna says key study of its CMV vaccine, expected to be its next big win, failed Moderna said its experimental vaccine for cytomegalovirus failed in a key trial, a significant setback for a company already facing pressure from Wall Street and Washington.

“Nobody succeeded ever, yet,” Moderna's Stephen Hoge said. “Now you can add our name to that long list of companies and academics that haven’t been able to show benefit.” Read more from @jasonmast.bsky.social and @matthewherper.bsky.social at @statnews.com

www.statnews.com/2025/10/22/m...

At a gathering of biopharma executives, a moment of wonder — and also of worry Sometimes the biggest moments at a conference happen backstage. At the annual STAT Summit, that kind of moment involved a pharma CEO and a toddler in a tuxedo.

At a gathering of biopharma executives, a moment of wonder — and also of worry

Industry confronts an era of innovation in the shadow of concerns about public trust, pricing

My takeaways from last week's #STATSummit

www.statnews.com/2025/10/24/p...

STAT's @matthewherper.bsky.social asks Eli Lily's Daniel Skovronsky about hiring Peter Marks and the revolving door of talent at the FDA.
#STATSummit

An email appointing Kyle Walsh is director of the National Institute of Environmental Health Sciences

VERY TROUBLING NEWS REGARDING NIH INSTITUTE DIRECTORS

A new appointment for NIEHS

1/3

Baby KJ's doctors will ask FDA this winter to OK a clinical trial of pioneering gene editing approach Baby KJ's medical team intend to ask the FDA to start a clinical trial that would be open to patients with seven different urea cycle disorders.

Baby KJ’s doctors will ask FDA this winter to OK a clinical trial of pioneering gene editing approach

Squirming toddler with a rare liver disease leaves barely a dry eye at #STATSummit

www.statnews.com/2025/10/16/b...

Baby KJ, in a tiny tuxedo, shows up at the #STATSummit. His parents Kyle and Nicole Muldoon give an update on how he’s doing after his life-saving CRISPR treatment for a rare liver disease earlier this year.

Read their story: www.statnews.com/2025/05/15/c...

At #STATSummit, Doctor Mike says medical organizations like the American Medical Association are losing the information war against health secretary Robert F. Kennedy.