STAT

Opinion: STAT+: RFK Jr. acknowledges receiving unproven stem cell treatment from an Antigua clinic

Welcome to Lab Dish, a First Opinion column on regenerative medicine from Paul Knoepfler.

Health and Human Services Secretary Robert F. Kennedy Jr. recently revealed on a health influencer podcast that he received unproven stem cells at a clinic in Antigua for his throat condition, spasmodic dysphonia. He also suggested that he wants to give the public much broader access to such unproven therapies, which would be extremely risky.

This revelation confirms what I had suspected for months about Kennedy. It also raises new concerns about a possible upcoming wave of reckless cell therapy deregulation from this administration.

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3 days 7 hours ago

First Opinion, Lab Dish, biotechnology, gene therapy, RFK Jr., STAT+, stem cells

STAT

STAT+: More Medicare plans cover Humira biosimilars, but do little to encourage patient use

Medicare drug plans significantly boosted coverage of biosimilar versions of the Humira rheumatoid arthritis medicine this year, but nearly all of them failed to take steps that would encourage greater use of these alternative treatments, a new government watchdog report finds.

The report found that 96% of the Part D plans and 88% of the Medicare Advantage drug plans agreed to cover at least one of the 10 available copycat drugs on their 2025 formularies. And some did not cover the brand-name version. This was a big jump in coverage from 2024, when only 64% of the Part D plans and 52% of the Medicare Advantage drug plans covered at least one biosimilar version of Humira.

Overall, 99% of enrollees in Part D Plans and 90% in Medicare Advantage drug plans had access to at least one Humira biosimilar in 2025. However, some plans are still restricting access to the biosimilars this year, which precludes usage. Specifically, 10% of Medicare Advantage drug plans and 1% of Part D plans cover only the brand-name medication.

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1 month 2 days ago

Pharmalot, Biosimilars, biotechnology, drug pricing, humira, Medicare, Pharmaceuticals, Public Health, STAT+

STAT

STAT+: Trump nominates Casey Means, entrepreneurial doctor and MAHA leader, for surgeon general

The health entrepreneur and “Make America Healthy Again” leader Casey Means has been nominated to be the U.S. surgeon general after President Trump pulled his prior nominee suddenly on Wednesday. 

Means, an M.D. and author who runs a holistic wellness blog and co-founded the health tech company Levels, is the sister of Calley Means, an adviser to Health Secretary Robert F. Kennedy Jr. Both Meanses have become key influencers in the MAHA world, with Casey lending her medical training and knowledge to the cause. 

Trump’s original nominee to the post of surgeon general was Janette Nesheiwat, a medical doctor and Fox News contributor. The White House withdrew her nomination a day before Nesheiwat was scheduled to appear before a key Senate committee. She came under fire in recent weeks for previous comments she’d made online in support of the Covid vaccine and masking during the pandemic. CBS News also reported that Nesheiwat received her medical degree from a school in the Caribbean, not, as she claimed, the University of Arkansas School of Medicine.

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1 month 3 days ago

Health, Politics, chronic disease, Donald Trump, Politics, RFK Jr., STAT+, White House

STAT

STAT+: Flatiron Health veterans raise $25 million for AI tool to forecast drug toxicity

In January, San Francisco’s Union Square was bustling with hordes of drug developers and investors, pounding the pavement on their way from meeting to meeting. But Rohan Ganesh, an investor at the VC firm Obvious Ventures, wasn’t among them. He only agreed to hear one company’s pitch during this year’s J.P. Morgan Healthcare Conference.

The meeting was with a startup created by Flatiron Health veterans Josh Haimson and Ben Birnbaum. The duo had built the first team at Flatiron focused on machine learning, and, a few years after pharmaceutical giant Roche snapped up the company for $1.9 billion, they launched their own company.

Their new venture, Inductive Bio, has created an artificial intelligence tool that biotechs can use to design and model different versions of a small-molecule drug, sussing out what variation might cause drug toxicity or be metabolized too quickly. 

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1 month 3 days ago

Biotech, Exclusive, Artificial Intelligence, biotechnology, drug development, STAT+, venture capital

STAT

STAT+: In Ireland, a global hub for the pharma industry, Trump tariffs are a source of deep worry

The hulking factories are tucked away off the roads around the village of Ringaskiddy — operated by the likes of Pfizer, Johnson & Johnson, and BioMarin, whose plant featured signs last week touting a new facility “coming Q1 2027.”

The nearby town of Carrigtwohill crows that it’s grown “+400% over the past 20 years,” a surge driven by sites run by AbbVie and Gilead. 

The hulking factories are tucked away off the roads around the village of Ringaskiddy — operated by the likes of Pfizer, Johnson & Johnson, and BioMarin, whose plant featured signs last week touting a new facility “coming Q1 2027.”

The nearby town of Carrigtwohill crows that it’s grown “+400% over the past 20 years,” a surge driven by sites run by AbbVie and Gilead. 

And down in Kinsale, an Eli Lilly campus rises up out of the Irish countryside, a hub that recently underwent an $800 million expansion to meet the surging demand for the company’s obesity and diabetes drugs. Placards along the edge of the property celebrate Lilly’s sponsorship of the upcoming Kinsale 10-mile road race

“It’s absolutely everything to this area,” Jack White, a member of the County Cork council, told STAT, referring to the presence of pharma manufacturing here. 

President Trump is less fond of the industry’s operations in Ireland. As he seeks to impose tariffs on goods worldwide, part of a bid to bring companies back to the U.S. and generate jobs, he has specifically called out pharma manufacturing in this country and pledged to announce new levies on drugmakers. In his view, the U.S. trade imbalance with Ireland — one largely driven by pharmaceutical exports — is a particular injustice. As a result, the industry is now caught in his crosshairs, anxiously awaiting details from the administration.

“All of a sudden Ireland has our pharmaceutical companies, this beautiful island of five million people has got the entire U.S. pharmaceutical industry in its grasp,” Trump said in a March meeting with Irish Prime Minister Micheál Martin marking St. Patrick’s Day. “I’d like to see the United States not have been so stupid for so many years, not just with Ireland, with everybody.”

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1 month 2 weeks ago

Biotech, Pharma, Pharmaceuticals, policy, STAT+

STAT

STAT+: Wyden claims Pfizer used a ‘colossal’ scheme to avoid paying billions in U.S. taxes

In what one U.S. lawmaker described as possibly the “largest tax-dodging scheme” by a pharmaceutical company in history, Pfizer sold $20 billion in medicines to U.S.

customers six years ago, but did not report any profits from those sales on its 2019 tax returns because all of the income was supposedly earned offshore, according to an investigation by the Democratic staff of the Senate Finance Committee.

As a result, the company was able to avoid paying billions of dollars in federal income taxes and, in fact, also did not report any taxable income in the U.S. for 2018 and 2020. To accomplish this, Pfizer used what was described as an “egregious tax gimmick” called “round-tripping,” a tax avoidance scheme that involves making sales to U.S. customers, but treating the profits as foreign income for tax purposes.

Often, round-tripping refers to offshoring manufacturing to a foreign subsidiary located in another country or jurisdiction with lower tax rates. The list includes Puerto Rico and Ireland, where Pfizer has various operations. Another tactic is to shift intellectual property rights to such havens or engage in transfer pricing, which involves a company selling itself products at artificially high prices.

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2 months 2 weeks ago

Pharmalot, biotechnology, Pharmaceuticals, policy, STAT+, Taxes

STAT

STAT+: AbbVie, J&J to add proprietary data to AI protein model in bid to accelerate drug discovery

Imagine standing on a vast, dark plain. Without light, you cannot see dips and rolls in the grass or make out hills and valleys. Even if there’s a city off in the distance to your right, it does nothing to illuminate the darkness on your left, unless there are pinpricks of light there which might indicate a mountain or level ground.

So, too, is the vast, unexplored drug-hunting territory of chemical space, waiting to be illuminated by data’s light.

Every AI model trained for biology only can see what’s illuminated by the data points it is trained on. AlphaFold succeeded in predicting protein structures because the 200,000 or so known protein structures in the Protein Data Bank covered enough of the limited ways amino acids can combine that the model was able to understand what almost the entire protein structure space looked like. But ask the PDB for only the structures where proteins are hugging other proteins or — even rarer — interacting with drug-like molecules, and there’s nowhere near enough illumination for AI biology models to understand what the topography of those plains look like, much less make useful predictions for drug discovery.

Life sciences data company Apheris on Thursday announced an effort to boost the capabilities of protein AI models by uniting several pharmaceutical companies’ proprietary data. Apheris’ consortium of pharma companies is partnering with OpenFold3 — Columbia professor Mohammed AlQuraishi’s open-source dupe of AlphaFold3 — to train the model on AbbVie and Johnson & Johnson’s vast stores of structural data. The collaboration will focus on structures relevant to drug discovery, such as small molecule-protein and antibody-antigen interactions. 

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2 months 2 weeks ago

Biotech, Health Tech, Pharma, Artificial Intelligence, Health Tech, STAT+

STAT

STAT+: Pharmalittle: We’re reading about NIH removing scientific advisers, GSK’s shingles shot, and more

Rise and shine, everyone, another busy day is on the way. We can tell by the parade of motor vehicles passing by the Pharmalot campus and the continuous rumble of commuter trains off in the distance. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is coconut rum, a delicious household favorite. As always, you are invited to join us.

After all, the neurons could use all the help they can get, would you not agree? Meanwhile, here are a few items of interest for you to digest as you embark on your own journey today, which we hope is meaningful and satisfying. On that note, time to hustle. Best of luck, and do keep in touch. …

Prominent outside scientists who help the U.S. National Institutes of Health evaluate its internal research programs are being abruptly removed, according to five advisers whose positions were terminated and a recording of an internal meeting obtained by STAT. The motivations behind the removals from the agency boards of scientific counselors remain unclear. But among those being terminated are non-U.S. citizens, women, scientists from underrepresented racial and ethnic groups, and individuals whose research focus or other work touches on areas the new administration considers taboo, such as diversity and equity. The removals come amid a broader attempt by the Trump administration to align health agencies with the president’s views on DEI, gender, immigration, and other issues, by terminating grants mentioning words like “diversity” or focused on environmental justice, while explicitly targeting such employees for removal.

GSK has teamed up with two research organizations in the U.K. to explore a possible link between its shingles vaccine Shingrix and a reduced risk of dementia, Pharmaphorum says. The tantalizing hypothesis — drawn from observational and retrospective studies — is that vaccination against shingles can help protect against dementia in the following years. To test it prospectively, GSK will work with the UK Dementia Research Institute and Health Data Research UK to use de-identified, population-level electronic health data from the National Health Service to look at the impact of shingles vaccination on dementia risk. Their study will look at real-world data from around 1.4 million people aged 65 and 66 at the time that the U.K. expanded its shingles national immunization program in 2023. Research has already shown that vaccines against shingles potentially reduce the risk of dementia, but past studies only identified associations, not causality.

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2 months 2 weeks ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Pharmalittle: We’re reading about a new CVS chief, obesity meds cutting overdoses, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We expect to tidy up around the increasingly leafy Pharmalot campus, promenade with the official mascots, and catch up on our reading. We also hope to hold another listening party with Mrs.

Pharmalot and the rotation will likely include this, this, this, this and this. And what about you? Once again, we maintain there is no better time to enjoy the great outdoors. And as seasonal festivities approach, you could start searching for the great pumpkin or, if you are particularly ambitious and visit the correct locales, you could hunt down your own turkey. For those inclined to hang around Gotham, there are always museums and moving picture shows to take in. Or you could hide indoors with a good book. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

CVS Health is naming longtime executive David Joyner as its new chief, succeeding Karen Lynch at the helm of the struggling health care giant, The Wall Street Journal writes. Joyner has been president of CVS Caremark, the company’s pharmacy benefit manager, as well as an executive vice president of CVS. He is set to take over as president and chief executive on Friday. CVS is making the changes after repeatedly cutting its forecasts for this year’s financial performance, moves that led to a 19% decline in its share price this year, a push for changes by a major hedge fund, and a board review of strategy that included the option of breaking up the company. Joyner will face a difficult task. Not only must he turn around CVS’s Aetna health insurance business, but he must also contend with U.S. Federal Trade Commission scrutiny of pharmacy benefit giants including Caremark. CVS also faces longstanding challenges in the retail pharmacy business. 

Donald Trump has backed off his ambitious plans to slash U.S. drug prices and repeal the Affordable Care Act, leaving something of a vacuum in his health policy agenda. One former Trump White House official says the policy ideas are there — but enacting them could take messy fights, STAT tells us. The official, Joe Grogan, said Republicans will need to repeal or revisit President Biden’s signature drug pricing law and expanded Affordable Care Act subsidies, should Trump take office. Trump had previously proposed tying U.S. drug prices to a basket of payments made by similarly wealthy countries, but has retreated from that approach. Grogan said this is because Biden’s plan to let Medicare negotiate drug prices directly with pharmaceutical companies, passed in the Inflation Reduction Act, changed the landscape. As the provisions go into effect, this has raised premiums, which Grogan forecasted could cause a “death spiral” in Medicare Part D, the program’s prescription drug benefit.

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7 months 3 weeks ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Ron Renaud, biotech’s serial CEO, is ready for a new assignment — and maybe another deal?

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

This story first appeared in Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

When it comes to delivering shareholder value through M&A, Ron Renaud is a biotech investor’s best friend. Over the last 10 years, all three of the companies he has helmed were sold to Big Pharma for a combined $16 billion. 

With that track record — and the financial windfall it brings — no one would have begrudged Renaud, 55, had he desired to spend more time with his Cape Cod fishing buddies. But he can’t quit biotech. Weeks after overseeing the close of Cerevel Therapeutics’s $8.7 billion acquisition by AbbVie, Renaud is back as CEO of Kailera Therapeutics, a newly formed company with a pipeline of weight loss drug candidates.

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8 months 1 week ago

Adam's Take, Biotech, biotechnology, Obesity, STAT+

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