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First came the new teaser for Nathan Fielder’s documentary on Elizabeth Holmes. Now come the memes. Bring it on.
FDA names permanent heads of drug and biologics centers
For the past few months, key centers at the FDA have been led by acting officials. The agency said yesterday it will now make them permanent. Michael Davis will be director of the Center for Drug Ev
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First came the new teaser for Nathan Fielder’s documentary on Elizabeth Holmes. Now come the memes. Bring it on.
FDA names permanent heads of drug and biologics centers
For the past few months, key centers at the FDA have been led by acting officials. The agency said yesterday it will now make them permanent. Michael Davis will be director of the Center for Drug Evaluation and Research, and Karim Mikhail will be director of the Center for Biologics Evaluation and Research.
WASHINGTON — The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month.
Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of th
WASHINGTON — The Trump administration permanently filled four key leadership roles at the Food and Drug Administration on Tuesday, after it nominated Heidi Overton to lead the agency late last month.
Three of the officials are serving in an acting capacity, and will take the same roles permanently, the administration said. They are Michael Davis, a psychiatrist who will be director of the Center for Drug Evaluation and Research; former Merck official Karim Mikhail, who will be director of the Center for Biologics Evaluation and Research; and Bret Koplow, an attorney who has been at the FDA since 2011 and will serve as director of the Center for Tobacco Products.
The fourth appointee, Jared Seehafer, will serve as the FDA’s first deputy commissioner for technology and artificial intelligence. He joined the FDA as an adviser in 2025 after founding a life science software company and working in investment advising in biotech, according to his LinkedIn. Under the Trump administration, the agency has pushed its staff to use AI to speed up its review processes.
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I hope you all had a good Labor Day weekend. Robots may be able to run extremely fast now, but at least we know how to stop. Run your thoughts to me anytime: bob.herman@statnews.com.
A cash parade for a top House Democrat
UnitedHealth Group’s top executives, including CEO Stephen Hemsley, and board members recently flooded the campaign coffers of Rep. Katherine Clark of Massachusetts, the No. 2 D
UnitedHealth Group’s top executives, including CEO Stephen Hemsley, and board members recently flooded the campaign coffers of Rep. Katherine Clark of Massachusetts, the No. 2 Democrat in the House who just beat two opponents in a closely watched primary.
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Today, we delve into how an FDA approval paradoxically complicated access to Revolution Medicines’ new pancreatic cancer drug for some patients, see standout mid-stage results for Roivant’s pulmonary hypertension drug, and more.
Hope you had a lovely long weekend! Estoy trabajando en este Readout de la Biblioteca Vasconcelos en la CDMX.Continue to STAT+ to read the fu
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Today, we delve into how an FDA approval paradoxically complicated access to Revolution Medicines’ new pancreatic cancer drug for some patients, see standout mid-stage results for Roivant’s pulmonary hypertension drug, and more.
Hope you had a lovely long weekend! Estoy trabajando en este Readout de la Biblioteca Vasconcelos en la CDMX.
In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday.
Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most
In a pair of late-stage trials, a drug from AstraZeneca reduced the dangerous flare-ups that drive the worsening of COPD, positioning it as a potential new option for the vast numbers of patients with the debilitating lung condition, according to data released Tuesday.
Results from the Phase 3 trials of the drug, called tozorakimab, also amount to a re-assuring victory for AstraZeneca, which is known for its metronomic success in trials but has seen some notable misses in recent months, most dramatically with a heart disease drug. Analysts and the company have projected that “tozo,” as the injectable drug is dubbed, could reap billions in annual sales if approved, both in COPD — which, as the third-leading cause of death globally, remains greatly underserved — and in other conditions including asthma.
In the trials, tozo reduced COPD exacerbations — any sudden worsening of the disease requiring medical care, whether a severe cough or breathlessness — by about 30% across all patients over a year, according to data presented at the European Respiratory Society’s annual conference in Barcelona and published in the New England Journal of Medicine. That finding makes tozo competitive with other COPD treatments that have reached patients in recent years, but notably, the tozo trials included participants not eligible for the other new drugs. The benefits seen in those patients could give AstraZeneca a large segment of the market to itself.
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Hello, diligent HCI readers! I hope everyone enjoyed their Memorial Day weekends. We’ve got a lot of numbers in today’s edition. Get out your abacus. And tell me if you want more or less math in here: bob.herman@statnews.com.
$775 billion
Centers for Medicare and Medicaid Services
Republicans’ recent tax law targets supplemental Medicaid funds that have increasingly propped up hospitals.
This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here.
Hello, diligent HCI readers! I hope everyone enjoyed their Memorial Day weekends. We’ve got a lot of numbers in today’s edition. Get out your abacus. And tell me if you want more or less math in here: bob.herman@statnews.com.
$775 billion
Centers for Medicare and Medicaid Services
Republicans’ recent tax law targets supplemental Medicaid funds that have increasingly propped up hospitals. The cuts are expected to be even bigger than originally forecast, which almost assuredly will provoke an opposition campaign from hospitals.
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Hi! Hope you had a nice extended weekend.
Today: Eli Lilly’s gene-editing data seems promising for high cholesterol, an AI drug discovery CEO dispelled some AI drug discovery hype, and the new interim FDA chief is so far well received.Continue to STAT+ to read the full story…
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Hi! Hope you had a nice extended weekend.
Today: Eli Lilly’s gene-editing data seems promising for high cholesterol, an AI drug discovery CEO dispelled some AI drug discovery hype, and the new interim FDA chief is so far well received.
WASHINGTON — People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025.
They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.
The credentials didn’t scream quali
WASHINGTON — People in the food world didn’t know what to expect when the Trump administration appointed a little-known Florida attorney as the FDA’s top food official in 2025.
They knew Kyle Diamantas worked at Jones Day representing food, beverage, and tobacco-industry clients. They saw the picture of him and Donald Trump Jr. holding giant, dead wild turkeys after a hunt. He had no experience in public health, in medicine or science, or in government.
The credentials didn’t scream qualified. And Diamantas was stepping into a center rocked by DOGE layoffs and a defiant resignation by former leader Jim Jones.
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Merck’s bet on an antibody-drug conjugate developed in China has paid off in a major Phase 3 lung cancer study, where sacituzumab tirumotecan paired with Keytruda sharply outperformed Keytruda alone in a subset of lung cancer patients.
Also, the NIH is down another leader, and Sam Altman-backed longevity startup Retro Biosciences raises more funds.Continue to STAT+ to
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Merck’s bet on an antibody-drug conjugate developed in China has paid off in a major Phase 3 lung cancer study, where sacituzumab tirumotecan paired with Keytruda sharply outperformed Keytruda alone in a subset of lung cancer patients.
Also, the NIH is down another leader, and Sam Altman-backed longevity startup Retro Biosciences raises more funds.
The Food and Drug Administration on Friday rejected — again — an experimental treatment for advanced skin cancer developed by Replimune Group.
Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency.
The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regul
The Food and Drug Administration on Friday rejected — again — an experimental treatment for advanced skin cancer developed by Replimune Group.
Replimune’s treatment, an engineered virus designed to rev up the immune system against melanoma, has been a flashpoint in a simmering debate over shifting standards at the agency.
The drug was initially rejected in July, just two months after Vinay Prasad was appointed the FDA’s head of biologics. As an academic oncologist, Prasad criticized regulators for approving drugs with limited data, and the Replimune decision was viewed as a possible sign of the stricter stance he might take at the agency.
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CAR-T therapies are continuing to gain traction in autoimmune disease, with a notable new case.
Also, the FDA has withdrawn approval of GSK’s leucovorin for a rare brain disorder tied to autism, closing out an unusual episode shaped in part by political pressure.Continue to STAT+ to read the full story…
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CAR-T therapies are continuing to gain traction in autoimmune disease, with a notable new case.
Also, the FDA has withdrawn approval of GSK’s leucovorin for a rare brain disorder tied to autism, closing out an unusual episode shaped in part by political pressure.
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In which RFK Jr. says the “government lies to us” while sitting in front of an HHS seal. Send news tips and podcast recommendations to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
First, control health care costs
Last month, a group of 12 Senate Democrats proposed a framew
You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays.
In which RFK Jr. says the “government lies to us” while sitting in front of an HHS seal. Send news tips and podcast recommendations to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
First, control health care costs
Last month, a group of 12 Senate Democrats proposed a framework for rebuilding the health care system. The idea was to spur input from others ahead of when Democrats might get a chance to act on those plans.
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PhRMA CEO Steve Ubl is stepping down. Biotech investors are grappling with pressure from AI and rising competition from Chinese labs, even though firms sit on large cash reserves.
Also, the Trump administration is stepping back from the “indirect cost” fight at the NIH, and new data suggest genetics may modestly influence responses to GLP-1 drugs.Continue to STAT+ to
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PhRMA CEO Steve Ubl is stepping down. Biotech investors are grappling with pressure from AI and rising competition from Chinese labs, even though firms sit on large cash reserves.
Also, the Trump administration is stepping back from the “indirect cost” fight at the NIH, and new data suggest genetics may modestly influence responses to GLP-1 drugs.
In a move that will grow its oncology pipeline, Gilead Sciences is spending more than $3 billion to buy the German biotech Tubulis, the companies said Tuesday.
The deal includes an upfront payment of $3.15 billion and up to $1.85 billion more if certain milestones are reached. It also highlights both the therapeutic and commercial promise of antibody-drug conjugates, the next-generation chemotherapy treatments that the privately held Tubulis is developing.
Gilead’s latest move comes just m
In a move that will grow its oncology pipeline, Gilead Sciences is spending more than $3 billion to buy the German biotech Tubulis, the companies said Tuesday.
The deal includes an upfront payment of $3.15 billion and up to $1.85 billion more if certain milestones are reached. It also highlights both the therapeutic and commercial promise of antibody-drug conjugates, the next-generation chemotherapy treatments that the privately held Tubulis is developing.
Gilead’s latest move comes just months after it said it would acquire Arcellx in a deal worth $7.8 billion. The two companies had already been working together on a multiple myeloma CAR-T therapy that could be approved later this year. Gilead last month also announced that it was buying Ouro Therapeutics, which is focused on drugs for autoimmune disease, for up to $2.18 billion.
An abdominal aortic aneurysm is a life-threatening vascular condition with limited treatment options.
Now, researchers from the University of Michigan Frankel Cardiovascular Center have identified a driving force behind the condition, opening up a potential target for new therapies. Their paper uncovering the causal link between triglycerides and abdominal aortic aneurysms won the STAT Madness 2026 popular vote. Read the rest…
An abdominal aortic aneurysm is a life-threatening vascular condition with limited treatment options.
Now, researchers from the University of Michigan Frankel Cardiovascular Center have identified a driving force behind the condition, opening up a potential target for new therapies. Their paper uncovering the causal link between triglycerides and abdominal aortic aneurysms won the STAT Madness 2026 popular vote.
WASHINGTON — The Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs.
FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers.
The Trump administrat
WASHINGTON — The Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs.
FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers.
The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. For example, many of the brand drugmakers that struck deals to lower U.S. prices also promised to increase domestic manufacturing, under the threat of tariffs.
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Well hullo! You think you can get the last word, literally, with AI? Think again. There’s always human interaction available here: bob.herman@statnews.com.
Today’s the day
By law, the 2027 Medicare Advantage payment regulation must come out today. It will set the tone for how the Trump administration wants to work with the health insurance industry: as the “new sheriff in town” or just another fr
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Well hullo! You think you can get the last word, literally, with AI? Think again. There’s always human interaction available here: bob.herman@statnews.com.
Today’s the day
By law, the 2027 Medicare Advantage payment regulation must come out today. It will set the tone for how the Trump administration wants to work with the health insurance industry: as the “new sheriff in town” or just another friendly regulator.
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A four-month FDA delay prompted a cash-strapped biotech company to shutter. The White House’s proposed NIH cuts are drawing bipartisan backlash. Peptide hype is outpacing evidence. And more!
The need-to-know this morning
Neurocrine Biosciences said this morning that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. Neur
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
A four-month FDA delay prompted a cash-strapped biotech company to shutter. The White House’s proposed NIH cuts are drawing bipartisan backlash. Peptide hype is outpacing evidence. And more!
The need-to-know this morning
Neurocrine Biosciences said this morning that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. Neurocrine is paying $53 a share for Soleno, a 34% premium to its closing price on Thursday.
A four-month FDA delay derailed a small biotech. Is it a sign of the times?
FDA delays can happen. For large drugmakers, they can be frustrating; for small drugmakers, they can be existential.
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