With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavored vapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem.
Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette selle
With thousands of illegal e-cigarettes for sale in the U.S., both the Trump and Biden administrations have vowed to crack down on the illicit fruit- and candy-flavoredvapes that hold particular appeal to minors. But a new government report suggests law enforcement efforts by the Department of Justice lag far behind the scope of the problem.
Most DOJ enforcement actions between fiscal year 2022 and fiscal year 2025 — 50 out of a total of 88 — were to add the names of remote e-cigarette sellers to a list of unauthorized businesses, according to the report from the Government Accountability Office. The second-most common type of enforcement actions (20 out of 88) noted in the report were injunctions to stop legal violations.
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.
NEW YORK — President Donald Trump’s administration this week acknowledged it made a significant error in figures it used to help justify a fraud probe into New York’s Medicaid program, a glaring mistake that undercuts a federal campaign to tackle waste, mostly in Democratic-led states.
The error, one of at least a few misrepresentations in its description of the program, prompted health analysts to question how many of the Republican administration’s sweeping anti-fraud efforts around the cou
NEW YORK — President Donald Trump’s administration this week acknowledged it made a significant error in figures it used to help justify a fraud probe into New York’s Medicaid program, a glaring mistake that undercuts a federal campaign to tackle waste, mostly in Democratic-led states.
The error, one of at least a few misrepresentations in its description of the program, prompted health analysts to question how many of the Republican administration’s sweeping anti-fraud efforts around the country were based on faulty findings. It also reflected a common criticism that’s been made of Trump’s second administration — that it tends to attack first and confirm the facts later.
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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.
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 includes promenading with the official mascots, escorting Mrs. Pharmalot to a musical happening and visiting a new eatery. We also hope to have yet another listening party, where the rotation will include this, this, this, this and this. And what about you? This may be an opportunity to enjoy the great outdoors, perhaps a st
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 includes promenading with the official mascots, escorting Mrs. Pharmalot to a musical happening and visiting a new eatery. We also hope to have yet another listening party, where the rotation will include this, this, this, this and this. And what about you? This may be an opportunity to enjoy the great outdoors, perhaps a stroll by the seashore or a walk in the woods. A long drive in the country may be nice, although it will cost you. Or perhaps simple pleasures such as noshing on a pastry with a hot cup of stimulation will do. You could also catch up on your reading or reach out to someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…
A flood of cheap copies of Novo Nordisk’s blockbuster weight-loss drug in India is already reshaping the country’s fast-growing obesity medicine market, showing how quickly the patent cliff will affect GLP-1 makers like Eli Lilly, Bloomberg News explains. Within days of dozens of generics hitting the Indian market after Novo’s patent expired locally, the drug’s share in the country’s GLP-1 segment jumped to 33% in March from 25% a month earlier, according to researcher Pharmarack. That gain came at the expense of Lilly’s Mounjaro, which is still under patent protection in India and whose share fell to 64% from 71%. The data marks the first meaningful snapshot of how market dynamics will change for GLP-1 makers as their patents near expiry.
The U.S. Food and Drug Administration withdrew approval of a GSK drug that the Trump administration had promoted as a treatment for autism, adding another twist to the unusual story of a decades-old drug, Bloomberg News informs us. The agency is pulling its approval of Wellcovorin, a branded version of leucovorin from GSK, according to a post in the Federal Register. GSK had requested that the approval be withdrawn. The FDA first approved leucovorin decades ago and it has been used to blunt the side effects of chemotherapy for some cancer patients. In September, Trump administration officials endorsed leucovorin as an autism treatment. Last month, the FDA approved its use for cerebral folate deficiency, which is seen in some people with autism.
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Buyer beware: If you are an avid consumer of WAP Sensual Enhancement, the Food and Drug Administration says the pill “may be harmful.”
Want to learn about other dubious products under federal scrutiny? Scroll down.Continue to STAT+ to read the full story…
For most of the last 80 years, sports betting was limited to Las Vegas. But after a 2018 Supreme Court decision loosened regulations on professional sports wagers, it became possible to place bets on games 24/7 — with nothing more than a smartphone and a bank account.
In 2013, just five years prior to the landmark SCOTUS case, gambling was classified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in a new category called “Substance-Related and Addictive Disorders.” This
For most of the last 80 years, sports betting was limited to Las Vegas. But after a 2018 Supreme Court decision loosened regulations on professional sports wagers, it became possible to place bets on games 24/7 — with nothing more than a smartphone and a bank account.
In 2013, just five years prior to the landmark SCOTUS case, gambling was classified in the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) in a new category called “Substance-Related and Addictive Disorders.” This grouped gambling with alcohol use disorder and other addictions. Gambling is also known to have the highest suicide rate of any addiction.
I didn’t expect to find myself face to face with leaders and activists from the “Make America Healthy Again” movement in respectful dialogue, or to consider inviting one into a public health classroom. But that’s exactly where I found myself this spring.
At a national public health meeting in March, I attended a session that brought together public health professionals, physicians, and MAHA leaders for a rare, good-faith conversation. I went out of curiosity. I left with a level of clarity I
I didn’t expect to find myself face to face with leaders and activists from the “Make America Healthy Again” movement in respectful dialogue, or to consider inviting one into a public health classroom. But that’s exactly where I found myself this spring.
At a national public health meeting in March, I attended a session that brought together public health professionals, physicians, and MAHA leaders for a rare, good-faith conversation. I went out of curiosity. I left with a level of clarity I hadn’t expected — and a few unexpected connections.
The past few weeks have been nothing but discouraging for those of us who helped create the Make America Healthy Again movement, including a silly executive order on glyphosate that feels anathema to what we have fought for. I’d be lying if I said that my heart hasn’t been bent toward repentance for my part in the whole thing. I helped champion Bobby Kennedy as a campaign volunteer, and when he joined up with then-candidate Donald Trump, I reluctantly decided that the trade-offs were worth what
The past few weeks have been nothing but discouraging for those of us who helped create the Make America Healthy Again movement, including a silly executive order on glyphosate that feels anathema to what we have fought for. I’d be lying if I said that my heart hasn’t been bent toward repentance for my part in the whole thing. I helped champion Bobby Kennedy as a campaign volunteer, and when he joined up with then-candidate Donald Trump, I reluctantly decided that the trade-offs were worth what I believed Kennedy could advocate for within the walls of a Trump White House: the best fixes for a very sick and broken nation.
Yet I found myself recently, and reluctantly, headed to the citadel of arrogance: Washington (well, Arlington, Va., to be more specific). At the invitation of Brinda Adhikari — one of the hosts of the podcast “Why Should I Trust You?” — I attended the Association of Schools and Programs of Public Health’s annual meeting, where I spoke on a panel about engaging in civil conversation in a session called “A Dialogue Between Academic Public Health and MAHA.”
Zac Jiwa, a federal Medicare official, delivered a eulogy of sorts at a Thursday Medicare event highlighting the successes of the Health Tech Ecosystem initiative.
The eulogy’s subject? The clipboard.
For the past eight months, hundreds of health tech companies have been working to meet goals set out by the federal government to make patient records more portable, create systems that import patients’ data into providers’ electronic health records systems, and stand up various patient a
Zac Jiwa, a federal Medicare official, delivered a eulogy of sorts at a Thursday Medicare event highlighting the successes of the Health Tech Ecosystem initiative.
The eulogy’s subject? The clipboard.
For the past eight months, hundreds of health tech companies have been working to meet goals set out by the federal government to make patient records more portable, create systems that import patients’ data into providers’ electronic health records systems, and stand up various patient apps. The idea is to make filling out a stack of paperwork at every doctor’s visit, on that ubiquitous clipboard, a thing of the past.
After a courtroom defeat, Trump administration health officials have revised the governing documents for a key federal vaccine panel to broaden its membership, increase its focus on potential harms of vaccines, and empower allies of health secretary Robert F. Kennedy Jr.
The new charter for the committee that advises the Centers for Disease Control and Prevention on vaccine use appears aimed at trying to evade the type of legal challenge that has left the currently appointed body in limbo. In
After a courtroom defeat, Trump administration health officials have revised the governing documents for a key federal vaccine panel to broaden its membership, increase its focus on potential harms of vaccines, and empower allies of health secretary Robert F. Kennedy Jr.
The new charter for the committee that advises the Centers for Disease Control and Prevention on vaccine use appears aimed at trying to evade the type of legal challenge that has left the currently appointed body in limbo. In addition, the document puts greater emphasis on the role of the Advisory Committee on Immunization Practices in studying injuries possibly linked to vaccination — though the committee has always paid close attention to any emerging evidence that called into question the safety of individual vaccines.
Why is old exon science getting new traction? What’s unsettling biotech VCs? And who will be the next CEO of PhRMA?
We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s weekly biotech podcast.Read the rest…
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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.
Georg Schett had two things: a young patient deathly ill with lupus, and a couple of mouse studies raising the possibility that special T cells could tame the condition.
The German physician-scientist could produce the cells — chimeric antigen receptors, or CARs — at his institution, which was half the battle. Another hurdle: The patient’s parents. “They were like, ‘Don’t do that. You’re crazy,’” recalled Fabian Müller, Schett’s collaborator at the University of Erlangen-Nuremberg. A widespre
Georg Schett had two things: a young patient deathly ill with lupus, and a couple of mouse studies raising the possibility that special T cells could tame the condition.
The German physician-scientist could produce the cells — chimeric antigen receptors, or CARs — at his institution, which was half the battle. Another hurdle: The patient’s parents. “They were like, ‘Don’t do that. You’re crazy,’” recalled Fabian Müller, Schett’s collaborator at the University of Erlangen-Nuremberg. A widespread fear at the time was that T cells would trigger or worsen autoimmune disease.
The rest of the story is the rare scientific fairy tale: The patient got better. Five years on, she is still in remission, and working in the very clinic where she was treated. Her case upended the world of autoimmune disease, driving a flood of experimentation and investment and offering new hope to millions of patients.
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Good morning health tech readers!
Everyone told us the Trump administration was going to deregulate medical AI and let developers do whatever they want. And yet, there are some ideas that go too far, it seems.Continue to STAT+ to read the full story…
You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday.
Good morning health tech readers!
Everyone told us the Trump administration was going to deregulate medical AI and let developers do whatever they want. And yet, there are some ideas that go too far, it seems.
Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay
Top of the morning to you, and a fine one it is. Sunny skies and mild breezes are enveloping the Pharmalot campus once again. And to celebrate, we are brewing still more cups of stimulation and inviting you to join us. Our choice today is Jack Daniel’s. Yes, this is a real thing. And remember, a prescription is not required. So no need to mess with rebates, coupons, or TrumpRx. Meanwhile, here are a few items of interest. Hope you have a smashing day and conquer the world. And of course, do stay in touch. We appreciate feedback, criticism and tips. …
Steve Ubl, the chief executive of Pharmaceutical Research and Manufacturers of America, plans to step down at the end of the year, after more than a decade of leading the main trade group for brand-name drug makers, STAT notes. Ubl led the organization during tumultuous times that included the Covid-19 pandemic and aggressive political attacks on prescription drug pricing. Democrats passed a law directing Medicare to negotiate drug prices and the Trump administration struck voluntary deals with individual drugmakers aimed at lowering U.S. prices to levels in other high-income countries. The next head of PhRMA will face increasing political pressure on prices and an increasingly populist mood.
Specific changes in two genes appear to help predict whether patients will lose substantial weight on GLP-1 drugs used to treat obesity — and whether the drugs will cause nausea or vomiting, which are some of their most common side effects, STAT writes, citing a paper in Nature. “I think we have proof of concept here that genetics is playing a role in terms of GLP-1 efficacy and side effects,” said Adam Auton, a vice president at the 23andMe Research Institute and the senior author on the paper. Outside researchers were impressed and intrigued by the findings, but some doubted whether the genetic results would impact patient care. Still, consumers who use what 23andMe calls its Total Health platform will have access to information about these genes and what they predict about GLP-1 use.
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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
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.
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.
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