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Also, the FDA has withdrawn approval of GSK’s leucovorin for a rare brain disorder tied to autism, closing out an unusual episode shaped in part by political pressure.Continue to STAT+ to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Also, the FDA has withdrawn approval of GSK’s leucovorin for a rare brain disorder tied to autism, closing out an unusual episode shaped in part by political pressure.
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.
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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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