STAT+: FDA’s gene therapy turmoil unpacked
Published: June 20, 2025 15:53
And other biotech news brought to you by The Readout.
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STAT+: Researchers push back on ‘sloppy’ botched citation in MAHA report
Published: June 20, 2025 13:24
And more health news stories featuring milk and vaccines.
STAT+: Pharmalittle: We’re reading about FDA forcing out top gene therapy regulator, Gilead’s HIV challenges and more
Published: June 20, 2025 13:11
And more pharma news updates from Pharmalittle.
Opinion: The MAHA children’s health report mis-cited our research. That’s sloppy — and worrying
Published: June 20, 2025 08:30
Being cited in a major government report, like the MAHA report on children’s health, should be gratifying. Not this time.
STAT+: As AI device market grows, FDA’s accounting goes silent
Published: June 20, 2025 08:30
As the market for AI enabled medical devices grows, experts say there is less transparency around device approvals.
Opinion: Six former CDC vaccine advisory committee chairs warn: U.S. risks losing access to life-saving immunizations
Published: June 20, 2025 08:30
“We are witnessing a dismantling of the systems that develop, license, recommend, and monitor vaccines,” write six former chairs of the CDC’s vaccine advisory committee.
Why MAHA wants whole milk back on the table
Published: June 20, 2025 08:30
In the nutrition world, the question of how whole milk compares with lower-fat options is the subject of debate. In MAHA world, it's time to embrace full fat.
FDA’s gene therapy turmoil, and an alternative model for funding research
Published: June 19, 2025 18:54
Why did the Food and Drug Administration suddenly oust one of its top gene therapy regulators?
STAT+: What’s next for Sarepta Therapeutics with gene therapy under fire?
Published: June 19, 2025 10:30
The death of a boy with Duchenne muscular dystrophy, tied to a gene therapy, is above all a tragedy. But it is also undermining investor confidence in the company that…
STAT+: Cogent Biosciences-Blueprint Medicines tiff turns spicy on eve of immune drug study readout
Published: June 19, 2025 10:30
A rivalry between two drugmakers, Cogent Biosciences and Blueprint Medicines, has turned ugly.
STAT+: Gilead’s CEO on the approval of a powerful new drug to prevent HIV
Published: June 19, 2025 08:30
Gilead's CEO says he's committed to making sure people around the world can get his firm's new HIV prevention shot Yeztugo.
Opinion: Curbing the overdose crisis requires professional standards, patient safety
Published: June 19, 2025 08:30
Two advocates demand systemic change in addiction treatment that prioritizes safety and accountability above all else.
STAT+: Brain implant captures speech tone, pitch through analyzing activity
Published: June 19, 2025 08:30
New brain-computer interface reduced time lag in translating thoughts into speech in a meaningful advance for the field.
Opinion: STAT+: AI-powered nudges for chronic disease care need emotional intelligence
Published: June 19, 2025 08:30
Emotionally intelligent AI can generate trust, motivate action, elevate the relationship between patients and their care teams, and drive meaningful change.
STAT+: U.K. decision blocks a pair of Alzheimer’s drugs from access through its national health service
Published: June 18, 2025 23:01
A U.K. health agency said the Alzheimer's drugs Kisunla and Leqembi are not cost-effective, meaning they won't be offered through the NHS.
STAT+: Top gene therapy regulator forced out at FDA
https://www.statnews.com/2025/06/18/top-gene-therapy-regulator-forced-out-at-fda/?utm_campaign=rss
Published: June 18, 2025 22:47
Nicole Verdun, top gene therapy regulator at the FDA, has been forced out of the agency.
STAT+: More universities open to private equity deals, and emerging companies turn to new targets
Published: June 18, 2025 21:57
The latest from the BIO 2025 conference: more universities open to private equity deals, emerging companies turn to new targets, and more.
STAT+: What David Baker’s AI biotech unicorn Xaira has been up to
Published: June 18, 2025 21:22
This is the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to AI in health care and medicine.
Opinion: Following second patient death, Duchenne muscular dystrophy families deserve answers about Elevidys
Published: June 18, 2025 19:49
Duchenne muscular dystrophy families are sharing stories about Elevidys complications on social media. But they aren’t getting answers from Sarepta.
STAT+: Gilead won U.S. approval for HIV prevention shot, but when will low-income countries gain sufficient access?
Published: June 18, 2025 18:25
Gilead has won FDA approval for an HIV prevention shot that is administered only once every six months. When will low-income countries gain access?
HIV protection with just two shots a year: FDA approves Gilead drug
Published: June 18, 2025 18:24
A new twice-yearly shot could be a "game changer" in the fight against AIDS, but experts' hopes have dimmed because of the current political climate.
STAT+: Vaccine advisers to consider MMRV vaccines, ‘thimerosal containing’ flu shots in pared-down meeting
Published: June 18, 2025 16:43
RFK Jr.'s handpicked advisers will discuss two long-approved shots at their next meeting
STAT+: Zealand’s GLP-2 candidate shows early weight loss results
Published: June 18, 2025 16:32
Zealand Pharma said that its obesity candidate that uses a unique mechanism led to notable weight loss in an early trial.
Research funding has unexpected benefits. A lizard study led to Ozempic
Published: June 18, 2025 15:00
In a new weekly video series, STAT's @HoganAlex examines the stakes of ongoing court battles over NIH grant funding.
STAT+: New neuro company raises $140M for depression drug
Published: June 18, 2025 14:35
And other biotech news stories brought to you by The Readout.
Supreme Court ruling on gender-affirming care delivers major setback for transgender rights
Published: June 18, 2025 14:31
Tennessee’s ban on gender-affirming care for minors can stand after the Supreme Court ruled that it does not constitute sex-based discrimination, in a 6-3 decision.
STAT+: Vinay Prasad named chief medical and science officer at FDA
Published: June 18, 2025 13:56
Vinay Prasad is taking on several big roles at the FDA, solidifying his position as a top adviser to Commissioner Marty Makary.
Opinion: Obesity drugs don’t just offer weight loss. They give patients agency
Published: June 17, 2025 08:30
Many focus on what weight-loss drugs take away: pounds. But they also offer patients something new: a sense of agency.
STAT+: Nabla raises $70 million as market for AI tools to help doctors heats up
Published: June 17, 2025 08:30
AI developer Nabla has raised $70 million as the company looks to expand the capabilities of its software that automates clinical documentation.
Opinion: How farming theory has helped me live beyond my original cancer prognosis
Published: June 17, 2025 08:30
Christopher Gregg has lived years beyond what his oncologists originally accepted. Lessons from farming may have helped.
STAT+: China, where obesity levels are low, becomes hotbed for weight loss drug trials
Published: June 17, 2025 08:30
China is a one of the most important regions for the booming obesity market, thanks to government incentives and changing demographics.
To boost Medicare Advantage profitability, Humana turns to old tactic: the annual wellness visit
Published: June 16, 2025 23:41
Humana leaders asserted at the company’s investor day Monday that there’s still money to be made on Medicare Advantage
STAT+: Senate GOP proposes to rein in states’ tools to boost Medicaid funding
Published: June 16, 2025 21:26
Republicans are moving to limit states' ability to boost their Medicaid funding
Dismissed members of CDC vaccine committee call Kennedy’s actions ‘destabilizing’
Published: June 16, 2025 21:16
All 17 experts recently dismissed from a government vaccine advisory panel published an essay Monday decrying “destabilizing decisions" made by HHS Secretary Robert F. Kennedy Jr. that could lead to more preventable…
Medicaid cuts could result in more than 16,000 preventable deaths annually
Published: June 16, 2025 21:00
Health care proposals in the One Big Beautiful Bill Act could lead to more than 16,000 preventable deaths, a new analysis finds.
CDC workers fired from prominent STI, hepatitis labs are rehired
Published: June 16, 2025 20:53
The staff of two world-class CDC laboratories that were slated to be closed by the Trump administration have been informed that their terminations have been canceled.
STAT+: What we’re hearing on Chinese NewCos, AI, and BIO’s executive ranks
Published: June 16, 2025 20:48
This is an online version of our BIO 2025 conference newsletter.
STAT+: After second Sarepta death, Duchenne muscular dystrophy community is racked by recrimination and worry
Published: June 16, 2025 19:18
Another gene therapy death of a Duchenne patient has some parents and doctors criticizing the FDA's actions, even as other parents still push for the therapy.
STAT+: Hundreds of NIH grant terminations are ‘void and illegal,’ federal judge rules
Published: June 16, 2025 18:49
A federal judge ruled that some of the grant terminations by the National Institutes of Health on DEI grounds are “void and illegal.”
STAT+: Sage Therapeutics gets acquired by Maryland drugmaker for up to $795 million
Published: June 16, 2025 17:44
Following a turbulent few years, Sage Therapeutics has been acquired by Maryland-based Supernus Pharmaceuticals for up to $795 million.
STAT+: Private equity firm will finance Harvard research lab, in possible template for future
Published: June 16, 2025 17:00
A private equity firm will finance a Harvard University research lab, a possible template for the future as schools nationwide absorb federal funding cuts.
STAT+: Lilly’s amylin candidate shows early promise
Published: June 16, 2025 13:35
Plus more biotech news stories, brought to you by The Readout.
HHS plans ‘bold, edgy’ campaign on ultra-processed foods
Published: June 16, 2025 13:14
And more health news stories from the weekend.
STAT+: Pharmalittle: We’re reading about a Sarepta setback with a DMD drug, FDA workload causes a delay, and more
Published: June 16, 2025 13:07
In today's Pharmalittle roundup, we're reading about a Sarepta setback with its Duchenne drug, the FDA workload causing a delay, and more.
Opinion: I’m a fertility doctor, and I think IVF needs more regulation
Published: June 16, 2025 08:30
An IVF doctor and clinic founder writes that his industry needs increased governmental oversight and more comprehensive regulations, not less.
Opinion: Even full fetal personhood shouldn’t end abortion rights
Published: June 16, 2025 08:30
The law shouldn’t force pregnant people to assume greater duties to their fetuses than parents have to their children.
STAT+: To prevent ovarian cancers, fallopian tube removal is on the rise
Published: June 16, 2025 08:30
To prevent ovarian cancers, fallopian tube removal is on an upsurge — and diagnostic manuals are finally catching up.
STAT+: Sarepta reports second patient death after treatment with Duchenne gene therapy
Published: June 15, 2025 08:16
Sarepta said it was halting shipments of its Duchenne gene therapy for patients who can no longer walk, following the death of a second recipient.
STAT+: Hospitals would be hit hardest by Medicaid cuts in GOP tax bill, report finds
Published: June 14, 2025 16:22
To finance tax cuts, a GOP bill would reduce Medicaid payments to hospitals by $321 billion, hitting both blue and red states hard, a new report calculates.
Opinion: STAT readers on animal models, sexual assault kits, and more
Published: June 14, 2025 11:00
Is science ready to move away from animal models? STAT readers' opinions vary.
STAT+: Anne Wojcicki wins back 23andMe, this time as a nonprofit
Published: June 13, 2025 22:15
23andMe, which became a household name for its genetic testing services, is set to emerge from bankruptcy as a nonprofit.
STAT+: HHS plans ‘bold, edgy’ campaign on ultra-processed foods and diabetes
Published: June 13, 2025 21:28
RFK Jr. is pursuing a "bold, edgy" "Take Back Your Health” campaign that will inveigh against ultra-processed food and seek to make health wearables "cool."
STAT+: RFK Jr.’s new vaccine panel raises questions of how Kennedy defines conflicts of interest
Published: June 13, 2025 19:34
The entanglements and strongly expressed views of the new vaccine panel raises questions of how Robert F. Kennedy Jr. defines conflicts of interest.
STAT+: HHS tries pushing pharma to the negotiating table
Published: June 13, 2025 17:00
And more biotech news stories, brought to you by The Readout.
STAT+: Up and down the ladder: The latest comings and goings
Published: June 13, 2025 15:39
From new hires to departures, promotions and transfers, here are the latest comings and goings in the pharmaceutical industry.
STAT+: In fight over research overhead funding, universities propose alternatives to Trump’s cuts
Published: June 13, 2025 15:30
Exclusive: Facing NIH cuts in "indirect cost" funding, universities float new models to streamline requests and ensure support for research overhead, labs, and federal grants.
The life-and-death stakes of RFK Jr.’s decision to remake a vaccine panel
Published: June 13, 2025 14:40
Take a moment to consider the stakes involved in health secretary Robert F. Kennedy's remake of a vaccine advisory committee.
STAT+: Pharmalittle: We’re reading about a vaccine adviser’s conflicts, a pharma court win in Minnesota and more
Published: June 13, 2025 13:03
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.…
More than 70 nutrition scientists call for freedom from censorship at NIH
Published: June 13, 2025 11:39
And more health news stories this Friday.
STAT+: A vaccine expert explains why she’s ‘very worried’ about RFK Jr. and new CDC vaccine advisers
Published: June 13, 2025 08:30
A conversation with Kathryn Edwards, a physician and expert in childhood respiratory diseases and vaccine safety, on RFK Jr.'s latest ACIP shakeup.
Opinion: STAT+: Don’t cut NIH and NSF budgets — let the government invest like a venture capitalist
Published: June 13, 2025 08:30
Cutting science to fix the deficit is like burning your seed corn because you’re low on groceries. It’s fiscally shortsighted and strategically self-defeating.
Opinion: The AMA is not properly representing physicians
Published: June 13, 2025 08:30
Billing codes are just one way the American Medical Association has strayed from its core mission.
Opinion: STAT+: Recursion CEO: Biotech’s rainy season is not over — but we must race ahead
Published: June 13, 2025 08:30
After layoffs at Recursion, the company’s CEO writes about taking inspiration from an unexpected source: “The Art of Racing in the Rain.”
STAT+: Feds greenlight $9 billion in supplemental Medicaid funds as GOP weighs new limits
Published: June 13, 2025 08:30
States are securing billions in extra Medicaid funding before Congress caps future deals.
FDA clears Moderna’s RSV vaccine for use in people aged 18 to 59
Published: June 13, 2025 00:33
The FDA expanded the approval of Moderna’s RSV vaccine, extending the license to include more adults and giving the company a welcome win.
The upheaval of CDC’s vaccine panel, and drug pricing confusion
Published: June 12, 2025 21:26
This week on "The Readout LOUD": Why did RFK Jr. abruptly fire all members of CDC's vaccine advisory panel? Vaccine expert Kathryn Edwards joins the podcast to parse through the…
STAT+: Trump administration demands pharma companies begin drug price negotiations, a day after key deadline
Published: June 12, 2025 21:14
Trump wants drug companies to bring their prices in line with what other countries pay.
STAT+: Pharma wins a victory over a Minnesota law designed to provide transparency into drug pricing
Published: June 12, 2025 20:42
Once again, Pharma fends off an effort by a state to impose more transparency on drug pricing.
Systematic reviews cited retracted articles, new study finds
Published: June 12, 2025 19:48
A new study found some systematic reviews included retracted studies from paper mills, journals that produce low quality research
Opinion: I study conflicts of interest. Here’s why RFK Jr.’s approach to the vaccine advisory committee could backfire
Published: June 12, 2025 19:08
Ridding the government, including CDC’s vaccine advisory committee, of industry interests should not play out this way, writes an expert on conflicts of interest.
RFK Jr. names new vaccine advisers
Published: June 12, 2025 14:44
In today's D.C. Diagnosis newsletter, RFK Jr. names new vaccine adviers, GOP interest in most-favored nation grows, and more.
STAT+: FDA clears Capsida gene therapy for clinical trials
Published: June 12, 2025 13:56
And other biotech updates brought to you by The Readout.
STAT+: Pharmalittle: We’re reading about Trump and drug prices, BioNTech buying Curevac, and more
Published: June 12, 2025 13:16
The Trump administration had said it would disclose by Wednesday the target prices for drugs, but pharma companies are still waiting
STAT+: Medicare Advantage’s supplemental benefits will cost taxpayers $86 billion this year, with little transparency
Published: June 12, 2025 13:00
Taxpayers will send an estimated $86 billion to Medicare Advantage insurers this year to pay for supplemental benefits for their members. But how that money is spent remains a black…
Where abortion providers are practicing post-Dobbs
Published: June 12, 2025 12:56
And more health news stories of the day.
STAT+: BioNTech to buy CureVac in $1.25 billion deal, saying it will bolster cancer work
Published: June 12, 2025 12:11
BioNTech said Thursday it would buy CureVac, its onetime competitor in the Covid-19 vaccine race, for about $1.25 billion in an all-stock transaction.
STAT+: Insmed is an attractive, but expensive takeout meal
https://www.statnews.com/2025/06/12/insmed-biotech-regeneron-igan/?utm_campaign=rss
Published: June 12, 2025 10:30
June is delivering sunshine for biotech investors. Will it last?
STAT+: Why autism researchers aren’t convinced NIH can keep science and politics separate
Published: June 12, 2025 08:30
A new $50 million NIH initiative to find the causes of autism faces questions about transparency and independence.
Opinion: I’m adopted. I still won’t use genetic testing services like 23andMe
Published: June 12, 2025 08:30
A company like 23andMe can answer a lot of questions for an adoptee. But those answers come with a high cost to privacy.
Opinion: Medicaid cuts would devastate mental health, substance use treatment services in red states
Published: June 12, 2025 08:30
Though behavioral health conditions do not discriminate between Democrats and Republicans, the Medicaid cuts may be particularly damaging for residents of red states.
Addiction experts grow restive as they wait for Kennedy to take action
Published: June 12, 2025 08:30
Despite his compelling personal story of recovery from addiction, RFK Jr. has said much less about the U.S. drug crisis than other priorities like food additives.
A closer look at the new members of the CDC vaccine advisory panel
Published: June 12, 2025 03:08
For more than a half-century, the Centers for Disease Control and Prevention has relied on outside experts to guide the agency’s recommendations on how vaccines should be used to prevent…
Opinion: By remaking CDC’s vaccine advisory panel, RFK Jr. is destroying public trust
Published: June 12, 2025 01:37
Eliminating ACIP’s expertise on the eve of critical votes about flu and RSV vaccines will delay guidance, confuse clinicians, and cost lives.
STAT+: Braced for details on Trump’s ‘most favored nation’ policy, pharma industry is still waiting
Published: June 11, 2025 22:18
Braced for details on President Trump’s "most favored nation' policy, the pharma industry is still waiting.
RFK Jr. names new members of CDC’s vaccine advisory panel
Published: June 11, 2025 20:59
Kennedy announced the new members of the panel of experts that advises the CDC on vaccine policy.
STAT+: Cassidy is circulating a proposed law to push down U.S. drug prices, backing a key Trump ambition
Published: June 11, 2025 19:57
Cassidy and Trump both aim to lower U.S. drug prices closer to what other countries pay
HHS reverses hundreds of CDC firings
https://www.statnews.com/2025/06/11/hhs-reverses-firings-cdc/?utm_campaign=rss
Published: June 11, 2025 19:44
The Trump administration has reversed the firings of hundreds of staffers at the CDC.
STAT+: Coalition for Health AI is building the plane as it’s flying it
Published: June 11, 2025 16:20
This is the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to AI in health care and medicine.
STAT+: Gilead pauses trials of HIV combination therapy
Published: June 11, 2025 15:05
And more biotech news of the day, brought to you by The Readout.
Women, young adults, and Native people hit hard by rapid increase in alcohol liver deaths, study finds
Published: June 11, 2025 15:00
A new study suggests that the surge in pandemic-fueled drinking caused a sharp and continuing rise in fatal liver disease, particularly in women, young adults, and Native Americans.
New data analysis on trans health and well-being
Published: June 11, 2025 13:24
And more health news this A.M.
STAT+: Pharmalittle: We’re reading about Trump and drug prices, Gilead trial delays, and more
Published: June 11, 2025 13:13
Trump administration officials are expected to release more details on their plan to lower prescription drug prices in the coming days
Opinion: How physicians like me are grappling with requests for unvaccinated donor blood
Published: June 11, 2025 08:30
As a transfusion medicine physician, Jeremy W. Jacobs has increasingly faced requests for “unvaccinated donor blood.” So he and colleagues looked closer at what the data say.
MAHA-friendly bill in Texas would put warning labels on foods with any of 44 additives
Published: June 11, 2025 08:30
Europe’s comparatively cautious approach to food additives is the envy of health secretary Robert F. Kennedy Jr. and the Make America Healthy Again movement. A Texas bill now before Gov.…
STAT+: RFK Jr.’s new chronic disease agency faces a road block: Congress
Published: June 11, 2025 08:30
The new agency at the center of RFK Jr.'s agenda is hitting its first hurdle: Congress.
Opinion: The crucial Sickle Cell Data Collection program is in jeopardy
Published: June 11, 2025 08:30
Without the Sickle Cell Data Collection program, we will see greater burdens and higher costs for both families and health care systems.
STAT+: Ousted CDC vaccine adviser says RFK Jr.’s message is clear: ‘Scientific expertise is no longer of use’
Published: June 11, 2025 00:21
Terminated CDC vaccine adviser Helen Chu spoke with STAT about her fears for the future of vaccine policy
STAT+: Exclusive: Coalition for Health AI will help Joint Commission write responsible AI ‘playbooks’
Published: June 10, 2025 22:44
The playbooks are designed to create a roadmap and offer guidance for more than 80% of U.S. health care organizations and programs.
Firing of CDC’s vaccine advisers puts spotlight on RFK Jr.’s promises to Cassidy
Published: June 10, 2025 21:03
The firing of the CDC's vaccine advisers has put a spotlight on RFK Jr.'s promises to a key Senate Republican health leader during his confirmation process.
STAT+: 23andMe leaders grilled on genetic data risks by federal lawmakers
Published: June 10, 2025 20:08
The future of the genetic data owned by 23andMe is uncertain as the company undergoes a court-supervised sale.
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