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WASHINGTON — In hours of combative congressional hearings Wednesday, health secretary Robert F. Kennedy Jr. swung between defending sweeping changes at his agency and backtracking on aspects of a reorganization he nevertheless said would be “painful.” He repeatedly cast doubts on reports about negative impacts of the changes, often calling them a “canard.
Leading trade organizations representing the makers of cell and gene therapies are calling for a 10-year international moratorium on the use of CRISPR and other DNA-editing tools to create genetically modified children, according to a draft of the declaration provided to STAT. The move — coming more than seven years after Chinese researcher He Jiankui announced the birth of the world’s first CRISPR babies — is intended to send a clear signal to the global scientific co
For a recent therapy session, Andria Donaghy’s insurance plan paid her psychiatric nurse practitioner only $11 on a $125 service. “To even put that on paper is insulting,” she said. “These people give their lives [to help others] and that’s what you pay them?
The now 13-year-long legal saga over who invented CRISPR took yet another unexpected turn on Monday, in a ruling that could not only change U.S. ownership of patent rights to the groundbreaking gene-editing technology but more broadly redefine how the law determines when an invention has been made. The U.S. Court of Appeals for the Federal Circuit sided with the University of California and the University of Vienna in their bid to revive a fight over foundational CRISPR-Cas9 patents that t
Philanthropist Bill Gates announced Thursday that he will wind down his massive charity in 20 years, doubling spending over that time to accelerate the work it hopes to achieve. Gates made the announcement on the 25th anniversary of the launch of the Gates Foundation, the third-largest player in international philanthropy. He said the foundation would spend $200 billion between now and 2045, when its operations will wind down.
As a primary care physician serving Medicaid patients, I recently witnessed a preventable hospitalization that perfectly illustrates America’s health care dysfunction. My homebound patient with heart failure needed a routine lab test to adjust their medication. While commercially insured patients can access electronic lab orders, my patient’s Medicaid plan contracted exclusively with a laboratory requiring physical forms by mail.
A federal judge has sided with the U.S. Food and Drug Administration over a decision last year to remove two Eli Lilly drugs — the Zepbound weight loss medicine and the Mounjaro diabetes treatment — from a shortages list kept by the agency. The move means that patients will no longer have access to cheaper versions from compounding pharmacies.
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.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, there’s been a lot of discussion lately about how the U.S. can stay competitive in science, biomedical innovation, and drug development. We’ve got several pieces of news relevant to that issue today.
Shares of Eli Lilly dropped in pre-market trading Thursday, as competitor Novo Nordisk secured a major win on insurance coverage of its obesity drug and as Lilly reported first-quarter earnings that fell short of what investors wanted to see. CVS Caremark, the largest pharmacy benefit manager in the U.S., announced Thursday that starting in July, Novo’s weight loss treatment Wegovy will be the preferred GLP-1 medicine on its largest commercial formularies, likely making Wegovy more access
Top of the morning to you, and a fine one it is. Clear blue skies and pleasant breezes are wafting across the Pharmalot campus, where the official mascots are foraging for their breakfast and rousing the neighbors. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is lavender vanilla.
CVS Health will not sell its Aetna health plans in the Affordable Care Act’s individual marketplaces in 2026, marking the second time in the past decade that Aetna has given up on ACA coverage. CVS expects to lose up to $400 million this year in its ACA plans. The conglomerate set aside $448 million in the first quarter to cover medical claims from ACA members that won’t be covered by insurance premiums.
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. Biotech mood check: Happy Two acquisitions. Strong drug launches. FDA drug approvals. A rebounding XBI now 18% higher from its recent low. All in, a very pleasant week so far.
The recent news that the NIH will require universities to certify their diversity programs comply with federal civil rights law created understandable anxiety in the academic community. The confusion is partly due to coverage that suggested NIH is terminating support for any universities that operate diversity, equity, and inclusion (DEI) programs. But reading the actual NIH notice carefully provides clarity — and perhaps some reassurance.
The era of “tranq” may be ending. But tranq, as the powerful veterinary tranquilizer xylazine is known in the illicit drug supply, is being replaced at least in part by a dangerous new sedative: medetomidine. In the past year, the anesthetic has become an increasingly common element in the drug supply, with cities and states including Philadelphia, Pittsburgh, Chicago, and San Francisco reporting cases of medetomidine-involved overdoses.
As a professor of physiology, I study how scientific evidence gets translated, sometimes clumsily, from the lab to real life. Whether it’s scaling dietary supplements to humans or using biomimicry to mitigate sports concussion , my work often centers on the fine line between meaningful evidence and misleading extrapolation. That’s why I was immediately skeptical when the Food and Drug Administration announced its decision to ban synthetic food dyes like the controversial red dye No
The word came down at 9 a.m. Pacific on April 14 that they were done. Marcia Stefanick of Stanford and three other leaders of regional centers that for decades have researched women’s health heard from their study’s national leaders that their funding would end with the fiscal year. They all had contracts ready and waiting to be signed to extend their parts of the Women’s Health Initiative, a massive, groundbreaking study that has changed medical practice on hormone therapy,
Gilead Sciences agreed to pay $202 million to settle allegations of paying kickbacks to doctors in exchange for prescribing several of its HIV medicines, the latest example of a controversial practice that has come back to haunt numerous drugmakers over the years. From 2011 through 2017, Gilead held more than 17,300 speaker programs of which 9,500 were dinners to promote sales of HIV drugs that were supposed to be educational.
BridgeBio’s recently approved heart drug brought in $36.7 million in sales in the first quarter, blowing past expectations as the biotech continues to see a strong demand for its first major commercial product. Analysts had estimated that the treatment, called Attruby, would bring in sales of $12 million, but Wall Street’s “whisper number” was $17 million to $20 million.
Y ou’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. As of last week, Chris Klomp is in charge of the Center for Medicare. Unlike predecessors, he’s not a policy wonk.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning, we’ve got a bunch of news this morning about GLP-1 drugs, compounding, and biotechs’ interactions with the FDA. Let’s get into it.
Novo Nordisk is expanding its efforts to sell its obesity drug Wegovy directly to patients, striking agreements with telehealth companies including Hims & Hers, Ro, and LifeMD. Novo last month launched a new direct-to-consumer website called NovoCare Pharmacy that sells Wegovy, which normally carries a list price of about $1,350 a month, at $499 a month to patients who are paying on their own without insurance.
Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are once again enveloping the Pharmalot campus, where the official mascots are bounding about the grounds in search of creatures to terrorize. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own hectic agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is roasted coconut — and attack the fast-growing to-do list.
File this under “So close, yet so far.” After several years of struggling with regulatory hurdles to win approval for its rare disease drug, Stealth BioTherapeutics had expected the U.S. Food and Drug Administration to respond on Tuesday to its marketing application. But late last week, the company received a letter saying there was a delay.
After 15 years, the Affordable Care Act (ACA) has survived its share of challenges at the Supreme Court. On April 21, I attended the court’s first hearing in the latest of the series of ACA challenges, Kennedy v. Braidwood, which is focused on the ACA’s preventive services coverage requirement. I proudly represented 20 HIV advocacy organizations as amici in the case , urging the court to uphold the law, which requires payer coverage of items and
For the second consecutive year, the pharmaceutical industry saw its reputation slip among patient advocacy groups, largely due to ongoing concerns over pricing issues, according to a new survey. Of more than 2,500 groups queried, 56% reported the industry had an “excellent” or “good” reputation as it goes about the business of developing and providing medicines.
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Novo Nordisk has notched a major legal win against compounding pharmacies that make copies of its diabetes and obesity drug semaglutide, sold under the brand names Ozempic and Wegovy. A federal judge on Thursday ruled against a compounding trade group’s request for a preliminary injunction that would have prevented the Food and Drug Administration from taking action against its members for making copies of semaglutide.
The Belgian antitrust regulator sanctioned some of the largest purveyors of over-the-counter medicines — Haleon, Kenvue, and Boehringer Ingelheim — the equivalent of $12.8 million for engaging in a long-running scheme that favored placement of their products in pharmacies. Known as category management arrangements, this involves using one or more companies allegedly conspiring to ensure their products receive favorable placement in stores.
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 still shaping up. We expect to promenade with the official mascots and catch up on our reading, but are, otherwise, open to suggestion. Of course, we do hope to hold another listening party, where the rotation will likely include this , this , this , this and this.
Health and Human Services Secretary Robert F. Kennedy Jr. has railed against what he sees as a “revolving door” between workers at drug companies and the Food and Drug Administration. But his department’s actions now seem to be causing that door to spin ever faster. Scores of FDA employees are searching for an exit from an agency in turmoil, particularly staff members tasked with reviewing drug applications, according to interviews with former employees and industry re
The federal health department is not creating a new registry of Americans with autism, a Department of Health and Human Services official said in a written statement Thursday. Instead, the official said, HHS will launch a $50 million research effort to understand the causes of autism spectrum disorder and improve treatments. The announcement arrives two days after National Institutes of Health Director Jay Bhattacharya announced the intent to create such a registry at an all staff meeting, kicki
How did Ireland become a hotspot for pharmaceutical manufacturing? What are the products that will come out of Flagship’s latest startup centered around “preemptive medicine”? And who among the co-hosts is the best singer? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s biotech podcast.
NASHVILLE, Tenn. — Robert F. Kennedy Jr.’s appearance at a major addiction and drug policy conference was marked by repeated interruptions on Thursday, as protesters and jeers forced him to pause and wait for noise to subside at least five times during his 36-minute speech. A packed and deeply divided audience at the Rx and Illicit Drug Summit, taking place at a conference center on the city’s outskirts, applauded the health secretary as he entered and exited the stage
Some key public health figures are taking an extraordinary step to try to shore up U.S. vaccination policy, feared to be under threat from Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine critic. The “Vaccine Integrity Project,” which was publicly launched Thursday by the University of Minnesota’s Center for Infectious Disease Research and Policy, will be aimed at assessing the best ways for vaccine proponents to safeguard vaccination policy and
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. I think I’ll go for a walk outside now The XBI is callin’ my name (I hear ya now) I just can’t stay uninvested all day I gotta get out get some of those bio-rays Biotechs are smilin’ Sunshine day Biotechs are laughin’ Sunshine day Every biotech seems so happy today It’
The debate over the future of Medicaid continues to rage among Republicans. A House budget proposal released in February would slash up to $880 billion in spending over the next decade from the public health insurance program that 80 million low-income Americans rely on — including children, seniors, and people with disabilities.
The young people who wanted to quit e-cigarettes didn’t necessarily think they were addicted. But they did think nicotine cravings were a problem. When they enrolled in a Massachusetts General Hospital trial, they told researchers they couldn’t study in the library or work at their desks for long before getting the urge to vape. “They really didn’t like that loss of control,” said Eden Evins, director of the addiction center at Mass General.
Y ou’re reading the web edition of STAT’s AI Prognosis newsletter, our subscriber-exclusive guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday. We’re going to dive into a wonky one today. As Ms. Frizzle would say , “Seatbelts, everyone!
Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Hey all, it’s Lev Facher again. It’s late April, which means it’s already STAT Wunderkinds season! This is your chance to nominate your favorite accomplished, motivated early-career researcher for nationwide recognition.
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. It’s been one year since I began co-authoring this newsletter! It’s been a great time bringing you biotech news every week, and please continue to send any ideas and tips my way: elaine.chen@statnews.com.
Amid ongoing battles over alternate supplies of blockbuster weight loss drugs, Eli Lilly filed new lawsuits against four telehealth firms and their affiliates, but is using a new line of attack — the drugmaker accused two of the companies of engaging in the corporate practice of medicine. To date, Lilly and its rival, Novo Nordisk, have filed dozens of suits against numerous companies involved in compounding versions of semaglutide and tirzepatide, the obesity and diabetes drugs known as
When a person with dementia gets something fundamental wrong — the year it is, your relationship to them — it can be difficult to know what to do. Do you correct them and risk upsetting them? Is it a lie or unethical to go along with it? Ted Johnson, who chairs the Department of Family and Preventive Medicine at the Emory School of Medicine, says that playing along is not only OK; it’s often the best thing for both the patient and the caretaker.
Many Americans were forced to postpone cancer screenings — colonoscopies, mammograms, and lung scans — for several months in 2020 as Covid-19 overwhelmed doctors and hospitals. But that delay in screening isn’t making a huge impact on cancer statistics, at least none that can be seen yet by experts who track the data.
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