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A planned executive order that would have greatly enhanced White House influence over grants at the National Institutes of Health is “looking dead,” according to one person familiar with the decision and Sen. Susan Collins (R-Maine). On Tuesday, Collins, the chair of the appropriations committee, sent a letter to Office of Management and Budget Director Russell Vought and NIH Director Jay Bhattacharya, decrying the White House plan to establish a commission of political appoin

WASHINGTON — In her opening statement for Thursday’s hearing before a key Senate committee, President Trump’s pick to lead the Food and Drug Administration, Heidi Overton, plans to emphasize the need for speed and efficiency at the FDA to compete with China’s accelerating biotechnology industry.  “President Trump’s direction for me in this role, should I be confirmed, is to ‘go fast.’” Overton says in the statement, an advanc

A Food and Drug Administration advisory panel on Wednesday endorsed Galleri, a blood test designed by the biotech firm Grail to screen for multiple types of cancer, concluding that the benefits of the test outweighed its risks. The panel voted 10 to 0 that it believed there is “reasonable assurance” the test is safe. The panel voted 6 to 4 that there was reasonable assurance the test is effective. And it voted 7 to 2 with one abstention that it believed “the benefits of G

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. STAT is hosting a virtual event tomorrow on the future of biosimilars. Check it out here. VCs rush to invest in osteoporosis drugs Developing drugs for brittle bones has long been a difficult endeavor, due to safety concerns and regulatory barriers. But now with new guidance from the FDA, pharma companies are returning to osteoporosis resear

This is the web edition of STAT’s AI Prognosis newsletter, our guide to artificial intelligence in health care and medicine. Sign up to get it delivered in your inbox every Wednesday.  *Bernie Sanders voice* I am once again asking you to … forward this email to a friend! Non-subscribers can now sign up to get (a truncated version of) AI Prognosis. Tell ya buddies and coworkers! Also, tell your buddies about this essay from our new trust-in-science reporter, Nic

Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a couple of more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cup of stimulation. Our choice today is hot buttered rum. A shot of salvation, if you will. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Good morning. Yesterday was the first official day of autumn. “Fall, leaves, fall; die, flowers, away,” Brontë wrote for those of you who have been thinking about pumpkin spice lattes since July. Read the rest…

Major insurers are pushing back on a Medicare proposal that would significantly disrupt how many doctors bill for tracking the health of patients using devices like connected blood pressure cuffs, scales, and blood glucose meters. These remote monitoring services help patients manage a range of medical conditions, including hypertension, diabetes, and heart failure. UnitedHealth Group, CVS Health, and Kaiser Permanente all wrote letters to the Centers for Medicare and Medicaid Services opposi

Medicines for brittle bones and breakages are grabbing the attention of the pharma industry, which has been incentivized by a long-awaited regulatory change.  Osteoporosis, a condition affecting older adults that causes bones to become thin and fragile, used to be a top priority for pharmaceutical companies. Eli Lilly, Merck, Novartis, and GSK each had their own treatment designed to stop bones from weakening. But the cumbersome requirements for taking the drugs, as well as a series of s

A friend once told me approvingly that someone she knew had talked his schizophrenic adult son into having a vasectomy. Though I read “talked into” as “coerced,” I didn’t say anything.   Oh my god, I thought instead, maybe I shouldn’t be a mother. I’d had a break with reality after stopping my antipsychotic 10 years before, frustrated with weight gain. I had returned to taking medication and my mental health had stabilized long before this

When Greg Kiser gave the mayor and county judge a heads up about a change underway at his hospital, they responded with sighs of relief. One of the town’s biggest employers wasn’t closing. “They said, ‘Greg, we can’t make it without this hospital in our little town,’” said Kiser, who’s been CEO of Three Rivers Medical Center in Louisa, Kentucky — population less than 3,000 — for 32 years.  It wasn’t an unreas

For the second time this year, the Department of Health and Human Services announced a new set of strategies to speed a shift toward human-based research methods and reduce the use of animals in medical testing. In one move, the Food and Drug Administration issued a final rule stating that research methods other than animal testing can be used when “appropriate” for determining the safety of drugs and biologics. Specifically, the rule replaces terms like “animal tests&#x2

Heidi Overton has been nominated to lead the Food and Drug Administration at a moment of significant opportunity, but also big challenges. Innovation in medicine has never moved faster, providing more ways for Americans to improve their health and for the United States to advance the health of its population. But the institutions that carry that progress forward are under strain. Overton has a chance to help bridge that divide — and the experience to do it. She has the opportunity to d

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. Dr. Oz praised GLP-1s from Eli Lilly’s lab, where he said MFN agreements have drastically cut the price of obesity drugs. Problem is, at least Lilly’s GLP-1s are exempt from the MFN agreements (see below). But who am I to correct people? I incorrectly attr

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. As an avid Pilates goer, I appreciated this story. The need-to-know this morning Roche reported a positive Phase 2 trial of enicepatide (previously known as CT-388) in patients with type 2 diabetes and obesity, with the drug helping patients lose weight and lower blood sugar. The company already has two Phase 3 weight loss studies ongoing a

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! My kids have been in school for one week and everyone is already sick. But the newsletter marches on!Continue to STAT+ to read the full story…

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required, nor is a copay. Our choice today is butter pecan. Meanwhile, here are a few item

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. Teen social media bans are hot these days, with new regulations installed or soon to come in Australia, Indonesia, and the European Union. But how will we know these rules are working? And what does “working” even mean?Read the rest…

CLEVELAND — Amy Acton couldn’t speak.  Supporters of Acton, the Democratic nominee for governor of Ohio, were waiting for her remarks along the banks of the Black River, once known as the “river of fish tumors” because of the catfish deformed by steel mill slag. Now the river was being rehabilitated. Acton, a physician who vaulted to national fame when she led Ohio’s aggressive response to Covid-19 as the state’s director of public health back in

WASHINGTON — Brian Blase, president of Paragon Health Institute, has become a trusted adviser to Republicans in Congress, who passed sweeping changes to federal funding for health care last year. The Medicaid program is expected to pay out some $1 trillion less than projected over the coming decade, thanks to policies Blase supported. The changes are causing health providers to scramble and rethink how they offer care.  The cuts to the Medicaid program through the One Big Bea