On:

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

The Trump administration is using newly announced 100% tariffs as leverage to push both large and small drugmakers into confidential pricing and manufacturing agreements.

Also, the burgeoning peptide craze is highlighting a trust gap in medicine, in which patients increasingly favor unproven treatments over well-established drugs.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Companies that sell Medicare Advantage plans will receive a 2.5% pay bump on average in 2027, up significantly from what was proposed and a win for an industry that has experienced higher medical costs and has opposed nearly all reforms to the lucrative taxpayer-financed program.

More importantly, the Trump administration scrapped its proposal that would have used more updated data in the payment process, ensuring that Medicare Advantage insurers retain billions of dollars.

In addition to base payments, Medicare Advantage insurers get paid based on how sick their members. This process is known as risk adjustment and has been flagged by watchdogs, auditors, and federal attorneys as rife with abuse. Trump officials proposed using newer data that goes into seniors’ “risk scores,” but after intense industry pushback over the past two months, they are dropping the proposal for now. 

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

For the second time in two years, a bill is moving through the Colorado legislature that would exempt orphan drugs, which are used to treat rare diseases, from pricing caps that might be pursued by the state’s Prescription Drug Affordability Board — a panel whose work is being closely watched elsewhere in the country.

The effort reflects concerns that patients may lose access to these drugs if pharmaceutical companies halt sales of such treatments in the state. But opponents argue exemptions would unnecessarily extend to numerous big-selling medicines for common conditions that — thanks to regulatory endorsements — also happen to have an orphan designation.

As a result, consumer advocates complain the maneuver would only increase the risk that countless patients could have trouble paying for a wide variety of medicines. They further argue that the legislation would preserve profits for drug companies at the expense of the state government — and its taxpayers — as it tries to cope with budgetary strains.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

This is the online version of STAT’s weekly email newsletter Health Care Inc. Sign up here.

Well hullo! You think you can get the last word, literally, with AI? Think again. There’s always human interaction available here: bob.herman@statnews.com.

Today’s the day

By law, the 2027 Medicare Advantage payment regulation must come out today. It will set the tone for how the Trump administration wants to work with the health insurance industry: as the “new sheriff in town” or just another friendly regulator.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

It’s the latest in a flurry of executive appointments from health insurers looking to strengthen their leadership teams amid regulatory headwinds and elevated medical costs.

This post was originally published here. 

On:

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating because that oh-too-familiar routine of meetings, deadlines, and the like has returned with a vengeance. You knew this would happen, yes? To cope, we are relying, as always, on cups of stimulation. Our choice today is laced with traces of cocoa. Feel free to join us. Remember, no prescription is required. Meanwhile, here are some tidbits to help you along. Best of luck accomplishing your goals today and, of course, do keep in touch. …

In February, a small biotech company called Kezar Life Sciences reached a breakthrough with the U.S. Food and Drug Administration, agreeing to a plan for a clinical trial it hoped could lead to the approval of its treatment for a rare, debilitating liver disease called autoimmune hepatitis. The problem: The agreement came four months too late, STAT explains. The meeting to discuss trial design, a critical step in the drug development process, had been scheduled for last October. But the FDA abruptly canceled it without explanation. The company could no longer proceed as planned and, without clarity from regulators, its path forward was unclear. Kezar’s investors wanted out, and the biotech was forced to start the process of winding down.

Americans starting weight loss medicines for the first time want lower cost and greater convenience as they consider pills from Novo Nordisk and Eli Lilly, Reuters says, citing seven doctors who specialize in obesity. Novo’s Wegovy pill ​has been on the market since January, while Lilly’s newly approved Foundayo joins the fray this week. Interviews with the specialists show a promising landscape for oral weight loss drugs as ‌the companies compete for share in the fast-changing obesity treatment market that is seen topping $100 billion a year in the next decade. All seven doctors said they had begun prescribing oral Wegovy, and three said they have prescribed the pill to ⁠about 10% of their patients. Of those patients, most are taking a GLP-1 for the first time, rather than switching from injectables, and have not yet reached the highest dose. 

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning. You have until 9 pm ET tonight to vote in the final round of STAT Madness! Make your voice heard, and then make sure to read Sarah Todd’s great story on the inverse Fannee Doolee attitude that RFK Jr. and others seem to take on peptides vs. vaccines.

Read the rest…

This post was originally published here. 

On:

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

A four-month FDA delay prompted a cash-strapped biotech company to shutter. The White House’s proposed NIH cuts are drawing bipartisan backlash. Peptide hype is outpacing evidence. And more!

The need-to-know this morning

  • Neurocrine Biosciences said this morning that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. Neurocrine is paying $53 a share for Soleno, a 34% premium to its closing price on Thursday.

A four-month FDA delay derailed a small biotech. Is it a sign of the times?

FDA delays can happen. For large drugmakers, they can be frustrating; for small drugmakers, they can be existential.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Neurocrine Biosciences said Monday that it would buy Soleno Therapeutics and its treatment for Prader-Willi syndrome for $2.9 billion. 

Neurocrine is paying $53 a share for Soleno, a 34% premium to its closing price on Thursday. 

Soleno’s drug, Vykat, was approved in March 2025 to treat hyperphagia in patients with the rare genetic disease. Hyperphagia is one of the defining features of Prader-Willi syndrome, causing relentless hunger and leading patients to overeat. Vykat is the only approved treatment for hyperphagia in Prader-Willi patients. 

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

In February, a small biotech company called Kezar Life Sciences reached a breakthrough with the Food and Drug Administration, agreeing to a plan for a clinical trial it hoped could lead to the approval of its treatment for a rare, debilitating liver disease called autoimmune hepatitis. The problem: The agreement came four months too late.

The meeting to discuss trial design, a critical step in the drug development process, had been scheduled for last October. But the FDA abruptly canceled it without explanation. The company could no longer proceed as planned and, without clarity from regulators, its path forward was unclear. Kezar’s investors wanted out, and the biotech was forced to start the process of winding down.

It laid off most of its staff of about 60 people. Then, it auctioned off its lab equipment and sold much of its office furniture, except for the table and chairs in one conference room it kept in case the company got its meeting with FDA staff.

Last week — after the meeting and the breakthrough happened — the company said it would be sold. Kezar hopes the buyer, Aurinia Pharmaceuticals, will take the drug forward, though how quickly that can happen, if at all, is not guaranteed.

It’s also not clear why Kezar’s initial meeting was canceled. But to CEO Chris Kirk, the chain of events fits a pattern over the past year in which volatility at the FDA — including staff departures and decision-making seen as inconsistent — has ricocheted across the industry, impacting drugmakers. Those impacts can fall disproportionately on small companies, which, unlike major drugmakers, often operate on one financing to the next. 

“In my career, I’ve often not agreed with what the FDA has said, but I’ve at least relied on their consistency,” said Kirk, who’s worked in biotech for more than two decades. “That doesn’t appear to be what’s happening now. It feels more stochastic and maybe even capricious, what’s going on at the FDA. And this isn’t good for patients. It’s definitely not good for the biotech ecosystem as a whole.”

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Robert F. Kennedy Jr. tends to favor health choices he sees as natural — whether that means eating “real food” like meat and vegetables instead of ultra-processed food or suggesting, falsely, that nutrition and vitamins are a good alternative for fighting off measles instead of vaccines.

But there’s at least one area where the health secretary breaks with his own tradition. He’s among the many influential voices in health and wellness in favor of people injecting themselves with experimental drugs known as peptides — much to the concern of mainstream public health experts, who warn that these drugs haven’t been sufficiently studied for efficacy or potential side effects, including higher cancer risk.

With demand for peptides on the rise and would-be self-optimizers seeking out the drugs on gray and black markets, Kennedy said on Joe Rogan’s podcast in February that he thought the Food and Drug Administration would take action within a couple of weeks to make them more accessible. That means reclassifying around 14 drugs so that compounding pharmacies can once again offer them after a 2023 rule change under the Biden administration. “I’m a big fan of peptides,” Kennedy said, having “used them myself to really good effect on a couple of injuries.” 

Read the rest…

This post was originally published here. 

On:

I am sitting in a firm recliner with a wipeable surface during a two-day hospital admission for testing at our local children’s hospital. The chair is designed for durability, not sleep. The pillow beneath my head is flat and smells faintly of disinfectant. A thin hospital blanket scratches against my arms as I shift, unsuccessfully, trying to rest. The room is dim but never quiet. Monitors beep. Machines hum. Footsteps pass the door. Hospital noise does not fade. It embeds itself in the nervous system.

My 13-year-old is finally asleep. His thin body is curled beneath a blanket identical to mine. One shoulder peeks out, bruised from repeated injections of calming medication. A neon orange bandage marks the most recent one, given about an hour ago. I watch his chest rise and fall and allow myself a brief moment of relief.

Read the rest…

This post was originally published here. 

On:

My son is now in high school, but when he was in the second grade, I received a call that changed everything: “We think he had a stroke.”

He had developed a facial droop and couldn’t walk on his own. His teacher carried him to the nurse’s office with the entire class following. He was eventually diagnosed with metabolic strokes due to mitochondrial disease, a genetic disorder that prevents your cells from producing enough energy.

Read the rest…

This post was originally published here. 

On:

From a scan of its job openings, it would be easy to mistake UnitedHealth Group for Silicon Valley’s latest artificial intelligence juggernaut.

Hundreds of postings seek applicants with expertise in data science and artificial intelligence, part of a sweeping campaign to embed AI in the company’s core business operations. Already, UnitedHealth employs 22,000 software engineers worldwide, with more than 80 percent using AI to write code or build new agents, a sharp uptick from a few years ago, executives said.

“Since the advent of generative AI, we’ve really doubled down on training, on investments, on driving meaningful use cases,” Sandeep Dadlani, the chief executive of Optum Insight, the company’s technology division, told STAT. He said the company’s goal is to use AI to speed up decision-making and streamline health insurance’s notoriously time-consuming bureaucracy. 

UnitedHealth Group is far from alone in the quest for AI transformation. But its rapid scale up portends major changes in the machinery of American health care, swapping manual processes for ones driven by a multitude of AI products. While that may increase speed and efficiency, it will also pose new risks to patients who don’t always know whose interests an AI agent is serving, or even when and how the technology is being used to make decisions about their care.

A STAT examination sought to gauge those risks, along with potential benefits, by tracing how UnitedHealth Group is incorporating AI into operations that touch tens of millions of Americans. The effort involves building up engineering teams to reinvent how billions of medical claims are processed and audited, automating everything from fraud detection, to clinical documentation, to the selection of billing codes that determine how much a given medical encounter costs — and who pays.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

The Trump administration is requesting about $111 billion in discretionary funding for the HHS, nearly $16 billion less than its budget in 2026.

This post was originally published here. 

On:

The White House is asking Congress to cut $5 billion from the National Institutes of Health and to downsize the number of its institutes and centers from 27 to 22 — a plan that is expected to receive a chilly reception from lawmakers from both parties. 

The president’s fiscal year 2027 budget request, released Friday, asks for $41 billion for the NIH and eliminates the National Center for Complementary and Integrative Health, the Fogarty International Center, and the National Institute on Minority Health and Health Disparities. The 2027 budget also proposes consolidating two institutes focused on research on drug and alcohol abuse into a new entity called the National Institute of Substance Use and Addiction Research, as well as relocating the National Institute of Environmental Health Sciences into the Centers for Disease Control and Prevention. 

The White House proposal also asks Congress to slash the budget for the Advanced Research Projects (ARPA-H), which funds cutting-edge science, from its current $1.5 billion to $945 million.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

WASHINGTON — The White House wants Congress to cut spending on the Department of Health and Human Services by more than 12%, according to its proposed 2027 federal budget, released Friday. 

The budget is broadly similar to what the Trump administration proposed last year. That includes deep cuts to the National Institutes of Health, the elimination of a health research agency, and the creation of a new agency devoted to chronic diseases called the Administration for a Healthy America. 

The president’s budget is as an agenda-setting document, offering a sense of what the administration hopes to focus on in the coming year. Congress, however, is ultimately responsible for passing laws that set federal spending.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Lawmakers are considering bills that would unwind the state’s oversight over Ballad, the largest state-sanctioned hospital monopoly in the U.S. The FTC argues that’s a bad idea.

This post was originally published here. 

On:

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 rather modest so far. We plan to tidy up around the castle, promenade with the official mascots, and catch up on our reading. We also plan another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The change of seasons opens up all sorts of possibilities, from long walks through woods to strolling along city streets to drives through the countryside. Of course, if the weather fails to cooperate, you could open a book, watch the telly, or spin a platter and dance about. Or maybe it is an opportunity to connect with someone special. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

The Trump administration announced 100% tariffs on imported brand-name drugs — but with significant caveats, STAT explains. Many large drugmakers will not have to pay the tax because they struck deals with the U.S. to build manufacturing facilities here and lower the prices of their medications. Drugmakers that have not struck such deals but pledge to bring production to the U.S. can have tariffs reduced to 20% for the remainder of Trump’s term. The tariffs open a new front in the Trump administration’s efforts to rein in the pharmaceutical industry and in its push to bring manufacturing back to the U.S. The announcement comes as Trump has looked to emphasize his administration’s work to make prices — especially for medicines — more affordable ahead of the midterm elections.

Meanwhile, the Trump administration is negotiating more drug-pricing deals, now with smaller companies, according to STAT. The new talks offer a pathway for smaller pharmaceutical companies — those not included in the first round of deals — to pledge lower prices and potentially avoid tariffs or new pricing policies through Medicare. The negotiations suggest the administration is looking to replicate the strategy it used with larger drugmakers: extract voluntary, confidential agreements in pursuit of lower prices and more domestic manufacturing. They also offer smaller players in the sector the chance to cut a deal and gain more certainty about how they might be affected by federal policies. But the number of companies in talks with the administration remains unclear, as does whether or when the sides will reach agreement.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

The U.S. Supreme Court ruling this week against Colorado’s ban on licensed mental health providers engaging in gender and sexuality “conversion therapy” could narrow the authority of state medical boards to regulate aspects of health providers’ care that involves speech, according to legal experts. The implications could extend far beyond matters related to LGBTQ+ rights to other forms of talk therapy, telehealth, and physician advice on Covid-19, vaccines, or reproductive care.

Because the therapist who challenged the law, Kaley Chiles, engages in talk therapy — without prescribing medications or having any physical contact with patients — the majority decided that the Colorado law constitutes a restriction on her speech due to her particular viewpoint, or opinion. In an 8-1 decision, the judges sent the case back to a lower court for a higher level of judicial scrutiny, which will likely result in the ban being overturned. 

Read the rest…

This post was originally published here. 

On:

The U.S. Supreme Court ruling this week against Colorado’s ban on licensed mental health providers engaging in gender and sexuality “conversion therapy” could narrow the authority of state medical boards to regulate aspects of health providers’ care that involves speech, according to legal experts. The implications could extend far beyond matters related to LGBTQ+ rights to other forms of talk therapy, telehealth, and physician advice on Covid-19, vaccines, or reproductive care.

Because the therapist who challenged the law, Kaley Chiles, engages in talk therapy — without prescribing medications or having any physical contact with patients — the majority decided that the Colorado law constitutes a restriction on her speech due to her particular viewpoint, or opinion. In an 8-1 decision, the judges sent the case back to a lower court for a higher level of judicial scrutiny, which will likely result in the ban being overturned. 

Read the rest…

This post was originally published here. 

On:

A patient came to my office recently and told me she had stopped her statin. She’d been on it for two years. Her coronary artery calcium score was 280 and LDL was 168, up almost 100 points since she had stopped taking her statin. Her father had died from a heart attack at 58.

When I asked about the decision, she crossed her arms and furrowed her brow.

Read the rest…

This post was originally published here. 

On:

A patient came to my office recently and told me she had stopped her statin. She’d been on it for two years. Her coronary artery calcium score was 280 and LDL was 168, up almost 100 points since she had stopped taking her statin. Her father had died from a heart attack at 58.

When I asked about the decision, she crossed her arms and furrowed her brow.

Read the rest…

This post was originally published here. 

On:

Figure 2 from the PURPOSE-1 trial changed the world.

Between gray and red bars representing the study’s background HIV incidence and the arms randomized to receive oral pre-exposure prophylaxis (PrEP) was white space filled only by a previously unimaginable number: zero. Zero infections over one year among the 2,134 cisgender adolescent girls and young women who received the novel long-acting injectable antiretroviral lenacapavir.

Read the rest…

This post was originally published here. 

On:

Figure 2 from the PURPOSE-1 trial changed the world.

Between gray and red bars representing the study’s background HIV incidence and the arms randomized to receive oral pre-exposure prophylaxis (PrEP) was white space filled only by a previously unimaginable number: zero. Zero infections over one year among the 2,134 cisgender adolescent girls and young women who received the novel long-acting injectable antiretroviral lenacapavir.

Read the rest…

This post was originally published here. 

On:

The Trump administration is slashing the number of quality and care measures that Medicare Advantage plans will be graded on, a move that will funnel an extra $18.6 billion toward health insurers over the next decade.

The final regulation, released Thursday by President Trump’s Centers for Medicare and Medicaid Services, is significantly more beneficial for the insurance industry than originally expected. CMS previously estimated these changes to star ratings would cost $13.2 billion between 2028 and 2036 when the rule was proposed in November.

The extra funding from star ratings provides a sizable buffer for Medicare Advantage insurers, which are awaiting final payment rates for 2027 and experiencing higher medical claims. Insurers have lobbied Trump officials for more money in their baseline payments, and to scale back changes in how they record the sicknesses of their members. The government is supposed to release that regulation no later than April 6.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

The Environmental Protection Agency on Thursday proposed including microplastics and pharmaceuticals on a list of contaminants in drinking water for the first time, a step that could eventually lead to new limits on those substances for water utilities.

EPA Administrator Lee Zeldin said the agency is responding to Americans who have worried about plastics and pharmaceuticals in their drinking water. The gesture also aims to hand a win to Health Secretary Robert F. Kennedy Jr.’s MAHA movement, which for months has pressured Zeldin to further crack down on environmental contaminants.

Read the rest…

This post was originally published here. 

On:

How has the Food and Drug Administration’s recent decisions on rare disease drugs affected investment trends? Why is Eli Lilly getting into sleep medicine? And where did Allison go on her vacation?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast. Biotech investor Rod Wong joins us to talk about why an industry-patient coalition he’s part of sent a letter to President Trump asking for more regulatory flexibility at the FDA.

Read the rest…

This post was originally published here. 

On:

WASHINGTON — The Trump administration announced Thursday 100% tariffs on imported brand-name drugs — but with significant caveats.

Many large drugmakers won’t have to pay the tax because they’ve struck deals with the U.S. to build manufacturing facilities here and lower the prices of their medications. Drugmakers that haven’t struck those deals but pledge to bring production to the U.S. can have their tariffs reduced to 20% for the remainder of Trump’s term. 

The tariffs open a new front in the Trump administration’s efforts to rein in the pharmaceutical industry and in its push to bring manufacturing back to the U.S. The announcement comes as Trump has looked to emphasize his administration’s work to make prices — especially medicines — more affordable ahead of the midterms.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

WASHINGTON — The Trump administration is negotiating new drug-pricing deals, now with smaller companies, according to three people with knowledge of the meetings, including a White House official.

The new talks offer a pathway for smaller pharmaceutical companies — those not included in the first round of deals — to pledge lower prices and potentially avoid tariffs or new pricing policies through Medicare.

The new negotiations suggest the administration is looking to replicate the strategy it used with larger drugmakers: extract voluntary, confidential agreements in pursuit of lower prices and more domestic manufacturing. They also offer smaller players in the sector, which have faced substantial uncertainty about how federal policies would affect them, the chance to cut a deal and gain more certainty about how they might be affected by federal policies. 

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

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!

On top of being a day for brands to post “pranks” on social media, April 1 was also the deadline to apply for the CMMI ACCESS Model’s first cohort. Did you apply? Decide not to? Let me know: mario.aguilar@statnews.com

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

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.

Former Theranos CEO Elizabeth Holmes and real housewife Jen Shah bonded in prison while cleaning toilets. Send news tips and your least favorite chores to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

Two ways health care could complicate reconciliation

There’s been some hubbub about whether health care cuts might be used to offset the cost of immigration enforcement and the Iran war if Republicans try to use a party-line budget process, called reconciliation, to avoid a Senate filibuster by Democrats.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Community Health Systems completed the divestiture of Crestwood Medical Center this week as the for-profit operator continues paying down its debt.

This post was originally published here. 

On:

The FDA yesterday approved Eli Lilly’s weight loss pill, orforglipron. The agency is also facing renewed scrutiny over transparency gaps related to advisory committee conflicts, and its “breakthrough” label for devices is drifting toward more ambitious — but not necessarily better-validated — AI tools.

Meanwhile, Insilico Medicine is pitching AI drug discovery as a sort of asset factory rather than a means to guaranteed approval ends.

Trump may not be done with import tariffs on drugs

The Trump administration has prepared an order that would impose a 100% tariff on some imports of patented medications and their active ingredients, according to a draft obtained by STAT reporter Daniel Payne. The tariffs could be announced as soon as today, according to a person familiar with the matter, although it’s also possible timelines and plans could shift. 

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus, but our spirits remain sunny, nonetheless. And why not? As the Morning Mayor suggested to us long ago, “Every day should be unwrapped like a precious gift.” While you tug on the ribbon, we will fire up the trusty kettle for a cuppa ginger honey. Of course, you are invited to join us. Remember, no prescription is required. This is strictly cash money. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

The Trump administration has prepared an order to impose a 100% tariff on imports of patented medicines and their active ingredients, STAT writes. The tariffs could be announced as soon as Thursday, but the timeline or details could change. The order offers several options for drugmakers to avoid the tariffs, which will not apply to companies that have struck “most-favored nation” deals to sell drugs in the U.S. at similar prices to other wealthy countries, or to those negotiating such deals, until the end of Trump’s term in office. Companies that agree to move production to the U.S. will have their tariff rate cut to 20%, as long as the plan is approved by the U.S. Secretary of Health and Human services, though the rate would rise back to 100% in 2030. The tariffs also will not apply to generic drugs, orphan drugs, fertility medications, plasma-derived therapies, gene or cell therapies, antibody drug conjugates, threat countermeasure medicines, or other specialty drugs as approved by the HHS secretary.

Eli Lilly’s obesity pill was approved by the U.S. Food and Drug Administration on Wednesday, setting it up for fierce competition against Novo Nordisk’s new Wegovy pill as more people seek alternatives to GLP-1 injections, STAT tells us. Lilly’s drug, which is called orforglipron and will be marketed as Foundayo, was approved under the new FDA voucher program, which grants speedy reviews to drugs that are aligned with national health priorities. Investors are hoping that orforglipron will be a major growth catalyst for Lilly. The Wegovy pill, as an oral peptide that’s harder for the body to absorb, must be taken in the morning at least 30 minutes before any food or drinks other than water, restrictions that can be unappealing to many people. Orforglipron doesn’t carry any such restrictions.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus, but our spirits remain sunny, nonetheless. And why not? As the Morning Mayor suggested to us long ago, “Every day should be unwrapped like a precious gift.” While you tug on the ribbon, we will fire up the trusty kettle for a cuppa ginger honey. Of course, you are invited to join us. Remember, no prescription is required. This is strictly cash money. Meanwhile, here are a few items of interest. Hope you have a meaningful and productive day and, of course, do stay in touch. …

The Trump administration has prepared an order to impose a 100% tariff on imports of patented medicines and their active ingredients, STAT writes. The tariffs could be announced as soon as Thursday, but the timeline or details could change. The order offers several options for drugmakers to avoid the tariffs, which will not apply to companies that have struck “most-favored nation” deals to sell drugs in the U.S. at similar prices to other wealthy countries, or to those negotiating such deals, until the end of Trump’s term in office. Companies that agree to move production to the U.S. will have their tariff rate cut to 20%, as long as the plan is approved by the U.S. Secretary of Health and Human services, though the rate would rise back to 100% in 2030. The tariffs also will not apply to generic drugs, orphan drugs, fertility medications, plasma-derived therapies, gene or cell therapies, antibody drug conjugates, threat countermeasure medicines, or other specialty drugs as approved by the HHS secretary.

Eli Lilly’s obesity pill was approved by the U.S. Food and Drug Administration on Wednesday, setting it up for fierce competition against Novo Nordisk’s new Wegovy pill as more people seek alternatives to GLP-1 injections, STAT tells us. Lilly’s drug, which is called orforglipron and will be marketed as Foundayo, was approved under the new FDA voucher program, which grants speedy reviews to drugs that are aligned with national health priorities. Investors are hoping that orforglipron will be a major growth catalyst for Lilly. The Wegovy pill, as an oral peptide that’s harder for the body to absorb, must be taken in the morning at least 30 minutes before any food or drinks other than water, restrictions that can be unappealing to many people. Orforglipron doesn’t carry any such restrictions.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Love it or hate it, BMI is back in the news. But that’s just the starting point in a debate over how to define obesity.

Critics have long faulted the weight-divided-by-height-squared measure as too blunt an instrument to define obesity. BMI, or body mass index, alone can group people with excess muscle mass in the same bucket as people with excess fat, all while ignoring population differences. Over a year ago, a Lancet Diabetes and Endocrinology global commission took aim at redefining obesity, relying less on BMI and more on such consensus-gaining metrics as waist circumference, waist-to-hip ratio, or waist-to-height ratio. 

What was new in the commission’s framework was drawing a bright line between preclinical and clinical obesity, all with an eye toward sharper diagnosis that starts with BMI and other body fat numbers. Someone with preclinical obesity might have excess body fat and be at risk for — but not yet be diagnosed with — cardiovascular problems, type 2 diabetes, some cancers, or other signs of organ dysfunction. Someone with clinical obesity would have already developed an ongoing illness. 

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here.

Good morning. A new Gallup poll found that health care is back on top of the list of Americans’ domestic worries. Does staying informed on the news help combat that concern? Read on and let me know. 

Read the rest…

This post was originally published here. 

On:

A lot of artificial intelligence tools in medicine pitch themselves as breakthroughs. But there are some that can put some extra oomph behind that claim. Since 2016, the Food and Drug Administration has handed out “breakthrough” designation to more than 1,200 devices, including many powered by AI.

The designation comes with priority FDA review, with the goal of enabling innovative devices to reach patients and hospitals quicker. But what does the agency count as a breakthrough, especially in clinical AI, a decade after it established the Breakthrough Designation Program?

An analysis of STAT’s Breakthrough Device Tracker — which tracks all publicly available breakthrough designations, not just those the FDA has authorized — shows that the agency appears to be prioritizing big-picture, multi-problem AI solutions. Algorithms that simply improve a doctor’s capabilities are no longer enough: AI breakthroughs increasingly solve problems that physicians simply can’t, like detecting multiple cancers from a single image, or predicting the risk of dying from cancer or heart failure.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.

In the nick of time

Biotech’s most-watched stock index, the XBI, was heading for a first-quarter loss until Tuesday, when Eli Lilly said it was buying Centessa Pharma, and Biogen announced a takeover of Apellis Pharma. Investors love M&A. Those deals plus an easing of Iran war concerns contributed to a huge 7% surge in the XBI on the last day of the quarter.

How are you feeling about biotech as we enter the second quarter? Are you worried about China? AI? Gas prices? The year-over-year pace of M&A activity is up, but FDA drug approvals are down.

Continue to STAT+ to read the full story…

This post was originally published here. 

On:

A recent study in the journal Radiology tested whether 17 radiologists could identify when an X-ray was created using artificial intelligence. The results were interesting — the medical professionals correctly differentiated the real from deepfake images about three-quarters of the time. STAT reporter Katie Palmer, who reported on the study last week (and is not a trained radiologist,) took the quiz and also scored about 75%. 

In this week’s STATus Report, host Alex Hogan spoke with Palmer about the study and what implications AI could have for patient safety. Hogan also took the quiz himself and sees if he can beat the radiologists’ (and apparent X-ray reading prodigy Palmer’s) score.

This post was originally published here.