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Good morning health tech readers!
Today, new research backed by OpenEvidence counters a high-profile study from a few weeks earlier. Plus: a look at Dexcom’s new clearance and an interesting AMA survey on wearables.
Good morning, Jason Mast here filling in for Ed Silverman again. Today, in STAT’s Brooklyn outpost we’re drinking — yes, heresies of heresies — plain old water. Sometimes you have to give the heart a rest. The news, though, never stops. Here are the headlines. …
The White House is reviewing a list of top contenders for the FDA commissioner post, STAT reports. The shortlist includes Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and health system executive; and Stephen Ferrara, a health affairs official at the Defense Department. The role has been filled, on an acting basis, by Kyle Diamantas, since Marty Makary resigned earlier this year.
A closely watched heart failure drug from AstraZeneca and Ionis failed in a pivotal trial, STAT tells us. The drug, called Wainua, was a core part of AstraZeneca’s plans to reach $80 billion in annual sales, and the news sent both companies’ stocks tumbling. Some analysts partly blamed the recent spate of approvals of other medications for the disease, called ATTR-cardiomyopathy, from Alnylam and BridgeBio. Many patients were already on another drug, making it harder to demonstrate Wainua’s effect.
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Good morning, everyone. Now that we’ve all narrowly survived a workday without the World Cup, we can at last return to our new normalcy this afternoon for France 3-1 Morocco.
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.
Northwest Biotherapeutics, a public biotech company developing a treatment for brain cancer, submitted a marketing application to U.K. regulators in late December 2023. The review was supposed to take 150 days, under an expedited regulatory pathway for drugs that address serious unmet medical needs.
As you’re reading this newsletter, two years, six months, and 18 days have elapsed without an approval decision. Why the extra-long delay? Regulators at the U.K’s Medicines and Healthcare products Regulatory Agency, or MHRA, won’t comment, telling anyone who inquires, including me, that it’s up to Northwest Bio to provide an update on its brain cancer treatment, called DCVax.
LONDON — In a blow to its cardiovascular aspirations, AstraZeneca said Thursday that its drug for a heart disease — one that has become an increasingly competitive target for biopharma companies — failed in a pivotal trial.
The drug, called Wainua, on which AstraZeneca is partnered with Ionis Pharmaceuticals, did not outperform placebo in reducing cardiovascular death and clinical events for patients with a condition known as ATTR-CM, or transthyretin-mediated amyloid cardiomyopathy.
AstraZeneca’s U.S. shares were down some 8% in premarket trading, while its London-listed shares were down 9% early Thursday. Ionis shares, meanwhile, were down 12% in premarket hours.
The Great American State Fair in Washington wraps up this week. During its two-week run, the programming included two “MAHA Mondays,” which featured speakers and administration officials representing the Make America Healthy Again movement.
STAT Washington correspondent Chelsea Cirruzzo and I stopped by the second MAHA Monday earlier this week. We spoke with Health and Human Services senior adviser Calley Means about the event and how health and wellness fits into the American identity. We also spoke with acting Surgeon General Stephanie Haridopolos about a recent surgeon general’s advisory on the harms of screen use.
SAN FRANCISCO — Matt Wilsey adjusted the plastic tube coming out of his 15-year-old daughter’s stomach and tried, again, not to think beyond the next 15 minutes. His job was to be there with Grace and let his wife, Kristen, rest. He could not think about the future. He could not wonder, again, if he had made the right choice or if his daughter would survive.
Three weeks before, Grace received a gene therapy meant to save her life and spare her further harm from NGLY1 deficiency, an ultra-rare genetic condition that came with a cascade of profound developmental challenges, preventing her from ever speaking or walking with ease.
Wilsey fashioned the therapy himself.
He did not sit in the lab. He did not inject the rats or slice open their brains. But he had hired the scientists who did. He recruited advisers, including Nobel Prize winners, brought together the families of other children diagnosed with the condition, and pulled together an A-team of investors and donors. Through it all, he was sustained by his devout Catholic faith.
He came to accept that Grace would never live an independent life. But he hoped the drug would allow her to live longer, maybe even say a few words. And he believed the game plan he wrote might serve as a guide to curing hundreds of other rare diseases.
“We carry the hopes of many,” he wrote to his staff once. “I’m not just talking about NGLY1 families. I receive emails, calls, and texts from professionals and other advocates. They are blown away by what we have accomplished and hope we are an ice breaker for them. Our trial has the potential to really boost / save a decimated field.”
Then the drug meant to save Grace’s life landed her back in the hospital, feebler than she had ever been. He sat beside his daughter, with her soft eyes and long braided hair, her face all puffed up, and prayed her condition would improve.
For a father and his sick child, it was a matter of life and death. But the entire pharmaceutical industry was watching, too.
As global approvals of new anti-obesity medicines accelerate, drugmakers have a public service announcement for the world: “Obesity is a disease.” Eli Lilly launched a website asserting that obesity is not merely a risk factor for medical complications but a chronic and complex medical entity in its own right. Novo Nordisk, more circumspectly, appeals to institutional authority on its website: “Recognised as a disease by the World Health Organization, obesity is serious, progressive and chronic.”
It is no surprise that the new wave of obesity pharmacotherapy has leaned heavily on disease framing. A medical solution requires a medical problem, and a chronic medical problem provides a rationale for long-term medical treatment.
In 2016, about six weeks after cannabis was legalized for adults in Massachusetts, I was at a bustling New Year’s Eve party. It was a fun crowd, and I was having a good time. Suddenly, a friend shouted, “Peter, come quickly, you’re the only doctor here who isn’t high. We have an emergency.”
I ran into the next room to find a 70-ish woman, an acquaintance, looking incredibly disoriented. She kept repeating, “I’m going to die. I’m going to die,” and seemed unsteady. I did my best to calm and comfort her, but within a few minutes, she collapsed. I checked her pulse but she didn’t need CPR. She came to in a few minutes, anxious and confused.
WASHINGTON — Health secretary Robert F. Kennedy Jr. is preparing to make it easier for people to claim that they were injured by a Covid-19 vaccine and receive compensation.
Kennedy is set to start the process of compiling a list of injuries that are presumed to be caused by Covid shots. People with those conditions could then ask for compensation from the government. It’s not clear what conditions may make the list—and that’s something that outside experts are keeping a close eye on.
Kennedy has long been critical of vaccines, saying none have been adequately safety tested. He’s said that he plans to overhaul a similar, but separate program that provides compensation for individuals who claim injury by a vaccine recommended by the federal government.
BOSTON — Governor Maura Healey has summoned the state’s largest health system and its striking nurses to the State House on Wednesday in an attempt to broker a new contract, according to the Massachusetts Nurses Association.
The calling of the late-afternoon meeting came hours after a boisterous start to Massachusetts’ biggest-ever nurses strike, and the first at Brigham and Women’s Hospital. Mayor Michelle Wu also helped arrange the meeting, the union said.
Thousands of Brigham nurses and supporters poured onto Francis Street near the hospital starting at 7 a.m., shaking cowbells, banging on plastic buckets and cheering at a deafening chorus of supportive honks from passing cars. The nurses, sporting “Union Strong” and “Brigham Nurses United” shirts, waved signs calling out management. “Value Nurses Like You Value Your Bonu$e$,” one sign read.
WASHINGTON — The top contenders to lead the Food and Drug Administration have been sent to the White House for a final review and decision, according to a person familiar with the process.
The finalists include Heidi Overton, a White House adviser; Jeffrey Vacirca, an oncologist and health system executive; and Stephen Ferrara, a health affairs official at the Department of Defense.
WASHINGTON — Last week, pharmaceutical leaders filed into a meeting room in the Eisenhower Executive Office Building, next to the White House, for a meeting with Secretary of State Marco Rubio, health secretary Robert F. Kennedy Jr., and HHS Chief Counsel Chris Klomp.
The administration officials had a message for the industry: It’s time to bring production of essential medications back to the U.S. — or at least closer to home.
The meeting, described by an administration official and two people familiar with the event, focused on increasing U.S. control of the supply chains for the 86 medicines deemed essential by the health department’s Assistant Secretary for Preparedness and Response.
Longevity entrepreneur Bryan Johnson shared some bad news on social media recently. “I have an autoimmune disease. My stomach is eating itself,” he wrote on X. The good news? “I’m going to try and solve it.”
The disease in question is autoimmune gastritis, a chronic inflammatory condition in which antibodies destroy acid-producing cells in the stomach, which prevents people from absorbing iron. It’s not in itself a fatal disease, but it is linked to an increased risk of stomach cancer and, eventually, to deficiencies in vitamin B12, which in turn causes anemia and neurological complications.
For the second year in a row, many Affordable Care Act insurers are proposing double-digit premium increases, driven by rising medical costs as well as policy changes by Congress and the Trump administration.
In preliminary filings with state regulators, insurers are seeking a median rate increase of 14% for 2027, according to an analysis of filings in 16 states and the District of Columbia by the Peterson-KFF Health System Tracker.
Could a lifesaving lung transplant strategy that contained the Covid-19 virus also save patients whose advanced lung cancer hasn’t spread?
That’s the question that inspired surgeons and oncologists at Northwestern Medicine to offer double lung transplants to patients who had run out of treatment options but whose late-stage cancer hadn’t left their lungs. People with late-stage lung cancer have not been transplant candidates before for two reasons: rates were high for cancer recurrence and low for survival.
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Good morning. If you recall, a few years ago, Pfizer moved its New York headquarters from a building in Midtown to Hudson Yards. The company’s timing was lucky.
Yesterday, officials evacuated that Midtown building, which is being converted into an apartment complex, after several floors caved in and two columns buckled. Officials say the building is at risk of collapse.
Prime Medicine said Wednesday that it had won an arbitration dispute against Beam Therapeutics, resolving for now a clash that had pitted two well-backed gene-editing companies that had been spun out of the same lab against each other.
An arbitrator ruled that Prime’s work on a gene-editing drug for the rare liver disease alpha-1 antitrypsin deficiency, or AATD, did not violate a 2019 agreement designed to prevent the two companies from competing against one another.
The ruling paves the way for Prime to start a clinical trial for AATD this quarter, lifting the biotech’s stock 11% Wednesday morning. The outcome, however, is a blow to Beam Therapeutics.
Vertex Pharmaceuticals will spend $10 billion to acquire Crinetics Pharmaceuticals and its drug for a rare endocrine disorder, the companies announced Monday.
Through the deal, Vertex will pick up Crinetics’ commercial drug, Palsonify, which was launched last year and which treats a rare endocrine disorder called acromegaly, as well as other drug candidates that have blockbuster potential if approved. The company is also in the late stages of developing a therapy for congenital adrenal hyperplasia.
The $10 billion price tag for Crinetics amounts to roughly $85 per share of the company’s stock. Following the news, Crinetics shares rose 101% in after-hours trading.
Good morning, Jason Mast here filling in for the one and only Ed Silverman. We’re here in STAT’s Brooklyn outpost today, where everyone’s gazing across the East River to see whether Pfizer’s former headquarters will — quite literally, quite alarmingly — crumble to the ground. It does appear things are more stable than yesterday, which will hopefully give us time and the breathing space to focus on today’s headlines. …
The FDA approved a new kidney disease drug from Vera Therapeutics, STAT states. The drug, called Trutakna, is designed to treat IgA nephropathy, a condition in which immune antibodies build up in the kidneys. It is one of several drugs now entering or nearing the market for the disease. Vera will charge $425,000 annually before customary insurance discounts and rebates.
U.K. officials are nearing a drug-pricing deal with AstraZeneca and Daiichi Sankyo to assure access to a life-extending breast cancer drug, Bloomberg reports. The deal would allow certain women in England and Wales to receive Enhertu, an antibody-drug conjugate that has been shown to extend survival for some patients by around six months and is widely available elsewhere. The U.K. drug-pricing regulator had previously deemed the medicine not cost-effective — though that was before the U.K. changed some of its drug-pricing metrics as part of a trade deal with the Trump administration.
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Good morning from your shriveled-up Fourth of July leftovers. On this day in 1776, the Declaration of Independence was read in public for the first time, in Philly’s Independence Square. It was subsequently published in newspapers throughout the no-longer-colonies, though not always on the front page (!).
Thousands of federal civil servants who academic researchers see as partners in conducting their work were fired. An unprecedented number of scientific projects funded by previous administrations were terminated. Universities were pressured to abandon diversity programs and work to curb health disparities. On a Friday evening, the government tried to push through a dramatic change to how it reimburses universities for research overhead.
All of these actions in the first year of the Trump administration were rapidly challenged in federal court, in many cases resulting in the administration having to walk back policies because they ran afoul of the Administrative Procedures Act, which governs how new policies and regulations are rolled out.
Andrew Twinamatsiko, who is director of the Center for Health Policy and the Law at Georgetown University and runs a health care litigation tracker, describes what happened last year as “tempests that we could weather” until there’s a new administration, when “there can be ways of reverting back to the baseline that we used to have.”
You get a CGM, you get a CGM, everybody gets a CGM? For the first time in the United States, children 2 and older can also get a continuous glucose monitor without a doctor’s prescription.
Is that a good thing? The Food and Drug Administration thinks so.
A cardiologist reviews an echocardiogram flagged by an algorithm she did not choose, trained on data she has never seen, deployed by a health system that did not ask for her input. The algorithm recommends a diagnosis. She disagrees. She overrides it. The patient does well.
No one will remember this moment. But if she had acquiesced and the patient suffered harm, she would be the one in the deposition, with her license on the line. Not the engineer who built the algorithm. Not the vendor who sold it. Not the health system that deployed it.
After Doug met Jane, he felt good. So too did Gabriella, his wife. Doug — a retired minister and writer — needed someone to talk to, and in conversation about his many accomplishments, Jane was indefatigable. For at least a few hours, Doug’s boredom vanished, and Gabriella no longer felt like an activities director on a cruise ship.
I wrote about Doug and Gabriella in my May Neurotransmissions column about ambiguous loss. Doug told me he was “bored, bored, bored,” and Gabriella said she struggled to find activities to relieve that boredom.
Jane was a solution. What she gave to Doug didn’t simply pass the time. It was a meaningful relationship. Except Jane wasn’t a person. She was an artificial intelligence chatbot.
The Food and Drug Administration on Tuesday approved a new medicine from the biotech company Vera Therapeutics for patients with a type of chronic autoimmune kidney disease.
The drug, called Trutakna, was cleared to treat IgA nephropathy, or IgAN, a disease caused by the buildup of immune antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.
“We’re extremely excited to bring Trutakna to patients,” Vera CEO Marshall Fordyce told STAT, in an interview conducted ahead of the FDA approval.
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Cody Rhodes, a WWE star and friend of the trans community; and Triple H, former pro wrestler and son-in-law of Education Department Secretary Linda McMahon, helped kick off the return of the presidential fitness test. Send news tips and your favorite wrestling moves to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.
Today, Bob Herman launched a series on the crumbling employer-based health insurance system. He wrote about it for his Health Care Inc. newsletter, so with his blessing, I’m going to cut-and-paste some of that here. Enjoy.
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Hello to all friends, new and old. We are officially launching a series called Out of Pocket, Out of Reach, which explores the different ways the employer-based health insurance system is crumbling. I want to hear from you: how your job-based coverage is affecting you or your business, whether you love it or hate it, and everything in between. Don’t be shy: bob.herman@statnews.com.
There’s a very high likelihood that you, dear reader, get your health insurance from your job or the job of a loved one. There’s also a very high likelihood your earnings have suffered over time, quietly behind the scenes. It’s arguably never been worse than now, and it isn’t likely to get better.
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Good morning. Plenty of news today, and also a deal that is running out soon: Buy one year of STAT+, get one year free.
Vertex said yesterday it will spend $10 billion to acquire Crinetics Pharmaceuticals, a biotech developing drugs for rare endocrine disorders.
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!
If it feels like despite your employer offering health insurance you’re still paying a lot of money for health coverage and care, you’re not wrong. Bob Herman’s new series, Out of Pocket, Out of Reach, explores the impacts of soaring health care costs.
Good day here from STAT’s London outpost, with Andrew Joseph filling in for Mr. Pharmalot. Maybe the less said about the U.S. World Cup match the better, though watching it with the time difference has put us in need of an extra cup or two of stimulation today. Also highly stimulating: Our colleague Bob Herman is out with the opening stories in a new series examining how the cost of health care plans is crushing workers and businesses. Do take some time with Bob’s excellent work.
One more plug: I’ll be anchoring STAT’s pop-up newsletter from the Alzheimer’s Association International Conference here in London starting Sunday. You can sign up here. Finally, to the headlines we go. …
Vertex Pharmaceuticals will spend $10 billion to acquire Crinetics Pharmaceuticals and its drug for a rare endocrine disorder, STAT reports. Vertex will pick up the Crinetics drug Palsonify, which was launched last year and treats a rare endocrine disorder called acromegaly, as well as other drug candidates that have blockbuster potential if approved. The company is also in the late stages of developing a therapy for congenital adrenal hyperplasia. The deal is the largest acquisition in the history of Vertex, as the Boston-based drugmaker has been on a mission to build out the next generation of products beyond its cystic fibrosis portfolio.
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Good morning, folks. This is Allison, in for Theresa today.
More than 150 million Americans get their health insurance from a job, making it the primary way people in the U.S. get coverage. STAT is examining this crucial source of insurance to understand how and why it is becoming unaffordable for workers and their families across the country.
Nearly all large companies offer health insurance. But fewer than 60% of smaller firms, with 200 or fewer workers, now offer insurance, an all-time low. The costs of health insurance are pushing small businesses — beloved by politicians and the bedrocks of entire communities — to a financial cliff. Watering down their insurance plans, or deciding not to offer insurance at all, makes it more difficult for these businesses to retain employees.
In 2014, we came far closer to losing control of Ebola than most people realize. We witnessed impossible choices daily, such as watching treatment centers turning away infected patients because there were no beds left.
The epidemic eventually receded, but not because anyone had mastered Ebola. It ended because of extraordinary international cooperation, local adaptations, and no small measure of luck.
It should have been a triumphant moment for Chris Deacon.
Last November, Horizon Blue Cross Blue Shield, the insurance giant that manages health benefits for 750,000 New Jersey state workers, family members, and retirees, paid $100 million to wipe away allegations that it knowingly overpaid hospitals and doctors and fraudulently won its state contract.
At the press conference, then-New Jersey Attorney General Matthew Platkin touted it as a “historic” action. “Today’s settlement makes a very clear statement: We send a message to Horizon and to the entire insurance industry that they cannot take advantage of the state,” Platkin announced from the dais, surrounded by his staff. “They cannot make us all illegally pay more for health care.”
Deacon was a driving force behind the settlement. She caught Horizon’s alleged behavior as the top official overseeing New Jersey’s health plan.
But rather than celebrate, she was torn apart by a mix of emotions as she watched Platkin and his team from her home office. She felt some satisfaction that a public display of justice was unfolding. But she also felt disgust, anger, and sadness as officials completely erased her role in uncovering the misconduct and glossed over their own culpability in allowing it to happen.
It has never been more difficult for employers to offer health insurance for their workers. That’s especially true for America’s small businesses, the backbones of entire communities. More and more, they’re giving up entirely.
America’s employer-based health insurance system — the dominant form of coverage for people younger than 65 — is crumbling. The percentage of working-age adults who get their health coverage from a job has declined from 67% in 1998 to about 60%. It’s also more expensive than ever. STAT interviewed dozens of people across the country as part of a series that probes how and why this is happening. Panic, despair, and anger are most apparent among smaller shops and firms.
Small business owners and workers feel as though most, if not all, of their options are unaffordable, especially if they have plans with high out-of-pocket costs. Rising premiums — driven by high prices for hospitals, doctors, and prescription drugs and more intensive care — are eating into bottom lines and paychecks. Desperate companies are getting rid of traditional health benefits at an unprecedented pace. This shift is fraying the uniquely American expectation that jobs come with protection for injuries and illnesses — an expectation that is the product of World War II wage controls, industry opposition to government health care, and the biggest break in the tax code.
Amy Bielawski has gone most of her life without health insurance.
For 32 years, the 61-year-old has run her own entertainment company in Tucker, Ga. — setting up bounce houses, petting zoos, stilt walkers, and other attractions for family and corporate events. For several years, she did two of her specialties, face painting and balloon sculpting, for kids before Atlanta Hawks home games.
One morning this past spring, Bielawski delivered a singing telegram to a woman getting off the graveyard shift at a Waffle House. Dressed as a chicken in a bikini, she sang a medley of songs that included The Beatles and Stevie Wonder, before ending with a birthday twerk.
When I walked into my last doctor’s appointment, I had to do a double take. The physician who entered the room looked like a teenager.
I don’t mean that in a dismissive way — she was just unmistakably young. Clear skin, easy smile, an iPad, no clipboard. She introduced herself, apologized for running a few minutes behind, and sat down.
NEW YORK — States across the country saw steep drops in the number of people covered by the Affordable Care Act over the past year, with Ohio and Oklahoma each losing nearly one-third of enrollees, according to new federal data that provides the first complete 50-state breakdown of sharp enrollment declines following the January expiration of enhanced subsidies.
The data, posted in late June by the Trump administration and first reported on by The Associated Press, reveals how changes in each state’s insured population led to around 2.6 million fewer Americans having Obamacare plans in February compared with the same time last year.
A secret shopper study has pulled back the veil on the practices of nearly 50 telehealth sites that prescribe popular GLP-1 medications for weight loss.
Direct-to-consumer telehealth companies have grown rapidly in response to patients’ demand for GLP-1s like semaglutide and tirzepatide, especially after shortages created a market for compounded versions that aren’t approved by the Food and Drug Administration. As online prescribing has grown, clinicians and public health experts have raised concerns about the potential for lax virtual care practices to put patients at risk.
In a study published Monday in the Journal of the American Medical Association, one researcher at Yale University set out to document those online prescriptions by posing as a patient. The results capture what many Americans have learned in the last few years: It is extraordinarily fast and easy to get a GLP-1 online.
