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Rise and shine, everyone, another busy day is on the way. However, this is also shaping up as a beautiful day, despite forecasts predicting rising heat. The skies are tranquil, birds are chirping, and the official mascots are chasing creatures on the Pharmalot campus. This calls for celebration with a cup of stimulation. After all, staying cool on a hot day calls for a hot drink. So we are opening a new package of pecan pie for the occasion. What is upon us right now, however, is our ever-growing to-do list. Sound familiar? So here are some items of interest. Have a great day, everyone. …

A U.S. appeals court revived a lawsuit brought by Teva Pharmaceuticals that accuses Eli Lilly of breaching ​an agreement allowing Teva to market a generic ‌version of Lilly’s osteoporosis drug Forteo, Reuters says. The court reversed a lower court decision that found the deal expired before Lilly allegedly broke it. Lilly sued Teva in 2016 for patent infringement, but the companies ​settled in 2018 with a deal that allowed Teva to launch its generic in 2019, just before the relevant Lilly patents expired. The U.S. ​Food and Drug Administration separately granted Lilly three more years of exclusivity in 2020. Teva launched its generic in 2023 and sued Lilly ‌in ⁠2024, arguing that Lilly’s new exclusivity period unlawfully delayed its launch.

A large-scale trial has been launched, with $100 million in backing, to explore whether lifestyle changes coupled with GLP-1 agonists or similar therapies can reduce the risk of dementia, Pharmaphorum conveys. The three-year PROTECT-Cog study, announced at the 2026 Alzheimer’s Association International Congress in London, is drawing on earlier study results showing that lifestyle changes can help improve memory, thinking, and overall cognitive function. The study will enroll older adults who are at increased risk for cognitive decline and compare two structured lifestyle-change programs — one intensive and the other a slightly less rigid version — with and without drug treatment.

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Good morning. I’m a little in awe of all the great reporting that STAT published while I was out of office, including Bob Herman’s excellent series and Rose Broderick’s heartbreaking dispatch on family caregivers. And in July, no less! Help me catch up or just say hi: theresa.gaffney@statnews.com

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Four years into the U.S. Food and Drug Administration’s review of Zyn nicotine pouches, and not long before the agency approved them for sale, an FDA toxicologist ran some informal tests in her kitchen that led her to question whether the agency truly understood the addictive product it was about to green-light.

Christy Leppanen worked for the FDA’s Center for Tobacco Products, where she led a project examining the potential for microplastics exposure. A scientist who had worked on an environmental assessment of Zyn had repeatedly told her that the nicotine pouches melt in the mouth. But during a public health conference in late 2024, Leppanen said, she talked to an academic who reinforced her understanding that they don’t. 

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In 2020, the CASP competition vaulted AlphaFold to prominence and a Nobel Prize. But the era of people being impressed by an artificial intelligence model correctly predicting the structure of a protein — once a challenge many experts didn’t think would be solved in their lifetime — is over. Now drug developers want AI that can solve their big problems, like discerning whether the body is going to attack a drug candidate and render it useless. 

One such example is the pregnane X receptor, or PXR. When activated, PXR increases the production of an enzyme that specifically breaks down foreign organic molecules — such as drug molecules — so the body can dispose of them. The specific enzyme that PXR regulates can metabolize approximately 50% of all marketed drugs. 

Most drug development campaigns only discover whether candidates trip this sensor late in the game, forcing drug developers to go back to the drawing board. But if an AI model could reliably predict whether a given drug candidate will activate the PXR receptor, it could fix a lot of problems that present hurdles for new potential drugs, including the drug exiting the body too fast or creating drug–drug interactions.

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Alcohol kills more than 178,000 Americans each year. It doesn’t have to. 

Drinking’s deadly toll in the U.S. is the result of decades of policy decisions, industry influence, and cultural inertia, as STAT shows in its investigative series, The Deadliest Drug. The U.S. has not made a concerted effort to reduce heavy drinking since Prohibition ended nearly a century ago. 

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“The Deadliest Drug,” a multipart series by STAT, spotlights an epidemic hidden in plain sight: excessive alcohol use. Alcohol kills more Americans each year than all illicit drugs combined, and yet health officials, industry leaders, and the public rarely focus on it. STAT reporters Isabella Cueto and Lev Facher examined the epidemic’s human cost and the complex causes — from personal to political — of the most harmful substance use crisis in the U.S. STAT data editor J. Emory Parker amplified many of the findings in data-rich charts. 

These charts capture the toll, emerging risks, shifting usage, and economic stakes of America’s relationship to alcohol. 

1. Alcohol-related emergency department visits nearly doubled in the U.S. between 2003 and 2022

Drinking-related adverse events, including emergency room visits, have soared in recent decades. American emergency rooms recorded roughly 5.4 million visits due to alcohol in 2022, and in many states, alcohol-related hospitalizations dwarf those stemming from other substances, like opioids. 

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Imagine a patient who arrives at her doctor’s clinic furious. She shows her doctor a video of him — white coat, plausible exam room, familiar cadence — endorsing an over-the-counter hormone supplement for menopausal symptoms, dismissing standard therapies as “pharma scams,” and offering a discount code.

But the physician never recorded that message. Someone built a deepfake from online recordings, including interviews, webinars, and patient-facing videos, and used the synthetic likeness to sell an unregulated product. This scenario is no longer hypothetical. Investigations have documented AI-generated videos impersonating specific clinicians whom they name to promote supplements and other dubious treatments on major platforms. 

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The HHS Office of Inspector General said it had kicked over 1,200 people and entities off federal programs between October and March as the Trump administration ratchets up oversight into what it says is rampant fraud in healthcare.

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Middle-income Americans who buy their own health insurance are unlikely to catch a break next year, according to a new analysis released Wednesday by health policy nonprofit KFF, which found that insurers are proposing a second consecutive year of double-digit premium increases. Across the 77 Affordable Care Act insurers that have filed public rate requests in 16 states and Washington, D.C., the median proposed premium increase for 2027 is 14%, according to the Peterson-KFF Health System Tracker.

The proposed increase comes on top of already steep increases this year. Median premium requests for 2026 reached 20%, meaning marketplace premiums could rise by more than one-third between 2025 and 2027 if regulators approve the latest filings. Cynthia Cox, Director of KFF’s Affordable Care Act Program, described the situation as a triple hit for consumers who have already faced higher premiums and reduced federal tax credits.

Insurers cited several factors driving the proposed increases. The largest remains the rising cost and use of healthcare services, including hospital care, physician visits and prescription drugs. Growing demand for GLP-1 weight-loss medications has also added significant pressure to insurers’ medical costs. More broadly, inflation continues pushing higher labor costs and provider expenses throughout the healthcare system.

Another important factor stems from changes to federal subsidies. According to KFF, roughly four percentage points of the proposed increases are tied to the expiration of enhanced Affordable Care Act premium subsidies that lapsed at the end of 2025. The organization estimates that change alone contributed to a 58% average increase in out-of-pocket premiums during 2026, while increasing deductibles by roughly $1,000 per person.

Some insurers also pointed to regulatory changes affecting enrollment and eligibility, along with higher medical claims resulting from patients requiring more intensive care. Several companies noted that healthcare providers are increasingly using artificial intelligence tools to identify billing codes that maximize reimbursements, contributing to higher claims costs.

Most marketplace enrollees will continue receiving some level of financial assistance that shields them from the full premium increases. However, households earning more than 400% of the federal poverty level—approximately $62,600 annually for an individual—generally no longer qualify for premium assistance and therefore face the full cost of rising insurance prices. Stacey Pogue of Georgetown University’s Center on Health Insurance Reforms, whose independent research reached similar conclusions, said those consumers will experience the greatest financial impact.

The effects extend well beyond individuals purchasing coverage through Affordable Care Act exchanges. The same medical inflation affecting marketplace plans is also increasing the cost of employer-sponsored health insurance. PwC projects that healthcare costs for employer-sponsored plans will rise another 9% during 2027, placing additional pressure on businesses already coping with higher labor and operating expenses. Small employers, in particular, may face difficult decisions involving employee benefits, hiring and compensation.

Affordable Care Act enrollment has already declined by approximately 3 million people compared with a year earlier as higher costs have caused some consumers to leave the marketplace. While insurers still have until July 15 to submit final filings and regulators may reduce some requested increases before approval, the early data point toward another challenging enrollment season when consumers begin shopping for 2027 coverage later this year.

For households, employers and insurers alike, the underlying trend remains the same: healthcare costs continue climbing faster than overall inflation. Unless medical spending moderates or new policy changes provide relief, Americans shopping for individual health coverage should prepare for another year of higher premiums and rising out-of-pocket costs.

JBizNews Desk | Washington

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This is the web edition of STAT’s AAIC in 30 newsletter. Sign up to get it in your inbox here.

Hi there from Day 2 of AAIC. There may be 10,200 people here at the Alzheimer’s Association International Conference — up 1,700 from last year — from 115 countries, as the association’s Maria Carrillo announced at Monday’s plenary session. But by far my favorite person is the woman I saw taking a nap on a bench in a corridor, her sunhat pulled over her eyes. You are an inspiration.

One housekeeping note: Due to the vagaries of newsletter scheduling, we won’t have an edition tomorrow, but will be back in your inbox with a wrap-up edition on Wednesday. Keep your eyes on statnews.com tomorrow though and expect some conference news around 9:15 a.m. Eastern.

Latin American study praised as ‘landmark’ effort

For a disease that’s proven as intractable to treat as Alzheimer’s, it’s been known for quite some time what factors can heighten one’s risk for dementia. Poor nutrition, sleep, and cardiovascular health; a lack of physical activity and social engagement; and lower education levels all increase the likelihood that a person will develop Alzheimer’s.

A study reported at last year’s AAIC put interventions designed to reduce risk to the test. The U.S. Pointer study found that an intensive, structured program that encouraged improved diet and exercise, cardiovascular health monitoring, and other steps helped protect cognitive function among older adults at risk of dementia to a greater extent than a lower-intensity program that participants navigated on their own, even as both groups saw benefits. The study underscored that healthy habits contribute to a healthy brain.

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I first visited a Buc-ee’s a few years ago in Kentucky on a road trip. It’s a melting pot of American culture and consumerism (with a really good cherry limeade pop). It’s also apparently an aggressive trademark litigator over its beaver mascot. Take a pit stop and share your news and tips here: bob.herman@statnews.com.

[Tim Robinson voice] You sure about that?

UnitedHealth Group was happy to promote a new audit that said nearly all of the diagnoses recorded for its Medicare Advantage members during home visits (97%) were justified by medical records. But the results are not nearly as clean, or useful, as the company suggests.

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Martha Lillard had just turned 5 when she was diagnosed with polio and depended on an iron lung to live. She died June 26 in Oklahoma, the last U.S. polio patient who used the machine, her sister said. She was 78.

“They told her she wasn’t supposed to live past 20 years old,” Lillard’s younger sister, Cindy McVey, told The Associated Press on Friday. “She had the enthusiasm and the drive to continue living and make the best of her life.”

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The model, which is set to sunset at the end of this year, generated $988 million in savings for Medicare in 2024, according to new CMS data. That’s up from almost $695 million in savings from the year prior.

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Good morning, everyone, and welcome to another working week. And of course, it is nice to see you again after we stepped away for a brief hiatus (and thanks to our pinch hitters last week). Not surprisingly, we are scurrying to catch up on events and way too many emails, but also making time for a cup of stimulation. Our choice today is maple bourbon. So please join us as we dig in. To that end, we have accumulated a brief menu of tidbits for you to peruse as you brace yourself for what lies ahead. We hope that all goes well and that you conquer the world. Meanwhile, do keep in touch. …

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. is pressing forward with his effort to help Americans stop taking psychiatric drugs, a medical practice known as deprescribing, STAT reports. Earlier this month, dozens of mental health professionals met with federal health officials to map out forthcoming clinical guidance they hope will help providers instruct patients on how to come off of antidepressant medications. A senior HHS official said they discussed gaps in the research around deprescribing SSRIs, including the side effects a person may experience, which vary depending on the drug and how long the person was on it.

The U.S. Food and Drug Administration ​approved a wearable form of Sanofi’s blood cancer drug, Sarclisa, offering multiple ‌myeloma patients a less burdensome alternative to intravenous infusions, Reuters writes. This becomes the first cancer drug approved by the FDA that can be delivered through an on-body injector, attached ​to the skin. Subcutaneous dosing can significantly reduce time spent in infusion centers for patients who receive repeated treatment courses, while also easing the strain on oncology clinics and nurses. The ​infusions can take up to three hours, while the median injection ​time for the wearable device is 13 minutes

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Lots happening in London these days, my colleague Andrew Joseph reports: At a pancreatic cancer meeting, researchers were buzzing about the implications of daraxonrasib, and at a major Alzheimer’s meeting, tau therapies are taking center stage.

Back here in the U.S., HHS has begun to craft national guidance on safely tapering SSRIs, and the FDA just cleared Sanofi’s wearable injector for a myeloma drug.

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Good morning. In case you missed it, my pal Bob Herman got the Joe Kernan treatment on CNBC’s “Squawk Box” on Friday, where he discussed his excellent new series “Out of Pocket, Out of Reach.” Kernan got in a lot of digs at Democrats and Obamacare, but Bob kept his comments apolitical. A true professional! 

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The settlement could be the end of a long legal saga for Omnicare, which filed for bankruptcy last year after a judge ordered the company to pay nearly $950 million for fraudulently billing government health programs.

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WASHINGTON — Health secretary Robert F. Kennedy Jr. is pressing forward with his effort to help Americans stop taking psychiatric drugs, a medical practice known as deprescribing.

Earlier this month, dozens of mental health professionals met with federal health officials to map out forthcoming clinical guidance they hope will help providers instruct patients on how to come off of antidepressant medications. While the Department of Health and Human Services has discussed plans to hold such a meeting, the outlines of the discussion haven’t been reported.

During those talks, they reviewed guidance from European nations and worked on recommendations for nonmedication-based options for patients to address their mental health, such as therapy. A senior HHS official said they discussed gaps in the research around deprescribing SSRIs, including the side effects a person may experience, which vary depending on the drug and how long the person was on it, and how to recognize the difference between those side effects and a return of a patient’s depressive symptoms.

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LONDON — When researchers started planning a pancreatic cancer conference here, the aim was to simply offer a counterpart to a regular U.S. meeting, where international scientists and doctors could discuss the latest developments in the specialty. 

Then came the biggest shake-up in pancreatic cancer care in decades. 

“It’s one of those moments,” Talia Golan, an oncologist at Israel’s Sheba Medical Center, said on a panel that conference organizers hastily added to the schedule centered on a new pancreatic cancer drug. She likened the medicine’s recent clinical trial performance to other milestones in cancer treatment such as the arrival of the first checkpoint inhibitors. 

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On three of my last seven flights, a request came over the cabin speakers: “Is there a doctor on board?” Like many physicians, I responded automatically.

What struck me afterward was not the frequency of those requests but how unremarkable the whole process seemed — to the crew, to other passengers, and, eventually, to me. None of the patients were in cardiac arrest. The complaints were the kind that fill any urgent care waiting room on a Tuesday afternoon: dizziness, nausea, feeling faint, generalized malaise.

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In 2018, Kristine Fifer was lucky to avoid bankruptcy. 

Her son, Eddie, had lost the nurse provided to him by the state after he turned 22. Maryland health officials told Fifer that he didn’t qualify for nursing care, even though Eddie’s cerebral palsy, feeding tube, and other complex medical conditions require around-the-clock care. Fifer spiraled as she sought to pay for the care Eddie needed. She lost her job, took on heaps of debt as bills piled up, and eventually called a lawyer about filing for bankruptcy. 

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Across the United States, the shortage of forensic pathologists has reached a critical level. According to the National Association of Medical Examiners (NAME), only about 850 forensic pathologists are currently practicing nationwide — roughly 400 fewer than the number needed to meet today’s demands, as more than 3 million Americans die each year.

With the increased demand for autopsies and medicolegal death investigations, many states are facing delays in cases that impact justice and public health. In some regions, a single medical examiner may oversee hundreds of deaths each year, leading to bottlenecks that can slow criminal cases, complicate insurance claims, and leave families waiting months and sometimes years for answers.

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Welcome to the first edition of our pop-up newsletter from AAIC. I’m STAT’s London-based reporter, and I’ll be here with you over the next couple days. I hope those of you in town can find time to escape the abyss of the conference center and enjoy London, because this city in the summer is something special. Maybe you’re ahead of the curve and took in England’s win last night. In which case, maybe you’re joining me in needing to pound the coffee. Any thoughts, questions, or hot takes on Zverev v. Sinner, I’m at Andrew.Joseph@statnews.com.

One other note before we get going: STAT has put together a special report on dementia diagnostics, treatments, and care. We also have a special conference discount on offer, so head here and use the code “AAIC” to download the report for only $5. With the exchange rate, that’s less than the cost of this morning’s flat white.

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The number of American employees taking leave for mental health conditions has risen sharply in recent years, creating new challenges for employers struggling to balance workforce well-being with business operations.

According to workforce management company ComPsych, mental health-related leaves increased approximately 300% between 2017 and 2023, including a 33% jump during 2023 alone, reflecting a significant shift in how employees use protected medical leave for stress, anxiety, depression and burnout.

Additional research released this year by workplace mental health provider Spring Health found that 61% of human resources professionals reported an increase in mental health leave requests over the past year.

Much of the increase involves the Family and Medical Leave Act (FMLA), which allows eligible employees to take up to 12 weeks of unpaid, job-protected leave for qualifying medical conditions, including diagnosed mental health disorders.

For many employees, the leave provides an opportunity to recover before workplace stress develops into more serious medical problems.

Mental health professionals say the COVID-19 pandemic permanently changed how many workers view burnout, work-life balance and seeking professional treatment.

Surveys consistently show younger employees reporting the highest levels of workplace stress, with many citing heavier workloads, staffing shortages and ongoing economic uncertainty.

While the trend reflects greater awareness of mental health, employers increasingly face operational and financial challenges.

When employees take extended leave, companies often redistribute responsibilities among remaining staff, increasing workloads for coworkers and sometimes contributing to additional burnout across teams.

Spring Health reported that 16% of HR professionals experienced increases of 25% or more in mental health leave requests during a single year.

Approximately 40% identified disability claims and employee leave management as one of their organization’s fastest-growing workplace concerns.

The financial impact extends well beyond temporary staffing shortages.

Research cited by workforce specialists estimates untreated mental health conditions cost U.S. employers between $31 billion and $51 billion annually through absenteeism, reduced productivity and lower workplace performance.

Additional healthcare costs, employee turnover and recruiting expenses further increase the financial burden.

Companies have responded in different ways.

Some employers have expanded counseling services, employee assistance programs and flexible work arrangements in hopes of addressing problems before employees require extended leave.

Others have strengthened leave management policies to ensure medical leave is used appropriately while continuing to comply with federal and state employment laws.

The legal landscape also continues to evolve.

Although the Family and Medical Leave Act establishes nationwide protections, many states provide additional employee benefits, paid leave programs and broader workplace accommodations, creating compliance challenges for employers operating across multiple jurisdictions.

Human resources professionals increasingly view mental health leave as a permanent workforce planning issue rather than a temporary post-pandemic trend.

Many organizations are investing more heavily in wellness initiatives, manager training and early intervention programs designed to reduce burnout before employees reach the point of needing extended leave.

Business leaders also recognize that supporting employee mental health can improve retention, productivity and overall workforce stability.

At the same time, companies continue balancing those investments against rising healthcare costs, staffing shortages and operational demands.

For employers, the message is becoming increasingly clear: mental health has evolved from an employee benefit issue into a core business concern affecting productivity, labor costs and long-term organizational performance.

As awareness continues growing and employees become more comfortable seeking treatment, experts expect mental health leave to remain an increasingly important factor in workforce management across nearly every industry.

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The rapid growth of weight-loss drugs such as Ozempic and Wegovy is beginning to reshape the retail industry, with one of the biggest effects showing up in the plus-size clothing market.

Torrid, one of the nation’s largest plus-size apparel retailers, reported that net sales fell 7.6% to $245.8 million during its latest quarter ended May 2. At the same time, the company reduced its store count to 463 locations, down from 632 stores a year earlier—a decline of nearly 27%.

Company leaders say the closures are part of a broader restructuring plan, but the changing shopping habits of customers taking GLP-1 weight-loss medications are adding new pressure to the business.

These medications suppress appetite and can lead to significant weight loss over time. As consumers move through that transition, many are delaying clothing purchases until their weight stabilizes.

Harvey Kanter, chief executive of plus-size retailer DXL Group, recently told investors that as many as 25% of the company’s customers may now be using GLP-1 medications.

Rather than repeatedly purchasing clothing in different sizes while losing weight, many customers are waiting before replacing their wardrobes.

That pause has created a temporary drop in demand across the plus-size apparel sector.

Torrid closed 151 stores during 2025 and has announced plans to shutter additional locations during the first half of 2026, focusing on stores with weaker financial performance.

DXL has experienced similar challenges, reporting a 6% decline in quarterly sales while also planning additional store closures.

According to CoreSight Research, retail store closures across all sectors increased 67% during 2025 compared with the previous year, with specialty apparel retailers among the hardest hit.

The trend is also influencing major clothing brands.

Companies including H&M, Nike, Old Navy, L.L. Bean, Ralph Lauren and Shein have reduced portions of their extended-size offerings as they adjust inventory to changing consumer demand.

Still, analysts caution that the plus-size market remains substantial.

Industry estimates value the global plus-size apparel market at more than $114 billion, with continued long-term growth expected despite the short-term disruption.

Many retailers also believe today’s slowdown could become tomorrow’s opportunity.

Once customers complete significant weight loss, they often need entirely new wardrobes.

Research from Dentsu found that roughly half of Americans using GLP-1 medications report shopping for clothing more frequently after losing weight, while nearly one-third purchase more accessories.

Analysts at eMarketer estimate that wardrobe replacement alone could eventually generate approximately $13 billion in additional annual apparel sales.

The challenge for retailers is surviving the transition period before that new demand arrives.

Torrid continues to invest in digital sales, new product lines and brand expansion while reducing underperforming locations.

The company ended its latest quarter with approximately $301 million in debt and $22.8 million in cash, underscoring the importance of improving profitability during the restructuring.

For consumers, the changes may mean fewer dedicated plus-size stores and a smaller selection of extended sizes at traditional retailers.

For investors and the retail industry, the broader story is becoming increasingly clear.

Weight-loss medications are beginning to influence purchasing behavior well beyond healthcare, affecting apparel, food, consumer products and other industries.

As millions more Americans adopt GLP-1 medications, retailers across multiple sectors are adjusting business strategies to reflect changing consumer habits.

For Torrid, the immediate focus is reducing costs while positioning itself for the next wave of demand—when today’s customers finish losing weight and begin rebuilding their wardrobes.

JBizNews Desk | Los Angeles
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Vivani Medical is wagering that a matchstick-sized device tucked under the skin can fix the costliest weakness of the blockbuster weight-loss drugs: keeping patients on them long enough to hold onto the pounds they shed. On Tuesday, July 7, the Alameda, California biopharmaceutical company said it had signed an agreement letting Novo Nordisk run an internal evaluation of NPM-139, its experimental implant that releases semaglutide — the same molecule inside Novo’s Wegovy obesity injection and Ozempic diabetes shot — in a slow, steady dose over six months to a year. Adam Mendelsohn, Vivani’s president and chief executive, said the deal reflects Novo’s interest in the platform and reinforces the company’s confidence in a “market opportunity” for a treatment patients could receive once or twice a year.

The pitch is aimed squarely at a real and expensive problem. Real-world studies show that up to 65% of GLP-1 users stop treatment within a year of starting, driven off by cost, gastrointestinal side effects and the burden of weekly injections. One large analysis of more than 125,000 patients found 64.8% of those without type 2 diabetes discontinued within a year, versus 46.5% of those with diabetes. The consequences show up on the scale: withdrawal trials such as STEP 4 and SURMOUNT-4 found that roughly two-thirds of lost weight is regained within a year of stopping, often erasing the metabolic gains that made the drugs so sought after in the first place. An implant that delivers the medicine automatically for months removes the daily and weekly decision-making that trips patients up.

Vivani’s device is essentially a tiny titanium reservoir preloaded with a fixed dose of semaglutide, built on the company’s proprietary NanoPortal platform, which is designed to leak the drug out at a controlled rate. Mendelsohn has argued the approach could also blunt the nausea and other side effects tied to the peaks and troughs of injections, and the company says the implant can be removed or swapped for a higher or lower dose if needed — a feature it frames as giving patients the “peace of mind” of stopping whenever necessary. Skeptics note the flip side: those insertion and removal procedures add friction for patients and clinicians that a self-administered pen does not.

The Novo agreement carries no exclusivity, licensing terms or upfront payment, and amounts to the world’s dominant obesity player kicking the tires rather than committing. Novo confirmed the arrangement and said it aims to complement its own research with outside innovation. Still, for a company Vivani’s size, the validation matters. The stock closed near $1.60 on July 8, giving the clinical-stage firm a market value of roughly $116 million — a rounding error against a GLP-1 market that some analysts project could top $100 billion by the early 2030s. Lake Street rates the shares a buy with a $4 price target, though the company still carries no revenue and steady losses.

The science remains early. In June, an Australian human research ethics committee cleared Vivani to begin SLIM-1, the first human study of the semaglutide implant. The Phase 1 trial, expected to start in mid-2026, will enroll about 20 overweight or obese adults who have never taken a GLP-1, testing the implant’s safety, tolerability and drug levels against a low starting dose of Wegovy over four weeks. Vivani chose Australia partly to tap government research tax incentives. Preclinical work has been encouraging — a single implant produced more than 20% sham-adjusted weight loss sustained for a full year in animals — but human efficacy is unproven, and the road from a four-week safety readout to a marketable product runs through a Phase 2 dose-ranging study and years of larger trials.

For the broader industry, Vivani’s bet underscores where the obesity gold rush is heading next. The first wave of competition was about who could produce the most weight loss; Wegovy has averaged about 15% over 68 weeks, reaching nearly 28% at a higher dose. The next battle is durability and adherence — turning a drug people quit into a therapy people stay on. Whether the answer is an implant, a cheaper oral pill, or better insurance coverage is unsettled, and questions about the implant’s eventual price and reimbursement remain wide open. But the maintenance problem is now the field’s central commercial question, and a small California biotech has put a physical device on the table as one possible fix. With Novo Nordisk watching, the coming Phase 1 data will determine whether the idea graduates from intriguing to investable.

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WASHINGTON — The Trump administration’s pick to oversee preparedness and response to public health emergencies and disasters has questioned the use of the hepatitis B vaccine in infants and raised the disproven link between vaccines and autism in past comments reviewed by STAT.

Those comments by Sean Kaufman, nominated to be Assistant Secretary for Preparedness and Response, are part of an undercurrent of vaccine skepticism among some high-ranking Department of Health and Human Services officials under Secretary Robert F. Kennedy Jr. — despite efforts from White House officials to steer the conversation away from vaccines.

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About 4,500 workers at Mass General Brigham are striking this week, while employees at Mount Nittany Medical Center in Pennsylvania said they would take to the picket line later this month.

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Good morning, everyone. Damian Garde here, filling in for Ed Silverman at Pharmalot’s satellite campus along the East River, where today’s cup of stimulation is filled not with coffee but rather a smoothie of curious color and questionable contents (what exactly is an “adaptogen”?). Anyway it’s Friday, as you’re almost certainly aware, and here are some tidbits to help you through the waning hours of another working week. …

German lawmakers passed a bill that would more than double the discount on branded medicines drugmakers must provide to the government, Reuters reports. The policy, part of an effort to plug a sizable budget gap in the country’s health insurance system, would increase the mandatory rebate from 7% to 15.5%. Industry groups have said the bill, if it clears Germany’s upper chamber, would deter investment and imperil the country’s access to new medicines.

The rapid rise of China’s biotech industry has led some American drug developers to do their work in near total secrecy, the Wall Street Journal observes. U.S. startups are increasingly loath to publish early data, disclose their scientific ambitions, or even publicize which diseases they hope to treat, all in fear that nimble Chinese firms will use that information to whip up competing drugs and beat them to the punch of starting clinical trials.

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ARPA-H has unveiled a $160 million effort to speed bespoke gene-editing therapies for rare diseases into the clinic. Meanwhile, Roche has abandoned two Huntington’s gene-silencing drugs after disappointing data, and drugmakers have stepped in to promote Medicare’s new obesity drug discount program.

I got coffee with my cousin this morning here in SF. Before leaving for his job at an AI behemoth, he said the bone-chilling July gloom is perfect “working weather.” 

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In case you missed the launch of Bob Herman’s incredible “Out of Pocket, Out of Reach” series about the soaring costs of employer-based health insurance, he will be talking about the series during his office hours later this month. Sign up here.

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Jeremy Faust cuts through a hallway of Boston’s Brigham and Women’s Hospital on his way to see a patient who is struggling to breathe. It’s the start of his evening shift, and the emergency department hums with ambient sound: bleeping monitors, the rumbling wheels of medical carts, the squeaky soles of hustling staff. People on gurneys line the corridor, some wincing in pain, others chatting with relatives.

On this Wednesday evening in May, Faust is working what is typically a quieter shift, as far as emergency departments go. Still, he is overseeing a team of doctors, students, and physician assistants, and will tend to more than two dozen patients before signing off for the night.

It’s an understatement to say Faust likes to keep busy. Minutes earlier, he’d posted an article on his influential Substack newsletter, Inside Medicine, providing an update on a major international news story. An alert sent to the newsletter’s nearly 85,000 subscribers announced his “scoop”: Twenty-six passengers aboard the MV Hondius, the hantavirus-hit cruise ship docked at the time off Cape Verde, had disembarked much earlier than previously known — raising the possibility they could spread the rare virus in the United States.

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NEW YORK — A couple of years ago, a reporter approached the Boys’ Club of New York looking to interview some of its middle-schoolers for a story about the mental health crisis in boys. 

It’s easy to see why. Many of the about 2,500 boys who participate in the 150-year-old organization’s after-school and weekend activities come from disadvantaged socioeconomic backgrounds, often living in single-parent households or facing the threat of immigration enforcement. With limited access to academic and developmental support, the risk factors are plentiful. 

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In March, the Medicare Payment Advisory Commission (MedPAC) released its annual report to Congress on Medicare payment policy. The data related to physician payment are clear: By every metric we track, primary care in America is succeeding, and it has been for years. Nearly all Medicare beneficiaries have a primary care provider (PCP). Over three-quarters can see their PCP within two weeks. Patients in rural environments have less trouble finding a PCP and even shorter wait times. Services and spending on evaluation and management codes are increasing, and compensation among PCPs is rising faster than the rest of the field.

Yet this runs counter to the pervasive narrative that investing more in primary care is the key to solving the American health care crisis.

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Why does getting family health insurance through a job cost as much as buying a new car? How did a whistleblower take on an insurance contractor? And who might be the new Food and Drug Administration commissioner?

We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast. 

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ARPA-H, the U.S.’ “moonshot” agency for health research, announced Thursday that it will spend up to $160 million to push forward custom gene editing treatments for a spate of rare diseases. 

The program, called THRIVE, will back seven different teams pursuing various groups of conditions affecting different organ systems. 

Each team has a deadline of starting clinical trials by year three of the program, although some may start much sooner.  

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NEW YORK — Nearly 1,000 people in Michigan have been diagnosed with a parasitic infection that can cause weeks of watery diarrhea, making it the largest such outbreak in state history and one of the nation’s largest in years.

No deaths have been reported and the source of the cyclospora infections hasn’t been identified. Meanwhile, investigations into similar illnesses have been going on in 28 other states, including in Ohio, where people just across the Michigan border are also becoming sick.

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I’m only just learning about the Norse soccer god Erling Haaland, who lives on copious amounts of organ meat and raw milk. Send news tips and “ancestral diets” to John.Wilkerson@statnews.com or John_Wilkerson.07 on Signal.

ACA premium spikes, and a thong-clad chicken suit

There are many reasons to care about the skyrocketing cost of ACA marketplace plans costs. One of them is the impact on small businesses.

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A father fights to create and then save his daughter’s gene therapy, the White House nears a decision on an FDA chief, and the Trump administration pushes drugmakers to reshore generics manufacturing.

A quest to save Grace — and help rare disease patients everywhere

With $70 million and seemingly every fiber of his being, Matt Wilsey built a gene therapy company from scratch — recruiting Nobel laureates and biotech veterans to will an experimental treatment into existence for his daughter Grace. The treatment, for the ultra-rare disorder NGLY1 deficiency, landed her back in the hospital before she slowly began to recover, STAT’s Jason Mast and Matt Herper write.

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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.

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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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A former executive is claiming that the MA insurer recorded millions of dollars as capital expenditures that should have been operating expenses, inflating its value. Alignment strongly denied the allegations.

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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.

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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.

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