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In the winter of 2022, two parents carried their sick, coughing baby boy into an emergency room deep in California’s Sierra Nevada mountains. The small rural hospital had no pediatric specialists, no pediatric nurses, and no children’s intensive care unit. But it was hours closer than any hospital that did.

The doctor at that rural hospital recognized immediately that the baby’s condition was beyond their capacity to treat. They called regional children’s hospitals like ours for help. But the winter of 2022 was the peak of the “tripledemic” — Covid, influenza, and RSV striking children simultaneously — and every children’s hospital in northern California was overwhelmed. None of us had room for one more.

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At the annual European Society for Medical Oncology Congress, a new report brought forward yet another monumental moment in cancer science: A Phase 3 study showed that the “cancer vaccine” intismeran autogene reduced the risk of recurrence or death by 42% compared with pembrolizumab (Keytruda) alone. This is the first neoantigen and mRNA therapy to have met its Phase 3 endpoint in oncology and is part of a collection of well-conducted studies showing promise for cancer therapeutic vaccines.

The question is no longer whether personalized cancer vaccines can work. The question now becomes how to accelerate development and increase access for the patients who could benefit.

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LANCASTER, Pa. — They saved Petunia first. She was the second cow. Her brother Louie had died within hours of his birth. But over two harrowing, sleepless nights, the three researchers kept Petunia alive to wheel her from the barn to the veterinary hospital and inject her with a virus carrying new genes.

Petunia had a bovine form of maple syrup urine disease (MSUD), a life-threatening condition that is also unusually prevalent within the Mennonite community here. The goal wasn’t to save the 79-pound calf. That would be a bonus. The goal, for Kevin Strauss, was to prove that an MSUD gene therapy could work — that after two decades he could finally offer the desperate families who entered his medical clinic here a simple, one-time fix.

It worked. Today, Petunia is a feisty, 5-year-old, hay-munching, 1,500 pound heifer. Yet not a single one of Strauss’s patients has received the treatment that saved her life, not even in a clinical trial.

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Prior to Alexander Fleming’s accidental discovery of penicillin 100 years ago, almost half of all deaths were caused by infections. Fleming’s petri-dish experiments and the resulting development of modern antibiotics have added an average of 23 years to human life expectancy and are estimated to save millions of lives each year. 

Sandoz, the Swiss pharmaceuticals company, is one of the last producers of this vital medicine in Europe. Its €150 million ($168 million) factory in the Alpine town of Kundl, Austria, is the continent’s only fully integrated antibiotic manufacturing facility, capable of producing the active ingredients and turning it into medication ready for patients. 

However, Sandoz faces strong competition from China. Last year, 86% of EU imports of penicillins and their derivatives came from China, up from 44% in 2019, according to Eurostat. China is now the largest exporter of antibiotic ingredients in the world. 

Losing the ability to produce antibiotics in Europe raises questions about security and sovereignty, according to Richard Saynor, the CEO of Sandoz. “We’re now the last remaining penicillin manufacturer left in the Western world,” he says. “Do you really want to be in a world where all of your antibiotics come from Asian suppliers? I don’t think you do.” 

In written evidence to U.K. lawmakers, Sandoz warned that Europe’s dependence on China for antibiotics represented an “Achilles heel” for its public health and defense, adding that the restriction of supply could become a “tool of economic coercion or hybrid warfare” during times of diplomatic tension. 

Sandoz has also claimed that “market-distorting behavior” has helped Chinese manufacturers to undercut their competitors and “flood” global markets with ultra-cheap pharmaceutical ingredients.  

The company filed a complaint to the European Commission in May requesting an anti-dumping probe into Chinese imports of the active ingredient used in the antibiotic amoxicillin. “We’re competing with heavily subsidized Asian players,” Saynor says. “We want a level playing field.” 

The EU’s Critical Medicines Act, which was provisionally approved in May and aims to improve the availability and production of key medicines such as antibiotics and painkillers across Europe, is a step in the right direction, according to Saynor.  

However, he adds: “What’s not clear is how that then translates into European governments paying a little bit more for these drugs. As always, everyone agrees with you, but the moment you ask for the check, everyone has suddenly left the table.” 

The U.K.’s National Health Service currently pays £1.06 ($1.41) for a 21-pack of 250mg Amoxicillin capsules, according to the British National Formulary, a reference book which provides guidance on the prescribing and administration of drugs for healthcare professionals.  “Why should we sell a pack of antibiotics more cheaply than a Mars bar?” Saynor asks. “Do we value a Mars bar more than the medicine that has saved more lives than any other invention? Governments are very good at seeing the price, but they don’t necessarily see the value.” 

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Sandoz group’s rank on fortune 500 europe

Public health services globally are facing financial challenges and funding cuts, but Saynor does not think paying a higher price is unreasonable. “It’s not a fair comparator to say all drugs should be sold at the same price as a Mars bar when it costs $100 billion to develop and then bring products to the marketplace,” he adds. 

A “golden decade” for cheaper drugs 

Sandoz specializes in developing generic and biosimilar medicines. These off-patent drugs offer the same clinical effectiveness as their branded counterparts and are significantly cheaper for health services to purchase. Generic drugs constitute 80% of all medicines used globally.  

Sandoz estimates that the patents for medicines worth a combined $650 billion are set to expire in the next 10 years, leading to what Saynor describes as an “unprecedented golden decade” for the biosimilars market. 

“We’re now the last remaining penicillin manufacturer left in the Western world. Do you really want to be in a world where all of your antibiotics come from Asian suppliers?”

Richard Saynor, CEO of Sandoz

Last month, Sandoz unveiled its ambition to produce more than 100 biosimilar products by 2040—almost eight times its current total of 13. Sandoz estimates that bringing these products to market could create almost $1 trillion in social impact, partly through direct savings for healthcare systems. 

Sandoz has invested $300 billion in a new drug substance facility in Ljubljana, Slovenia, to support this ambition. “We see a huge opportunity there in biologics,” Saynor says. 

He believes that Sandoz’s spin-out from Novartis in 2023 put the company in a good position to capitalize on this upcoming opportunity. “Our job is to challenge patents and bring products to market as early as possible,” Saynor explains. In contrast, pharma companies, like Novartis, are seeking to protect their patents. “Intellectually, those are very different things,” he says. 

Now, as an independent company, Saynor says Sandoz can be a “voice of the industry”. He adds: “I’ve had access to the White House, to the European regulators, to European governments, international governments all over. I couldn’t have said half of the things that I’ve said as part of our parent company. It’s allowed us to shape policy.” 

Saynor has also been reshaping his leadership team. In July, Pascal Bouye, who previously held senior operations and supply roles at Mars and Danone, was appointed president of generics and manufacturing supply, and Keren Haruvi moved from Novartis to Sandoz to lead its North America operations. Remco Steenbergen, the former CFO of the German airline Lufthansa, was hired in 2024.  

Bringing in knowledge from other industries is crucial to Sandoz’s future growth, according to Saynor. “Pascal [Bouye] came from a very complex consumer goods organization, so he knows how to manage complex supply chains with many partnerships,” he says. Meanwhile, Steenberg has brought an understanding of managing finances within an asset-heavy industry with relatively thin margins.  

As Sandoz enters a new stage of growth and faces up to Chinese competition, Saynor recognizes that fresh perspectives will be important: “I don’t have all the answers as CEO. We need different points of view to challenge our thinking and people who can bring knowledge from different industries—not necessarily just a pharma viewpoint.” 

This story was originally featured on Fortune.com

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You’re reading our ESMO in 30 Seconds newsletter. Sign up here to get updates from future major European cancer conferences in your inbox.

We’ve made it. Here’s our last newsletter from this year’s European Society for Medical Oncology meeting. But before we bust out of this convention center for the final time, a reminder that we’ll be recapping ESMO on Thursday at 10 a.m. Eastern. Register for the virtual event here, and thanks very much for reading.  

Roche gets a lung cancer win

One of the more impressive data sets at this year’s ESMO came from a Roche study of its drug divarasib, which inhibits G12C KRAS mutations, in second-line advanced non-small cell lung cancer, where it outpaced older KRAS inhibitors from Amgen and Bristol Myers Squibb.

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Welltower sign beside a landscaped seniors housing property

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Welltower acquired 43 seniors housing properties for $2.7 billion in the third quarter as rising occupancy and higher revenue per occupied room lifted operating results, the healthcare real estate company reported Monday.

The purchases were part of $4.1 billion in gross investments completed during the quarter, including development funding, according to the company’s October 26 earnings release. Investment figures reflect Welltower’s ownership share rather than the full value of jointly owned properties.

Same-store net operating income in its seniors housing operating portfolio rose 21% from a year earlier. Revenue in that portfolio increased 9.1%, supported by a 3.2-percentage-point gain in average occupancy and 5.3% growth in revenue per occupied room.

Net income was $415 million, with net income attributable to common stockholders of 54 cents per diluted share. Normalized funds from operations, a supplemental measure used by real estate companies, reached $1.67 per diluted share, up 24.6% from a year earlier. It is not the same as net income under generally accepted accounting principles.

Welltower also sold 25 outpatient medical properties for $139 million and seven seniors housing properties for $145 million during the quarter. Those amounts, like the acquisition figures, are reported on a pro rata basis.

The company said its gross investments completed or under contract for the year totaled $21 billion, excluding development funding. Of that amount, $13.3 billion had been completed in the first nine months; another $7.7 billion was closed or under contract after quarter-end. Transactions that have not closed remain subject to customary closing conditions.

The board declared a quarterly cash dividend of 85 cents per share, payable November 19 to stockholders of record November 10.

JBizNews Desk | Toledo, Ohio

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Bon Secours Mercy Health could soon become one of the country’s biggest ambulatory surgery center operators, a move that’s likely to boost the Catholic health system’s profitability and leverage over health insurers. 

The nonprofit system announced Monday that it plans to acquire Surgery Partners, a publicly traded chain of over 200 ambulatory surgery centers, short-stay hospitals, and multispecialty physician practices in 30 states, in a deal valued at $5.7 billion. The deal, expected to close in the first quarter of 2027, would also deepen the health system’s ties with the private equity firm Bain Capital.

Traditional hospital operators, nonprofit and for-profit alike, have been buying up ambulatory surgery centers at a rapid pace in recent years. The facilities are seen as an increasingly attractive investment as more procedures migrate into outpatient settings under payment changes in Medicare and as commercial insurers steer their members to the lower-cost facilities. Earlier this year, nonprofit Ascension paid $3.9 billion for Amsurg, growing its network of ambulatory surgery centers to about 300.  

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New York’s Health Department said Monday that influenza is now prevalent in the state and launched a combined dashboard tracking flu, COVID-19 and respiratory syncytial virus, giving nursing-home administrators and other health care operators a single place to follow regional respiratory-illness trends.

The department said the flu season is starting earlier than usual and that vaccination rates, based on doses reported to the state, are lower than in previous years. Those are the department’s assessments in its October 26 announcement; it did not provide a statewide case total or a percentage increase in that release.

The change is in how the public and providers can see the information together. The new Seasonal Respiratory Virus Dashboard combines laboratory-confirmed cases and associated hospitalizations for the three viruses, with geographic views and trends over time. The department says the dashboard is updated on Fridays, and its figures are provisional and subject to revision.

For a nursing home, statewide surveillance is useful context for preparedness, but it is not a report that a particular building has an outbreak. A rise in a region’s laboratory-confirmed cases also is not a count of every infection in that region. The state’s case definition depends on a positive qualified laboratory test reported into its communicable-disease surveillance system.

That difference is important when administrators explain the figures to staff and families. People with respiratory symptoms who have not had a qualifying positive laboratory test are not automatically represented in the dashboard’s case count. Changes in testing and reporting can therefore affect what appears in the surveillance data, as well as changes in the circulation of the viruses themselves.

The hospitalization measure has its own boundaries. According to the dashboard’s methodology, hospitals report aggregate admissions associated with laboratory-confirmed flu, COVID-19 or RSV by age group. The count includes patients admitted to inpatient or observation beds, but excludes people treated in an emergency department and released.

Hospitals must complete that weekly survey on Wednesdays for the preceding Sunday-through-Saturday period, the department says. The information is now collected through the state’s Survey Management and Response Tool, or SMART. Before October 2026, it was collected through the Health Electronic Response Data System, known as HERDS. A Friday dashboard update should therefore not be read as a real-time tally of what is happening inside every facility that day.

State Health Commissioner Dr. James McDonald urged eligible residents, particularly vulnerable groups, to receive seasonal influenza and COVID-19 vaccines. The department says older adults and people with underlying health conditions are among those at heightened risk of serious illness. It also points to handwashing, staying home when sick, cleaning frequently touched surfaces and considering a well-fitting mask around others when symptomatic or at higher risk.

Flu, COVID-19 and RSV can have similar early symptoms, including fever, cough, sore throat, congestion, aches and fatigue, the department said. Surveillance showing which viruses are circulating can inform awareness, but it does not determine the cause of an individual resident’s symptoms or replace clinical assessment.

For operators, the practical distinction is between a new source of regional information and a facility-specific finding. Monday’s announcement supplies the former. It does not identify an outbreak at a named nursing home or announce a new staffing ratio, Medicaid reimbursement change or inspection penalty. The dashboard’s weekly reporting schedule and definitions are part of the information readers need to interpret it correctly.

File image: H1N1 influenza virus, CDC Influenza Laboratory, via Wikimedia Commons. Public domain. Resized. This historical laboratory image does not identify the strains circulating in New York this season.

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RadNet agreed to acquire ONRAD on Monday, adding a hospital radiology and remote-reading business that supports more than 225 hospital facilities across 26 states.

Under the definitive agreement, ONRAD shareholders would receive $350 million in cash and five million RadNet shares at closing, subject to customary adjustments. An additional earnout worth up to $210 million would depend on achieving a 2027 earnings target and could be paid in cash, shares or both at RadNet’s choice.

The companies expect the transaction to close in early 2027, subject to regulatory review and other customary closing conditions. The agreement is not a completed acquisition.

ONRAD works through more than 130 contracted radiologists, providing remote final-read interpretations and in-hospital professional staffing, including interventional radiology. Its customers include hospitals, health systems and other diagnostic imaging sites.

RadNet said ONRAD would form the foundation of a third reportable operating segment, Radiology Professional Services, after closing. The business would sit alongside RadNet’s outpatient imaging operations and DeepHealth digital health and artificial-intelligence tools.

The proposed combination expands RadNet’s services inside hospitals as well as outside them. The company already operates imaging centers in markets including New York, New Jersey, Maryland, Delaware and several other states.

ONRAD is a portfolio company of Housatonic Partners. Robert W. Baird is its exclusive financial adviser, according to RadNet’s October 26 announcement.

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New Jersey health regulators have assessed a $45,000 penalty against Morris View Healthcare Center after finding repeated failures to meet the state’s nursing-home staffing ratios, an October 21 notice shows.

The assessment raises the penalty rate to $3,000 for each day of noncompliance found in a September 17 survey. The Department of Health said the facility failed to meet the requirements on 15 of 21 day shifts reviewed, producing the $45,000 total.

The notice is an assessment with dispute and hearing rights, not a court ruling or evidence that the penalty has been paid. A separate $45,000 assessment issued October 7 is already being appealed at the New Jersey Office of Administrative Law, according to the new notice.

The department classified the September findings as F-level deficiencies: widespread violations resulting in no actual harm, but with potential for more than minimal harm that is not immediate jeopardy. That classification should not be confused with a finding of actual resident injury or immediate jeopardy.

The action shows how penalties can rise when New Jersey nursing homes receive repeated citations for the same or substantially similar F-level or higher deficiency within three years. The department cited state law requiring a more severe penalty than the one imposed for the previous violation.

For Morris View, the notice traces the daily penalty from $1,000 in an earlier assessment to $1,500, $2,000 and $2,500 in subsequent actions, before the latest increase to $3,000. Those figures describe the department’s enforcement sequence; the October 7 assessment remains contested.

The underlying state staffing law requires one certified nurse aide for every eight residents on the day shift. For the evening shift, it requires one direct-care worker for every 10 residents, with at least half of those workers being certified nurse aides and staff assigned to perform aide duties. The night-shift requirement is one direct-care worker for every 14 residents, with workers assigned to perform those duties, as described in the notice.

The notice allows the facility to challenge factual survey findings through informal dispute resolution and to request a formal administrative hearing on the findings or penalty. It states that failure to request a hearing within 30 days of the notice would make the assessment a final agency decision. The published notice does not establish whether the facility has requested a hearing on this latest assessment.

New Jersey lists the October 21 action on its health-facility enforcement page as a notice of assessment of penalties.

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New York nursing homes and other long-term-care providers were scheduled to receive the federal share of a one-time funding increase in a Medicaid payment cycle with an October 21 check-release date, according to the state Department of Health.

The payment is part of a $445 million gross increase in the state fiscal year 2026 enacted budget for nursing homes, adult day health centers, AIDS adult day health centers and hospice programs. The $445 million figure describes the overall gross funding increase, not a new $445 million federal-only payment.

In its October 1 letter to administrators, the department said the federal-share payment would be processed in Medicaid cycle 2563, with checks released October 21. The letter establishes the planned processing date; it does not confirm that a particular provider has received its money.

The state used two components to calculate each provider’s lump sum. It allocated $385 million of the overall increase based on Medicaid service days, producing a nursing-home payment component equivalent to $14.49 per day. Another $60 million was allocated in proportion to each provider’s Medicaid revenue.

The department said each nursing home and specialty unit’s first component was calculated by multiplying $14.49 by its days reported in the 2024 cost report. For the revenue component, it used each facility’s Medicaid rate as of January 1, 2024, multiplied by Medicaid patient days in that cost report.

These are calculations for a one-time lump sum. The letter does not announce a permanent $14.49 increase in a facility’s daily Medicaid rate.

Providers with multiple service units under the same Medicaid Management Information System identification number have their payment values combined into one payment for that number.

The amount reaching a provider can also be lower than the calculated award. The department said it will recover existing balances owed to the state from these payments, leaving providers only the amount above their liability balance.

The letter directs questions about payments and liabilities to bimamail@health.ny.gov and questions about the one-time payment to NFRates@health.ny.gov.

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TA Associates has agreed to become the anchor shareholder of Alloheim Group, the German elder-care operator with more than 320 senior residences and about 30,000 employees, in a transaction expected to close in the first quarter of 2027.

Nordic Capital, which has backed Alloheim since 2018, will sell its entire holding when the transaction closes. The companies did not disclose a purchase price in their October 26 announcement.

The deal is not yet complete. It remains subject to customary regulatory approvals, including merger-control clearance.

Alloheim said its strategy, management and operating direction will remain unchanged under the new ownership. The company also said local management teams and points of contact will stay in place.

The group operates more than 30,000 residential care beds, more than 4,500 assisted-living apartments, 112 assisted-living locations and 36 outpatient care services across Germany. Its services extend beyond care for older adults to specialized care for young adults, patients with psychiatric needs and people in a persistent vegetative state.

Alloheim said it has integrated more than 160 facilities since 2018, including more than 30 in its most recent acquisitions. Its workforce more than doubled over that period, according to the announcement.

The portfolio includes Alloheim Senioren-Residenzen and operations under the CMS Group, Itertalklinik Seniorenzentren, Pro Talis, ProCurand, Integra and Katharinenhof brands.

TA, a private-equity investor focused on healthcare, technology, business services and financial services, said it will support Alloheim’s growth. Nordic Capital will remain the existing shareholder until the transaction closes.

JBizNews Desk | Germany

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The U.S. Department of Health and Human Services finalized a rule Monday that removes 14 health-technology certification requirements and revises seven others, narrowing the compliance work required of software developers in the federal certification program.

The rule, known as HTI-5, leaves 39 of the program’s 60 certification criteria unchanged. HHS projects more than $1.5 billion in regulatory cost savings. That is the department’s estimate, not money already saved by hospitals, nursing homes or software customers.

The changes affect the Office of the National Coordinator for Health Information Technology’s certification program, which evaluates capabilities of health IT products. They are not an announcement of a new nursing-home staffing standard or a change in Medicaid reimbursement rates.

In its final-rule overview, ONC said it removed or reduced longstanding requirements involving functions already well established in the market or requirements it considers an obstacle to innovation. The 39 unchanged criteria include new and revised requirements adopted in the earlier HTI-4 rule on electronic prior authorization and real-time prescription benefits.

The agency’s criteria table lists removals involving family health history, care plans, patient health information capture and certain older application-access functions. Other criteria, including transitions of care and clinical information reconciliation, are revised rather than removed.

Those changes have different implementation dates. The table places removal of family health history and patient health information capture requirements on January 1, 2027, while the transition-of-care revision is listed for January 1, 2030. Several other changes are tied to the final rule’s effective date. The announcement therefore does not mean every listed requirement disappears immediately.

ONC is also scaling back requirements for real-world testing plans and results and reducing reporting under its Insights program. The agency said it is retaining the measure covering use of FHIR bulk-data access. FHIR is a standard for exchanging health information through software interfaces.

HHS said the changes are intended to let developers devote more resources to their products instead of compliance. In its October 26 announcement, the department said ONC plans additional proposals involving interoperability standards, application programming interfaces and certification conditions. Those future proposals are separate from the rule finalized Monday.

One closely watched part of the earlier proposal remains unsettled: information blocking. HHS said comments on the proposed information-blocking changes remain under consideration. The final announcement should not be read as finalizing those proposed changes to electronic health-information access and use.

JBizNews Desk | Washington, D.C.

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MADRID — In the past week, a GSK cancer drug picked up an approval for another tumor type, the company unveiled the first data from a global study of a promising next-generation chemotherapy, and a medicine that the firm has licensed got the limelight in a presidential session at a major oncology conference here. 

GSK is also awaiting another expected approval in the coming weeks, this time for a new lung cancer drug. 

It’s a good run considering GSK was out of oncology a decade ago.

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Merck’s experimental cancer drug sacituzumab tirumotecan helped patients with previously treated advanced or recurrent endometrial cancer live longer than standard chemotherapy in a global late-stage trial, the company reported Monday.

Patients receiving the drug, also called sac-TMT, had median overall survival of 19 months, compared with 12.1 months for those receiving chemotherapy. The result represented a 32% reduction in the risk of death over the study period, Merck said in its October 26 results announcement.

The Food and Drug Administration has accepted an application for priority review, with a target decision date of June 15, 2027. The treatment remains investigational for this use; priority review is not an approval.

The Phase 3 TroFuse-005 trial enrolled 776 patients whose cancer had already been treated with platinum-based chemotherapy and an immunotherapy targeting PD-1 or PD-L1. Participants were randomly assigned to sac-TMT or a physician’s choice of doxorubicin or paclitaxel.

Median time before cancer progression or death was 7.2 months with sac-TMT versus 3.9 months with chemotherapy, a 41% reduction in that risk. Tumor responses occurred in 35.1% of patients receiving sac-TMT, compared with 17.3% in the chemotherapy group.

The gains came with more severe treatment-related side effects. Grade 3 or higher events affected 54.4% of patients receiving sac-TMT and 41.4% receiving chemotherapy. Common serious events with sac-TMT included anemia, low levels of infection-fighting white blood cells, and inflammation in the mouth. Treatment-related adverse events led to three deaths in each group.

Sac-TMT is an antibody-drug conjugate designed to attach to the TROP2 protein on tumor cells and deliver a cancer-killing payload. Merck is developing it with Kelun-Biotech, which developed the therapy.

NYU Langone Health, whose researchers helped lead the study, said patients were enrolled at more than 200 cancer centers in 29 countries. Merck funded the research. The results are being presented at the European Society for Medical Oncology congress and published in The Lancet.

JBizNews Desk | Rahway, New Jersey

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People seeking financial help to buy Affordable Care Act coverage would have to clear eligibility checks before receiving subsidies under a federal proposal that would begin with 2028 health plans.

The Centers for Medicare & Medicaid Services proposed the changes on October 23. They are not a new requirement for the upcoming 2027 coverage year, and the rule is still open for public comment.

Under the CMS proposal, exchanges would verify household income and family size, citizenship or eligible noncitizen status, place of residence, and eligibility for or enrollment in other qualifying coverage before providing advance premium tax credits or income-based cost-sharing reductions.

Currently, applicants who otherwise appear eligible can receive financial help during a period when the exchange is seeking documents to resolve information it could not verify electronically. The proposal would stop financial assistance during that period. Consumers could still enroll without subsidies while verification is pending.

Returning customers would also have to confirm eligibility information annually and have it verified to keep financial assistance through automatic re-enrollment. Someone who did not return and complete that process could be re-enrolled in coverage without the subsidies.

CMS proposes an earlier verification window beginning August 1 each year. The first would open August 1, 2027, for 2028 coverage, giving new and returning applicants time to submit information before open enrollment.

The proposal includes a contingent plan-selection option: consumers could choose a plan that would start only after they qualify for financial assistance. For people who instead enroll while checks are pending, CMS proposes retroactive assistance for months they were enrolled during that period once eligibility is verified.

CMS says the changes would implement provisions of the 2025 federal tax-and-spending law and reduce improper enrollments. The proposed rule also includes exceptions for certain family-size changes that trigger special enrollment periods. Public comments are invited for 30 days after publication in the Federal Register.

JBizNews Desk | Washington, D.C.

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A House lawmaker is investigating whether the three largest pharmacy benefit managers targeted independent pharmacies with audits in retaliation for supporting a bill that would require the companies to adjust payments to the retailers.

James Comer (R-Ky.), who heads the House Committee on Oversight and Government Reform, late last week sent letters to CVS Caremark, OptumRx, and Express Scripts, claiming that independent pharmacies “experienced an unusual surge in burdensome audits” after many openly backed the legislation he introduced last year.

Called the Pharmacists Fight Back Act, the bipartisan bill would require pharmacy benefit managers participating in the Federal Employees Health Benefits Program to fairly reimburse pharmacies for the actual cost of medicines and to pay a reasonable fee for dispensing the drugs.

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The St. Louis-based insurer is adding onto a growing pile of lawsuits from insurers trying to get their quality scores recalculated — and nab hundreds of millions of dollars in extra payments as a result.

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Enrollees must jump through more hoops to verify their income and residency status before receiving subsidies for Affordable Care Act plans. Over 300,000 enrollees are expected to leave each year as a result.

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MADRID — A type of targeted chemotherapy developed by Merck and China’s Kelun-Biotech cut by one-third the risk of death in patients with advanced endometrial cancer, a common gynecological cancer, according to randomized Phase 3 study results presented Monday. 

The drug, called sacituzumab tirumotecan, or sac-TMT, has already shown survival-extending benefits for patients across multiple cancer types in studies conducted by Kelun in China, where it’s approved. 

Merck is conducting 18 global Phase 3 studies of sac-TMT, including 10 studies in women’s cancers, to support approvals in the U.S., Europe, and elsewhere outside China. The drug plays a crucial role in Merck’s efforts to replace revenue that will be lost when Keytruda, its blockbuster immunotherapy, loses patent protection in 2028. 

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This is Tara, filling in for Bob. And no, I haven’t yet seen “You Can See Everything,” but a bunch of my colleagues did and here’s what they thought. Can we all agree to shut up about it now? Talk to me about anything else: Tara.Bannow@statnews.com.

A cost shift back to workers? 

Employers have mostly protected their workers from the sky-high premium spikes they’d otherwise see as health care costs continue to rise. That’s in part to stay competitive, but it’s especially tough on small businesses. This year, there are signs that employers could be reaching a breaking point. 

Continue to STAT+ to read the full story…

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MADRID — A targeted drug from Incyte, when used in combination with chemotherapy, induced lasting tumor responses in certain patients with pancreatic cancer — results, the biotech said, that support its prior decision to advance the treatment into a late-stage clinical trial.

The approval of Revolution Medicines’ pancreatic cancer drug Rasonque earlier this year showed that a medicine capable of attacking mutations in a group of genes called RAS could prolong survival for patients with the particularly aggressive cancer. 

Now, companies like Incyte, Revolution Medicines, Verastem, and China’s Hengrui are developing next-generation drugs that selectively target specific mutations within the RAS family of genes, seeking even better results for patients. 

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I know we’ve had a lot of “You Can See Everything” content in this newsletter, but allow me one more plug. A recent STAT letter to the editor included a message from the former director of a Phoenix lab. When Theranos rolled out its products there, this writer said he heard from former colleagues about frustrations.

Read the rest…

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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. But what can you do? The world, such as it is, continues to rotate. To nudge it in a better direction, we are brewing another cup of stimulation. Our choice today is butter pecan with a dash of raw honey. 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. …

Bristol Myers Squibb reported that one patient died after receiving its investigational CAR-T therapy in an early autoimmune trial, adding to safety concerns about a growing field of research, STAT notes. In a Phase 1 trial that tested the therapy in multiple sclerosis, the patient experienced motor symptoms that did not resolve with standard autoimmune treatments. They were then given a potent immunosuppressant, but developed septic pneumonia and died, Bristol said in a press release. In a subsequent statement, Bristol said this patient was treated for a series of other complications prior to receiving the CAR-T therapy, “confounding our ability to determine the root cause of the issue.”

A Roche drug billed as a potential blockbuster helped patients with a form of lung cancer that had spread live almost six months longer than two competitive medicines, Bloomberg News says. The experimental treatment, called divarasib, fared better than similar drugs from Amgen and Bristol Myers Squibb in a late-stage study. The drug was given to patients with non-small cell lung cancer that had spread, in part because of a genetic mutation, after other treatments, including chemotherapy. The findings could help divarasib become the treatment of choice for this type of lung cancer, in which a mutation called KRAS G12C drives the tumor cell growth.

Continue to STAT+ to read the full story…

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Soundtrack at present: Iggy Pop, The Idiot.

Moderna CEO sees vaccine possibility beyond melanoma

Moderna CEO Stéphane Bancel is looking well beyond melanoma after the company’s personalized cancer vaccine, intismeran, succeeded in a pivotal Phase 3 trial. In an interview with STAT at the ESMO meeting in Madrid, Bancel said Moderna and partner Merck are racing to submit the vaccine for FDA approval, which he expects in 2027. The companies, he said, are also preparing to test it aggressively in other cancers.

The results offer a measure of vindication for Moderna’s longstanding bet that mRNA could do more than prevent infectious diseases, particularly after years of financial turmoil and setbacks in drug development. Bancel said the company will remain disciplined about its vaccine business while pursuing new opportunities in oncology, rare diseases, and autoimmune disorders. One particularly ambitious idea: using mRNA to train T cells to destroy the B cells responsible for autoimmune disease.

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HealthSpan Partners agreed Monday to acquire Surgery Partners in a transaction with an enterprise value of about $5.7 billion, turning one of the country’s largest outpatient surgical operators into a privately held company.

Shareholders other than affiliates of Bain Capital would receive $23.50 in cash for each Surgery Partners share. Bain, which currently owns approximately 39% of the company, would exchange its shares for equity in the acquiring entity and remain invested alongside HealthSpan.

The definitive agreement replaces uncertainty about whether a sale would materialize with specific terms, though the acquisition is not complete. The companies expect it to close in the first quarter of 2027, subject to Surgery Partners shareholder approval, regulatory approvals and other customary conditions.

HealthSpan is a contractual affiliate and supporting organization of Bon Secours Mercy Health, the U.S.-based nonprofit health system. Surgery Partners, headquartered in Brentwood, Tennessee, operates a network spanning more than 200 locations in 30 states, with approximately 5,000 affiliated physicians.

The network includes ambulatory surgery centers, surgical hospitals and physician partnerships. Its specialties include orthopedic and spinal care, cardiology, gastroenterology and ophthalmology. The acquisition would expand HealthSpan’s presence in care delivered outside traditional inpatient hospital settings.

The companies said Surgery Partners’ name, brand, headquarters and operations are expected to remain in place after closing. They also said it is expected to remain a secular organization, operate under the Statement of Common Values and not be characterized as a Catholic ministry entity.

HealthSpan intends to finance the purchase with cash on hand and new debt, for which financing commitments have been secured. Surgery Partners’ board approved the transaction after a unanimous recommendation from a special committee made up entirely of independent, disinterested directors.

Bain entered a voting and support agreement committing all of its Surgery Partners shares in favor of the deal and setting out the rollover of its investment. The cash payout therefore does not apply to Bain’s shares in the same way it applies to other shareholders.

After completion, Surgery Partners’ common stock would no longer trade on Nasdaq. Until the required approvals and closing conditions are met, it remains a pending acquisition rather than a completed change of ownership.

JBizNews Desk | Cincinnati and Brentwood, Tennessee

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Women’s hearts are different from men’s. Research from clinical trials that have required female participants only since 1993 have repeatedly drummed home that message, from varying chromosomes in heart muscle cells to different heart attack symptoms and causes. Yet wide gaps remain in heart health care for girls and women across specialties. 

Recognizing that clinical fragmentation and the resulting harm to women’s health, four medical societies — the American Heart Association, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, and the American College of Obstetricians and Gynecologists — have issued a framework intended to unite clinicians and patients over a lifetime of care, all aimed at dethroning cardiovascular disease as the leading cause of death in women. In that spirit, three articles offering guidance across the course of a woman’s life were published Monday in Circulation.

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President Donald Trump renewed his criticism of the Iran nuclear agreement and defended private health insurance in a Sunday television interview, putting energy costs and the future of health coverage at the center of his economic message ahead of the midterm elections.

Speaking by telephone with Larry Kudlow on Fox News in an October 25 interview, Trump attacked the agreement negotiated under former President Barack Obama and argued that government-run health insurance would leave patients facing delays. The remarks were made in the Sunday interview, a day after his campaign rally in Perry, Georgia.

The interview contained political arguments and predictions, not an announcement of a new nuclear agreement or a new health-insurance law. That distinction matters for households and businesses weighing fuel bills, employee benefits and medical expenses.

Iran policy and the cost of energy

Discussing Iran, Trump called the Joint Comprehensive Plan of Action, or JCPOA, potentially “the worst and dumbest deal I’ve ever seen.” He also criticized the transfer of $1.7 billion to Iran during the Obama administration and alleged that Tehran used money to pursue nuclear weapons and buy missiles.

The payment he cited has a separate legal history from the nuclear restrictions themselves. In an August 2016 White House briefing, the Obama administration described $400 million as the return of Iranian funds deposited before the 1979 revolution for military equipment that was never delivered. It described another $1.3 billion as interest paid to settle the financial dispute. That was the administration’s stated explanation for the settlement, rather than a payment to purchase Iranian compliance with the nuclear agreement.

The Obama administration’s archived account of the nuclear deal describes limits on enrichment equipment and material, together with international monitoring, as its means of restricting Iran’s nuclear program. Trump’s allegation about how Iran used the money is his claim; the interview did not supply documentation tracing the settlement funds to particular weapons expenditures.

Trump framed his current choice on Iran as whether to negotiate a deal or pursue further action. He also predicted gasoline prices would fall quickly. Those comments offered no firm timetable that consumers or businesses could use to budget for lower fuel costs.

Private coverage and Medicare for All

On health care, Trump defended private plans, including coverage connected with employment. He said the United States had the best health plans while acknowledging that they did not cover everybody.

Criticizing government-run coverage, he said, “It’s socialized medicine,” and, “It’s expensive.” He also asserted that cancer patients could face nine-month waits, in a discussion that referenced Canada and the United Kingdom. He did not identify a study or a specific waiting-time measure supporting that figure during the interview.

Medicare for All is a proposal for a broader national insurance system, not simply another name for the existing Medicare program. The Congressional Research Service summary of the House Medicare for All Act, H.R. 3069, says it would establish a national program covering U.S. residents, prohibit patient cost-sharing for covered services and limit private insurers and employers to supplemental coverage that does not duplicate the program’s benefits.

Those provisions explain why the debate reaches beyond seniors. It concerns how people receive coverage, what employers provide and how medical care is financed. The bill’s provisions are proposals, not changes put into effect by Trump’s interview.

For readers, the immediate takeaway is to separate campaign claims from changes already in force. Sunday’s remarks did not change an insurance policy, establish a new patient charge or guarantee a particular price at the gas pump. They set out Trump’s position on two policy debates with direct consequences for household and business costs.

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Medicare’s annual open enrollment period is underway, giving people with Medicare until December 7 to review and change health or prescription-drug coverage for 2027.

The choice is about more than the monthly premium. Medicare says costs, benefits and participating providers can change each year, so a plan that worked in 2026 may have different terms next year.

Changes made during this enrollment period take effect January 1, 2027. The plan must receive the enrollment request by December 7.

Start with the notice from your current plan

Medicare’s yearly review guide tells beneficiaries to read their Annual Notice of Change. That document explains how a current plan’s costs and benefits will change for 2027.

Then compare options using your actual prescription drugs, preferred pharmacies and doctors. A low premium is only one part of the bill. The official comparison service provides estimates of total out-of-pocket costs and lets users compare coverage, quality ratings and provider networks.

Medicare Advantage is private-plan coverage that bundles hospital and medical benefits and usually prescription drugs. Original Medicare provides hospital and medical coverage, with a separate drug plan available. The two routes can have different provider-access rules and out-of-pocket costs.

What you can change

During the October 15 through December 7 window, beneficiaries can join, drop or switch Medicare Advantage or drug plans, or move between Medicare Advantage and Original Medicare, subject to the coverage options that apply to their situation.

If you review your options and are satisfied with your current coverage, Medicare’s guide says you generally do not need to make a change for it to continue. Review plan notices carefully rather than assuming all existing benefits, prices or providers will stay the same.

Do not confuse this window with Medigap enrollment

Medigap is supplemental insurance that can help pay certain costs under Original Medicare. The annual fall enrollment period does not create a new unrestricted right to buy it.

Medicare explains that the federal Medigap open enrollment period generally lasts six months, starting the first month a person has Part B and is 65 or older. Outside that window, an insurer may be able to deny an application or charge more unless a protection applies. State law may provide additional rights. Check those rules before dropping existing coverage or deciding to switch.

The official Medicare Plan Compare tool can show available plans and estimated costs. For individual help, beneficiaries can call 1-800-MEDICARE at 1-800-633-4227 or use their State Health Insurance Assistance Program. Medicare’s open enrollment page and Medigap guidance explain the enrollment limits.

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MADRID — Moderna CEO Stéphane Bancel had every reason to be smiling and happy on a brilliantly sunny, Saturday afternoon here in Spain’s capital. In a couple of hours, a decade of the company’s research — boosted by a partnership with Merck — was going to culminate in the presentation of the first Phase 3 study to successfully demonstrate that a customized mRNA-based therapy called intismeran could improve outcomes for patients with melanoma. 

“It’s an amazing feeling,” he told STAT from the sidelines of the European Society for Medical Oncology annual meeting. “We’ve been working on intismeran for 10 years. Most people in the field thought this was never going to work, and many people had tried cancer vaccines before. But we were convinced, so it has been really special to be able to see all this work by so many people coming together to help patients.” 

In a wide-ranging interview, Bancel spoke to STAT about what’s next for intismeran, and how the drug’s success impacts the company’s R&D and business strategies. The conversation has been condensed and edited for clarity. 

Continue to STAT+ to read the full story…

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WASHINGTON — Earlier this month at a private event, Robert F. Kennedy Jr. and other top federal health officials announced a new National Institutes of Health center that would focus on patients with vaccine injuries, drawing fresh scientific firepower to an issue that’s long been central for the health secretary.

Yet days later, two leaders at the NIH said the center would also focus on long-term symptoms that people experience after an infection, a phenomenon most recently amplified among those experiencing long-term symptoms post-Covid. 

In fact, one senior NIH official, who asked not to be identified to speak freely, said that for people with long Covid symptoms, it can be hard to separate out whether those symptoms began because of a vaccine or an infection, as many people have experienced both. The immunological response mechanism is similar, they said, which means the treatment is similar.  

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The 43-year-old woman sitting across from me in my exam room is exasperated. “I just don’t feel like I have the energy or stamina I used to,” she tells me. “I could run 5 miles a day no problem when I was 23.”

Today we are reviewing her labs, all of which are normal. She has been my patient for several years and recently lost 50 pounds. In many ways, she feels better. Despite all that, despite a normal exam, vital signs, and labs, she just doesn’t have the energy she used to. Something must be wrong.

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OpenAI recently announced that it is tracking signs of user distress across sessions, rather than only within them, and using that information to inform model responses. The announcement follows a wave of new safeguards for mental health and well-being conversations with artificial intelligence at OpenAI and elsewhere, such as parental controls for teens, usage limits and break reminders, and crisis detection and referral. Policymakers have also moved to address associated risks, with a dozen states now requiring companion chatbot operators to disclose to users that their tools are not human, and to institute crisis referral procedures.

This attention, within AI companies and legislatures, is important and urgent. But it is directed almost entirely at acute harm from interacting with AI, rather than the cumulative harm that develops over time, such as the gradual replacement of one’s connections with friends and family by AI interaction.

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Adults with moderately to severely active Crohn’s disease can now begin Skyrizi treatment at home rather than starting with intravenous infusions, under an expanded U.S. Food and Drug Administration approval announced by AbbVie on October 23.

The change concerns how treatment starts, not a new medicine or a cure. Skyrizi was already used for Crohn’s disease, with initial doses through a vein followed by maintenance injections under the skin. The new option allows eligible patients to use an on-body injector from the beginning, after training by a health care professional.

For patients and caregivers, the practical difference is the setting: treatment no longer has to begin with three infusion appointments. Medical supervision, testing and follow-up still matter.

The starting phase is called induction. Its job is to bring active disease under control. Maintenance treatment then continues to help keep that response. Crohn’s disease causes inflammation in the digestive tract and can produce persistent diarrhea and abdominal pain.

Under the updated prescribing information, the at-home starting regimen is given at weeks zero, two, four and eight. Each starting dose is 720 milligrams, delivered as two 360-milligram injections using the on-body injector. The intravenous option remains available: 600 milligrams at weeks zero, four and eight.

Both routes lead to maintenance injections starting at week 12 and then every eight weeks. The patient’s clinician chooses the maintenance dose. These schedules are specific to Crohn’s disease; patients should not apply them to another condition treated with Skyrizi.

The drug, also called risankizumab-rzaa, blocks interleukin-23, a protein involved in inflammation. The approval adds another way to deliver that treatment rather than changing its basic target.

AbbVie said the approval was supported by the Phase 3 AFFIRM study, which compared the injected starting regimen with placebo. In the overall population reported in the company’s approval announcement, 56% of patients receiving Skyrizi reached clinical remission at 12 weeks, compared with 30% receiving placebo. Clinical remission was measured using a Crohn’s disease activity score; it does not mean the disease has been cured.

The company also reported an endoscopic response in 43% of treated patients, compared with 15% in the placebo group. That measure looks for improvement in inflammation seen during an examination of the bowel. These results do not establish that the new starting injections work better than the existing intravenous regimen: the comparison described was against placebo.

At-home administration does not remove the medicine’s risks. The prescribing information warns about serious allergic reactions, infections and possible liver injury. For Crohn’s treatment, liver tests are required before treatment and during the starting phase, at least through 12 weeks. Live vaccines should be avoided during treatment, and patients need instruction on how to use the injector.

The approval does not establish what an individual patient will pay or whether a particular insurance plan will cover the new starting regimen. AbbVie says assistance programs are available for people who meet their eligibility rules.

The company’s updated prescribing information lists both starting options, while its patient dosing guide says people using the device at home receive training from a health care professional first.

JBizNews Desk | North Chicago, Illinois

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The Food and Drug Administration has proposed cadmium action levels for processed foods intended for children younger than two, opening a public-comment period on limits ranging from 10 to 45 parts per billion across food categories.

The October 22 announcement is part of the agency’s Closer to Zero initiative to reduce children’s dietary exposure to heavy metals while maintaining access to nutritious food. The proposal is draft guidance, not a finalized new requirement.

The Federal Register notice sets out proposed action levels of 10 parts per billion for fruits, vegetables other than single-ingredient carrots, and mixtures including grain- and meat-based mixtures; 25 parts per billion for single-ingredient carrots; 45 for dry infant cereals; 20 for yogurts, puddings and custards; and 25 for single-ingredient meats.

Action levels would help inform whether the FDA regards a food as adulterated and whether to take enforcement action in a particular case. The agency says it would consider other factors as well. The guidance itself would remain nonbinding when finalized.

Cadmium occurs naturally in the earth’s crust and can also enter the environment through pollution. Foods can absorb trace amounts from the environments where they are grown or raised. The FDA says low-level exposure is common and generally not harmful, but excessive exposure can pose health risks. Babies and young children can be more susceptible because of their small bodies and different metabolisms.

The agency says completely eliminating heavy metals from food may not be possible, but manufacturers can take steps to reduce them. It considers the proposed levels achievable when control measures are used.

Comments under docket FDA-2025-D-4023 are due December 22 for consideration before the agency begins work on final guidance. A separate draft on controlling chemical hazards in food manufacturing is open for comment through January 21, 2027.

For food makers, the proposal gives a clearer target for reducing cadmium in products for very young children. For parents, it is important to distinguish that proposed target from a recall or a finding that every product above it is unsafe: the FDA says action levels would inform case-by-case enforcement, and the guidance would be nonbinding.

JBizNews Desk | Washington, D.C.

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The Food and Drug Administration has approved Awiqli as the first once-weekly insulin for children aged 10 and older with type 2 diabetes, extending an option already cleared for adults earlier this year.

The FDA says the long-acting insulin, insulin icodec-abae, is used alongside diet and exercise to improve blood-sugar control. It is given as an injection under the skin once a week.

Novo Nordisk announced the expanded approval October 23 from its U.S. headquarters in Plainsboro, New Jersey. The change reduces the frequency of basal insulin injections from seven per week to one. It does not mean every child with diabetes can replace all treatment with a weekly injection: the approval is specifically for type 2 diabetes in patients aged 10 and older.

What changed from older daily insulins?

Long-acting, or basal, insulin supplies background insulin between meals and overnight. Older molecules include glargine, degludec and detemir. They are not insulin icodec under another name. Their schedules also differ: degludec is labeled for once-daily use, while detemir’s label describes once- or twice-daily use. Glargine is another daily option. Awiqli’s adult trials compared its weekly schedule with daily glargine or degludec.

Icodec is an engineered insulin molecule, not simply ordinary insulin poured into a more concentrated pen. Its prescribing information describes changes to the building blocks of insulin and an added molecular side chain. It temporarily attaches to albumin, a protein in the blood. This creates a reserve that releases insulin slowly. Its half-life, the time for the amount in the body to fall by half, is about a week. It still sends the same insulin signal to cells to lower blood sugar.

The pen is concentrated at 700 units per milliliter, but how much fits in a pen is not the same as how long it works. The engineered molecule and its albumin binding support the weekly action. The concentration allows insulin units to fit into a smaller volume; it does not mean a patient should improvise a dose conversion. The label warns about medication errors and requires individualized dosing and monitoring when changing insulin regimens.

There are two developments here: a weekly basal-insulin design, and a new U.S. approval extending it to children 10 and older with type 2 diabetes. The FDA had already approved Awiqli for adults earlier in 2026. The European Medicines Agency lists an EU authorization dated May 17, 2024 for adults with diabetes, covering type 1 and type 2; its overview still describes adult use, not this new U.S. pediatric indication. The EMA also flags a higher low-blood-sugar risk in type 1 compared with daily long-acting insulin. Regional approvals are not identical: the U.S. indication is type 2, not type 1.

For an eligible patient already using daily basal insulin, the practical change can be one basal injection per week instead of seven. It is not a cure for diabetes, a replacement for glucose monitoring, or a promise to eliminate other diabetes medicines or mealtime insulin.

How is weekly insulin different from Ozempic?

Awiqli and Ozempic are different medicines, not the same formula in different pens. Both are injected once a week, but Awiqli contains insulin icodec-abae, a long-acting form of insulin. Ozempic contains semaglutide, a GLP-1 receptor agonist, not insulin.

The FDA explains that insulin helps move sugar from the blood into cells and reduces the liver’s production of glucose. Awiqli supplies insulin action over a weekly interval. Semaglutide instead activates the body’s GLP-1 hormone receptors: when blood sugar is high, it helps the pancreas release insulin and lowers glucagon, a hormone that raises blood sugar. It also delays stomach emptying, according to Ozempic’s FDA label. The National Institute of Diabetes and Digestive and Kidney Diseases says GLP-1 medicines can reduce hunger and help with weight loss. Awiqli is not a weight-loss medicine; weight gain is a listed possible side effect.

Why might a child need insulin instead?

The type of diabetes matters, not just age or weight. In type 1 diabetes, the immune system destroys insulin-producing cells. Insulin is needed to replace what the body cannot make, the NIDDK explains; a GLP-1 drug does not replace that missing insulin. In type 2, the body does not use insulin well or make enough of it, and some people need insulin as well as, or instead of, other medicines. This Awiqli approval is for type 2 diabetes, not type 1.

Ozempic’s U.S. label covers adults with type 2 diabetes, including specified heart and kidney risk-reduction uses. It is not approved for children: the label says pediatric safety and effectiveness have not been established. That does not mean all GLP-1 medicines are off-limits to children. For example, once-weekly Trulicity (dulaglutide) is approved for type 2 diabetes from age 10. Wegovy injection contains semaglutide, like Ozempic, but has its own formulation, dosing and approval for weight management in children 12 and older with obesity, alongside diet and physical activity. Ozempic itself is not approved for weight management. An obesity approval is not an approval to replace insulin.

Awiqli is now approved for adults and children 10 and older with type 2 diabetes. Its availability does not mean every child with diabetes needs insulin or should switch medicines. The NIDDK says treatment depends on diabetes type, blood-sugar control and other health factors. A shared weekly schedule does not make these drugs interchangeable. Their ingredients, doses, actions and approved uses differ; Ozempic’s label also warns that combining it with insulin can increase low-blood-sugar risk.

What did the studies show?

In a 52-week trial of 984 adults with type 2 diabetes who had not previously used insulin, Awiqli’s prescribing information reports a 1.51-percentage-point reduction in HbA1c, a measure of longer-term blood-sugar control, versus 1.33 points with daily insulin glargine. Both groups continued background non-insulin medicines. These are adult blood-sugar results, not proof of weight loss or a head-to-head comparison with Ozempic.

Separately, Ozempic’s label reports that a 30-week adult trial using placebo, an injection without the active medicine, found HbA1c reductions of 1.4 and 1.6 percentage points with the two studied semaglutide doses, versus 0.1 point with placebo. Its label also reports body-weight reductions. Different study populations and designs mean those figures cannot establish which medicine is better for a particular child. The new approval for children relied on adult results and a study of how children process the drug:

The pediatric decision drew on evidence from adult studies and a single-dose study involving 18 pediatric patients. The FDA says children absorbed the first dose faster than adults, but mathematical modeling indicated that blood levels become similar after the first few doses. On that basis, the agency expects the treatment to lower blood glucose in children in a similar way to adults.

Low blood sugar is the most common adverse reaction associated with insulin, including Awiqli. The FDA warns that severe episodes can cause seizures, unconsciousness, life-threatening complications or death. Other risks include allergic and injection-site reactions, swelling and weight gain.

The agency also warns about medication errors and accidental overdose because the product is dosed differently from other insulins. Its notice directs patients to check the product label and the dose displayed on the pen before each injection and consult the prescribing information for the full risks.

JBizNews Desk | Plainsboro, New Jersey

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MADRID — For AstraZeneca, a major oncology conference here this weekend has been a sign of how the company’s cancer work is steamrolling ahead, with highlights from a mix of old standbys and new molecules that could expand its armament of medicines even further.

Four of the 12 presentations slotted in the presidential sessions at this year’s European Society for Medical Oncology’s congress featured AZ medicines. The meeting captured just how wide-ranging the company’s cancer work is, showing the power of new combinations of approved drugs and putting a spotlight on what could be the company’s next targeted chemotherapy to reach the market. 

“That does speak to the breadth of the portfolio, but also the depth and quality of the data that we’re presenting,” Susan Galbraith, the head of AZ’s cancer R&D, told STAT. 

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Over 50,000 people were killed this past summer in Europe due to a brutal heat wave, marking it as the deadliest the continent has ever faced, CNN reported on Friday.

The report cited a new analysis published in two peer-reviewed papers in the journal Nature Health that attributed over half of the deaths to climate change driven by fossil fuel pollution.

According to the journal, temperatures reached levels 2.9 degrees Celsius above the 1991-2020 average, with some areas seeing periodic temperatures over 12 degrees Celsius above the average.

The findings come as world leaders are set to attend annual United Nations climate talks in Turkey, according to CNN, with a UN report earlier last week warning that the planet has missed its chance to limit the effect of global warming to an increase of 1.5 degrees Celsius above pre-industrial levels.

The Nature Health report concluded that the 2026 summer season was “likely to have been the most dangerously hot summer that Europe has experienced to date,” with southern and western Europe being worst affected.

UK, other generally cooler European regions experienced record heat, CNN reports 

CNN noted that the United Kingdom and other European regions known for cooler climates also suffered from thousands of heat-related deaths.

Nature Health evaluated 854 European cities in 30 countries, comparing recorded temperatures with those estimated after removing climate change from the equation. Scientists then used the relationship between high temperatures and daily deaths to model the likely number of heat-related deaths between June and August through peer-reviewed research.

According to the report, over 800 people between the ages of 20 and 44 were killed by the heat wave, though the highest rates were among those 85 and older.

An estimated total of 50,391 people died over the summer, with the analysis noting the death toll as being substantially higher than the 2022 and 2003 summer heat waves in Europe, as well as the highest in 26 years.

The journal also found that fossil fuel pollution-driven climate change accounts for about two-thirds of modern heat-related deaths, compared with around 40% earlier this century.

“I think we can be quite confident in stating that the summer of 2026 is likely to have been the worst on record for heat-related mortality across much of Europe,” Clair Barnes, an author on the reports and an extreme weather and climate change researcher at Imperial College London, told CNN. “We’re well off-track to limit the worst consequences of climate change, and governments need to realize that without faster action and coordination, things will only get worse.”

“Until we kick the fossil fuel habit, we will continue to see increasingly hot and dangerous summers,” she added. “These numbers are a stark reminder that our hotter, more extreme summers are having an increasingly severe impact on public health. Behind these statistics are real people whose lives were lost and real families who grieve for them.”

Extreme heat a ‘silent killer,’ Warwick University associate professor says

Warwick University health and environment associate professor Raquel Nunes told CNN the findings are “growing evidence of how deadly extreme heat can be, despite being described as a ‘silent killer’ due to its impacts not always being immediately visible.”

Nunes, who CNN noted was not involved in the research, added that the high death toll amongst those under 65, numbering in the thousands, was particularly alarming.

European Mortality Monitoring Network (EuroMOMO) chief physician Lasse Vestergaard acknowledged that the Nature Health findings largely matched the network’s, but advised CNN that the results must be treated with caution “as they involve several uncertainties and assumptions.”

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MADRID — With the first pivotal trial showing a customized mRNA treatment improved outcomes for cancer patients presented here this weekend, the conversation has already turned to how melanoma specialists should adopt the medicine — and how widely these novel vaccines can be deployed. 

“In principle, this type of approach may be applicable to other types of tumors,” James Larkin of London’s Royal Marsden Hospital, the scientific co-chair for this year’s European Society for Medical Oncology meeting, said at an opening press conference.

The trial, from Merck and Moderna, demonstrated that the bespoke mRNA-based vaccine intismeran reduced the risk of recurrence or death by 42% when combined with Merck’s checkpoint inhibitor Keytruda versus Keytruda alone. The results are a clear victory for the field after what Vinod Balachandran of Memorial Sloan Kettering Cancer Center called in a lecture a “long and sordid” history of trying to develop cancer vaccines that, until now, has essentially added up to 100 years of failure. 

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You’re reading our ESMO in 30 Seconds newsletter. Sign up here to get updates from the major European cancer conference in your inbox.

Hello again from Madrid, where we can tell you it’s Day 2 of the European Society for Medical Oncology’s annual meeting, but definitely not what day of the week it is. Perhaps some of the other nearly 40,000 people here can relate?

Enjoy today’s newsletter; we’ll be back with one more edition wrapping up the conference Monday afternoon. And on Thursday, join us for The STAT Recap, where we’ll catch you up on all the ESMO news you need to know, and answer your questions live. 

Continue to STAT+ to read the full story…

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Five years after being diagnosed with multiple sclerosis, actor Christina Applegate revealed this week that she had been misdiagnosed. Her experience puts a public face on one of the most consequential challenges in neurology: how to diagnose a complex disease early enough to prevent irreversible damage without sacrificing accuracy.

How MS is diagnosed has changed dramatically during my nearly four decades in the field. When I began my career, physicians often had to wait for symptoms to recur before they could confirm MS. Today, advances in imaging, biomarkers, and diagnostic criteria are helping us recognize the disease earlier, when treatment may have the greatest opportunity to prevent irreversible neurological damage.

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To encourage robust, good-faith discussion about issues raised in First Opinion essays, STAT publishes selected Letters to the Editor received in response to them. You can submit a Letter to the Editor here, or find the submission form at the end of any First Opinion essay.

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Since five members of the American Diabetes Association were ejected from its scientific session in New Orleans on June 5, the professional organization has released two explanations, one apology, one summary of its review of the events, and one notice of further review. Members have protested through petitions and an 1,100-member boycott. The flagship journal has stopped accepting manuscripts and grant reviews, fundraisers, and educational activities have ceased. 

On Friday, the ADA posted a news release about the long-awaited review, three days after it disclosed without explanation the departure of Rita Kalyani, its chief medical and scientific officer. 

The post offered background for the evictions, citing a “written threat that there would be protest and disruption,” but also backed off from previous explanations, noting that the “ADA’s code of conduct didn’t explicitly state that distributing materials inside the convention center was prohibited.”

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Hello from Madrid, where this year’s European Society for Medical Oncology conference got off to an unexpected start with the leak of the meeting’s most anticipated data. See below for a rundown of what’s happened, and stay with us the next few days as we cover the reaction to that study and a whole lot more. We’re at andrew.joseph@statnews.com and adam.feuerstein@statnews.com for any thoughts, questions, or opinions on what makes a good vermouth. 

The Moderna-Merck melanoma cancer vaccine data arrived early 

As reporters, nothing juices your adrenaline, or spikes your frustration, more than a major embargo violation of the most highly anticipated data presentation at ESMO. All carefully laid plans went right out the window on the eve of the conference. We were NOT the guilty party. 

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Most new cancer medicines approved by European regulators over a recent four-year period do not offer high clinical benefit and those that do were generated by a small number of drugmakers, mostly based in Asia, according to a new analysis.

Just 31% of 97 approved indications for 63 different cancer treatments offered a high clinical benefit and only nine of those medications received the top grade based on measurement tools used by the European Society for Medical Oncology. And of the 63 cancer drugs, just 19 were deemed to have at least one high-benefit indication.

Meanwhile, five drugmakers accounted for more than half of all 30 high-benefit indications for medicines approved by European regulators from January 2022 through July 2026. And four of those five companies are based in either China or Japan, which the researchers suggested is a “fundamental shift in the innovation ecosystem” over the past decade.

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Bristol Myers Squibb on Friday reported that one patient died after receiving its investigational CAR-T therapy in an early autoimmune trial, adding to safety concerns about a growing field of research.

In a Phase 1 trial that tested the therapy in multiple sclerosis, a condition that causes muscle weakness and extreme fatigue, the patient experienced motor symptoms that did not resolve with standard autoimmune treatments. They were then given a potent immunosuppressant, but developed septic pneumonia and died, Bristol said in a press release.

This comes as safety events in CAR-T autoimmune trials have started to emerge. In September, in response to questions from analysts and reporters, Bristol said it paused studies of its therapy after observing “transient and reversible inflammatory events during routine study surveillance.” Around the same time, Novartis, also in response to questions, disclosed that three patients died in its CAR-T autoimmune studies after experiencing a condition in which the immune system becomes overactive.

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A multiple sclerosis treatment from Novartis cut by a third the rates of relapses that people with the condition have compared to a standard treatment, data presented Friday show. While that efficacy doesn’t match the performance of a rival drug from Roche, Novartis’ treatment has a cleaner safety profile that could give it a shot at being competitive in the market.

In two Phase 3 studies in the relapsing form of MS, the Novartis drug, called remibrutinib, reduced the so-called annualized relapse rate by 35.2% and 31.2% when tested against Sanofi’s approved drug Aubagio. That translates into about one relapse every 13 years, Heinz Wiendl, a neurologist at the University of Freiburg, said while presenting the data from the REMODEL-1 and -2 studies at an MS conference in Toronto. 

In its own pivotal studies, Roche’s drug fenebrutinib cut the relapse rate by more than 50% versus Aubagio. 

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