From Washington, DC,

• Federal News Network tells us,
  • “The White House is not requesting an increase in pay for federal employees in fiscal 2026. President Donald Trump released more details of his budget request for next year late Friday afternoon. The appendix section of the budget proposals also includes provisions to continue the pay freeze for certain non-career Senior Executive Service members and political appointees. In all, the new budget document details more specific discretionary spending requests for each agency. Unlike the “skinny” budget released in early May, the administration did include funding requests for the Office of Personnel Management, the Education Department and independent agencies like the Consumer Financial Protection Bureau.”

• Healthcare Dive adds,
  • “The White House released a more detailed budget proposal on Friday that yields more information on how the Trump administration is aiming to reshape the HHS next year, including drastic cuts to the National Institutes of Health.
  • “The updated proposal doubles down on plans to slash the NIH’s budget nearly in half, consolidate the HHS’ 28 operating divisions into 15, eliminate dozens of federal healthcare and social welfare programs and terminate more than 5,000 contracts.
  • “The Trump administration argues the changes are necessary to streamline HHS functions and eliminate priorities around diversity, equity and inclusion panned by conservatives.
  • ‘The administration can’t fully implement the budget without the support of Congress. Lawmakers usually make changes to the executive branch’s spending wish list in appropriations legislation.

• Beckers Hospital Review points out,
  • “HHS has proposed oversight of the 340B drug pricing program to the Centers for Medicare & Medicaid Services as part of a broader reorganization. 
  • “The move, initially referenced in a preliminary memo from White House officials in April, would place the 340B program under CMS’s Program Management authority, allowing the agency to use its in-house drug pricing expertise and streamline oversight, according to HHS’s Budget in Brief. 
  • “Funding for 340B oversight would be maintained at $12 million to “provide oversight and auditing of covered entities and drug manufacturers, support operational improvements, and increase operational efficiencies,” the document said. 
  • “The 340B drug pricing program requires drug manufacturers to offer discounts on outpatient prescription drugs to eligible safety-net hospitals. CMS Program Management is a key part of the federal health infrastructure, overseeing the administration of Medicare, Medicaid, the Children’s Health Insurance Program and the Federal Exchange.” 

• Per Federal News Network,
  • “The Trump administration is proposing changes that would make it easier to fire federal employees accused of misconduct in a matter of days, because they no longer meet “suitability and fitness” standards required to join the federal workforce.
  • “The Office of Personnel Management, in a proposed rule it will publish Tuesday in the Federal Register, plans to expand suitability adjudications normally reserved for federal job applicants to include current employees.
  • “The proposed rule, once finalized, would allow the Trump administration to fast-track the firing of federal employees, on the grounds that they no longer meet suitability standards for federal employment.
  • “OPM’s proposed rule states agencies must remove federal employees within five workdays, if it decides they no longer meet the suitability standard.”

From the Food and Drug Administration front,

• Cardiovascular Business reports,
  • “BiVacor has received the FDA’s breakthrough device designation for its titanium Total Artificial Heart (TAH), which serves as a bridge to transplant for patients with end-stage heart failure.
  • “BiVacor’s TAH is based on rotary blood pump technology and approximately the size of an adult’s fist. It has no valves or flexing ventricle chambers, and its only moving part is a magnetically suspended double-sided centrifugal pump impeller.
  • “The FDA’s decision signals just how much potential the agency sees in this technology. The breakthrough devices program is designed to help medical devices make it through the approval process faster than they would otherwise. Its representatives work directly with the manufacturer, for example, and submissions are prioritized.
  • “This is more than a regulatory milestone,” Daniel Timms, PhD, founder and chief technology officer of BiVacor, said in a statement. “It’s a validation of a concept we’ve spent decades proving that a fully implantable, TAH isn’t just possible, it’s necessary. Patients with biventricular failure have been overlooked for too long. The early results from our clinical trial show that we can give them a second chance, without the compromises of older technologies. The breakthrough device designation puts us on a faster track to deliver exactly that.”

• MedPage Today notes,
  • “The FDA granted de novo authorization to the first artificial intelligence (AI) program to support breast cancer risk prediction from screening mammograms.
  • “The program, called Clairity Breast, analyzes mammograms for subtle features that correlate with future breast cancer risk, according to a news release from Clairity. The analysis results in a 5-year risk score validated from analysis of more than 77,000 mammograms from multiple hospital-based and free-standing mammography facilities.
  • “The system can be applied immediately to clinical practice, Larry Norton, MD, a breast cancer specialist at Memorial Sloan Kettering Cancer Center in New York City, told MedPage Today.
  • “We’re very excited about it,” said Norton, who also is founding scientific director of the Breast Cancer Research Foundation, which supported development of Clairity Breast. “We were confident that it’s going to turn out to be something that’s going to help people, something that we think really has great science behind it.”

From the judicial front,

• Bloomberg Law reports,
  • “The US Court of Appeals for the Fifth Circuit granted a Texas doctor group’s request Friday to rehear its challenge to a Biden administration rule governing the arbitration process for surprise medical bill disputes.
  • “The No Surprises Act protects patients from most unexpected out-of-network bills by requiring insurers and medical providers to undergo an arbitration process for payment disputes. But the process is the subject of countless legal battles, and the Texas Medical Association has successfully challenged multiple provisions of the implementation regulations.
  • “A three-judge panel previously upheld several portions of the rule (RIN: 1210-AC17) in a mixed decision regarding the qualifying payment amount—a key factor arbitrators use to settle disagreements. The Texas Medical Association had asked the full panel to reconsider the decision upholding the exclusion of bonuses as well as the inclusion of “ghost rates,” or contracted rates for services that a doctor hasn’t actually provided.”

From the public health and medical research front,

• CBS News reports,
  • “The Centers for Disease Control and Prevention has updated its warning about the risk of contracting measles while traveling, after the agency tallied dozens of cases so far this year in travelers who were infectious while flying on airplanes within the U.S.
  • “Travelers can catch measles in many travel settings including travel hubs like airports and train stations, on public transportation like airplanes and trains, at tourist attractions, and at large, crowded events,” the agency now says, in an update published Wednesday.”

• Per HCPLive,
  • “Cardiac deaths have risen since 2020, with more occurring at home, indicating a potential gap in care for heart disease patients during the pandemic.
  • “Hospital data showed a 20–34% reduction in acute myocardial infarction hospitalizations, while at-home cardiac deaths increased, suggesting changes in care-seeking behavior.”

• MedPage Today informs us,
  • “Measles, mumps, and rubella (MMR) vaccination rates in children declined in some counties across the U.S. during the COVID-19 pandemic, researchers found.
  • “Across 2,066 counties in 33 states with both pre- and post-pandemic vaccination data, the county-level mean MMR vaccination rate decreased from 93.92% to 91.26%, according to Lauren Gardner, PhD, of Johns Hopkins University in Baltimore, and colleagues.
  • “A decline in coverage was reported in 78% of counties during this time, and only four states — California, Connecticut, Maine, and New York — had an increase in median county-level vaccination rates, they reported in a JAMA research letter.”

• The American Medical Association tells us what doctors wish their patients knew about e-cigarettes.

• Consumer Reports, writing in the Washington Post, discusses “What to know about nerve pain and tingling hands and feet. Tingling or painful sensations in your hands and/or feet are the main symptoms of neuropathy.”

• The Wall Street Journal reports,
  • “Novartis said Pluvicto demonstrated positive results in patients with PSMA-positive metastatic hormone-sensitive prostate cancer.
  • “The Swiss pharmaceutical company on Monday said Pluvicto showed statistically significant and clinically meaningful benefits—including combined with hormone therapy versus hormone therapy alone—with positive trend in overall survival.
  • “The results are from a prespecified interim analysis of a Phase 3 trial, it said.
  • “Pluvicto is already approved for metastatic castration-resistant prostate cancer and now shows potential in patients in an earlier disease setting, it said.
  • “The company will present results at an upcoming medical meeting and based on FDA feedback, will submit for regulatory review in the second half of the year, it said.
  • “Pluvicto is a radioactive medication used to treat some types of prostate cancer.”

• Per BioPharma Dive,
  • “An experimental medicine from Vera Therapeutics succeeded in a late-stage trial in a rare kidney disease, positioning the company to discuss an approval application with U.S. regulators in the near future. 
  • “According to Vera, the drug, called atacicept, met its main goal in a Phase 3 trial in IgA nephropathy, a chronic condition that can lead to kidney failure. After 36 weeks of treatment, atacicept was associated with a 42% reduction versus a placebo — and a 46% decline from the study’s start — in the amount of protein in participants’ urine, an important marker of kidney health. 
  • “Without providing specifics, Vera said atacicept’s other efficacy results were “consistent with or better than” what was observed in mid-stage testing and had a safety profile “comparable to placebo.” The company will share the data with the Food and Drug Administration in the coming weeks and intends to file an accelerated approval request in the fourth quarter.”

• Per Fierce Pharma,
  • “Amgen has detailed a positive phase 3 readout for its T-cell engager Imdelltra in previously treated small cell lung cancer (SCLC).
  • “The DLL3xCD3 bispecific has shown that it can help patients live longer, has a more tolerable safety profile and improves certain cancer-related symptoms compared with chemotherapy in second-line SCLC, according to results from the phase 3 DeLLphi-304 trial. The data will be presented June 2 at the 2025 American Society of Clinical Oncology annual meeting and simultaneously published in The New England Journal of Medicine.
  • “The drug significantly reduced the risk of death by 40% versus chemo in SCLC patients who had tried one line of platinum-based chemotherapy. Patients in the Imdelltra arm lived a median 13.6 months, compared with 8.3 months for chemo.
  • “All patient subgroups appeared to have benefited, regardless of their prior PD-1/L1 exposure, presence of brain metastases or liver metastases, and the type of prior chemotherapy. Among those who had tried a PD-1/L1 inhibitor, Imdelltra’s death risk reduction was 39%. In PD-1/L1-naïve patients, the number was 35%.
  • “These data underscore Imdelltra’s potential to transform patient outcomes and the small cell lung cancer treatment paradigm,” Amgen’s R&D chief, Jay Bradner, M.D., said in a statement.
  • “Findings from the DeLLphi-304 trial could help convert Imdelltra’s accelerated approval earned last year into a full approval.”

From the U.S. healthcare business front,

• Fierce Healthcare relates,
  • “UnitedHealth Group shareholders signed off on the planned compensation package for newly-reinstated CEO Stephen Hemsley.
  • “Hemsley, who returned to the CEO role last month, will earn a $1 million base salary each year. He will also receive a one-time $60 million equity award in nonqualified stock options.”

• The Wall Street Journal reports,
  • “BioNTech & Bristol Myers will jointly develop BioNTech’s BNT327 cancer-drug candidate.
  • “Bristol Myers will make a $1.5B upfront payment to BioNTech, with $2B in payments through 2028.
  • “BNT327 is being evaluated in Phase 3 trials as a first-line treatment in lung cancer.”

• Per Fierce Pharma,
  • “In late April, when Sanofi revealed that it was selling a controlling stake in its consumer health business Opella for 10 billion euros ($11.4 billion), chief financial officer Francois Roger said that the French drugmaker would “explore external growth opportunities for bolt-on acquisitions.”
  • “Just five weeks later, Sanofi has made a deal few would describe as “bolt-on,” as it has bought out Massachusetts-based Blueprint Medicines for up to $9.5 billion.
  • “With the deal, Sanofi gains Blueprint’s portfolio of rare immunological disease treatments, including systemic mastocytosis (SM) pill Ayvakit, which generated sales of $479 million last year and has peak sales potential of $2 billion, the 14-year-old company projected last year.
  • “Blueprint also brings a next-generation SM candidate in elenestinib, a KIT D816V inhibitor which is the subject of a phase 2/3 study, and an early-stage KIT inhibitor BLU-808. KIT plays a central role in mast cell activation, Sanofi said, which is implicated in a broad range of inflammatory diseases.”
    
• STAT News lets us know,
  • “Atai Life Sciences, among the most prominent biotechs focused on psychedelic medicines, said Monday it will merge with private psychedelic startup Beckley Psytech, pending results of a trial for a drug based on the practice of “smoking toad.”
  • “The new company will be known as Atai Beckley, with Beckley Psytech shareholders receiving 31% of shares in the entity.  The deal, which values Beckley at $370 million, comes as the Trump administration has expressed support for the field.” 

• Beckers Hospital Review informs us,
  • “St. Louis-based Ascension is reportedly in talks to acquire ambulatory surgery center company AmSurg for about $3.9 billion, according to Bloomberg.
  • “AmSurg split from Envision Healthcare when the company emerged from bankruptcy in 2023. It is now backed by Pacific Investment Management Co., King Street Capital Management and Partners Group.
  • “A potential acquisition would significantly expand Ascension’s footprint in the ASC space, aligning with the broader trend toward lower-cost, outpatient care settings. AmSurg has a network of more than 250 surgery centers across 34 states and supports nearly 2,000 physicians, according to its website.”
• and
  • “Blythe, Calif.-based Palo Verde Hospital is at risk of shutting down due to financial challenges over resignations and months of litigation, The Desert Sun reported May 30. Becker’s reached out to the hospital, which remains open as of June 2. 
  • “Congressman Raul Ruiz, MD, raised concern for the 51-bed hospital in a May 28 letter, obtained by the Sun, to California Gov. Gavin Newsom, asking the state for $4 million in emergency funding, otherwise the hospital could shutter “as soon as tomorrow.”

• Beckers Hospital Review also collected eight GLP-1 updates for your information.

• Per Healthcare IT News,
  • “The Clinic by Cleveland Clinic, an initiative with telemedicine technology and services company Amwell, has been getting life-changing results from leading-edge virtual care. 
  • “The Clinic has been providing virtual second opinions by the many top specialists at the renowned healthcare organization. The platform connects patients to more than 3,500 specialists across Cleveland Clinic without the need for the patients to travel to a major medical center.
  • “Misdiagnoses contribute to more than 800,000 deaths or disabilities each year in the U.S., Johns Hopkins has found, costing the healthcare system hundreds of billions, beyond the human cost. 
  • “Data from the Clinic by Cleveland Clinic shows that in 67% of cases patients receive a new diagnosis or treatment recommendation after seeking a second opinion.”

• Per Fierce Healthcare,
  • “Electronic health records giant Epic announced Monday that more than 1,000 hospital customers and 22,000 clinics using its EHR are now live on a government-backed data exchange, as the company doubles down on a commitment it made last year.
  • “Epic said in an announcement that it marks a significant milestone in “making health information seamlessly and securely available wherever care happens.”
  • “In March, Epic reported that more than 2,000 hospital customers and more than 50,000 Epic clinics were either live or preparing to go live on the federal Trusted Exchange Framework and Common Agreement (TEFCA) framework for nationwide health data exchange, according to Becker’s Health IT.
  • “The company’s goal is to have all its customers live on TEFCA by the end of the year, Epic said in August. The health IT company now commands 42.3% of the hospital EHR market, up from 39.1% a year prior, so shifting all its hospital customers to TEFCA would represent a significant share of U.S. hospitals.”
• and
  • “Digital health company Scripta Insights is joining forces with RxSaveCard with the goal of making it easier for employers to manage drug costs and meet their fiduciary duties.
  • “RxSaveCard offers a proprietary cost management and payment solution for pharmacy benefits, and those tools will be integrated into Scripta’s AI-powered Rx Navigation platform.
  • “For members, the integration is designed so they can better find savings for a variety of drugs, including high-cost specialty products.
  • “The platform is designed to identify lower-cost options both in the member’s prescription drug coverage or through cash-pay, according to an announcement from the companies.”