From Washington, DC,

• The American Hospital Association News tells us,
  • “President Trump today released his discretionary spending budget blueprint for fiscal year 2026. The “skinny budget” request, which includes top line discretionary funding priorities, is not binding but can act as a starting point for Congress and the administration as they begin the appropriations process to fund the government. The administration later this month is expected to issue its full budget request, which will include its proposed changes to mandatory spending and tax policy.”  

• Bloomberg Law adds,
  • “The president’s [skinny] budget calls for $557 billion in non-defense spending next year, which represents a cut of $163 billion from current levels. National security funding would increase to $1.01 trillion, a 13% increase from the previous year. Any final spending plan for regular agency budgets will need some Democratic support to pass the Senate, one of the few opportunities the minority party has to exert some leverage while Republicans have unified control over the federal government.”

• Federal News Network informs us,
  • “Amid the Trump administration’s sweeping overhaul of the federal workforce, the Office of Personnel Management has shuttered an office that was central to developing leadership skills governmentwide.
  • “The Center for Leadership Development (CLD), an arm within OPM’s Human Resources Solutions (HRS) office, was bulldozed as part of an OPM reduction in force (RIF) in April. Federal News Network confirmed the elimination of the office with OPM, as well as two sources who provided further information on the condition of anonymity for fear of professional retribution.
  • “About 140 employees were working in the CLD office back in January, but those numbers had dwindled to about 80 employees over the last few months, according to an OPM employee familiar with the situation. Many CLD employees opted into the deferred resignation program (DRP) or voluntarily left their jobs. OPM notified the remaining employees on April 18 that their positions were being eliminated as part of the agency’s RIF.”

From the Food and Drug Administration front,

• The Wall Street Journal reports,
  • “Novo Nordisk NOVO.B said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense race to get an oral weight-loss medication on the market.
  • “The Bagsvaerd, Denmark, company said Friday that if the application is approved, Wegovy would become the first oral formulation of a GLP-1 drug for chronic weight management.
  • “The FDA’s deadline to decide on the application will be in the fourth quarter, the company said.
  • “The application is based on results from a phase 3 randomized, controlled trial evaluating the efficacy and safety of the drug over 64 weeks, the company said.”

• Per a National Cancer Institute news release,
  • “The Food and Drug Administration (FDA) has approved the combination of two immunotherapy drugs for the initial treatment of some people with advanced colorectal cancer. The approval is for the use of nivolumab (Opdivo) and ipilimumab (Yervoy) for people whose tumors are classified as MSI-H or dMMR.
  • “About 5% of people with advanced colorectal cancer have MSI-H or dMMR tumors, which means the tumors are unable to properly repair certain types of DNA damage that can occur during cell division. Several colorectal cancer experts said the approval should immediately make the combination the preferred initial, or first-line, treatment for people with advanced MSI-H or dMMR colorectal cancer. 
  • “The approval was based on updated findings from a large clinical trial, called CheckMate-8HW in which all participants had advanced colorectal cancer with MSI-H or dMMR tumors. Patients in the trial who were treated with the combination of nivolumab and ipilimumab lived substantially longer without their cancer getting worse, a measure known as progression-free survival, than patients treated with nivolumab alone.”

• Modern Healthcare reports,
  • GE HealthCare said Friday it received Food and Drug Administration clearance for its artificial intelligence tool that uses deep learning to outline organs at risk in MRI images and help improve radiation therapy planning.
  • MR Contour DL can outline 37 organs and structures in the head-neck and pelvic areas. The process previously had to be done manually.
  • The AI model will be integrated into the company’s Intelligent RT radiation therapy workflow management solution, which provides clinicians with a real-time view of a patient’s radiation therapy treatment journey.

• Cardiovascular Business relates,
  • “The U.S. Food and Drug Administration (FDA) has approved the balloon-expandable Sapien 3 transcatheter aortic valve replacement (TAVR) platform from Edwards Lifesciences for treating asymptomatic severe aortic stenosis (AS). 
  • “This is the first time the FDA has approved any TAVR technology in asymptomatic patients. The decision covers the Sapien 3, Sapien 3 Ultra and Sapien 3 Ultra Resilia TAVR valves.
  • “This approval is a powerful opportunity to streamline patient care and improve the efficiency of the healthcare system,” Larry Wood, Edwards’ corporate vice president and group president of TAVR and surgical technologies, said in a statement announcing the news. “We are proud to partner with leading physicians to advance our knowledge of this deadly disease with high quality science and optimize the treatment pathway for patients.”

• MedTech Dive adds,
  • “Intuitive Surgical received Food and Drug Administration clearance for its da Vinci Single Port surgical system for procedures performed through the anus.
  • “The clearance covers the use of the system for transanal local excision/resection, enabling physicians to reach lesions in the upper rectum without cutting the abdomen, according to the Thursday announcement. Conventional transabdominal rectal resection can require multiple incisions and the removal of the rectum. 
  • “Intuitive designed the single port device to navigate narrow body cavities. Physicians can control up to three multi-jointed instruments and a camera through a single entry point.”

From the public health and medical research front,

• The Centers for Disease Control and Prevention announced today,
  • “Seasonal influenza activity continues to decline. COVID-19 and RSV activity are declining nationally to low levels.
  • “COVID-19
    • “COVID-19 activity continues to decline nationally. Wastewater levels are at low levels, emergency department visits are at very low levels, and laboratory percent positivity is stable.
    • “Additional information about current COVID-19 activity can be found at: CDC COVID Data Tracker: Home
  • “Influenza
    • “Seasonal influenza activity continues to decline.
    • “Additional information about current influenza activity can be found at: Weekly U.S. Influenza Surveillance Report | CDC
  • “RSV
    • “RSV activity continues to decline in most areas of the country.
  • “Vaccination
    • “Vaccination coverage with influenza, COVID-19, and RSV vaccines remained low among U.S. adults and children during the 2024─25 respiratory virus illness season.”

• Per the AHA News,
  • “The U.S. has had 935 confirmed cases of measles so far this year, according to the latest data from the Centers for Disease Control and Prevention. Cases have been reported by 29 states, with Texas reporting the most at 683 — a 20% increase from last week. There have been 12 outbreaks, and 93% of confirmed cases (869 of 935) are outbreak-associated. The vaccination status of 96% of all cases is classified as “unvaccinated or unknown.”
    
• The University of Minnesota’s CIDRAP adds,
  • “The nation is now experiencing 12 [measles] outbreaks, one more than the previous week, and 93% of illnesses reported are connected to outbreaks.
  • “In related developments, CBS News reported yesterday that Health and Human Services Secretary Robert F. Kennedy Jr. would ask the CDC to develop new guidance for treating measles with drugs and vitamins. Today, the CDC posted new resources for public health departments and parents, along with a fact sheet for clinicians that covers two alternative treatments that Kennedy has pushed, including vitamin A, antibiotics, and inhaled steroids.”
• and
  • “Twelve more US children have died of influenza, surpassing theprevious high for a flu season outside of a pandemic year, the Centers for Disease Control and Prevention (CDC) said in its weekly update today.
  • “The pediatric deaths push the season total to 216, surpassing last season’s total of 207. Ten of the children died of influenza A, and two died from influenza B. Subtyping showed that eight of the influenza A deaths were caused by the H1N1 strain, and four were H3N2.”

• CNN offers an interview with its wellness editor, who is an emergency medicine doctor, about whooping cough.

• Per the University of Minnesota CIDRAP,
  • “A study published earlier this week in Nature Communications using claims data from the US Veterans Affairs (VA) Healthcare System finds protection from the 2024-25 Pfizer COVID-19 vaccine was 68%, 57%, and 56% against COVID-19–associated hospitalizations, emergency department and urgent care (ED/UC) visits, and outpatient visits, respectively.
  • “However, the authors caution that uptake of the vaccine was extremely low—only 3.7% through November 2024—and the study did not assess waning effectiveness.”

• The New York Times reports,
  • The video is just under two and a half minutes long. A slim man with close-cropped hair walks into a room, pulls a long black mamba — whose venom can kill within an hour — from a crate and allows it to bite his left arm. Immediately after, he lets a taipan from Papua New Guinea bite his right arm. “Thanks for watching,” he calmly tells the camera, his left arm bleeding, and then exits.
  • Over nearly 18 years, the man, Tim Friede, 57, injected himself with more than 650 carefully calibrated, escalating doses of venom to build his immunity to 16 deadly snake species. He also allowed the snakes — mostly one at a time, but sometimes two, as in the video — to sink their sharp fangs into him about 200 times.
  • This bit of daredevilry (one name for it) may now help to solve a dire global health problem. More than 600 species of venomous snakes roam the earth, biting as many as 2.7 million people, killing about 120,000 people and maiming 400,000 others — numbers thought to be vast underestimates.
  • In Mr. Friede’s blood, scientists say they have identified antibodies that are capable of neutralizing the venom of multiple snake species, a step toward creating a universal antivenom, they reported on Friday in the journal Cell.

• The AHA News notes, “Older adults may be in circumstances that exacerbate challenges to accessing behavioral health care and have complex needs that can complicate behavioral health treatment. This new infographic gives statistics about how behavioral health care needs change in an aging population.” 

• Healio tells us,
  • “Once-weekly semaglutide 2.4 mg significantly reduced steatohepatitis and liver fibrosis symptoms among adults with metabolic dysfunction-associated steatohepatitis and moderate or advanced liver fibrosis, researchers reported.
  • “In findings from part one of the ESSENCE phase 3 trialpublished in The New England Journal of Medicine,semaglutide 2.4 mg (Wegovy, Novo Nordisk) conferred greater improvements in multiple liver endpoints compared with placebo. In addition to greater improvements in steatohepatitis and liver fibrosis, researchers also observed greater weight loss, reduced insulin resistance and improvement in noninvasive liver markers with the GLP-1 medication.”

From the U.S. healthcare business front,

• Healthcare Dive reports,
  • “Cigna is building on client demand for tools to support patients on GLP-1 weight loss drugs, announcing two new programs on Friday meant to improve clinical care around the dispensing of GLP-1s and provide home delivery of the medications.
  • “The programs come as payers that contract with Cigna’s massive pharmacy benefit manager Express Scripts for their drug benefits want to offer GLP-1s but are put off by the medications’ steep list prices and unpredictable long-term outcomes, according to Cigna.
  • “The programs were announced in tandem with Cigna’s first quarter results, which came in well above analysts’ expectations. Revenue of $65.5 billion was up more than 14% year over year, while net income of $1.3 billion compares to a loss of $277 million same time last year. Cigna raised its 2025 profit outlook following the results.”
• and
  • “Amwell narrowed its losses on growing revenue in the first quarter as the telehealth vendor continued to roll out products as part of a contract with the Department of Defense.
  • “The company posted a net loss of $18.4 million, down from $73.4 million in the prior-year period. Amwell reported revenue of $66.8 million, compared with $59.5 million in the first quarter last year. 
  • “The telehealth firm has deployed scheduled virtual visits across the Military Health System, executives said in an earnings call Thursday. However, rollouts for its automated and digital behavioral health programs will take place in the third quarter instead of the second due to leadership changes at the Defense Health Agency, leaders said.”

• Fierce Healthcare points out,
  • “UnitedHealth Group and Amedisys have found buyers for key divestitures aimed at getting their $3.3 billion merger over the finish line, according to new filings.
  • “In documents submitted to the Securities and Exchange Commission (SEC), Amedisys said April 30 the companies entered an agreement to sell off certain Amedisys home health and hospice centers, as well as some of UnitedHealth’s care centers, to BrightSpring Health Services and the Pennant Group.
  • “Completion of these sales is contingent on several factors, according to the filing, including the final closure of the UnitedHealth-Amedisys deal.
  • “Financial terms were not disclosed in Amedisys’ filing, but the Pennant Group noted in a separate SEC document that it would pay about $102.5 million for the assets it’s buying from Amedisys and UnitedHealth.”
    
• Per Biopharma Dive,
  • “Amgen on Thursday said its just-launched biosimilar of Johnson & Johnson’s autoimmune drug Stelara recorded $150 million in sales in the first quarter, spotlighting rising revenue from the biotech’s portfolio of copycat biologics.
  • “During the company’s first quarter earnings call, commercial chief Murdo Gordon said Amgen’s biosimilar products recorded $735 million in sales, roughly 9% of the company’s revenues. Those sales climbed 35% compared to the same period last year, showing the business “continues to contribute meaningfully to our long-term growth,” CEO Robert Bradway said.
  • “Still, Amgen’s overall performance is uneven. While some products are thriving, like an Avastin lookalike that booked $179 million in sales, others, such as its Humira biosimilar are struggling. Amgen recently launched a biosimilar version of Regeneron’s eye drug Eylea and could begin marketing a copycat form of AstraZeneca’s rare disease treatment Soliris sometime before the middle of the summer.”
• and
  • “Madrigal Pharmaceuticals said its pioneering medicine for a common liver disease brought in $137.3 million in the first quarter, surpassing analyst estimates by more than $20 million. 
  • “More than 17,000 patients have now taken the drug, known as Rezdiffra, Madrigal said Thursday. It won Food and Drug Administration approval in March 2024, becoming the first medication cleared to treat metabolic dysfunction-associated steatohepatitis, or MASH.
  • “The company said it’s now looking toward a potential mid-year approval that would position Rezdiffra as the first available MASH treatment in Europe. CEO Bill Sibold said he’s looking to build on what he described as an “exceptional launch” in the U.S.”

• Fierce Pharma adds
  • “AstraZeneca has taken a key step in advancing Breztri Aerosphere toward a potential label expansion and achieving its goal of annual sales of $3 billion to $5 billion for the 3-in-1 inhaler.
  • “Two phase 3 trials evaluating the effectiveness and safety of Breztri in a total of 4,434 patients with uncontrolled asthma have met their primary endpoints. The studies showed that Breztri delivered statistically significant and clinically meaningful improvements in lung function compared to dual-drug combinations of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) maintenance treatments, AZ said.
  • “Data from the KALOS and LOGOS studies will be shared with regulatory authorities and presented at an upcoming medical meeting, the company added.”