From Washington, DC,

• The Wall Street Journal reports,
  • “Senate Majority Leader John Thune (R., S.D.) is trying to release this week a revised version of President Trump’s “big, beautiful bill.”
  • “But as he races to pass the legislation ahead of Republicans’ self-imposed July 4 deadline, he has got about as many problems as there are GOP senators, with lawmakers battling over the additional borrowing and spending cuts that will be used to finance tax relief, plus spending on the border and military.
  • “The House in May passed its own version by a one-vote margin, and Trump has urged the Senate to move the multitrillion-dollar bill quickly. But GOP senators want changes, and lawmakers disagree over the depth of cuts to Medicaid, clean-energy tax credits and nutrition assistance, with some seeking to protect their own states’ interests and others accusing colleagues of not taking federal deficits seriously.”

• The American Hospital Association News tells us,
  • “The White House June 6 issued a memorandum directing the Secretary of the Department of Health and Human Services “to take appropriate action to eliminate waste, fraud, and abuse in Medicaid, including by ensuring Medicaid payments rates are not higher than Medicare, to the extent permitted by applicable law.” In the memo, the administration expresses its view that rapid growth in state directed payment programs [“SPDs”] is a threat to the nation’s long-term stability, and that the “imbalance between Medicaid and Medicare payment rates under these programs jeopardizes access to care for seniors.”  
  • “The memo is in addition to the ongoing congressional reconciliation deliberations, which also include provisions impacting SDPs.”

• Per HHS news releases,
  • “Jim O’Neill was sworn in today [June 9, 2025] as the Deputy Secretary of Health and Human Services by Secretary Robert F. Kennedy, Jr. With decades of experience at the intersection of health care, technology, and public service, O’Neill will help Kennedy oversee an agency that includes the National Institutes of Health, the U.S. Food and Drug Administration, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and many others.
  •  “Jim O’Neill’s extensive experience in Silicon Valley and government makes him ideally suited to transition HHS into a technological innovation powerhouse. He will help us harness cutting-edge AI, telemedicine, and other breakthrough technologies to deliver the highest quality medical care for Americans,” said Secretary Kennedy. “As my deputy, he will lead innovation and help us reimagine how we serve the public. Together, we will promote outcome-centric medical care, champion radical transparency, uphold gold-standard science, and empower Americans to take charge of their own health.”
• and
  • “The U.S. Department of Health and Human Services (HHS) today took a bold step in restoring public trust, links to an external website, opens in a new tab by totally reconstituting the Advisory Committee for Immunization Practices (ACIP), an advisory committee that makes recommendations on the safety, efficacy, and clinical need of vaccines to the Centers for Disease Control and Prevention (CDC). Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the agency removed the 17 sitting members of the ACIP committee and will replace them with new members currently under consideration.” * * *
  • “ACIP will convene its next meeting, links to an external website June 25 through June 27 at CDC headquarters in Atlanta.”

From the Food and Drug Administration front,

• Per Fierce Pharma,
  • “As several pharma juggernauts prepare for the upcoming respiratory syncytial virus (RSV) season, the FDA has blessed Merck’s entrant. 
  • “The monoclonal antibody, clesrovimab, will be known commercially as Enflonsia and will challenge Sanofi and AstraZeneca’s blockbuster Beyfortus.
  • “Enflonsia has been approved to prevent lower respiratory tract disease from RSV in children who are born during or entering their first RSV season, the U.S. regulator said in a social media post. The nod arrived one day ahead of the agency’s target decision date.” * * *
  • “Meanwhile, Sanofi and AZ have been unchallenged with Beyfortus as the lone prophylactic RSV antibody for children. The drug generated sales of 1.7 billion euros ($1.8 billion) last year. In 2023, reports emerged that demand for the antibody outstripped early supply.
  • “Also Monday, Sanofi said that it and partner AZ have already manufactured as many doses of Beyfortus as they supplied last year and that production remains ongoing. The companies added that they will begin shipping early in the third quarter.
  • “Enflonsia has delivered trial results that suggest it can compete with Beyfortus.” 
• and
  • “A new era of hypertension treatment is on the horizon for U.S. patients with the FDA approval of George Medicines’ Widaplik, a three-in-one pill that can serve as an initial treatment to help lower blood pressure.
  • “The drug combines established high blood pressure meds telmisartan, amlodipine and indapamide and is the first triple-combination therapy to boast a label from the FDA that allows its use as an early treatment, helping patients who may need multiple drugs to achieve blood pressure goals with one fell swoop. 
  • “Its three dosing options—one low dose and two standard doses—can deliver the benefits of a triple-combo approach “early in the treatment pathway with an established safety profile and good tolerability,” according to a June 9 press release from George Medicines.”
  • “The drug is specifically approved for patients who are likely to need more than one medicine to achieve blood pressure goals.”
• and
  • “When it comes to the use of PD-1 inhibitors in stomach cancer, the FDA has put its money where its mouth is.
  • “After questioning the benefits of checkpoint inhibitors in stomach cancer cases without PD-L1 expression, the FDA has moved to restrict the use of Merck & Co.’s and Bristol Myers Squibb’s immunotherapies in those patients.
  • “BMS’ Opdivo, used in combination with chemotherapy, is now allowed in advanced or metastatic gastric, gastroesophageal junction (GEJ) and esophageal cancers only among patients whose tumors express PD-L1. Simultaneously, the approval for a combination of Opdivo and BMS’ Yervoy in first-line esophageal squamous cell carcinoma has also been limited to PD-L1-positive disease.
  • “Similarly, the label for Merck’s Keytruda in gastric, GEJ and esophageal cancers has been narrowed to PD-L1-positive tumors as well. The amendment to Keytruda’s gastric or GEJ adenocarcinoma uses only touches HER2-negative disease in this situation because the drug’s HER2-positive approvals in those settings had already been narrowed to PD-L1-positive cases in March.
  • “The revised indications reflect the patient populations for whom the drugs have favorable risk-benefit assessments, the FDA said in two separate letters (PDFs) sent to the drugmakers late May.”

• Per MedTech Dive,
  • “Baxter has recalled its Novum IQ large volume pump in response to an under-infusion risk linked to one serious injury report, the Food and Drug Administration said Friday.
  • “Baxter is keeping the pumps on the market and updating the instructions to advise users on how to prevent the devices from infusing up to 50% less than the set amount. More than 34,500 units are affected across the U.S. and Canada, according to a recall database entry. 
  • “Variability of 10% or more can put infants at risk of dehydration, inadequate drug therapy and nutrition and insufficient blood infusion, the FDA said, leading to serious harm and death.”

From the judicial front,

• Fierce Healthcare tells us,
  • “The leading organization representing pharmacy benefit manager companies is now also suing Arkansas officials over its new law banning PBMs from owning pharmacies. 
  • “Joining the Pharmaceutical Care Management Association (PCMA) in the lawsuit as a plaintiff is alternative PBM and founding member of TransparencyRx, Navitus Health Solutions. The lawsuit was filed in the Eastern District of Arkansas against the Arkansas State Board of Pharmacy.”
  • “Express Scripts and CVS Health had sued state officials at the end of May.”

From the public health and medical research front,

• The Wall Street Journal reports,
  • “Health officials are investigating a salmonella outbreak linked to eggs from August Egg Co. and sold under several brands.
  • “As of June 5, 79 people had been reported infected with the outbreak strain, with at least 21 hospitalizations, the Centers for Disease Control and Prevention said.
  • “The CDC, the Food and Drug Administration and state officials are investigating.
  • “August Egg, of Hilmar, Calif., recalled 1.7 million dozen brown cage-free and brown certified organic eggs.
  • “The eggs were distributed at stores including Walmart, Ralphs, Safeway, Save Mart, FoodMaxx, Lucky, Smart & Final, Raleys and Food 4 Less. Brands include Clover, First Street, Nulaid, O Organics, Marketside, Raleys, Simple Truth, Sun Harvest and Sunnyside.
  • “The eggs were available from various retailers in California and Nevada. Additionally, they were sold at Walmart locations in Washington, Arizona, Wyoming, New Mexico, Nebraska, Indiana and Illinois.”

• The American Medical Association lets us know what doctors wish their patients knew about myocarditis.

• Beckers Hospital Review shares information from an “American Cancer Society [study that] used data from the North American Association of Central Cancer Registries to calculate incidence rates per 100,000 people for each state and each cancer type” over the period 2017 through 2021. Kentucky had the highest incidence rate.

• MedPage Today points out,
  • “Participation in a cervical cancer screening program in a safety-net health system more than doubled when patients received at-home test kits by mail rather than just a telephone reminder to get screened, a randomized trial showed.
  • “Six months after initial contact, 17.4% of patients invited by telephone to attend a clinic-based screening had participated in the program as compared with 41.1% of those who had an at-home test for human papillomavirus (HPV) mailed to them. The participation rate increased to almost 50% among patients who received the home test kit and a follow-up phone call from a patient navigator. More than 80% of screening participants in the two self-collection groups, returned the home test kit as opposed to being tested in a clinic.
  • “The results suggest that use of self-collection test kits could be considered in safety-net settings with low participation in cervical cancer screening programs, reported Jane R. Montealegre, PhD, of the University of Texas MD Anderson Cancer Center in Houston, and co-authors in JAMA Internal Medicineopens in a new tab or window.
  • “Too many women, especially those who are uninsured, live in rural areas, or come from marginalized and underserved communities, aren’t getting screened for cervical cancer,” Montealegre said in a statement. “These results show that self-collection testing could be a solution to increasing access to screening and, in turn, reducing the burden of cervical cancer in the U.S.”
• and
  • “More widespread and consistent use of pre-exposure prophylaxis (PrEP) has the potential to dramatically reduce the incidence of HIV in the U.S., but substantial barriers to PrEP remain, particularly access, stigma, and non-HIV specialist physicians’ knowledge of the growing slate of options.
  • “New PrEP options on the horizon may help alleviate some of these barriers as physician awareness also increases. 
  • “There’s data from contraception [studies] that if you have more choice, the uptake is higher overall,” Matthew Spinelli, MD, of the University of California San Francisco, told MedPage Today. “PrEP is highly effective, and if the populations that need it had access to it, we would see the end of the HIV epidemic.” 

• The Wall Street Journal relates,
  • “For patients with a rare type of blood cancer, treatment might finally be coming out of the Dark Ages.
  • “People with the chronic condition polycythemia vera make too many red blood cells, thickening their blood and increasing the risk for clots, heart attacks or strokes. The main treatment consists of regular blood draws—essentially bloodletting—to keep the disease in check.
  • “But a new drug from Protagonist Therapeutics and Takeda can slow down a patient’s production of red blood cells and nearly eliminates the need for phlebotomies, new data show, potentially reducing patients’ fatigue and other consequences of routine blood draws.
  • “I think that this drug would really be groundbreaking for patients,” said Dr. Bart Scott, a professor at Fred Hutchinson Cancer Center in Seattle, who treats patients with polycythemia vera and had some who enrolled in the drugmakers’ trial. “The time for leeches is over.” * * *
  • “The 52-week [trial] data is expected around the spring of 2026, and Takeda plans to file for Food and Drug Administration approval after that, said Dr. Phuong Khanh Morrow, head of the oncology therapeutic area at Takeda.”

• Per BioPharma Dive,
  • “An experimental cholesterol-lowering pill from Merck & Co. succeeded in a pair of late-stage studies, the company said Monday [June 9, 2025].
  • “In one study, Merck’s drug, enlicitide, was tested against a placebo in people already taking statins and who have either an inherited condition that causes high cholesterol or are at risk of atherosclerosis. The second trial evaluated enlicitide against other oral therapies, such as ezetimibe, in people on statins and with abnormally high levels of fats in the blood.
  • “Merck didn’t provide specifics but said in both cases enlicitide met all of its study objectives and demonstrated “statistically significant and clinically meaningful reductions” in LDL-C, or “bad” cholesterol, without any important differences in the number of adverse events. Details will be presented at a future medical meeting. Company shares climbed 2% in early trading Monday.”

From the U.S. healthcare business front,

• Healthcare Dive reports,
  • “The healthcare industry added 62,000 jobs in May, exceeding the sector’s average monthly gain of 44,000 workers over the past year, according to a new report from the U.S. Bureau of Labor Statistics released Friday [June 6, 2025]. 
  • “Employers added 30,000 hospital jobs, 29,000 ambulatory healthcare services roles and 6,000 skilled nursing positions last month, according to the report. 
  • “The monthly jobs data demonstrates continued strong demand for healthcare workers, despite broader economic uncertainty and reports of some health systems freezing hiring or implementing layoffs.”

• Beckers Payer Issues notes, “Many insurers are asking for double-digit rate increases in 2026 for the individual and small group exchange markets as they face a potential expiration of enhanced premium tax credits and rising costs.”

• Modern Healthcare reports,
  • “Dr. Bobby Mukkamala’s is tapping into decades of medical experience, as well as his recent time as a patient with a brain tumor, as he begins his one-year term as American Medical Association president.
  • “Healthcare runs in the family. His father is a retired radiologist, his mother a retired pediatrician and his wife is a obstetrician-gynecologist.
  • “In an interview, the Flint, Michigan-based otolaryngologist said he plans to focus on physician shortages related to burnout and the uptick in non-physician caregivers. He also plans to address the hoops most patients have to jump through to receive adequate care, an experience made clear to him late last year when he was diagnosed with a brain tumor. Most of the tumor was removed in surgery and he is receiving treatment for the residual 10%.”

• Beckers Hospital Review informs us,
  • Detroit-based Henry Ford Health recorded an operating income of $77.5 million (2.4% operating margin) in the first quarter of 2025, down from an operating income of $98.5 million (4.5% margin) during the same quarter in 2024, according to its May 28 financial report.  
• and
  • Pittsburgh-based Allegheny Health Network recorded an operating income of $7.7 million (0.6% operating margin) in the first quarter of 2025, up from an operating loss of $31.3 million (-2.5% margin) during the same period last year, according to its May 29 financial report. 
• and also
  • lists “seven drug new shortages and discontinuations, according to drug supply databases from the FDA and the American Society of Health-System Pharmacists.”