Simplicity is a virture.

From Washington, DC,

• The American Hospital Association News reports
  • “The Senate’s budget resolution to set up a third reconciliation bill was released Aug. 7 by Sen. Ron Johnson, R-Wis., chairman of the Senate Budget Committee. It instructs 11 Senate committees to provide up to $150 billion in funding by Sept. 11. No healthcare committees received instructions. The House passed its budget resolution July 21. That version instructs the House committees on Administration, Agriculture, Armed Services and Intelligence to draft legislation that provides up to $95 billion in funding by Sept. 11.
  • “Legislators continue to focus their efforts on a reconciliation bill that would narrowly provide additional funding for defense, farm aid and election-related provisions. The House and Senate must pass an identical budget resolution before moving forward with a reconciliation bill. Additional legislative activity is expected in September when Congress returns to session.” 

• The Wall Street Journal relates,
  • “President Trump signed a new executive order Monday calling for most children to receive fewer vaccines and made some of his most extensive comments yet linking childhood shots and autism—a connection that scientists have said is unfounded.
  • “The document Trump signed Monday is similar to a previous executive order to decrease the number of vaccines children receive. It also urges parents to spread out vaccines in more visits to pediatricians’ offices and encourages states to mandate fewer vaccines for school attendance. It calls for the measles, mumps and rubella vaccination to be given in separate shots rather than the combination shot commonly given in the U.S.
  • “The new executive order goes further than the prior effort by grouping vaccines into three buckets: those recommended for all children, those recommended only for high-risk children and those that are subject to “shared-decision making,” in which parents and doctors discuss risks and benefits for each child. Included in the final category are vaccines for Covid-19, the flu, hepatitis B and more.
  • “The order doesn’t explicitly link vaccines to autism, but the president did so in his remarks Monday at an Oval Office event.” * * *
  • “The order calls on Kennedy and a newly revived vaccine task force to, in the next 90 days, come up with new recommendations for the timing and sequencing of childhood vaccines and find alternatives to a common vaccine ingredient, aluminum. A study of more than one million children in Denmark last year found no link between aluminum in vaccines and childhood chronic diseases, but Kennedy denounced the study. Scientists have said children are exposed to more aluminum from daily life than they receive in vaccines.”
• and
  • “The Trump administration took a partial step Monday toward Health Secretary Robert F. Kennedy Jr. promised food-system overhaul.
  • “Here’s what to know:
    • “Kennedy’s health department is asking food companies for more information about the substances they are putting into the U.S. food supply.” * * *
    • “The new proposed rule falls short of what some food-safety advocates have hoped for. Acting Food and Drug Administration Commissioner Kyle Diamantas said the notifications for new substances are mandatory, but it was unclear how the government will enforce the requirement. Food suppliers can still put new ingredients on the market before they notify regulators, Diamantas said.” * * *
    • “Health officials said stronger regulation—such as blocking companies from going to market before the FDA signs off on the safety of their ingredients—would require congressional action.” * * *
    • “Kennedy blames ultraprocessed food for many of America’s health woes, and in February promised to release a definition of ultraprocessed food by April. Such a move would allow the FDA to craft labeling rules based on the definition, he said. 
    • “The health department was widely expected to release the definition on Monday, but health officials said the draft was still being reviewed by other agencies.” 

• Govexec tells us,
  • “The largely self-funded Postal Service is asking for “modest” annual funding from Congress, at least in the short term, to help the agency pay its bills. 
  • “USPS told lawmakers that it would run out of cash in early 2027, if it kept meeting all of its financial obligations. But the agency now expects to avoid a cash crisis for another few years by suspending its contributions to one of its employee retirement plans. 
  • “Agency leaders warn these extraordinary measures are just buying USPS more time to deal with what they consider a broken business model. 
  • “Postmaster General David Steiner said last Friday that USPS will seek a “relatively modest appropriation” from Congress, adding that those funds would “create a large return for the American economy.” 

From the U.S. Office of Personnel Management front,

• An OPM news release offers a transcript of (OPM Director Scott Kupor[‘s conversation during] Greg Kelly Reports on Newsmax to discuss the Trump Administration’s efforts to restore merit-based hiring and strengthen accountability across the federal workforce.

From the Food and Drug Administration front,

• The New York Times reports,
  • “Taylor Farms, which has been linked to a large outbreak of cyclosporiasis associated with iceberg lettuce in the United States, said on Sunday that it was voluntarily recalling several of its products made with fresh jalapeños that have been tied to a multistate salmonella outbreak.
  • “The recalled products include spicy guacamole, mango pico de gallo, taco dip and more than a dozen other Taylor Farms branded and unbranded products, the company said in a statement on its website. They were distributed across 26 states to major retailers — including Whole Foods, Trader Joe’s, Hannaford and Kroger’s — and have a “Best If Used By” date up to and including Aug. 16, 2026.”

• STAT News relates,
  • “The Food and Drug Administration has rejected a radiopharmaceutical therapy because of manufacturing issues, halting what would have been a competitor for Novartis. 
  • “The drug, ITM-11, had been developed by ITM Isotope Technologies Munich SE, a long-standing player in the field. Radiopharmaceuticals are an emerging type of treatment designed to shoot radioactive isotopes directly at tumor cells.” * * *
  • “ITM has more than a dozen drugs lined up behind ITM-11, for glioblastomas, renal cell carcinoma, as well as prostate and ovarian cancers.
  • “The company plans to resubmit the ITM-11 application. “Our confidence in ITM-11’s therapeutic potential has not wavered, and we are committed to working closely with the FDA and our partners to address the items outlined in the CRL,” CEO Andrew Cavey said in a statement.” 
• and
  • “Sanofi is experiencing shortages of two medicines used to treat Pompe disease, and the problem emerged shortly after the Food and Drug Administration warned the company over manufacturing issues at the Irish facility where the drugs are made.
  • “In recent days, the drugmaker has alerted patient groups and physicians in both the U.S. and Europe that supplies of Myozyme, an older standard of care, and Nexviazyme, a newer treatment, are dwindling due to what has been described as a bottleneck in the final manufacturing phase, as well as quality control issues at its Waterford plant.” * * *
  • “For now, it is not clear when normal supplies will return because Sanofi has indicated it could take months before production has sufficiently resumed and stabilized. But the shortage will continue to reverberate after that occurs, because it will likely take time for normal inventories to be rebuilt, according to a statement on the IPA website.”

From the judicial front,

• Beckers Hospital Review reports,
  • “A federal judge has dismissed an antitrust lawsuit brought by compounding pharmacy Strive Specialties against Eli Lilly and Novo Nordisk.
  • “The ruling, filed Aug. 3 in the U.S. District Court for the Western District of Texas, found the company failed to plausibly allege a legally cognizable product market or a cognizable antitrust injury.
  • “Strive filed the lawsuit in January, accusing the drugmakers of using exclusive-dealing agreements with telehealth providers and public statements questioning compounded drugs’ safety to unlawfully restrict competition and limit patient access to compounded GLP-1 medications.
  • “The court found Strive’s compounded products cannot be considered reasonably interchangeable with Lilly and Novo Nordisk’s branded GLP-1 medications, because compounded versions are legally available only when a prescriber determines a branded drug is medically unsuitable for a specific patient. That determination is driven by necessity rather than ordinary consumer preference, the court ruled, undercutting Strive’s proposed cash-pay submarket and its broader GLP-1 market theory alike. Without a viable relevant market, the court found Strive’s Sherman Act and Clayton Act claims, including its challenge to Lilly and Novo Nordisk’s exclusivity arrangements with telehealth platforms, also failed.”

• Health Exec relates,
  • “A newspaper reporter just got an exclusive peek inside a law-enforcement operation that most Americans—including the well-informed among us—know next to nothing about. He took notes and is sharing what he can. 
  • “The operation is the National Training Operations Center—NTOC, called “Noc” for short—of HHS’s Office of Inspector General (HHS-OIG). It’s largely hidden in plain sight for obvious reasons, but it’s a prime mover in the Trump administration’s ongoing crackdown on healthcare fraud. 
  • “The reporter is Chadwick Moore of the New York Post.” * * *
  • “Here are six telling observations the newshawk offers in his article, posted by the Post on Aug. 6. 
    • “More than a few agents are healthcare professionals who feel passionate about stopping healthcare fraud.” * * *
    • “The stealthy suburban facility features highly realistic mockups of medical offices—physical as well as virtual.” * * *
    • “Often the HHS-OIG anti-fraud team is not catching someone red-handed—they’re proving a negative.” * * *
    •  “A Faraday box is essential equipment for the team.” * * *
    • “HHS-OIG is exempt from HIPAA. * * *
    • “In cities where fraud is rampant, real patients are often part of the problem.” * * * 

From the public health and medical / Rx research front,

• The American Hospital Association News reports,
  • “Department of Health and Human Services Secretary Robert F. Kennedy Jr. Aug. 7 declared a public health emergency for Washington state to address the impacts of ongoing wildfires. This follows an emergency declaration approved by President Trump Aug. 4. Because of both a presidential declaration and a PHE, the loosening of certain regulatory requirements for Medicare, Medicaid and the Children’s Health Insurance Program is permitted under the Section 1135 waiver process. 
  • “The Administration for Strategic Preparedness and Response said it has sent regional staff to support Washington state officials and partners with the public health and medical response. The Washington State Hospital Association has also provided a series of resources to assist with response efforts.”

• The American Medical Association News lets us know “what doctors want patients to know about tickborne illnesses.”
  • “Tickborne illnesses can start with a single bite. Know the signs, prevention steps and when to call a doctor to protect your health.”

• ALS News Today relates,
  • “Traumatic brain injuries are often linked to a higher short-term mortality risk in patients with ALS [Lou Gehrig’s Disease].”
  • “The connection could suggest reverse causation, where early, undiagnosed ALS leads to falls and resulting head injuries.
  • “Further research is required to evaluate diagnostic timing and clarify the relationship between traumatic brain injury and ALS.”

• Health Day tells us,
  • “Yoga may help relieve symptoms of irritable bowel syndrome 
  • “People with irritable bowel syndrome who practice yoga experience fewer digestive symptoms, as well as reduced anxiety and depression
  • “Researchers think yoga’s combination of movement, breathing and mindfulness activates the body’s ‘rest and digest’ response.”

• MedPage Today points out,
  • “In 2024, the national incidence rate of type I diabetes was 24.0 per 100,000 persons under age 20, but state-level rates ranged from 17.0 to 27.8.
  • :The ratio of board-certified pediatric endocrinologists to patients with type 1 diabetes also varied widely.
  • :Three states had fewer than five pediatric endocrinologists per 1,000 patients under age 18; in contrast, Washington, D.C. had 46.4.”

• Genetic Engineering and Biotechnology News informs us,
  • “Targeted protein degradation is a therapeutic strategy that leverages the ubiquitin–proteasome system to eliminate disease-associated proteins—including those that have traditionally been considered undruggable.
  • “Protein degraders remove unwanted proteins from inside a cell by disposing of them using the cell’s built-in recycling system. Specifically, a molecular glue degrader binds an E3 ligase and redirects it to tag a disease-related protein for disposal.
  • “Now, investigators at Dana-Farber Cancer Institute have developed a platform for systematically discovering molecular glues that could become protein degradation drug candidates. The platform could help drug developers expand the range of disease-related proteins that can be therapeutically targeted for elimination via protein degradation. The platform also enabled their discovery of the first molecular glue degrader that is metabolically activated, suggesting that molecular glues could be more context dependent and potentially tunable than previously thought.
  • “The study was published in Nature in the paper, “DCAF11-dependent molecular glue degrader activated by glutathionylation.”
  • “This novel platform is an exciting scalable approach to the discovery of molecular glues that could help drive the significant expansion of molecular glue applications for the treatment of cancer and other diseases,” says Eric Fischer, PhD, professor of Biological Chemistry and Molecular Pharmacology at Harvard Medical School.”

• STAT News notes,
  • “Tenax Therapeutics on Monday reported negative results from a late-stage clinical trial evaluating an experimental treatment for a type of heart failure associated with high blood pressure in the lungs.” * * *
  • “Despite the failed study, Tenax does not appear ready to give up on oral levosimendan. The company believes the drug may have a benefit for PH-HFpEF patients with more severe disease, based on pre-specified and post-hoc analyses of the LEVEL study. 
  • “Having reviewed the available trial results, I am encouraged we have a clear path forward,” said Tenax Chief Medical Officer Stuart Rich, in a statement.
  • “The company said it will meet with the Food and Drug Administration to discuss the LEVEL study results and potentially make changes to a second Phase 3 study already underway.”
•  and
  • “Sionna Therapeutics said Monday that its experimental pill for cystic fibrosis did not show any benefit when added onto Vertex Pharmaceuticals’ Trikafta in a Phase 2 trial. 
  • “The company will no longer try to advance the drug, called SION-719, as an add-on therapy for CF patients. And it hinted at potential layoffs, saying it will “take actions to preserve capital while evaluating next steps.”

From the U.S. healthcare business and artificial intelligence front,

• Fierce Pharma reports,
  • “Everything is bigger in Texas. And so it is with Bristol Myers Squibb’s $2.3 billion investment in a manufacturing campus in Houston, which comes in at more than twice the price the company estimated in a government application earlier this year.
  • “In May, the New Jersey pharma filed documents with the state of Texas to build a $1 billion, 600,000-square-foot complex, with an option to expand, in the Generation Park Management District in northeast Houston. It was one of several U.S. sites BMS was considering, the company said at the time.
  • “On Monday, BMS made it official in a statement saying it intends to employ nearly 500 at the facility, which will be built to “grow in scale, capability and workforce for decades to come.” It will support drug product and finished manufacturing from late development through launch, the company added, with plans to finish construction in 2030.” 
    
• BioPharma Dive adds,
  • “Jazz Pharmaceuticals has agreed to buy a San Diego-based biotechnology company developing treatments for genetic epilepsies, through a deal that could be worth just over $1.3 billion.
  • “Terms hold that privately held Actio Biosciences will receive $820 million up front and be eligible for $500 million in additional payments if its research programs hit certain regulatory and sales milestones. The company’s most advanced drug is being tested against a rare form of epilepsy caused by mutations in a gene known as KCNT1.
  • “The companies expect to close their deal sometime in the final three months of the year. Concurrent with the closing, Actio will spin out a new private entity funded by existing investors and headlined by one of its other programs, an ion channel inhibitor in early-stage testing for a form of “Charcot-Marie-Tooth,” an uncommon neurological disease. Jazz said it will hold a minority stake in the spinout — an investment that, by focusing on rare diseases, “represents a strong strategic fit” for its long-term strategy.”
• and
  • “The race to build pharma’s most powerful supercomputer gained a new entrant last month, when Bristol Myers Squibb said a newly expanded partnership with Nvidia would give it “the most powerful and energy-efficient single-owned Nvidia infrastructure in life sciences.”
  • “Bristol Myers is the latest large pharmaceutical company to stake an AI-computing superlative claim along those lines. Eli Lilly said in October it would work with Nvidia to build “the most powerful supercomputer owned and operated by a pharmaceutical company.” In March, Roche said an expanded Nvidia collaboration gave it “the pharmaceutical industry’s largest announced hybrid-cloud AI factory,” with more than 3,500 GPUs, or graphics processing units.”

• Beckers Payer Issues identifies the ten insurers exiting the Affordable Care Act market next year (updated as of today).

• Beckers Hospital Review points out the 17 health systems with credit rating upgrades and tells us,
  • “A July 21 Center for Healthcare Quality and Payment Reform analysis found 700 rural hospitals are at risk of closing across the U.S. In almost every state, at least some rural hospitals are at risk of closing, with the exception of four. 
  • “The report did not classify a single rural hospital in Delaware, Maryland, New Jersey or Utah as “at risk of closing” or “at immediate risk.”
  • “Becker’s connected with hospital association and state agency leaders in each of those states to discuss what they credit for this stability. Their responses point to geography, a mix of specific state payment policy and long-standing regional partnerships.” 

• MedTech Dive informs us,
  • “IRhythm said Thursday it has struck a deal to buy VitalConnect for $287.5 million to add mobile cardiac telemetry capabilities. 
  • “VitalConnect sells a wearable device, VitalPatch, that monitors for 21 cardiac arrhythmias and several vital signs. The device lasts seven days, after which users can apply a new patch.
  • “IRhythm sells its own cardiac monitor and is working to secure clearance of a second device, but it has identified VitalPatch as a product that can unlock another part of the market.”  

• Beckers Clinical Leadership notes,
  • “This year, CMS has implemented eight changes to the HCAHPS survey and scoring.
  • “The changes are part of CMS’ HCAHPS 2.0 launch, which began in 2025. Last year, CMS began allowing patients to fill out the HCAHPS survey online; sunset two survey administration options; added three submeasures for care coordination, restfulness and information about symptoms; extended the data-collection period from 42 to 49 days; ended regulation that prohibits patients’ loved ones from filling out the survey on their behalf; limited the number of supplemental items; and required hospitals to collect information about the language patients speak.
  • “The first results of the HCAHPS 2.0 rollout are due to be published any day, Rick Evans, strategic advisor at New York City-based NewYork-Presbyterian, said in an Aug. 6 column.”

• Per Fierce Healthcare,
  • “Women’s health companies drew a record $1.55 billion in disclosed equity investment in 2025, up 41% from $1.1 billion in 2024, according to a recent report from W Group.
  • “The report, the organization’s first global women’s health investment report, was built on proprietary tracking of more than 500 funding stories and around 164 equity rounds, and it reveals a sector at its largest-ever scale, with capital reaching more companies, categories and countries than at any point on record, according to W Group, a data-first intelligence platform.
  • “Eighty-five companies raised equity in 2025, the highest single-year count ever recorded, and 10 rounds reached $50 million or more, double the number in 2024.” * * *
  • But the report’s central finding is not the headline number. It is that the money has stopped concentrating at the top. In 2024, the three largest rounds accounted for 41% of all disclosed capital; in 2025 that share fell to 32%, as funding to companies outside the top three grew 56% year over year. 
• and
  • “Doximity is boosting artificial intelligence spending, viewing it as a significant catalyst for growth, and CEO Jeff Tangney is bullish that hospital adoption of enterprise AI platforms will ramp up.
  • :Doximity is a digital platform for U.S. medical professionals that offers workflow tools such as a telehealth solution, a clinician-to-patient dialer tool and digital faxing capabilities. Its paying customers include pharmaceutical manufacturers, health systems and medical recruiting firms.
  • “The company aims to become a leading AI platform for doctors with plans to scale its clinical AI suite, including its ambient notetaking tool Scribe and clinical AI assistant and medical search engine Ask. A year ago, Doximity acquired clinical AI company Pathway and then integrated Pathway’s datasets and its AI into its free Doximity GPT product to offer DoxGPT (now Ask).
  • “Healthcare AI will increasingly be purchased by hospitals rather than individual physicians, with companies winning on accuracy and trust of the AI, Doximity executives assert.”

Notable Deaths

• The New York Times reports
  • “Maura Gillison once told an interviewer that she had wanted to be a doctor and a scientist since childhood. She trained in ballet, but as she grew, reaching a height of 6-foot-2, dance became an unlikely career path because she felt that it would draw too much attention to her height.
  • “Instead, she forged a trailblazing career as a medical oncologist and molecular epidemiologist, studying head and neck cancers. In the early 2000s, she was credited as the first researcher to show definitively that the human papillomavirus, or HPV — the most common sexually transmitted infection — caused the so-called oropharyngeal cancers of the throat, tonsils and base of the tongue.
  • “No head and neck medical oncologist has had a bigger impact on patients than Maura Gillison,” Dr. John V. Heymach, the chair of thoracic/head and neck oncology at MD Anderson Cancer Center in Houston, where Dr. Gillison conducted research beginning in 2017, said in an interview.
  • “Dr. Gillison died on June 21 at her childhood family home in Willoughby, Ohio, northeast of Cleveland. She was 61. The cause was a rare cancer of the small intestine, her husband Dr. David E. Symer, an oncologist, said.”

• Beckers ASC relates,
  • “American College of Cardiology Past President Robert Frye, MD, has died at age 94 after a career spanning more than 70 years in medicine, the ACC announced Aug. 7. 
  • “Dr. Frye served as ACC president from 1991 to 1992 and spent more than 60 years practicing and teaching cardiology at Mayo Clinic in Rochester, Minn.
  • “Dr. Frye earned his medical degree from Vanderbilt University School of Medicine in 1956 and trained in residency at Johns Hopkins Hospital in Baltimore. He went on to become the first physician research fellow and clinical associate at the National Institutes of Health, recruited by Eugene Braunwald, MD, MACC.” * * *
  • Valentin Fuster, MD, PhD, MACC, who worked alongside Dr. Frye as the first Braunwald fellow at the NIH, said Dr. Frye “helped lay the foundation for a generation of clinical discovery that transformed” cardiovascular medicine.
    
• RIP. The FEHBlog also encourages his readers to listen to Russ Roberts’ Econtalk discussion with former U.S. Senator Ben Sasse.
  • From the transcript
    • Ben Sasse: “So, to be pushing seven months when you had 90 days to live is pretty great. And, that’s because of the really wonderful experience of being on daraxonrasib, this new miracle drug at UCSF [UCSF] and a few other places, that’s a RAS [renin-angiotensin system] inhibitor. If you’re 80-something, pancreatic cancer might be environmental. If you’re 50 something, like I am, it’s almost always a genetic mutation. 89% of people have a RAS mutation. So, this new drug–there hadn’t been good news in pancreatic cancer in 40 years–this new drug essentially tries to inhibit the RAS mutation’s ability to toggle the on-off switches the wrong way.
    • “The great news is my tumors are down over 80% right now. The bad news is, it’s probably not going to be a cure for me because I presented so far along and so metastasized, but this drug is going to be super-interesting over the next two to ten years.
    • “My two rough byproducts right now of a really aggressive dose of chemo are a real hard time growing skin and hair, so my root follicles on my head are all kind of tingly and falling out and bleeding all the time. So, my scalp is real a bloody mess, but I have an amazing dermatological oncology team at MD Anderson>