Monday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

Simplicity is a virtue.

From Washington, DC

  • Roll Call takes a look at what’s ahead of Congress this week,
  • and also lets us know,
    • “President Donald Trump on Monday sent to the Senate the nomination of acting Attorney General Todd Blanche to fill the role permanently, teeing up what could be a bruising confirmation process for a Trump ally who has drawn bipartisan criticism for recent Justice Department moves.”
  • Per a HHS news release,
    • “The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Education today hosted eight of the nation’s leading accreditors, assessors, and medical organizations to announce a historic development to increase nutrition requirements at every level of U.S. medical education, competency-evaluation, training, and residency. Additionally, 19 medical schools across the country have signed the Trump administration’s Nutrition Education Pledge, vowing to incorporate 40 hours of nutritional education or its competency equivalent into graduation requirements starting this fall.
    • “Poor diets are the primary driver of America’s chronic disease epidemic, and today’s announcement reflects the shifting landscape toward placing nutrition and prevention at the core of patient health,” said Secretary Robert F. Kennedy, Jr. “Still, more work remains, and I look forward to seeing nutrition play an increased role as the latest science, data, and best practices develop.”
    • “Last August, HHS and the Department of Education sent a letter to medical organizations encouraging them to improve their standards and place nutrition at the core of their programs.”
  • Beckers Hospital Review informs us,
    • “TrumpRx.gov is adding 160 prescription drugs to the platform, bringing its total to more than 800  according to a June 5 Truth Social post from President Donald Trump.
    • “The president said the expansion would allow TrumpRx.gov to offer discounted pricing for medications that account for roughly four out of every five prescriptions filled in the U.S. The administration also claims the platform has saved American patients more than $400 million since its February launch.”
  • Per an OPM news release,
    • “The US Office of Personnel Management (OPM) today announced additional leading technology companies have committed to partnering with the US Tech Force (Tech Force), the government-wide initiative to recruit top technologists to modernize the federal government and strengthen America’s technical workforce.
    • “The new industry partners include Arista Networks, Armada, Cisco, Cognition AI, Cognizant, Payward, Moveworks from ServiceNow, Scale AI, and Wiz.
    • “These companies will contribute to Tech Force by providing technical training resources, executive engagement and programming, nominating employees for temporary government service, and helping create paths for Tech Force alumni into the private sector.” * * *
    • “More information about Tech Force is available here.”
  • The American Hospital Association News reports,
    • “The Drug Enforcement Administration today released a final rule implementing provisions from the Restoring Hope for Mental Health and Well-Being Act of 2022, which passed as part of the Consolidated Appropriations Act of 2023, eliminating the need for a separate waiver for qualified practitioners to dispense certain types of controlled substances for medications for opioid use disorder treatment, or MOUD. While the original requirements were amended by the SUPPORT Act of 2018 and changes were implemented in an interim final rule in 2020, the 2022 legislation struck the amended section from regulation, thus requiring DEA to respond to public comments on the interim final rule and update regulatory language accordingly.”

From the Food and Drug Administration front,

  • Fierce Pharma informs us
    • “The FDA has expanded the label for Pfizer’s subcutaneous hemophilia drug Hympavzi, now including patients age 6 and older who have hemophilia A or B.
    • “The anti-tissue factor pathway inhibitor was initially approved in October of 2024 for those age 12 and older with hemophilia A or B who have not developed the antibodies—also known as inhibitors—produced by the immune system that block or destroy infused clotting factor medications.
    • “The new expansion covers all patients 6 and older, regardless of their inhibitor status. The new nod also opens up the treatment to those 12 and older who have developed the inhibitors.”
  • CBS News reports,
    • “Retatrutide isn’t supposed to be everywhere.
    • “Touted as the next generation in the GLP-1 craze, it’s an experimental weight-loss drug that is not authorized outside of clinical trials. The Food and Drug Administration hasn’t reviewed whether it is safe and effective, which is the legal path for prescription drugs to come to market. And yet retatrutide is for sale all over the internet, a phenomenon with no modern precedent.
    • “It isn’t just shadowy online vendors offering what they claim to be research-grade retatrutide.
    • “A CBS News investigation found dozens of clinics across the country, staffed by licensed physicians and nurse practitioners, openly advertising retatrutide. That practice defies a longstanding norm in medicine – to wait for the FDA to approve a drug before prescribing it – and is contributing to a booming commercial marketplace for a drug that is barred from sale by federal law.” * * *
    • “It’s on the states to really police this kind of conduct,” said Nathan Cortez, a professor at SMU Dedman School of Law, adding that they often lack enforcement resources. “At some point it becomes so blatant and widespread that, you’re wondering, ‘What are we doing here? Are we going to enforce the law or not?'”
  • The Wall Street Journal adds,
    • Eli Lilly LLY shares rose in early European trade after a late-stage trial showed its drug was effective in weight loss and in alleviating obesity-linked conditions.
    • “Shares jumped 4.4% premarket to $1,181, extending a record high hit at Friday’s market close. The stock is up over 30% since the Indiana-based company reported first-quarter earnings on April 30.
    • “Participants in a Phase 3 trial of retatrutide—an experimental drug targeting obesity-related hormones—showed substantial weight loss, with those taking 12 mg doses losing an average of around 70 pounds over an 80-week period, the company said.
    • ‘One-third of participants on 12 mg doses saw their weight fall into a healthy weight range, while two-thirds fell below the threshold for obesity, Eli Lilly said.”

From the judicial front,

  • The American Hospital Association News reports,
    • “The U.S. District Court for the District of Massachusetts June 8 vacated the $100,000 fee for new H-1B visas established by a proclamation in September 2025. Judge Leo T. Sorkin declared the fees unlawful and said in his decision that it “exceeds the fee-setting authority delegated by Congress.” The AHA last year asked the administration to make healthcare personnel exempt from the fees. The federal government is likely to appeal the June 8 decision.”

Reports from the American Diabetes Association’s annual meeting,

  • Fierce Pharma adds,
    • “With an obesity green light already in hand, Eli Lilly is pushing for its newly launched Foundayo (orforglipron) to break into Type 2 diabetes, in turn rounding out its oral offering in line with Novo Nordisk’s duo of GLP-1 pills in both indications. 
    • “Now, in results from a trio of pivotal phase 3 studies presented Monday at the American Diabetes Association 2026 Scientific Sessions, Lilly is aiming its diabetes data squarely at two of the oral GLP-1’s biggest potential rivals.
    • “Sure to grab the most attention at the conference are results from Achieve-3, a head-to-head trial in which Foundayo topped Novo’s oral semaglutide on metrics of blood sugar reduction and weight loss in T2D patients.” 
  • STAT News notes,
    • “AstraZeneca’s investigational GLP-1 pill showed promise in mid-stage obesity and diabetes studies, but it may still be too early to determine how it stacks up against oral treatments already on the market.
    • “In one Phase 2 trial of people with obesity, called VISTA, those on the highest dose of the drug, called elecoglipron, lost 11.2% of their weight after 36 weeks, when looking at all patients regardless of discontinuations, according to data presented Monday at the annual meeting of the American Diabetes Association and published in the Lancet. (Eli Lilly’s pill Foundayo led to the same rate of weight loss in a Phase 3 study that lasted twice as long, but it’s hard to compare across trials in different phases.)”
    • “In a separate Phase 2 trial in people with diabetes, called SOLSTICE, patients on the highest dose saw up to a 1.74 percentage-point decrease in a measure of blood sugar called A1C after 26 weeks. The study, also published in the Lancet, enrolled people taking oral Ozempic open-label as a comparator group, and they experienced a smaller A1C decrease of 1.32 percentage points.”
  • The American Journal of Managed Care relates,
    • “A trio of studies presented at the American Diabetes Association 2026 Scientific Sessions has reframed the conversation of diet during pregnancy, pointing to diet quality, not just quantity, as a meaningful lever for managing gestational glycemia and postpartum metabolic risk. This is a conversation that has long been viewed through the narrow lens of weight gain and fetal growth.
    • “Across hundreds of pregnancies, researchers of 3 oral presentations found that higher intake of fiber, nonstarchy vegetables, and plant protein were independently associated with lower continuous glucose monitor (CGM) readings,1 while lower-carbohydrate diets in women with gestational diabetes improved glycemic control but raised micronutrient concerns.2 Perhaps most strikingly, women randomly assigned to a higher-complex carbohydrate diet during pregnancy still showed measurably lower postpartum glucose responses 2 months after delivery, suggesting that what a pregnant woman eats may matter long after the birth.3
    • “Together, these findings challenge prevailing assumptions about optimal gestational nutrition and open new questions about how prenatal dietary interventions might be designed to protect both mother and child over the long term.”

From the public health and medical / Rx research front,

  • BioPharma Dive reports,
    • “Tango Therapeutics said Monday its experimental drug vopimetostat showed promise in a small trial in pancreatic cancer, with nearly all of the enrollees followed so far responding to a regimen that combined its medicine with Revolution Medicines’ closely watched treatment daraxonrasib.
    • “The data suggest vopimetostat outperformed daraxonrasib alone in a similar population of people whose disease had progressed after at least one treatment line and exceeded Wall Street expectations. The company plans to initiate a Phase 3 trial later this year testing the combination.” 
  • The American Medical Association lets us know what doctors wish their patient knew about diverticulitis.
    • “Diverticulitis can turn silent colon pouches into painful inflammation. But plenty of interventions are available, depending on severity of diverticulitis.”
  • Per a National Institutes of Health news release,
    • “By inducing specific patterns of activity in small portions of the brain in awake mice, researchers supported by the National Institutes of Health (NIH) have triggered a recalibration of neural connections that normally only occurs during sleep. This new approach offset the effects of sleep deprivation in memory tasks and revealed features of sleep that are key to its restorative effect.
    • “What we’re essentially doing is forcing sleep in a local region of the brain. While that part is solidifying memories and restoring learning capacity, other parts stay aware/vigilant and connected to environment,” said corresponding author Chiara Cirelli, M.D., Ph.D., a professor of psychiatry at the University of Wisconsin-Madison. “Dolphins do something similar, sleeping with only one brain hemisphere at a time.”
    • “Non-rapid eye movement (NREM) sleep, which makes up about 80% of sleep for adults, is when the junctions between neurons that make memories are evaluated. During this phase, the brain protects important connections for long-term storage, prunes those that are less necessary, and makes space for new ones.”
  • Genetic Engineering and Biotechnology News relates,
    • “A study tracking thousands of B cells across more than 100 germinal centers (GCs) in mice has revealed how the system consistently produces highly effective antibodies. The findings overturn longstanding ideas about how germinal centers function, revealing that they are far more selective than once thought, and challenge the idea that antibody improvement is driven mainly by rare growth “bursts” among the most successful B cells. The discovery could have implications for immune cell evolution, and ultimately guide the design of vaccines against rapidly mutating pathogens like influenza. It could also lead to new ways of studying evolution itself.
    • “The traditional, mechanistic view of germinal centers is to think of them as selection machines sorting out the best antibodies,” said research lead Gabriel D. Victora, PhD, head of the Laboratory of Lymphocyte Dynamics at The Rockefeller University. “But when you look very, very closely, you see a process that’s almost essentially random—a little bit better than a coin toss—which repeats many times until the immune system arrives at the right answer consistently. That’s much more akin to how evolution operates than the way a machine does.”
    • “Victora and colleagues reported on their findings in Cell, in a paper titled “Replaying germinal center evolution on a quantified affinity landscape.”
  • Medscape points out,
    • “Metabolic-bariatric surgery (MBS) in patients aged 65 years or older resulted in long-term meaningful weight loss and remission of obesity-related conditions, although complication rates of about 8% were noted.”
  • The Cancer Therapy Advisor notes,
    • “Hyperthyroidism may be associated with an increased risk of breast cancer, particularly premenopausal breast cancer, according to research published in Cancer Epidemiology, Biomarkers & Prevention.
    • “Findings from in vitro studies have indicated that thyroid hormones can have estrogen-like effects. That suggests that thyroid hormones may affect cellular proliferation of breast tissue and subsequently increase breast cancer risk in people with hyperthyroidism, researchers explained. In this study, the researchers assessed the effects of hyperthyroidism and hypothyroidism on incident breast cancer in women from the Sister Study.
    • “Women diagnosed with hyperthyroidism or receiving related treatment may have elevated BC [breast cancer] risk, particularly premenopausal BC,” the researchers concluded. “Although more research is needed, premenopausal women treated for hyperthyroidism may benefit from enhanced breast cancer screening.”

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

  • Fierce Healthcare reports,
    • “Medicare Advantage insurer Essence Healthcare is continuing to build out its partnership with Oura and has unveiled a new clinical program that aims to identify potential sleep apnea risk.
    • “Essence is rolling out a new clinical workflow that will arm physicians with insights into patients’ nighttime breathing habits to identify those who may be at risk for obstructive sleep apnea. The insurer offers the ring as a covered benefit through some of its plans and has been working with Oura’s team to identify more clinical applications for its data.
    • “News of the partnership expansion was shared first with Fierce Healthcare.
    • “Through the program, insights into members’ sleep, as identified by the Oura Ring, will be shared with Essence with the patients’ consent. The insurer then uses Lumeris’ Tom platform to reach out to at-risk individuals and guide them through STOP-BANG, a common evidence-based screening for sleep apnea.”
  • and
    • “Artificial intelligence is here to stay in healthcare, and the industry’s largest players, like CVS Health, are making huge commitments to the tech.
    • “But embracing AI requires a workforce that’s ready for the revolution. With that backdrop, CVS has rolled out its internal AI Learning Academy, which aims to educate its workforce on practical applications for the technology and how it can impact and improve their workflows.
    • “The program was built in collaboration between human resources and tech leaders at the company. Greg Karanastasis, senior vice president for talent and development at CVS, told Fierce Healthcare that the aim was to build something bigger than just a training program.”
  • Per an Institute for Clinical and Economic Research (ICER) news release,
  • MedCity News tells us about “The 3 Biggest Roadblocks to Egg Freezing — and How Providers Are Working to Remove Them.”
    • “Egg freezing has gained popularity as a fertility preservation tool, but experts say high costs, uncertain outcomes and timing challenges continue to deter many women from pursuing it.”
  • MedTech Dive informs us,
    • “Boston Scientific is investing approximately $138 million to build a 500,000-square-foot distribution facility in Plainfield, Indiana.
    • “Indiana Gov. Mike Braun, who announced the project last week, said Boston Scientific will break ground on the facility this year and ultimately create up to 300 jobs. 
    • “Boston Scientific is building the facility to complement its existing distribution network, which includes sites in Georgia, Massachusetts and Minnesota.”
  • BioPharma Dive notes,
    • “Incyte, a drugmaker with a heavy focus on blood diseases and cancers, plans to take control of an experimental medicine that could help control bleeding in a variety of disorders.
    • “Vega Therapeutics, a subsidiary of the “hub-and-spoke” biotech Star Therapeutics, has been developing this “VGA039” medicine primarily as a treatment for von Willebrand disease — the most common inherited bleeding disorder. Now, Incyte has agreed to buy Vega for $1.25 billion up front. Star would be eligible to receive as much as $750 million more if certain sales goals are eventually met.
    • “Patients with von Willebrand disease lack an important clotting protein, meaning that, when they suffer any kind of injury, the bleeding usually takes longer to stop. In severe cases, this bleeding can cause joint or organ damage and be life-threatening. Current preventative treatments include so-called factor replacement therapies given as intravenous infusions two to three times a week. VGA039, meanwhile, comes as a once-monthly, under-the-skin injection that patients can do themselves.”
  • The Wall Street Journal relates,
    • “Roche Holding struck a deal with Nurix Therapeutics NRIX to license an experimental blood-cancer drug for up to $2.3 billion, expanding its pipeline in oncology and potentially other therapeutic areas.
    • The Swiss drugmaker on Monday said it would make an upfront cash payment to Nurix of $700 million, with additional payments subject to the drug, bexobrutideg, reaching development, regulatory and sales targets.
    • Bexobrutideg is due to enter late-stage studies for the treatment of chronic lymphocytic leukemia this summer, Roche said.
    • “The main opportunity for us is in B-cell malignancies. There are many B-cell malignancies and the most dominant of interest for us is chronic lymphocytic leukemia,” Roche’s deputy chief medical officer, Stefan Frings, said in an interview.
    • “The company said the medicine has potential to offer higher efficacy and more favorable tolerability than established therapies for leukemia. The drug is a so-called BTK degrader designed to remove the BTK enzyme from cells, rather than blocking its effects, and overcome resistance.”
  • and
    • “Johnson & Johnson JNJ  has agreed to buy biotechnology company Firefly Bio for $1 billion in cash in a deal that bolsters the drugmaker’s oncology pipeline.
    • “J&J on Monday said Firefly is developing its proprietary Firelink degrader antibody conjugate platform, for KRAS-driven cancers, which have limited treatment options with survival measured in months.
    • “Mutations of the KRAS gene have long been considered undruggable because the gene’s structure lacks the deep binding pockets most drugs need.
    • ‘J&J said the Firelink platform is a novel approach to overcome limitations of existing treatments by delivering a highly selective protein degrader to tumor cells, while avoiding healthy cells.”
  • and
    • “Novo Nordisk NOVO.B said prescriptions for its Wegovy weight-loss pill have surpassed three million since launching in early January.
    • “The Danish drugmaker said late Sunday that the pill hit one million prescriptions 12 weeks after reaching U.S. pharmacies and online providers, with a further two million prescriptions achieved in the following 10 weeks.
    • “More than 80% of new prescriptions filled for the Wegovy pill are for patients new to the GLP-1 class of drugs, which the company says indicates that the new oral formulation is expanding the obesity treatment market, rather than replacing existing injectable therapies.”
  • Fierce Pharma adds,
    • “On a weekly basis, total GLP-1 prescriptions were trending downward over the week of June 1, falling 5.7% week-over-week, Citi analysts noted. Other than the continued rollout of Lilly and Novo’s respective weight loss pills, the analysts cited the effect of the Trump administration’s “most favored nation” pricing policies as a key future event that they think could impact total prescriptions.” 

Noteworthy Death

  • AP reports
    • “Harvard University professor Robert Coles, the psychiatrist and Pulitzer Prize-winning author who championed the cause of children grappling with poverty and segregation, has died at 97, his son said Sunday.
    • “The son, also named Robert Coles, told The Associated Press that his father died Thursday at a hospice center in Lincoln, Massachusetts.
    • “The elder Coles was famed for documenting the needs of children, particularly those caught in the crucible of social upheaval. The second and third parts of his five-volume “Children of Crisis” won him a Pulitzer Prize in 1973 for general nonfiction.
    • “In a 1965 Washington Post essay, he wrote that, expecting to find many psychiatric problems among the children of poverty, that instead “I was constantly surprised at the endurance shown by children we would all call poor or, in the current fashion, ‘culturally disadvantaged.’”
  • RIP

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