Simplificity is a virtue.
From Washington, DC
- Roll Call reports,
- “The House Appropriations Committee advanced a draft fiscal 2027 Legislative Branch spending bill on Wednesday that would slash the budget for the Government Accountability Office by nearly one-quarter and give a boost to Capitol Police.
- “The party-line vote of 34-28 came after a contentious markup stretching late into the evening, as Democrats argued the GAO cut would undermine its mission.”
- The Hill informs us,
- “Federal Reserve Chair Kevin Warsh was sworn in Friday beside President Trump, kicking off his term as the new head of the central bank at a critical time for the U.S. economy.” * * *
- “Warsh, 56, returns to the Fed board after serving as a member from 2006 to 2011. He was nominated to the Fed by former President George W. Bush, whom he served as a White House economic adviser before becoming the youngest Fed board member in history.
- A graduate of Stanford University and Harvard Law School, Warsh also worked at Morgan Stanley and served in various academic and advisory roles outside of his government service.
- Warsh was most recently a fellow at Stanford’s Hoover Institution, an influential conservative think tank known for its close ties to prominent Republican policymakers.
- Healthcare Dive relates,
- “The HHS is continuing its crackdown on healthcare fraud, launching a program that will use artificial intelligence to examine audits from states and other federal grant recipients — and potentially affect Medicaid funds.
- “The Office of the Assistant Secretary for Financial Resources will look across all states to analyze at least five years of audits that grantees file annually with the federal government, the department said Thursday.
- “The agency says past audits include internal control issues and “chronic” noncompliance. If recipients aren’t able to fix those problems, the HHS could temporarily withhold payments, hold back future funds, or suspend or terminate awards.”
From the Food and Drug Administration front,
- The American Hospital Association News reports,
- “The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions. The FDA said that Abiomed identified an issue where if a patient is treated with a left ventricular Impella device and experiences an extended period longer than 80 minutes with no residual pulsatility, the Abiomed Automated Impella Controller may be forced to restart due to an internal software error.”
- “The Food and Drug Administration has issued an early alert for all heart pump controllers by Abiomed, which sent a correction notice to all customers with updated use instructions. The FDA said that Abiomed identified an issue where if a patient is treated with a left ventricular Impella device and experiences an extended period longer than 80 minutes with no residual pulsatility, the Abiomed Automated Impella Controller may be forced to restart due to an internal software error.”
- Per an FDA news release,
- “Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis. Bulevirtide is the first FDA-approved treatment for chronic HDV infection, a serious and life-threatening condition that can cause rapid development of liver fibrosis (scarring), liver cancer, liver failure, and even death.
- “Today’s approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available,” said Wendy Carter, D.O., Acting Director of the Office of Infectious Diseases in FDA’s Center for Drug Evaluation and Research. “For individuals living with this chronic viral infection, this new treatment option offers hope in managing a disease that can rapidly progress to serious liver complications.”
From the judicial front,
- Bloomberg Law reports,
- “The importance of the $885 million antitrust verdict this week against Takeda Pharmaceuticals Co. Ltd. had less to do with the nine-figure damages than ending private plaintiffs’ losing streak challenging deals delaying cheaper generics.
- “The Boston federal jury’s finding that Takeda improperly paid a competitor to delay it from bringing a generic version of its Amitiza constipation medication to market marked the first time a private plaintiff won at trial in a reverse-payment case.
- “Most challenges to deals between branded drug companies and generic makers either settle or are dismissed before reaching trial, with the more nuanced agreements sometimes making it to a jury. Three have been tried before a jury since the US Supreme Court put drugmakers on notice that the dealings could run afoul of antitrust laws. Until Monday, juries had rejected plaintiffs’ claims each time.
- “I expect the case to send ripples through legal departments — if not boardrooms — across the country,” said Robin Feldman, a law professor at the University of California in San Francisco who studies pharmaceutical regulation and intellectual property. She called the verdict a “groundbreaking decision.”
From the public health and medical / Rx research front,
- The Centers for Disease Control and Prevention announced today,
- “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country. Because of the later start, some areas of the country may continue to see higher levels of RSV through May. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is low in most areas of the country. Seasonal influenza activity is low.”
- “RSV activity started later than usual in most parts of the United States, but illnesses are not more severe than recent years. Activity has peaked in most regions of the country. Because of the later start, some areas of the country may continue to see higher levels of RSV through May. Emergency department visits and hospitalizations for RSV are highest among infants and children less than 4 years old. COVID-19 activity is low in most areas of the country. Seasonal influenza activity is low.”
- The University of Minnesota’s CIDRAP reports,
- “As the nation moves closer to topping last year’s measles total in just the first half of 2026, the Centers for Disease Control and Prevention (CDC) today confirmed 59 new cases in a nationwide outbreak that has now reached 1,952 infections.
- “All but nine cases are locally acquired, with the rest related to international travel. The total for all of last year was 2,288 confirmed cases.”
- and
- “Although an Ebola outbreak is growing rapidly in central Africa, experts say it doesn’t pose a public health threat to the United States.
- “The outbreak, centered in the Democratic Republic of the Congo (DRC), has grown to nearly 750 suspected cases and more than 170 deaths, the World Health Organization (WHO) announced today. Although the risk from Ebola in the DRC is high, the risk of global spread is low, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said.
- “Many US infectious diseases experts agree.
- “This is a horrible situation in affected areas of Africa,” said Michael T. Osterholm, PhD, MPH, director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, which publishes CIDRAP News. “But for the world, it is not.”
- “That’s because Ebola, which spreads through contact with bodily fluids, is far more difficult to spread than the airborne respiratory viruses that Americans have confronted in recent years, such as influenza, COVID-19, measles, and even the Andes strain of the hantavirus, which recently caused an outbreak on a cruise ship.”
- BioPharma Dive points out,
- “ASCO26: 5 data snapshots ahead of the year’s biggest cancer drug meeting.
- “Clinical trial abstracts posted Thursday ahead of this year’s ASCO meeting gave a peek at anticipated datasets from Merck, BioNTech, Eli Lilly and Moderna.”
- Per a National Institutes of Health news release,
- “A team of researchers at the National Institutes of Health (NIH) have unveiled new details about the events GLP-1 receptor agonists trigger within neurons, which have been largely unexplored until now. A study in mice identified key intracellular signaling processes that are tied to the weight-loss effects of the GLP-1 drug semaglutide. The findings improve our understanding of how increasingly prevalent GLP-1s may influence human behavior and identify new opportunities to potentially enhance treatment.
- “The weight-loss benefits of GLP-1s are well documented and scientists generally know the brain regions associated with these effects. However, several questions remain, such as why responses to medication differ between patients and why the effects for most eventually plateau.
- “We know much less about the nuts and bolts of what goes on within the neurons that these medications target. By digging into these mechanisms, we’re beginning to answer some of these questions,” said co-corresponding author Andrew Lutas, Ph.D., an investigator at NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).”
- CNN reports,
- “Pregnant women are routinely advised to take prenatal vitamins for their health and their baby’s development. Now, a new study published Monday in JAMA Network Open concluded that children whose mothers received higher-dose vitamin D supplements during pregnancy performed better on certain memory tests at age 10.”
- MedPage Today relates,
- “Preserved global brain structure appeared to buffer cognitive decline in people with Alzheimer’s pathology.
- “Younger-appearing brains had weaker links between pathology and poorer outcomes in multiple cognitive domains.
- “Other measures of brain reserve or cognitive reserve showed no clear protective cognitive effect.”
- Health Day tells us,
- “Middle-aged people who have migraine with an aura could be more at risk for stroke.
- “Those who had migraine with aura had a 73% increased risk of stroke
- “Middle-aged men who suffered any kind of migraine had a more than 3.5-fold increased risk of stroke.”
- and
- “Use of calcium, vitamin D, or combined supplementation has little to no effect on the prevention of fractures and falls in adults, according to a review published online May 20 in The BMJ.
- “Olivier Massé, Pharm.D., from CIUSSS du Nord-de-l’Île-de Montréal, and colleagues conducted a systematic review and meta-analysis to examine the effect of calcium, vitamin D, or combined supplementation on fractures and falls in adults. A total of 69 trials, with 153,902 participants, were included in the review.
- “Most trial participants were community dwelling (87 percent) and not at high fracture or fall risk (73 percent). The researchers found that little to no effect was found from use of calcium supplements (risk ratio, 0.91), vitamin D supplements (risk ratio, 1.00), or combined supplementation (risk ratio, 0.91) for the primary outcome of any fracture. There was little to no effect on other fracture and fall outcomes seen for calcium, vitamin D, or combined supplementation, based mainly on moderate-to-high certainty of evidence. After extensive exploration of heterogeneity across multiple subgroup analyses, the findings remained robust.”
- BioPharma Dive informs us,
- “The outlook for an experimental Parkinson’s disease drug dimmed on Thursday with the announcement that it had failed a key clinical trial.
- “Developed through a partnership Denali Therapeutics and Biogen, the drug is designed to inhibit an enzyme tied to one of the most common genetic drivers of Parkinson’s: a gene called LRRK2. When this gene mutates, it causes the waste disposal systems in cells to malfunction, leading to the buildup of toxic proteins that damage and destroy neurons.
- “In 2022, Biogen and Denali kicked off what would ultimately become a nearly 650-person trial that pitted their drug against a placebo. The companies are now saying this mid-stage study showed the drug — codenamed BIIB122 — was not significantly better at slowing the disease progression, as measured by a well-known scale clinicians use to assess how Parkinson’s is affecting a patient’s movement and daily life.”
From the U.S. healthcare business and artificial intelligence front,
- Per an EBRI news release,
- “The Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey found that the majority of insured individuals still receive health insurance through their employer.
- “Employment-based health coverage remained the dominant source of health insurance for privately insured adults, with six in 10 receiving coverage through their own job.” * * *
- “Coverage patterns have been largely stable, with about one-third enrolled in individual-only coverage and most others covering a spouse or partner.”
- Fierce Pharma relates,
- “With both Novo Nordisk’s and Eli Lilly’s oral GLP-1s establishing their footing in the U.S. obesity market, the companies’ respective Wegovy pill and orforglipron tablet Foundayo are making their mark on prescription trends for a class previously confined primarily to injectables.
- “Looking at the past four weeks, total U.S. GLP-1 prescriptions were up 3.6%, compared to 1.8% at the same time last year, analysts at Citi wrote in a Friday note to clients, citing script tracking data from IQVIA. The Citi team attributed that momentum to the ability of Novo’s and Lilly’s new oral launches to “broaden and reshape the market” for obesity incretin drugs.”
- GLP-1 pills are one of three big shifts for the GLP-1 market, according to Beckers Hospital Review.
- MedCity News considers whether “Mark Cuban’s Cost Plus Wellness Appeal to Employers?”
- Employer advocates said Cost Plus Wellness could help spur more direct contracting and transparency in healthcare, though they questioned whether the model can scale and adequately measure provider quality and outcomes.
- Beckers Hospital Review reports,
- “Philadelphia-based Penn Medicine reported an operating income of $238.5 million (2.4% margin) for the nine months ended March 31, up 46.3% from $163 million (1.9% margin) in the same period last year, according to financial documents filed May 20.
- “The results follow the April 1, 2025, acquisition of Doylestown (Pa.) Health. Doylestown Hospital, a 245-bed teaching hospital, became Penn Medicine’s seventh hospital and is now known as Penn Medicine Doylestown Health.”
- STAT News tells us,
- “Retro Biosciences, the longevity startup backed by OpenAI CEO Sam Altman, has raised more money at a $1.8 billion valuation, it announced Friday.
- “Retro has a big mission: Add 10 healthy years to the human lifespan. It is seeking to do that by using a variety of technologies, including in vivo gene therapies, cell replacement therapies, and other approaches to spur younger, healthier cells into aging tissues.
- “The company is currently running its first clinical trial — testing a pill designed to enhance the body’s ability to better clear out protein aggregates in patients with Alzheimer’s disease. Retro CEO Joe Betts-LaCroix told the audience at STAT’s Breakthrough Summit West on Tuesday that the trial is going “super good” and that researchers haven’t seen any dose-limiting toxicities. He said he anticipates releasing some data from the trial around August.”
- Fierce Healthcare informs us,
- “Innovaccer acquired CaduceusHealth to combine its AI platform with the company’s revenue cycle management services and staff to serve ambulatory care providers.
- ‘Innovaccer, founded in 2014, built software solutions to unify enterprise data and applies AI to automate manual tasks and streamline workflows for payers and providers. Last year, it rolled out Flow Auth, an AI-powered prior authorization solution that is part of Flow by Innovaccer, an AI-powered revenue cycle suite designed to modernize financial operations for health systems. Other capabilities include Flow Capture, an autonomous medical coding solution and Flow Collect, an AI-powered denial management and revenue recovery tool.
- “Innovaccer claims that it now serves over 200 health systems and payers, 95% of community pharmacies and 80 million patient lives across the United States. Flow is built on Gravity, Innovaccer’s healthcare AI infrastructure platform.”
- and
- “Eugene, Ore.-based Ksana Health is undertaking a multi-institutional research effort aimed at creating a new class of artificial intelligence to advance mental health and substance use disorder treatment and prevention.
- “The software company was awarded a $17.9 million contract by the U.S. Department of Health and Human Services (HHS) to create a Large Health Behavior Model (LHBM). Its goal is to train AI models on smartphones and other wearables data, including sleep, mobility and language use linked to large scale electronic health records (EHRs).
- “This initiative augments Ksana’s current efforts to shift behavioral healthcare from episodic, subjective assessment toward continuous, data-driven health promotion, reducing healthcare spending, improving quality of life, and reaching populations that currently lack access to effective behavioral health support,” said Tony Scripa, Ksana Health COO and project co-investigator, in a statement.”
- and
- “More than seven in 10 Medicare members report feeling confusion or uncertainty when navigating online health information, a new whitepaper from CVS Health found.
- “The research (PDF) drew insights from Medicare-eligible consumers through surveys, interviews and ethnographic studies.
- “Seventy-one percent of respondents report an eagerness to use more digital health care tools and 86% report an eagerness to use them. However, 58% of respondents report that low digital health literacy is negatively impacting their ability to manage their health.
- “We’re caring for the fastest-growing and most clinically complex population in the country, and what we found in the research challenges a common assumption—older adults actually are more open to engaging with technology than many think,” said Dr. Benjamin Kornitzer, M.D., Aetna senior vice president and CMO, in a statement. “It creates a real opportunity to meet them where they are and provide day-to-day support, whether it’s managing medications, following up after a visit, or staying on track with chronic conditions. Technology and engagement can help them live healthier, more independent lives.”
- “As a result, CVS said it is applying insights from the research across its digital offerings, including clearer navigation, stronger accessibility features and added privacy and security transparency.”
