
From Washington, DC,
- Yesterday, according to the American Hospital Association News, the President signed an
- “executive order, “Improving the Safety and Security of Biological Research,” orders the Director of the Office of Science and Technology Policy to immediately establish guidance for the heads of relevant agencies to end federal funding of gain-of-function research and other life-sciences research conducted by certain foreign entities. The order also directs OSTP to replace the “United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential” within 120 days and replace the “Framework for Nucleic Acid Synthesis Screening” within 90 days. The OSTP is also directed to establish a reporting mechanism for gain-of-function research.”
- Science interviewed Dr. “Jay” Bhattacharya, the Director of the National Institutes for Health.
- The Washington Post reports,
- “Vinay Prasad, a critic of the Food and Drug Administration, has been tapped as the agency’s top regulator of vaccines, gene therapies and the blood supply.
- “Prasad, a University of California at San Francisco professor and epidemiologist, will replace Peter Marks, whom the Trump administration forced out in late March. Prasad, who is also a hematologist and oncologist, is the latest vocal critic of pandemic-era policies to join the administration.
- “He brings a great set of skills, energy, and competence to the FDA,” Marty Makary, the FDA commissioner, wrote Tuesday in an email to staff obtained by The Washington Post.”
- and
- “President Donald Trump and the U.S. Postal Service’s governing board are expected to name FedEx board member and former Waste Management CEO David Steiner as the nation’s next postmaster general, according to two people familiar with the decision, helping solidify the White House’s control over the historically independent mail service.
- “Steiner replaces Louis DeJoy, whom Trump forced out of the role in March amid the mail chief’s clashes with billionaire Elon Musk’s U.S. DOGE Service and congressional dissatisfaction with the agency’s performance and finances, The Washington Post has reported. The people familiar with the decision spoke on the condition of anonymity to describe private conversations and meetings.
- Govexec lets us know,
- “The Trump administration is moving quick on its promise to conduct a massive overhaul of the Federal Acquisition Regulation, a project being called Revolutionary FAR Overhaul.
- “FAR is the subject of one of two executive orders President Trump signed in mid-April to reform how the federal government buys goods and services.
- “In documents released Friday, the administration is proposing the elimination of significant portions of the FAR. What would remain are only those provisions required by law or are “essential to sound procurement.” * * *
- “The government is also asking for “informal” feedback on Part 34 ahead of the formal rulemaking process. Follow this link to share your thoughts.”
- Per Federal News Network,
- “Just over 7,800 federal employees retired last month, the lowest amount so far in 2025. The Office of Personnel Management said more than 33,500 federal employees retired in the first quarter of 2025 compared to 29,700 during the first three months of 2024. OPM’s retirement backlog dropped to 16,700, almost 4,000 less than March. On average, OPM is processing retirement claims in 54 days, but those applications that took less than 60 days for the agency to get OPM the paperwork were processed in 33 days on average.”
- The Government Accountability Office released a WatchBlog post titled “Nonprofit Drug Companies Aim to Curb High Prices and Shortages.”
- “The rising cost of prescription drugs continues to make headlines. This increase has significant implications for people who rely on medications and for taxpayer-funded health care programs. For example, Medicare spending on prescription drugs nearly doubled between 2014 and 2022.
- “At the same time, the country has faced several drug shortages of medications ranging from antibiotics to chemotherapy drugs.
- “Nonprofit drug companies could play a role in helping to address rising prices and drug shortages. Today’s WatchBlog post looks at our new report on nonprofit drug companies.”
From the public health and medical research front,
- Your Local Epidemiologist, a Substack to which the FEHBlog subscribes, tells us,
- “As of Sunday, the U.S. had 967 confirmed cases. We are getting closer and closer to reaching the record high (1,200) since we eliminated measles in 2000.
- “Of that, 817 cases are from the Southwest outbreak. The good news is that it may be slowing down in West Texas. We know this from three soft data points:
- “This is the first week with no hospitalized children in West Texas for measles.
- “A downward trend in reported weekly cases * * *. Ultimately, we want a bell-shaped curve, which may be starting to take shape.
- “Fewer new cases are reported anecdotally by clinicians on the ground.”
- “Transmission continues, just at a slower pace. While any case could still spark a new outbreak in communities with low vaccination rates (for example, all eyes are on El Paso right now), big thanks to the public health workers working to contain.”
- MedPage Today informs us,
- “During the first respiratory syncytial virus (RSV) season in which a maternal vaccine and a monoclonal antibody for infants were available, most infants were immunized via either intervention, according to an analysis of Vaccine Safety Datalink data.
- “Overall, 72% of 36,949 infants were immunized in the 2023-2024 RSV season with either the bivalent RSV prefusion F protein vaccine (Abrysvo) or nirsevimab (Beyfortus), Stephanie Irving, MHS, of the Kaiser Permanente Center for Health Research in Portland, Oregon, and colleagues reported in Pediatrics.
- “This really is a success story,” Irving told MedPage Today, “but it is important to also point out that more than a quarter of infants were not immunized against RSV.”
- “The researchers also noted that there were disparities in access by race and ethnicity, with lowest uptake among Black (60.5%) and Middle Eastern/North African (60.2%) mothers. Rates were highest among Asian mothers (83.7%).”
- CNN reports,
- “Using marijuana during pregnancy is linked to poor fetal development, low infant birth weight, dangerously early deliveries and even death, according to a new meta-analysis of research.
- “The most striking finding is the increased risk of perinatal mortality — death either during the pregnancy or shortly after the pregnancy,” said obstetrician and lead study author Dr. Jamie Lo, an associate professor of obstetrics, gynecology and urology in the School of Medicine at Oregon Health & Science University in Portland.
- “Prior work we’ve done shows prenatal cannabis use impacts fetal lung function and development, reducing the baby’s lung volume,” Lo said. “We’ve also found that there is significantly decreased blood flow and oxygen availability in the placenta. These are the likely underlying mechanisms driving some of our findings.”
- “The placenta is a critical link between the mother and the developing fetus, delivering oxygen, nutrients and hormones necessary for growth. When that link is damaged, both the mother and the fetus are at risk.”
- The AP reports,
- “A new salmonella outbreak linked to backyard poultry has sickened at least seven people in six states, health officials said Monday.
- “Two cases were identified in Missouri, and one each in Florida, Illinois, South Dakota, Utah and Wisconsin, the Centers for Disease Control and Prevention said.
- “People got sick in February and March of this year, the CDC said. They all had the same strain of salmonella — a version that has been traced to hatcheries in the past. The investigation is continuing, health officials said.
- “Salmonella bacteria cause about 1.35 million infections in the United States every year, and recent outbreaks have been tied to sources such as cucumbers, eggs, unpasteurized milk, fresh basil, geckos and pet bearded dragons.
- “But one concern is that chickens and other backyard poultry can carry salmonella bacteria even if they look healthy and clean. A backyard poultry-associated outbreak that ended last year was tied to 470 cases spread across 48 states, including one death.”
- Beckers Hospital Review offers a list of “455 hospitals in the U.S. have a Clostridioides difficile infection rate of zero, as based on the healthcare-associated infections dataset from CMS.”
- NIH Research Matters covers the following topics this week “Youth vaping drug | How nerves sense heat & pain | Non-hallucinogenic LSD analogue.”
- Per Beckers Clinical Leadership,
- “In a first-of-its-kind procedure, clinicians at the University of Maryland Medical Center in Baltimore removed a rare spinal tumor through a patient’s eye socket.
- “The patient, Karla Flores of Rosedale, Md., had two slow-growing developmental bone tumors in her spine and wrapped around her brain stem, according to the University of Maryland Medical System. The tumors, called chordomas, are rare and diagnosed only about 300 times annually in the U.S., the system said in a May 5 news release.
- “In two procedures, surgeons removed the tumor around the brain stem with a traditional craniotomy — through the skull — and with an endoscope through her nose. A team of neurosurgeons, radiation oncologists, and skull base and facial plastic surgeons contributed to Ms. Flores’ care.”
- Health Day relates,
- “An experimental drug might help people with uncontrolled high blood pressure, according to early clinical trial results.
- “People taking lorundrostat experienced twice the decline in their systolic blood pressure than people taking a placebo, researchers reported recently in the New England Journal of Medicine. Systolic, the top number of a blood pressure reading, refers to the pressure within blood vessels during a heartbeat.
- “While blood pressure readings remained elevated at the end of this Phase II trial in some participants treated with lorundrostat, we find these results promising because almost all participants involved in the study were not able to sufficiently lower their blood pressure with medication before,” principal investigator Dr. Michael Wilkinson, an associate professor with the University of California-San Diego School of Medicine, said in a news release.”
From the U.S. healthcare business front,
- Fierce Healthcare informs us that “Each of the six major national insurers turned a profit in the first quarter of 2025, though financial pressures related to government programs—particularly Medicare Advantage (MA)—once again reared their ugly heads.”
- Reuters relates,
- “Bristol Myers Squibb (BMY.N), said on Monday it will invest $40 billion in the U.S. over the next five years, as it seeks to expand its research and manufacturing presence in the country amid U.S. President Donald Trump’s tariff threats.
- “The announcement of new investment was first made by CEO Christopher Boerner in an opinion piece published in Stat News on Monday and was later confirmed to Reuters by a company spokesperson.”
- STAT News adds,
- “Vertex Pharmaceuticals on Monday reported disappointing first-quarter earnings impacted by weaker-than-expected sales of its drugs for cystic fibrosis, and little or no contributions from a gene therapy for sickle cell disease and a recently launched pain medicine.
- “A “tolerability issue” caused a temporary pause to an early stage study involving a closely watched, inhaled, mRNA-based therapy for cystic fibrosis, the company said.”
- Per Healthcare Dive,
- “Rite Aid filed for bankruptcy on Monday, with plans to sell itself, and has already had “meaningful interest” from potential national and regional strategic buyers. Stores will remain open and operating, but plans are to liquidate all locations unless a buyer comes forward, according to court documents.
- ‘The drugstore retailer has secured commitments from some existing lenders to access $1.94 billion in new financing. That plus cash from operations is expected to be sufficient funding during the sale and court-supervised Chapter 11 process.
- “A sale is imminent, with an auction set for May 14 for the pharmacy assets and June 20 for other assets, per court documents. The company just exited a previous bankruptcy in September, after filing less than two years ago, emerging as a private business with about $2 billion less debt plus some $2.5 billion in exit financing.”
- Per Healio,
- “The FDA has approved a dihydroergotamine-based nasal powder for the acute treatment of migraine with or without aura in adults, according to the manufacturer.
- “In a press release, Satsuma Pharmaceuticals Inc. said that Atzumi, formerly known as STS101, is a proprietary product that combines an advanced nasal powder formulation of dihydroergotamine (DHE) and a novel nasal delivery device.
- “Oral DHE has poor absorption, so other formulations are important for delivering the medication,” Abby Metzler, MD, associate professor of neurology at the University of Minnesota, told Healio. “This new nasal powder formulation adds another option that may help by providing a non-invasive option that is less likely to drip down the back of the throat into the stomach, increasing absorption of the medication.”
- Outside of the U.S. STAT News lets us know,
- “For more than three decades, a charity here has funded research aimed at developing medicines for genetic diseases. Recently, though, it added an unusual new role — as a gene therapy company of sorts.
- “The charity, the Telethon Foundation, took ownership from a small biotech of a drug that has been approved in Europe to treat an ultra-rare immune disorder called ADA-SCID. In taking such a step — something no nonprofit had done anywhere — it hoped to both rescue the gene therapy from disuse, and to come up with a new model for delivering these one-time, cutting-edge medicines in a financially sustainable way.
- “The fact that a charity — and not a biopharma company — now has the rights to the medicine is a reflection of the bleak situation the gene therapy field has found itself in, and how other groups, from nonprofits to academic researchers, are trying to mend the failures of the drug development system.”