From Washington, DC,
- At 6:45 pm ET, the Senate confirmed by a 49-46 vote the President’s nomination of Scott Kupor to be Office of Personnel Management Director for a four-year term. The confirmation vote followed a 51-46 vote in favor of Mr. Kupor to close debate on his nomination. (Link to Govexec story) Congratulations and best wishes, Mr. Kupor.
- Govexec tells us,
- “President Donald Trump’s candidate to lead the Centers for Disease Control and Prevention advanced out of a Senate committee Wednesday following a party-line vote, moving her one step closer to confirmation.
- “Susan Monarez’s nomination now goes to the floor, where she will likely secure the backing needed to officially take on the role of CDC director after garnering support from Republicans across the political spectrum during the committee’s 12-11 vote.
- “Senate Majority Leader John Thune, R-S.D., will be in charge of scheduling that vote, though if it isn’t held during the next few weeks, Monarez will have to wait until after the chamber’s August recess.”
- BioPharma Dive informs us,
- “President Donald Trump is planning to introduce tariffs of 50% on copper imports and levies “at a very, very high rate, like 200%” on pharmaceutical products, he said at a cabinet meeting Tuesday.
- “Trump indicated official announcements of the tariffs would come “very soon” but did not elaborate on an exact timeline. He did say, however, that the U.S. would give pharmaceutical importers at least a year to shift their strategies before the implementation of the levies.” * * *
- “In a note to clients, Leerink Partners David Risinger wrote how the planned grace period is a “positive” for the sector, which has for years built up production capacity in countries like Ireland, Switzerland and the Netherlands. Many generic medicines and drug ingredients, meanwhile, are sourced from India and China.”
From the Food and Drug Administration front,
- BioPharma Dive relates,
- “The Food and Drug Administration has approved a modified dosing schedule for Eli Lilly’s Alzheimer’s disease drug Kisunla, permitting a smaller first dose and a more gradual increase that in clinical trials, reduced dangerous episodes of brain swelling, the company said Tuesday.
- “That side effect, called ARIA, has made physicians reluctant to prescribe the drug and resulted in its use being blocked in some countries. The new dosing protocol will “aid healthcare professionals in evaluating appropriate treatment options for their patients,” said Brandy Matthews, Lilly’s vice president for Alzheimer’s medical affairs, in a statement.
- “Approved in 2024, Kisunla was the third drug cleared by the FDA to slow Alzheimer’s progression by targeting toxic plaques of a protein called amyloid beta. Despite its potency, sales were only a modest $21 million in the first quarter of 2025.”
- Mobihealth News points out,
- “Mendaera, a robotics company, announced it has been granted FDA 510(k) clearance for Focalist, a handheld robotic system, which aims to combine handheld robotics with real-time imaging to enable clinicians to place needles with precision.
- “Mendaera said the system integrates robotics, ultrasound imaging and advanced software to make medical procedures more accessible.
- “Among Focalist’s features are touchscreen targeting, robotic needle positioning and continuous needle depth tracking, enabling a reproducible procedure experience.
- “While needle placement is used for a variety of procedures and in a broad range of clinical settings, the initial focus of the system will be in urology. Full commercialization is expected in 2026.”
- Per Fierce BioTech,
- “The FDA has cleared its first cuffless blood pressure monitor that will be available over-the-counter, with the Hilo wristband developed by Aktiia.
- “According to the Swiss company, the wearable’s optical sensors can capture continuous blood pressure readings similar to the traditional inflated cuff with monthly calibrations, and they have demonstrated accuracy across a variety of skin tones—as well as while the user is sitting, standing or lying down.
- “The system previously obtained a CE Mark approval in Europe, and Aktiia said its newly 510(k)-cleared product will reach the U.S. sometime in 2026. The Hilo bracelet has also been given go-aheads in Canada, Australia and Saudi Arabia, and more than 120,000 have already been sold, the company said.
- “This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management,” Aktiia’s co-founder and chief technology officer, Josep Sola, said in a statement. “With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions.”
From the public health and medical research front,
- The University of Minnesota’s CIDRAP reports,
- “The US Centers for Disease Control and Prevention (CDC) today reported 21 more measles cases from the past week, pushing the year’s total above a record set in 2019 for the most cases since the disease was eliminated in the United States in 2000.
- “So far this year, 1,288 cases have been reported from 39 states, and 88% have been part of 27 outbreaks. Among confirmed cases, 92% occurred in people who are unvaccinated or have unknown vaccination status.
- “Measles isn’t just striking young children and their school-age peers: about one-third of cases have been reported in those ages 20 and older. The measles surge was initially fueled by a large outbreak in West Texas that began in January, but smaller outbreaks have now been reported from multiple states, along with numerous infections in unvaccinated people who traveled abroad.
- ‘Measles activity has increased globally, including in North America, where the virus is spreading in communities with large numbers of unvaccinated people—including Mennonite communities linked to large outbreaks in the United States, Canada, and Mexico. Canada has reported 3,703 measles cases this year, the most since it eliminated the disease in 1998.”
- and
- “A study of more than 70,000 US pregnancies suggests a commonly used antibiotic for urinary tract infections (UTIs) may be tied to increased risk of congenital malformations when taken during the first trimester of pregnancy.
- “The study, published today in JAMA Network Open, found that exposure to trimethoprim-sulfamethoxazole (TMP-SMX) during the first trimester was associated with increased risk of any malformation, severe cardiac and other cardiac malformations, and cleft lip and palate compared with beta-lactam antibiotics. No increased risk of congenital malformations was observed with nitrofurantoin, which is also commonly used to treat UTIs.
- “The study partly substantiates the concerns of the American College of Obstetricians and Gynecologists (ACOG), which has suggested that TMP-SMX and nitrofurantoin be avoided during the first trimester when possible because of uncertainty about the risk of congenital malformations, though studies to date have produced mixed results. Despite the ACOG recommendation, the two antibiotics still account for more than half of first-trimester UTI prescriptions, according to the study authors.”
- STAT News adds,
- “When several countries endorsed the notion of some high-risk people taking the antibiotic doxycycline after unprotected sex to lower their chances of contracting a sexually transmitted disease, as the U.S. did last year, there was a theoretical concern the shift could drive antibiotic resistance in some bacterial infections.
- “That risk no longer appears to be theoretical.
- “In a newly published letter in the New England Journal of Medicine, researchers reported a steep rise in resistance to tetracycline — the antibiotic class to which doxycycline belongs — in gonorrhea isolates collected from across the country since results of the studies investigating the use of so-called doxy PEP were made public. PEP is short for post-exposure prophylaxis.
- “An earlier report out of the University of Washington showed a similar trend in the Pacific Northwest, as well as a rise in tetracycline resistance in other bacteria carried by people who took doxy PEP, specifically Staphylococcus aureus and group A Streptococcus.”
- and
- About 1 in 3 young people who are 12 to 17 years old have prediabetes, new national data show, putting them at risk not just for type 2 diabetes but also for heart disease and stroke. Developing chronic diseases early in life also heightens their chances for worse outcomes from these conditions.
- Experts said the data reflect a concerning rise in obesity among teens but also noted that not all teens with prediabetes will progress to diabetes.
- “The new report from the Centers for Disease Control and Prevention relied on the long-running National Health and Nutrition Examination Survey, which asked adolescents if they’d ever been diagnosed with diabetes and analyzed results of their fasting blood glucose or hemoglobin A1c tests. Its conclusion: In 2023, an estimated 8.4 million adolescents, or 32.7% of 12- to 17-year-olds, had prediabetes.”
- Health Day lets us know,
- “Three-quarters of stomach cancer cases could be prevented if doctors eradicate infection by a common type of bacteria, a new study says.
- “The bacteria, Helicobacter pylori, is linked to 76% of future stomach cancer cases, researchers reported July 7 in the journal Nature Medicine.
- “Most stomach cancers “are caused by chronic infection with H. pylori and can be prevented by treatment of the infection with a combination of antibiotics and proton pump inhibitors,” wrote the research team led by Jin Young Park, a scientist with the International Agency for Research on Cancer in Lyon, France.” * * *
- “About 30,300 new cases of stomach cancer will occur in the U.S. this year, and about 10,780 people will die from this type of cancer, according to the American Cancer Society. Most cases occur in seniors.” * * *
- “In the USA, there are currently no national guidelines or formal recommendations for gastric cancer prevention, although gastric cancer disproportionately affects Asian Americans, Hispanic Americans, African Americans and American Indian-Alaska Native individuals, and an increasing trend in young individuals (age <50 years) has been observed between 2016 and 2022, most notably in women,” researchers wrote.
- “While H. pylori infections can be easily treated, researchers said it would be best if a vaccine for the bacteria is developed.
- “Currently, only one H. pylori vaccine has passed phase 3 of a clinical trial,” researchers noted. “More investment in future vaccine trials focusing on pediatric populations should be made, clarifying the mechanisms of vaccine-associated immunoprotection.”
- and
- “Uterine cancer incidence and mortality rates are projected to increase significantly through 2050, according to a study published online July 1 in Cancer Epidemiology, Biomarkers & Prevention.
- “Jason D. Wright, M.D., from the Columbia University College of Physicians and Surgeons in New York City, and colleagues developed a natural history model for uterine cancer to project trends through 2050.
- “The researchers reported that uterine cancer is projected to increase in incidence and mortality through 2050. Black women will experience a disproportionate rise in incidence compared with White women between 2020 and 2050 (86.9 and 74.2 per 100,000, respectively), as well as a rise in mortality (27.9 and 11.2 per 100,000, respectively). For nonendometrioid tumors, White women will experience only a slight increase, while Black women will experience a substantial increase (10.8 and 36.3 per 100,000, respectively). Hypothetical screening and intervention methods were most effective when introduced at age 55 years with declines in cancer incidence that lasted up to 15 years in White women and up to 16 years in Black women.”
- and
- A healthy plant-based diet might protect people from inflammatory bowel diseases, a new study says.
- People noshing healthy plant-based foods had a 14% lower risk of Crohn’s disease and an 8% lower risk of ulcerative colitis, researchers found.
- On the other hand, an unhealthy diet containing more animal fats and vegetable oils was associated with a 15% increased risk of Crohn’s disease, results show.
- “Our research indicates that a healthy plant-based diet may protect against inflammatory bowel disease, with its anti-inflammatory properties playing a key role,” senior researcher Dr. Zhe Shen of the Zhejiang University School of Medicine in China said in a news release.
- The New York Times reports,
- “Few practices in mental health are debated more than the long-term use of antidepressant medications, which are prescribed to roughly one in nine adults in the United States, according to data from the Centers for Disease Control and Prevention.
- “A reassessment began in 2019, when two British researchers published a study that found that 56 percent of patients suffered from withdrawal symptoms when they stopped antidepressant medications and that 46 percent of those described their symptoms as severe.
- “The findings made headlines in Britain and had a powerful ripple effect, forcing changes to psychiatric training and prescribing guidelines. And they fed a growing grass-roots movement calling to rein in the prescription of psychotropic drugs that has, in recent months, gained new influence in the United States with the rise of Robert F. Kennedy Jr. as health secretary.
- “A new study, published on Wednesday in the journal JAMA Psychiatry, makes the case that these warnings were overblown. The authors of the new paper found that a week after quitting antidepressants, patients reported symptoms like dizziness, nausea and vertigo, but that they remained, on average, “below the threshold for clinically significant” withdrawal.”
- Per MedPage Today,
- “About half of teen vapers said they had tried to quit in the past year, and about a third wanted to try quitting in the next 6 months.
- “The most common nicotine cessation tools used in these attempts were apps.
- “No nicotine replacement therapy is approved for youth, but the American Academy of Pediatrics recommends considering off-label use for some adolescents.”
From the U.S. healthcare business front,
- The Wall Street Journal reports,
- “Merck will buy Verona Pharma for roughly $10 billion, adding Ohtuvayre to its cardiopulmonary pipeline and portfolio.
- “The acquisition helps Merck prepare for the loss of patent exclusivity for Keytruda in 2028.
- “Verona shareholders will receive $107 per share, a 23% premium to Tuesday’s closing price.”
- Healthcare Dive notes,
- “Health insurers are steadily expanding their control over the U.S. primary care market — especially in areas with a lot of seniors eligible for Medicare Advantage plans, according to new research.
- “In 2023, payer-operated practices accounted for 4.2% of the national Medicare primary care market by service volume, up from 0.8% in 2016, the study published in Health Affairs Scholar found. It’s the first concrete estimate of insurer ownership of physician practices nationwide and suggests that vertical consolidation is being driven by the potential for profits in nudging MA members to owned clinics, researchers said.
- “The paper could also intensify the microscope on UnitedHealth as lawmakers and regulators scrutinize the healthcare behemoth’s outsized control over the industry. UnitedHealth-owned Optum was the largest operator of primary care clinics of all the insurers included in the analysis, holding more than 2.7% of market share nationally and more than 35% in several large counties.”
- Per Beckers Health IT,
- “A recent survey from the American Medical Association found that 66% of medical providers used AI in some capacity in the past year. That represented a dramatic 78% increase from the prior year.
- “Usage is only going up, but many providers remain skeptical about AI. Resistance to change is understandable—particularly when AI-focused headlines often seem better described as “clickbait” than substantive. However, practices that dismiss the idea of AI-enabled workflows are missing out on valuable opportunities to measurably boost efficiency, increase patient satisfaction, and reduce costs.
- “When applied strategically, AI can make a real impact in day-to-day practice operations and throughout the patient journey. So, how should a practice best determine where to focus efforts when it comes to AI enablement?
- “First and foremost, AI adoption should be thoughtful, not frenzied,” says Dr. Sanjeev Kumar, Ph.D., chief data and analytics officer at NextGen Healthcare and a globally recognized AI expert. “An AI-driven tool should always address real need and make life easier for the humans using it.”
- Fierce Healthcare adds,
- “Nabla is integrating its AI medical scribe with Navina’s AI-enabled copilot to provide doctors with an AI layer that supports clinical workflows.
- “The aim is to deliver real-time support through the full clinical encounter, according to the companies.
- “The integration combines Navina’s clinician copilot with Nabla’s in-visit ambient documentation, reconciling historical patient records with live patient dialogue to help improve patient outcomes and financial performance.”
- Per Beckers Clinical Leadership,
- “Columbus-based Ohio State University Wexner Medical Center and James Comprehensive Cancer Center researchers found about 1% to 2% of all inpatient hospitalizations resulted in patients discharging against medical advice — and these patients led to more than $800 million in annual associated healthcare costs.
- “The study, published June 26 in Journal of the American College of Surgeons, used the data from 1,768,752 surgical patients between 2016 and 2020 in the Nationwide Readmissions Database. All patients underwent major surgeries in various medical specialties. Researchers evaluated trends in DAMA incidence, postoperative outcomes, risk factors for DAMA and 30-day healthcare expenditures.”