Simplicity is a virtue.

From Washington, DC

• STAT News reports,
  • ‘ARPA-H, the U.S.’ “moonshot” agency for health research, announced Thursday that it will spend up to $160 million to push forward custom gene editing treatments for a spate of rare diseases. 
  • ‘The program, called THRIVE, will back seven different teams pursuing various groups of conditions affecting different organ systems. 
  • “Each team has a deadline of starting clinical trials by year three of the program, although some may start much sooner.” * * *
  • “Each of the groups will work with a partner, such as a biotech company or contract manufacturer, or multiple partners to assure they can manufacture the program to Food and Drug Administration standards.”

• Beckers Hospital Review relates,
  • “Peptides have become one of the most closely watched regulatory questions in healthcare this summer, with a federal advisory committee vote set for July 23-24 that could reshape what’s legally available to prescribers, wellness clinics and patients nationwide.
  • “What are peptides?
    • Peptides are short chains of amino acids that often serve as signaling molecules for physiological functions in the body, including tissue repair, metabolism and inflammation. Some peptides, like insulin and semaglutide, the active ingredient in Ozempic and Wegovy, are FDA-approved drugs. Others — including BPC-157, TB-500 and a handful of others marketed for injury recovery, weight loss, sleep and anti-aging — have circulated for years through wellness clinics, medical spas and online retailers without ever being FDA-approved or added to the list of substances legally allowed in pharmacy compounding. 
    • “That distinction matters because of how compounding law works. Under Section 503A of the Food, Drug and Cosmetic Act, a licensed pharmacy can only compound a drug for an individual patient using a bulk substance if it’s FDA-approved, has a recognized USP monograph, or appears on the FDA’s 503A Bulks List. If a peptide isn’t on that list, pharmacies generally can’t legally compound it — which is exactly the question now in front of regulators. 
  • “The upcoming vote 
    • “The FDA’s Pharmacy Compounding Advisory Committee meets July 23-24 to decide whether seven peptides should be added to the 503A bulks list: BPC-157, KPV, TB-500 and MOTs-C, Emideltide (also called DSIP), Semax and Epitalon. The committee’s recommendation is non-binding, but the FDA has historically followed it.”

• Tammy Flanagan, writing in Govexec, explains OPM’s new all-digital federal retirement benefit application process.

• Per an HHS news release,
  • “President Donald J. Trump signed an Emergency Declaration for the Northern Mariana Islands and the Territory of Guam, and Secretary Robert F. Kennedy, Jr. has declared a public health emergency to address the consequences of Typhoon Bavi. Under these circumstances, the Secretary has also exercised the authority to waive sanctions and penalties against a covered hospital that does not comply with the following provisions of the HIPAA Privacy Rule:
    • the requirements to obtain a patient’s agreement to speak with family members or friends involved in the patient’s care. See 45 CFR 164.510(b).
    • the requirement to honor a request to opt out of the facility directory. See 45 CFR 164.510(a).
    • the requirement to distribute a notice of privacy practices. See 45 CFR 164.520.
    • the patient’s right to request privacy restrictions. See 45 CFR 164.522(a).
    • the patient’s right to request confidential communications. See 45 CFR 164.522(b).
  • “When the Secretary issues such a waiver, it only applies: (1) in the emergency area and for the emergency period identified in the public health emergency declaration; (2) to hospitals that have instituted a disaster protocol; and (3) for up to 72 hours from the time the hospital implements its disaster protocol. When the Presidential or Secretarial declaration terminates, a hospital must then comply with all the requirements of the Privacy Rule for any patient still under its care, even if 72 hours has not elapsed since implementation of its disaster protocol.”

From the Food and Drug Administration front,

• USA Today reports,
  • “If headlines about heavy metals in tampons raised concerns, the Food and Drug Administration says there’s some reassuring news.
  • “A new agency study found trace amounts of metals including arsenic, cadmium and lead in tampons sold in the U.S., but concluded the levels released during use are too low to pose a health risk.
  • “The findings are the FDA’s latest response to a widely publicized 2024 study that detected metals in popular tampon brands and sparked questions about possible health effects. After analyzing 11 tampon products from six brands, FDA researchers found that while metals can be detected in the products, exposure during normal use remains far below levels considered harmful.”

• MedTech Dive informs us,
  • “Johnson & Johnson has won Food and Drug Administration approval for a catheter that delivers radiofrequency and pulsed field energy to treat atrial fibrillation.
  • “The approval, which J&J disclosed Wednesday, covers the Dual Energy Thermocool Smarttouch SF Platform. J&J already had approval for a single, radiofrequency energy version of the device.
  • “Integrated into the company’s Carto mapping system, the dual-energy catheter is part of J&J’s push to leverage its electrophysiology strength to reverse market share losses triggered by PFA.”

• The American Hospital Association News relates,
  • “The Food and Drug Administration has issued an early alert for specific lots of BD ChloraPrep Applicators by Medline because of a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. Medline has instructed impacted customers to remove the recalled convenience kits from where they are used or sold. The company said that other components within the convenience kits may still be used.” 

• BioPharma Dive cautions,
  • “The regulatory gears in the U.S. are increasingly creaking under the weight of new, complex drug technologies and intensifying overseas clinical trials competition from countries like China and Australia.
  • “Now, the Department of Health and Human Services is making moves to speed early drug research under a new plan dubbed Operation Trialblazer. The blueprint, which involves initiatives at multiple federal agencies, including the Food and Drug Administration and the National Institutes of Health, focuses on modernizing regulations and processes, improving patient access and participation, and enhancing the use of data and technology to streamline the regulatory process.
  • “It’s the latest in a series of actions aimed at supporting drug research. But whether the new reforms will make a meaningful impact is an open question.” 

From the judicial front,

• Fierce Healthcare reports,
  • “CVS Health and its embattled Omnicare unit have agreed to pay $440 million to the Department of Justice to satisfy a nearly $950 million judgment against the company as part of an ongoing fraud case.
  • “In April 2025, a federal jury ruled that Omnicare submitted more than 3.3 million fraudulent prescription claims between 2010 and 2018, earning $135.6 million in overpayments as a result. Then, in July 2025, a judge ordered Omnicare to pay $948.8 million in fees and damages as part of the case.
  • “In the new court docs, CVS said that it has agreed to make an initial $130 million payment within 14 days of the agreement’s effective date. The remaining $310 million must be paid out by March 15, 2028.
  • “The agreement with DOJ is contingent on the closure of Omnicare’s sale to GenieRx Holdings, according to the filing. As it navigated the legal fallout of the False Claims Act case, Omnicare filed for bankruptcy in September 2025, and CVS announced plans to sell to GenieRx in May of this year.”

From the public health and medical / Rx research front,

• The Washington Post reports,
  • “Annual cancer cases are projected to rise considerably worldwide by 2050, according to a World Health Organization report on cancer published Wednesday. With its assessment, the United Nations body tempered optimism about improvements in cancer surveillance and treatment and warned that global health care inequities are driving further cases and deaths. 
  • “Around 20.6 million people were diagnosed with cancer in 2024, according to the findings. That number could reach 35 million a year by 2050.
  • “The new cases will disproportionately appear in lower-income countries with poorer access to cancer surveillance and treatment, according to the report.” * * *
  • “In the United States, the rate of new cases has generally been stable in recent years, according to the National Institutes of Health. The WHO report predicts that cancer rates will increase in all regions across the world, though the biggest increases are projected in Africa and the Eastern Mediterranean region.”

• Health Day adds,
  • “More men die from cancer than women, and a new study suggests one potential reason why.
  • “Men are more likely than women to be diagnosed with advanced cancer that has spread to other parts of the body, researchers report in the July issue of the journal Cancer Epidemiology, Biomarkers & Prevention.
  • “That means their cancer is being detected too late, when it’s tougher to treat and more likely to be fatal, researchers said.
  • “We know that, overall, males are more likely than females to die from many types of cancer. We also know that cancer stage at diagnosis is a key predictor of cancer survival,” lead researcher Beth Maclin, a postdoctoral fellow at the National Cancer Institute in Bethesda, Maryland, said in a news release.” * * *
  • “My overall message is that everyone should go to the doctor regularly,” Maclin said. “Don’t delay seeing a doctor if you notice something has changed in your body.”

• The AP relates,
  • “Nearly 1,000 people in Michigan have been diagnosed with a parasitic infection that can cause weeks of watery diarrhea, making it the largest such outbreak in state history and one of the nation’s largest in years.
  • “No deaths have been reported and the source of the cyclospora infections hasn’t been identified. Meanwhile, investigations into similar illnesses have been going on in 28 other states, including in Ohio, where people just across the Michigan border are also becoming sick.
  • “Michigan officials first announced the outbreak last week, when they were aware of more than 170 cases — all in the southeastern corner of the state — since June 22. Michigan usually identifies only about 50 cases each year.
  • “On Wednesday, the state reported the number had grown to 992, including about 40 hospitalizations. Just across the state line, Lucas County, Ohio, reported 306 cases as of Wednesday. Northwest Ohio has seen more than 500 cases.
  • “Cyclospora surges can be tricky to investigate, and food poisoning sources can be hard to establish. But “there is clearly a linked outbreak happening right now,” Dr. Natasha Bagdasarian, Michigan’s chief medical executive, told The Associated Press on Wednesday.”

• MedPage Today tells us,
  • “Chronic kidney disease prevalence held steady at around 14.8% over the last decade, despite treatment advances.
  • “This translated to an estimated 36 million affected U.S. adults, based on national health survey data.
  • “The prevalence of diabetes-related chronic kidney disease increased during the period spanning 2013-2014 to 2021-2023.” * * *
  • “This means single-organ care is no longer enough, said [Sophie] Claudel [, MD]. Based on the data, a growing proportion of the population may be at risk for progressive cardiovascular-kidney-metabolic (CKM) syndrome.

• Healio informs us,
  • “GLP-1s may prevent adverse outcomes in patients with peripheral artery disease and diabetes, according to data published in the Journal of the American Heart Association. 
  • “Researchers reported that GLP-1 receptor agonist use among patients with PAD and diabetes was associated with lower risk for mortality, hospitalization, revascularization and amputation compared with those prescribed metformin.
  • “Obesity and PAD, including chronic limb-threatening ischemia, are linked to increased inflammation, poor blood vessel function, insulin resistance, oxidative stress and faster hardening of the arteries,” Akiva Rosenzveig, MD, cardiology fellow at Cleveland Clinic, said in a press release. “These results indicate GLP-1 [receptor agonists] can help reduce inflammation, improve blood vessel function and manage blood sugar levels.”

• Medscape adds,
  • “The FDA approved Zepbound (tirzepatide) in December 2024 for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in patients with obesityafter research showed that the medication improved outcomes in these patients.
  • “Sleep apnea is among the most common sleep disorders. It occurs when the airways relax and block breathing during sleep. Patients may repeatedly stop breathing, leading to disrupted sleep, snoring, and excessive sleepiness during the day.
  • “Now new research has shown that certain patients seem to benefit more than others from the medication. Patients with the most severe sleep apnea along with those who are younger and have less severe obesity experienced nearly twice the reduction in symptoms compared to those who are older and have more severe obesity.”

• Fierce Pharma points out,
  • “In a first for the neurotoxin market, Ipsen announced Thursday that its Dysport has hit the goals in two phase 3 trials for the prevention of both episodic and chronic migraines.
  • “While AbbVie’s market-leading Botox has been approved by the FDA to prevent headaches in patients with chronic migraine since 2010, Dysport is now the first botulinum toxin to also report positive phase 3 results in episodic migraine, according to Ipsen.
  • “The readouts come from studies in Ipsen’s Beond program, comprising 1,510 patients, split between C-Beond (chronic) and E-Beond (episodic). Both trials have met their primary endpoints, showing a statistically significant reduction in monthly migraine days versus placebo.
  • “Together, these findings position Dysport as a potential first-in-class treatment for a broad migraine population,” Ipsen’s global head of R&D, Christelle Huguet, Ph.D., said in a July 9 statement.
  • “Ipsen will review the full data and prepare for regulatory filings, including with the FDA, a company spokesperson told Fierce Pharma.” 

• BioPharma Dive lets us know,
  • “A nucleic acid-based medicine from AstraZeneca and Ionis Pharmaceuticals missed its main objective in a big study of people with a deadly heart condition in a major setback with notable ramifications for multiple other drugmakers. 
  • “In a pair of statements, the companies said that when compared to a placebo in people with transthyretin-mediated amyloid cardiomyopathy, or ATTR-CM, their drug, eplontersen, didn’t significantly reduce the risk of death or recurrent cardiovascular events after 140 weeks. Eplontersen had no treatment effect among participants already receiving a commonly used “stabilizer” medication. A 29% risk reduction was observed in people who weren’t getting those drugs, AstraZeneca and Ionis said.
  • “The companies didn’t provide additional study details, only noting that the drug was “well tolerated” and showed positive signs on multiple other secondary study measures. Those specifics will be presented at a medical meeting in August. “
• and
  • “Roche said Thursday it’s discontinuing two Ionis-partnered drugs for Huntington’s disease after clinical setbacks, with one missing its main trial goal and the other suspended because of a safety worry.
  • “A Phase 2 test of the antisense oligonucleotide tominersen “did not meet its efficacy objective” in spite of having a significant impact on biological disease signs, Roche said in a letter to patient groups. Meanwhile, enrollees in a Phase 1 trial of a drug codenamed RG6496 won’t receive a second dose because animal safety testing revealed that it “cannot be given chronically with repeated doses,” Roche said.
  • “The Swiss pharmaceutical giant had once before suspended a late-stage trial of tominersen because it didn’t appear to be helping patients. Roche forged ahead with a hypothesis that younger and less-advanced patients might benefit, but now that pathway has hit a dead end.”

• Per Genetic Engineering and BioTechnology News,
  • “A landmark Phase I/II clinical study led by researchers at Skåne University Hospital and Lund University has shown that transplanting stem-cell-derived dopamine progenitor cells into the brain is feasible. Eight patients with Parkinson’s disease (PD) received transplants of STEM-PD, a cryopreserved, off-the-shelf dopaminergic progenitor product derived from human pluripotent stem cells. The three-year Phase I/II, open-label, multicenter, single-arm, dose-escalation study identified no serious side effects linked to the transplanted cells during the first year of follow‑up.
  • “The possibility of replacing dopamine neurons that are lost in Parkinson’s disease has been a long-standing goal in the field,” said Malin Parmar, professor of cellular neuroscience at Lund University, and lead of the STEM-PD program. “The findings represent an important milestone for regenerative medicine approaches in Parkinson’s disease and support continued clinical development of stem cell-based therapies.”
  • “Results from the study were reported by Parmar and colleagues in Nature Medicine. In their paper, titled “Human embryonic stem cell-derived dopaminergic cells for Parkinson’s disease: a Phase I/II open-label trial,” the team wrote, “In conclusion, particularly in the context of other recently published trials using human PS cell-derived dopaminergic cell therapies for PD, these findings further support the continued development of this therapeutic approach, including evaluation of the STEM-PD product in larger patient cohorts.”

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

• Healthcare Dive reports,
  • “CVS’ insurance division Aetna has a finally gotten a handle on medical spending after a turbulent few years, according to the healthcare giant’s chief executive.
  • “We’ve got, I think, our arms around how to project and predict where healthcare costs are going, and making sure we’re pricing our products accordingly,” CVS CEO David Joyner said at an event hosted by the Economic Club in Washington, D.C., on Thursday.
  • “Joyner’s comments — which come about a month before CVS is scheduled to report second quarter results — are likely a welcome signal for investors that Aetna can continue recent progress on controlling spending.” * * *
  • “The biggest challenge for CVS isn’t managing members’ costs: It’s policy uncertainty out of Washington, Joyner said.
  • “I spend a lot of my time, both at the federal level and in the states, trying to help educate and also describe what are the real drivers of healthcare costs, and then making sure that we play an active role to help with members of Congress,” the CEO said.”
    
• Fierce Healthcare relates,
  • “UnitedHealthcare is rolling out a new benefit option aimed at making it easier for employers to offer more personalized wellness programs.
  • “Called Lifestyle Spending Accounts (LSAs), the benefit allows employers to offer a stipend that members can put toward wellness solutions. The LSAs are integrated with UnitedHealth’s UHC Store, which is a digital storefront where members can purchase select health and wellness programs at a discount.
  • “The accounts exist alongside health savings accounts or flexible spending accounts, allowing individuals to purchase health and wellness generally not available under HSAs or FSAs, UnitedHealthcare said.”

• Benefits Pro tells us,
  • “Both the levels and growth of health care spending from 2005 to 2023 were greatest among Americans with the highest incomes, according to a new report in Health Affairs.
  • “Among the lowest income quintile, spending grew more rapidly just after 2014 but declined from 2018 to 2023. By contrast, spending in the highest income quintile grew more rapidly in recent years. As a result, the difference in age and health status-adjusted spending between the highest and lowest income quintiles declined after implementation of the Affordable Care Act subsidies but increased more recently. The adjusted per capita spending difference in 2023 was more than $4,700.
  • “If spending continues its most recent trajectory, that difference will continue to grow,” the report said. “These spending patterns were driven largely by outpatient and prescription drug spending, which tend to be more discretionary than inpatient and emergency department spending. Prescription drug spending showed a particularly pronounced recent divergence for the top income quintile. Recent spending growth was most evident in the population younger than age 65, which has more variation in insurance coverage, affecting both service use and prices.”
    
• Psychology Today lets us know,
  • “Mental health leave [under federal and state leave acts] has sharply increased in the U.S. since the pandemic.
  • “Women, especially caregivers, account for the majority of mental health leaves.
  • “Access to mental health leave highlights structural inequalities in the workplace.
  • “Early, ongoing treatment with an established provider can support the mental health leave process.”

• Beckers Hospital Review points out,
  • 24 large health systems growing bigger
  • States ranked by primary care physicians per 100,000 residents, and
  • 10 states where people spend the most, least on health insurance

• Per Smart Brief,
  • “Healthcare AI’s next challenge isn’t adoption. It’s reliability
  • “Healthcare has reached a point where the challenge with AI is not adoption but ensuring it is accountable and dependable post-deployment, writes Sina Bari, vice president of healthcare and life sciences AI at iMerit.”

• Per MedTech Dive,
  • “Stereotaxis said Thursday it finalized the acquisition of French surgical robotics company Robocath.
  • “Announced in April, the deal is valued at up to $45 million and brings together two robot developers focused on endovascular interventions, which are performed inside blood vessels.
  • “Combining the companies’ expertise will speed development of next-generation robotic technologies for electrophysiology, interventional cardiology and neurointerventions, the companies said.”

• Per Fierce Pharma,
  • “Unexpectedly catapulted into global fame as a COVID-19 vaccine maker, BioNTech is on the verge of returning to its oncology roots with potentially its first commercial cancer drug. Yet, to Chief Commercial Officer Annemarie Hanekamp, the upcoming launch is less of a standalone milestone than a strategic springboard for a far more critical pipeline product. 
  • “Backed by positive phase 2 data and an ongoing confirmatory phase 3 trial, BioNTech is readying its Duality Biologics-partnered antibody-drug conjugate (ADC) trastuzumab pamirtecan (T-Pam) for submission with the FDA for previously treated HER2-expressing endometrial cancer. 
  • “If approved, the drug will compete with AstraZeneca and Daiichi Sankyo’s blockbuster HER2 ADC, Enhertu, which boasts a pan-tumor indication. Challenging the market leader, however, is not BioNTech’s end goal for T-Pam.
  • “This is not about competing head to head with Enhertu and overtaking them,” Hanekamp said in a recent interview with Fierce Pharma. “We’re very realistic, and we know in the oncology space, first-mover advantage matters. They’ve been in the market for a while, it’s an amazing drug, and we don’t claim to be all that differentiated versus Enhertu.”
  • “Instead, Hanekamp views T-Pam as a “strategic launch,” an exercise to “run water through the pipes” and test BioNTech’s commercial infrastructure in oncology.”