From Washington, DC,

• The OPM Inspector General recently issued a data brief titled Evaluation of FEHBP Medical Conditions by Premium Expenditure during Contract Years 2019 through 2021. The most expense conditions, representing 10% of spending, was cancer.

• STAT News reports,
  • “The Centers for Disease Control and Prevention is increasing security after the shooting at its Atlanta headquarters earlier this month, leaders told employees in an email reviewed by STAT.
  • “Additional guards have been added to nearly all campuses, according to the email. CDC is in talks with the Federal Protective Services to increase security at two the campuses where it provides security as well, per the email.”
• and
  • “Sens. Roger Marshall (R-Kansas) and John Hickenlooper (D-Colo.) are leading a new push to strengthen requirements on price transparency in hospitals, Marshall writes in a new STAT First Opinion article.
  • “The two senators introduced a new bill, the Patients Deserve Price Tags Act, which would require machine-readable files for all negotiated and cash prices, require hospitals to post prices for services, and require patients to receive an explanation of benefits as well as an itemized bill.
  • “It’s part of a years-long movement to crack down on billing practices among providers — one the White House joined in earlier this year via executive order.
  • “But the bipartisan push is far from a guarantee of changes in the current law. Even some widely backed health proposals in Congress have been left behind in must-pass packages. Read Marshall’s piece.”

• Per a CMS news release,
  • “The U.S. Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) are establishing the Healthcare Advisory Committee—a group of experts charged with delivering strategic recommendations directly to HHS Secretary Robert F. Kennedy Jr. and CMS Administrator Dr. Mehmet Oz to improve how care is financed and delivered across Medicare, Medicaid and the Children’s Health Insurance Program (CHIP), and the Health Insurance Marketplace.
  • “Every American high-quality, affordable care – without red tape, corporate greed, or excessive costs,” said HHS Secretary Robert F. Kennedy Jr. “This new advisory committee will unite the best minds in healthcare to help us deliver real results, hold the system accountable, and drive forward our mission to Make America Healthy Again.” * * *
  • “For more information or to submit nominations, visit the Federal Register Notice at: https://www.federalregister.gov/d/2025-16136.” 
    
• Healthcare Dive observes,
  • “White House data sharing plan boasts big ambitions, but has scant details.
  • “Improving health data exchange is a worthy goal, but the initiative has to overcome challenges like data security, under-resourced providers and slow technology uptake, experts say.”

• Per BioPharma Dive,
  • “The United States and the European Union formalized the terms of the framework trade agreement the two trading partners announced at the end of July, per a joint statement published by the White House Thursday.
  • “The statement provides additional clarity and detail surrounding the terms U.S. President Donald Trump and European Commission President Ursula von der Leyen shared following negotiations in Scotland on July 27, including a 15% tariff on EU imports by the U.S. The two trading partners will “promptly document” the agreement, per the statement.
  • “Under the agreement, the U.S. committed to apply either a tariff of 15% or a “most-favored nation” duty rate on EU imports, with the higher of the two to be enforced. The U.S. will set a cap of 15% on tariffs for imports of pharmaceuticals, semiconductors and lumber, per the statement. Those sectors are currently under Section 232 investigation. Similar probes have led to sector-specific tariffs of up to 50%.
  • “The U.S. also plans to apply only the most-favored nation rate set by the World Trade Organization to aircraft and aircraft parts, generic pharmaceuticals, chemical precursors and “unavailable natural resources,” effective Sept. 1. The two trading partners will “consider other sectors” to add to that group.”

• The Government Accountability Office tells us,
  • “Over the last decade, federal revenues from tobacco excise taxes have dropped by more than 30%—from about $14 billion to $9 billion from fiscal years 2014 to 2024.   
  • “This loss in revenues is the result of 1) declines in sales for smoking products and 2) differing tax rates for these products. It also coincides with the emergence of new products that aren’t taxed at all.” * * *
  • “If similar tobacco products were taxed the same rate (keeping in mind that some aren’t taxed at all), federal revenues would increase. We estimated that if the tax rate for pipe tobacco were increased to the same rate as roll-your-own tobacco, the federal government could collect at least $1.5 billion dollars in additional revenue for both products from fiscal years 2025-2029.  
  • “Federal revenue would also likely increase if the minimum tax rate for large cigars was the same as that for small cigars. However, it’s a bit trickier to determine a precise estimate because of limited information about the retail prices of large cigars and how consumers might respond to increased taxes.  
  • “We previously recommended that Congress consider leveling (or equalizing) the tax rate on similar tobacco products.  For a more in-depth look at tobacco taxes, check out our new report.” 

• Tammy Flanagan, writing in Govexec, points out that “Federal employees older than 70 may be leaving thousands on the table. Find out if you or your spouse is missing Social Security benefits.”

From the Food and Drug Administration front,

• STAT News reports,
  • “Major U.S. drug manufacturing plant did not properly investigate cat hair, pests, and other problems, FDA finds.
  • “Plant, once owned by Catalent and now owned by Novo Nordisk, is widely used by pharma industry.
• and
  • “The Food and Drug Administration has agreed to decide by late next month whether to approve an ultra-rare disease drug developed by Stealth BioTherapeutics, a significant step after the company claimed it may have to close its doors if an agency endorsement is not made in coming weeks.
  • “The move comes after protracted uncertainty surrounding the fate of the medication, which was developed to treat Barth syndrome, a rare illness that afflicts about 150 people in the U.S. The company and the FDA have struggled to agree on ways to generate enough of the right kind of study data to make the drug available to this tiny population of patients.”

• PharmaPhorum lets us know,
  • “Iterum Therapeutics has become the first drugmaker to bring an oral antibiotic in the penem class to market in the US, launching Orlynvah as a treatment for uncomplicated urinary tract infections (uUTIs).
  • The launch of the product – which comes a few months after Orlynvah (sulopenem etzadroxil and probenecid) was approved by the FDA – keeps the Dublin, Ireland-headquartered biotech ahead of rival companies bidding to bring new therapies for uUTIs to the US market.
  • That includes GSK with Blujepa (gepotidacin) – which was approved in March by the FDA as the first drug with a new mechanism of action for uUTIs in nearly three decades – as well as Alembic Pharma with Pivya (pivmecillinam), cleared for uUTIs in 2024 and acquired when Alembic bought Utility Therapeutics last month. Both Blujepa and Pivya are due to be launched in the US before the end of the year.
  • Specifically, Orlynvah was given a green light by the FDA for adult women with uUTIs caused by Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis with limited or no alternative oral antibacterial options. It was initially turned down by the agency, which issued a complete response letter (CRL) to Iterum in 2021 with a request for more data.

• Per MedTech Dive,
  • “NeuroOne Medical Technologies received Food and Drug Administration clearance for a minimally invasive nerve ablation system to treat trigeminal neuralgia, a condition that causes severe, chronic facial pain.
  • “Trigeminal neuralgia is typically treated with medication or invasive procedures. NeuroOne’s OneRF ablation system uses radiofrequency energy to create lesions to interrupt pain signals.
  • “NeuroOne filed its FDA submission in April, earlier than previously anticipated. The Eden Prairie, Minnesota-based company said Monday it now expects to launch the device on a limited basis in the fourth quarter of this year.”

• BioPharma Dive informs us,
  • “The Food and Drug Administration on Thursday approved a drug Ionis Pharmaceuticals developed for the rare genetic disease hereditary angioedema, making the therapy, known as donidalorsen, the third new medicine to reach market this year for the rare genetic condition.
  • “Donidalorsen, which Ionis will sell under the brand name Dawnzera, is approved to prevent the swelling attacks associated with hereditary angioedema in adults and children at least 12 years of age. Dawnzera has a list price of $57,642 per dose, company executives said in a conference call.
  • “The price is “based on the efficacy, the data and the supporting evidence,” Chief Global Product Strategy Officer Kyle Jenne told analysts on the call. “The payers, we believe, will be very accepting of the price, since it’s in line with the other products that are in the HAE space today.”
• and
  • “A total of 1,176 products have received the Food and Drug Administration’s breakthrough device designation since 2015, according to the agency’s latest update on Wednesday.
  • “The FDA gives the designation to devices that may provide more effective treatment or diagnosis of life-threatening or debilitating conditions. In its 2025 fiscal year, which began in October, the agency had granted 136 breakthrough designations as of June 30.
  • “The FDA shared the update as medical device companies lobby for faster Medicare coverage of breakthrough devices.”

From the judicial front,

• Bloomberg Law reports,
  • “A divided US Supreme Court let the Trump administration cut off potentially hundreds of millions of dollars in medical research grants that government officials say don’t align with the president’s policies.
  • “The justices largely put on hold a federal trial judge’s decision that the National Institutes of Health acted in an “arbitrary and capricious” manner when it terminated thousands of grants as part of President Donald Trump’s crackdown on diversity, equity and inclusion.”

From the public health and medical research front,

• Per an FDA news release,
  • “FDA Advises Restaurants and Retailers Not to Serve or Sell and Consumers Not to Eat Certain Frozen, Raw, Half-shell Oysters from Republic of Korea Potentially Contaminated with Norovirus.”

• Health Day informs us,
  • “Seniors with known heart-related problems aren’t doing a very good job taking steps to protect their health, a new study says.
  • “Older folks with high blood pressure, stroke survivors and heart failure patients in the United States all have been neglecting Life’s Essential 8 — a checklist of lifestyle factors that can protect heart health, researchers found.
  • “On average, participants with one cardiovascular disease had a Life’s Essential 8 score 9 points lower than those without cardiovascular disease,” lead researcher James Walker, a medical student at Northwestern University in Chicago, said in a news release.
  • “Life’s Essential 8 recommends that people eat healthy, exercise, avoid smoking, sleep better, lose excess weight, and manage their cholesterol, blood sugar and blood pressure levels, according to the American Heart Association.”

• MedPage Today lets us know,
  • “Patients taking GLP-1 agonists for weight loss had a small but significantly lower risk of developing cancer, a large retrospective cohort study showed.
  • “With follow-up ranging from 1 to 11 years, use of GLP-1 agonists, such as semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound), was associated with a 17% lower cancer risk as compared with non-users. Cancer incidence was lower for 12 of 13 recognized obesity-related cancers, plus lung cancer. The difference between users and non-users reached statistical significance for endometrial and ovarian cancers and meningioma.
  • “The only outlier was kidney cancer, which occurred more often among users of GLP-1 agonists and was associated with a non-significant 38% increased risk, reported Jiang Bian, PhD, of the Regenstrief Institute in Indianapolis, and co-authors in JAMA Oncology.
  • “Given that more than 137 million individuals in the U.S. are currently eligible for GLP-1RA [receptor agonist] therapies, even modest changes in cancer risk could have substantial public health implications,” the authors stated in their discussion. “This study is one of the first to assess the association between GLP-1RA use and cancer risk in the broad, real-world population with obesity or overweight who are eligible for AOMs [anti-obesity medications].”

• Per a National Institute of Standards and Technology news release,
  • “Scientists at the National Institute of Standards and Technology (NIST) have developed a new technology for measuring how radiation damages DNA molecules. This novel technique, which passes DNA through tiny openings called nanopores, detects radiation damage much faster and more accurately than existing methods. It could lead to improved radiation therapy for cancer and more personalized care for individuals during radiological emergencies.
  • “With nanopore sensing, we’re not just measuring radiation damage; we’re rewriting the rules on how quickly and effectively we can respond to both cancer care and emergencies,” said NIST physical scientist Joseph Robertson.”

• Per a National Institutes of Health news release,
  • “In a first-of-its-kind study, researchers found that the brain’s control center for a lost appendage can persist long after surgical amputation, which stands in stark contrast to longstanding theories about the brain’s ability to reorganize itself, also known as plasticity. Scientists from the National Institutes of Health (NIH) and their colleagues examined human brain activity before and after arm amputation and found that the loss of a limb does not prompt a large-scale cerebral overhaul. Published in the journal Nature Neuroscience, this study offers new insight into the mysterious phantom limb syndrome and could help guide the development of neuroprosthetics and pain treatments for people with limb loss.
  • “A team of scientists from NIH and University College London acted on a unique window of opportunity, running MRI scans on three participants in the months prior to a planned amputation (performed for separate medical purposes) and then up to five years after.
  • “It’s not often you get the chance to conduct a study like this one, so we wanted to be exceedingly thorough,” said co-author Chris Baker, Ph.D., of NIH’s National Institute of Mental Health (NIMH). “We approached our data from a variety of angles and all of our results tell a consistent story.”

• Per NCQA.
  • ‘Chronic kidney disease (CKD) affects nearly 36 million adults in the U.S., yet it remains underdiagnosed and undertreated. NCQA convened an expert panel of clinicians and patient advocates to discuss current challenges and future opportunities associated with the assessment, diagnosis and management of CKD.’
  • This NCQA article discusses this convention.
    

From the U.S. healthcare business front,

• Healthcare Dive reports,
  • “UnitedHealth is forming a new board committee to “monitor and oversee financial, regulatory and reputational risks” as the healthcare juggernaut tries to improve its standing with lawmakers, regulators, investors and the U.S. public.
  • “The “public responsibility committee” will “provide an additional layer of governance,” UnitedHealth said in a securities filing on Wednesday. The committee’s key responsibilities include underwriting and forecasting, regulatory relationships, reputational matters and mergers and acquisitions — all areas for which UnitedHealth has been in the public eye.
  • “Michele Hooper, who’s served on UnitedHealth’s board since 2007, will step down as lead independent director to chair the committee. Hooper, who will remain a director, will be replaced as lead independent director by F. William McNabb, the former CEO of investing firm the Vanguard Group who has served on UnitedHealth’s board since 2018.”

• The International Foundation of Employee Benefit Plans discusses various GLP-1 coverage strategies.

• Per Beckers Hospital Review,
  • “Philadelphia-based Temple Health has acquired Redeemer Health’s 20% stake in Chestnut Hill Hospital, giving the academic system an 80% ownership interest in the hospital.
  • “This was a planned transaction that comes approximately two and a half years after Chestnut Hill Hospital was acquired by an alliance consisting of Temple Health, [Meadowbrook, Pa.-based] Redeemer and the Philadelphia College of Osteopathic Medicine,” a spokesperson for the health system told Becker’s. “Temple Health manages Chestnut Hill Hospital and now has an 80% ownership stake in the hospital.”
  • “With the transaction, Redeemer has exited the alliance, while the Philadelphia College of Osteopathic Medicine retains a 20% ownership stake in the148-bed hospital.”
• and
  • “Sacramento-based Sutter Health plans to close its Jackson, Calif.-based Sutter Amador Surgery Center on Oct. 3.
  • “In an open letter to the community, obtained by Becker’s, Sutter Amador Hospital CEO Michael Cureton, Sutter Amador Surgery Center’s ambulatory services administrator, Branden Nelson, and the surgery center’s executive of operations, Johnny Russell, said the outpatient surgery center closure will help “align resources with areas of growing need” in the community it serves.”

• Radiology Business relates,
  • “A “hybrid” artificial intelligence strategy—using a combination of radiologist readers and standalone AI interpretation of cases—can cut rads’ workloads by nearly 40%, according to new research. 
  • “Such technology has shown great promise in boosting physician performance, including helping to triage scans requiring added attention. However, AI implementation in breast cancer screening remains limited for various reasons, amid concerns it may miss some relevant cases, experts wrote Tuesday in RSNA’s Radiology.” 

• BioPharma Dive reports,
  • Gilead Sciences is deepening its investment in cancer cell therapy, announcing Thursday a deal to pay $350 million to buy privately held Interius BioTherapeutics for a technology designed to reprogram immune cells in patients’ bodies.
  • If successful, Interius’ “in vivo” approach could yield a simpler alternative to the CAR-T therapies Gilead’s Kite Pharma division have brought to market, each of which includes extravagant production processes that involve manipulating cells in a lab. 
  • Gilead spent $12 billion to buy Kite nearly a decade ago and, since then, has become a leader in CAR-T therapies. That business has sputtered recently amid declining demand and competition from other developers. But Gilead is still investing through acquisitions and partnerships, such as a collaboration with Arcellx in multiple myeloma.
• and
  • “Sarepta on Thursday said it’s reached agreements that remove about $700 million from a pile of debt due in 2027.
  • “The private agreements with debt holders will allow Sarepta to exchange the 1.25% convertible senior notes due in 2027 for $602 million worth of 4.875% convertible senior notes due in 2030, up to 6.7 million shares of Sarepta stock and about $123 million in cash. Separately, the company entered into a private placement of about 1.4 million shares.
  • “The transaction “significantly enhances our balance sheet flexibility and strengthens our financial position,” Sarepta CEO Doug Ingram said in a statement. Sarepta will still have $450 million in existing convertible notes due in 2027.”
• and
  • “Xoma Royalty Corp. is acquiring another struggling biotechnology company in further sign of interest among certain firms in buying floundering drugmakers and shutting them down.
  • “Xoma on Wednesday agreed to buy Mural Oncology, a cancer biotech once spun out of Alkermes. Per deal terms, a Xoma subsidiary will acquire Mural for $2.035 per share. Mural stockholders could get up to another $0.205 per share if the company’s net cash holdings at the deal’s closing exceeds $36.2 million.
  • “The deal values Mural at the level of its cash reserves and represents a roughly 13% premium to the company’s closing share price of $1.80 on Tuesday. Xoma will wind down Mural’s business afterwards, according to the announcement.
  • “In acquiring and liquidating Mural, Xoma is extending a pattern among certain firms and investors to shut down drug companies whose depressed share prices leave them worth less than their cash holdings. Historically, these biotech “zombies” would pivot to new projects or merge with another drug company. Of late, however, investors are heightening pressure on company boards to return cash to shareholders instead.”