From Washington, DC,

• The New York Times reports,
  • “The director of the National Institutes of Health, Dr. Jay Bhattacharya, will take on the additional role of acting director of the Centers for Disease Control and Prevention, two administration officials said on Wednesday.
  • “Dr. Bhattacharya will continue to run the N.I.H., according to the officials, who insisted on anonymity to speak about personnel decisions before President Trump announces them. He will serve until Mr. Trump appoints a permanent director — a position that now requires confirmation by the Senate.
  • “The C.D.C. has run through a series of leaders since Mr. Trump returned to the White House last year.
  • “A physician and medical economist who left Stanford University to join the Trump administration, Dr. Bhattacharya has no formal training in public health. But his research has focused on the well-being of populations, which is the core mission of public health, and thus the C.D.C.”

• Bloomberg Law relates,
  • “Centers for Medicare & Medicaid Services Administrator Mehmet Oz said Tuesday that potential legislation to codify the Trump administration’s plan to link US drug prices to lower prices in other countries would need to take into account the needs of the pharmaceutical industry. 
  • “I think we’ve established a deep passion to preserve innovation,” Oz said at an annual forum hosted by the Pharmaceutical Research and Manufacturers of America, as he discussed the Trump administration’s most-favored-nation proposal. “If it’s not done right, a future administration will take more drastic, draconian steps in ways that would hurt this industry.”
  • “Oz also said during his fireside chat at the PhRMA forum with Pfizer Inc. CEO Albert Bourla that he wanted to “codify MFN in a way that industry finds is reflective of what was signed in the contracts.”

• The American Hospital Association tells us,
  • “The Department of Health and Human Services Office for Civil Rights Feb. 13 announced the launch of a program to implement and enforce statutory and regulatory requirements under 42 CFR Part 2, which protect the confidentiality of substance use disorder patient records. As of Feb. 16, the program uses a range of civil enforcement mechanisms, including civil money penalties, to ensure compliance with new provisions from section 3221 of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act. This section aligns federal privacy standards for SUD records more closely with those under HIPAA and strengthens confidentiality protections. In compliance with the provisions, HHS OCR has begun accepting complaints of alleged confidentiality violations and SUD record breach notifications.”

• Adam Fein, writing in his Drug Channels blog, let us know,
  • “The Centers for Medicare & Medicaid Services (CMS) has just released its initial 2026 data on enrollment in Medicare Part D prescription drug plans (PDPs).
  • “DCI’s exclusive analysis shows that 83% of seniors remain enrolled in PDPs with preferred pharmacy networks—essentially unchanged from 82% in 2025, but sharply lower than the 99% peak in 2023. Meanwhile, the number of major Part D plans offering preferred networks has fallen to a record-low eight.
  • “The new enrollment data reveal a clear shift in competitive positioning: Albertsons and Publix are now preferred in every major plan. Walgreens is holding strong. Walmart—the company that invented the Part D preferred network model—has slipped to the middle of the preferred pack.
  • “Meanwhile, smaller pharmacies have fully abandoned PDPs’ preferred networks in 2026. 
  • “At the same time, the IRA’s expansion of the Low-Income Subsidy (LIS) means a growing share of beneficiaries have little financial incentive to use a preferred pharmacy at all. Add in the PBM reforms in the Consolidated Appropriations Act of 2026, and the preferred network model will gradually lose relevance.” 

From the Food and Drug Administration front,

• The Wall Street Journal reports,
  • “The Food and Drug Administration reversed course and agreed to begin a review of Moderna’s MRNA 6.08%increase; green up pointing triangle application to sell a new seasonal flu shot after the vaccine maker agreed to conduct additional testing in the elderly.
  • “The move means that Moderna’s experimental flu shot is largely back on track after the FDA’s surprise decision earlier this month to refuse to start a review of its application. The decision came after discussions with White House and health department officials, people familiar with the matter said. Moderna said it also met with the FDA and proposed a revised approach. 
  • “Now, the FDA will review the application and is expected to make a decision by August, though approval isn’t guaranteed. If approved, Moderna’s flu shot, mRNA-1010, could become available for the 2026-27 flu season.”

• BioPharma Dive tells us,
  • “The Food and Drug Administration has accepted Bristol Myers Squibb’s approval application for its experimental multiple myeloma drug iberdomide, setting a decision deadline of Aug. 17, the company said Tuesday. The drug, from a new class of protein-degrading treatments, is intended for use in combination with Johnson & Johnson’s Darzalex and the steroid dexamethasone in people whose disease has advanced or become resistant to early lines of treatment.” 

• MedTech Dive informs us,
  • “Medtronic has received Food and Drug Administration clearance for a next-generation spine surgery system that combines artificial intelligence-based planning, real-time navigation and robotic assistance.
  • “The Stealth AXiS system has a modular design that can be used in both hospital settings and ambulatory surgery centers and can accommodate a range of surgeon preferences, Medtronic said Friday.
  • “The underlying architecture can also support cranial applications and ear, nose and throat surgeries, pending 510(k) clearance, according to the device maker.”
• and
  • “Medtronic said Tuesday that a surgeon completed the first U.S. procedure for its Hugo robotic surgery system, shortly after the company received Food and Drug Administration clearance for the platform.
  • “The first surgery was a prostatectomy procedure performed at the Cleveland Clinic. Along with the Cleveland Clinic, Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first hospitals in the U.S. to install Hugo, with Atrium Health being the first hospital in the U.S. to do so that was not part of the investigational device exemption clinical study.”

• Beckers Hospital Review notes,
  • “The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy.
  • “Filkri is indicated for patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia undergoing induction or consolidation therapy, bone marrow transplant recipients, individuals with severe chronic neutropenia and patients exposed to myelosuppressive radiation.
  • “The biosimilar marks the sixth FDA-approved product in Accord BioPharma’s biosimilar portfolio and the seventh overall, according to a Feb. 17 news release.”

From the judicial front,

• Bloomberg Law reports,
  • “A prominent US physicians group is suing the Trump administration, alleging it violated its free-speech rights over its public support of gender-affirming care for minors.
  • “The American Academy of Pediatrics said it was hit in January with a Federal Trade Commission civil investigative demand for a “sweeping array of information” that includes comments the group has made about gender dysphoria treatment and communications with other groups regarding the development of clinical guidance on gender-affirming care.
  • “Filed Tuesday in the US District Court for the District of Columbia, the complaint is the latest turn in an ongoing battle between the AAP and the Trump administration.
  • “The parties are fighting in another federal court over Trump administration vaccine policy under the leadership of Health and Human Services Secretary Robert F. Kennedy Jr.”

From the public health and medical / Rx research front,

• Progeny Health released its “2026 Progeny Health Trends Report — your essential guide to the evolving landscape of maternal and infant health in America.” Check it out.

• Cardiovascular Business reports,
  • “Reducing the activity of a specific protein, RBM20, may provide significant relief for certain patients with heart failure, particularly those with preserved ejection fraction (HFpEF), according to a new analysis published in Cardiovascular Research.[1] 
  • “HFpEF is associated with stiff, rigid cardiac muscles. A team of researchers out of the University of Missouri School of Medicine believe they may be able to improve HFpEF symptoms by limiting RBM20’s influence in the heart and encouraging another protein, titin, to thrive. 
  • “Titin is a protein found in cardiac muscle cells and acts as a ‘spring,’ enabling the heart chamber to recoil and stretch sufficiently,” lead author Mei Methawasin, MD, PhD, said in a statement. “In HFpEF, it’s common for the titin to stiffen and no longer be as flexible. We learned that if we reduced the activity of a different protein, RBM20, it caused longer and more flexible filaments of titin and significantly improved heart filling in mice.”
  • “There are certain risks associated with too much RBM20 inhibition. Methawasin emphasized that it would be critical to find the “right balance” and not taking things too far.” 

• Per a National Institutes of Health news release,
  • “A study in mice found that after a bone fracture, the nerves that sense pain also promote healing by signaling for bone repair and wound healing.
  • “The findings could lead to new treatments that stimulate bone repair and might be used to drive bone formation in bone disorders such as osteoporosis.”  

• Per Healio,
  • “Less than 2 extra hours of walking per week could help mitigate the increased mortality risk among women with breast cancer who also have a higher genetic predisposition to obesity.
  • “An analysis of more than 4,000 women with breast cancer found those who have the highest value of genetic score genes linked to obesity had a 15% greater risk for death than those with the lowest value.
  • “However, if women in that highest tertile of the genetic score walked approximately 15 additional minutes per day, their mortality risk would be similar to those with lower scores.”

• Per Health Day,
  • “A new advance might help doctors improve movement in people with Parkinson’s disease by tracking their gait-related brain waves in real time.
  • “An experimental brain implant can capture the signals of movement-related brain regions while Parkinson’s patients perform daily activities like walking to the kitchen or strolling through a park, researchers reported Feb. 13 in the journal Science Advances.
  • “What’s more, researchers have figured out how to read those brain recordings, allowing a deeper understanding of the gait problems associated with Parkinson’s, researchers said.”

• Per Fierce Pharma,
  • “With their blockbuster obesity drugs, Eli Lilly and Novo Nordisk have uncovered a variety of ailments the incretin treatments can combat.
  • “Chalk up another new potential expansion for Lilly as it has found in a phase 3b trial that combining Zepbound and its autoimmune treatment Taltz can provide added benefits for psoriasis patients who are obese or overweight.” 
• and
  • “Less than half a year after winning an inaugural green light in chronic hives, Novartis’ oral BTK inhibitor Rhapsido is jockeying to expand its urticaria reach into a new indication where it has the potential to become the first targeted therapy. 
  • “In top-line results issued Wednesday, Novartis revealed that a phase 3 trial of Rhapsido (oral remibrutinib) met its primary endpoint in patients with the three most prevalent types of chronic inducible urticaria (CIndU): symptomatic dermographism, cold urticaria and cholinergic urticaria. 
  • “Specifically, the company’s BTK inhibitor helped patients achieve “significantly higher complete response rates” compared with placebo after 12 weeks of treatment, Novartis said in a Feb. 18 press release.” 

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

• Beckers Payer Issues points out
  • “Paul Markovich, president and CEO of Ascendiun, the parent company of Blue Shield of California, is not one to sugarcoat the state of the healthcare system.
  • “I don’t see how you can look at it and say there isn’t a fundamental problem. It’s systemic in nature,” Mr. Markovich said on the Becker’s Healthcare podcast.
  • “Mr. Markovich was one of five health insurance CEOs who testified before House lawmakers in January over the broad topic of rising healthcare costs. The hearings lasted more than nine hours and covered industry consolidation, prior authorization and executive compensation. Most people would be nervous to be summoned before Congress in general, much less to speak to lawmakers about controversial topics — but not Mr. Markovich.” * * *
  • “His message to the industry is blunt: Stop asking for more money.
  • “This is our new normal. We have to, as many other industries have, figure out how to make an impact and do better with fewer resources and be more productive. That has not been the mindset of the industry for most of my career,” he said.
  • “We have to get into a different mindset: How do we make healthcare affordable? We all have to be financially viable, but how do we make healthcare affordable and worthy of our family and friends? That means we have a cost problem that we need to address,” he added. “I’m hopeful that creating that kind of budgetary, top-down pressure helps create that mindset and gets us into a much more innovative phase in healthcare, one where we really are focused on how to make things better for the patient and more efficiently.”
  • “To listen to the full conversation with Mr. Markovich about PBM reform, the company’s efforts to unbundle pharmacy benefits and keep Blue Cross Blue Shield plans competitive, plus his scathing rebuke of fax machines, you can tune in here.“

• Modern Healthcare reports,
  • “More than 20 health systems have teamed up in a bid to use technology to improve access to care in rural and underserved areas. 
  • “The National Specialty Care Access Coalition, which launched Wednesday, will prioritize standardizing care models, reforming policy and deploying pilots to speed innovation, a news release said.
  • The model enables shared learning and a unified perspective, among other advantages, according to its website.

• MedCity News tells us,
  • “Daffodil Health, an AI platform for health plan administration and claims processing, has raised $16.3 million in Series A funding to help scale the company, it announced on Tuesday.
  • “The San Francisco-based startup provides AI-based software for U.S. health plans and third-party administrators to manage claims pricing and payment integrity. Its platform allows payers to handle out-of-network repricing in-house, using transparent benchmarks and real-time reporting. This work has historically been outsourced to vendors that have built “multi-billion dollar businesses sitting between providers and payers,” according to Navin Nagiah, CEO and co-founder of Daffodil Health. It offers a SaaS pricing model, versus a percentage-of-savings pricing model that companies like MultiPlan and Zelis use.
  • “We have automated that entire workflow end-to-end,” he said. “When a claim comes in, we benchmark it against market data, Medicare rates, historical allowed amounts by MSA, percentile distributions, and even provider-specific acceptance history. It takes minutes to configure, and then the system runs automatically claim by claim. Our goal is to give plans control, automation, and transparency at a fraction of the historical cost.”

• Fierce Healthcare adds,
  • “Optum is rolling out a new AI tool that aims to address some of the key barriers to value-based care, from data fragmentation to administrative burden.
  • “The company said in an announcement on Wednesday that the Value Connect platform supports both payers and providers in value-based care work, leaning on artificial intelligence to surface ways to improve and identify areas where programs are underperforming. The tool can also identify and quickly facilitate interventions that improve outcomes, either directly or embedded within other platforms, Optum said. 
  • “The goal of Value Connect, per the company, is to make it easier for payers and providers to collaborate as well as improve the performance of value-based care programs.
  • “We’re accelerating the shift to value-based care by meeting payers and providers where they are in their journey,” said Beth Merle, senior vice president of provider enablement at Optum Insight, in the announcement. “The solution empowers organizations to proactively manage risk and costs while improving outcomes for the people they serve.”

• Health Data Management informs us,
  • “Clinician turnover and burnout have been two of the core issues threatening healthcare, with staffing trends already having been exacerbated by the COVID-19 pandemic. 
  • “However, there are growing indications that some of the churn caused by revolving-door policies to staffing are abating. But a recent report suggests that some of the negative effects of staffing upheaval remain, including restrictions on access, rising cost pressures and inconsistent outcomes. 
  • “Still, the suggestion that staff churn is abating suggests that healthcare organizations are improving efforts to find appropriate clinicians and staff, and then keeping them happier and willing to stay where they are.” 

• Per MedCity News,
  • “Eli Lilly has been scouting for drugs to follow the trail blazed by its blockbuster cardiometabolic medicines. Its latest pipeline-building deal has the pharmaceutical company paying $100 million for rights to a clinical-stage CSL Limited drug addressing an increasingly competitive target associated with chronic inflammation.
  • “Under deal terms announced late Tuesday, CSL retains rights to the drug, clazakizumab, for prevention of cardiovascular events in patients with end-stage kidney disease while Lilly gains rights in other indications. Lilly has not disclosed its plans for the antibody but cardiovascular disease has become a particular area of interest for the company and it’s also the focus of clinical-stage programs in clazakizumab’s drug class.
  • “Clazakizumab is a monoclonal antibody designed to bind to and block IL-6, a signaling protein that in excessive amounts plays a role in inflammation. While FDA-approved antibody drugs that block this target have already reached the market in certain inflammatory disorders, there’s renewed industry interest in expanding this approach to more diseases, particularly the inflammation that drives cardiovascular conditions.”
    
• Per Fierce Pharma,
  • “With $55 billion earmarked to bolster its U.S. operations, Johnson & Johnson is the latest drugmaker to zero in on expansion plans that are aimed, at least in part, at abating the Trump administration’s pharmaceutical tariff threats. 
  • “J&J will spend more than $1 billion to build out a next-generation cell therapy production plant in Montgomery County, Pennsylvania, the company said in a Feb. 18 release. Once up and running, the facility will create some 500 new permanent biomanufacturing positions, not to mention more than 4,000 construction jobs while the plant is being developed, J&J said. 
  • “J&J did not lay out a timeline for the plant’s expected completion, nor did the company specify the types of “cutting-edge cell therapy technologies” it plans to employ at the new site. 
  • “Still, Wednesday’s announcement adds more color to J&J’s overall $55 billion U.S. investment plan, unveiled last March, which came with a pledge to construct three new domestic manufacturing sites and expand others in the company’s existing drug and medtech network.”