Tuesday Report

Tuesday Report

From Washington, DC

Capitol Hill News

  • Roll Call lets us know,
    • “The Senate took its first procedural step Tuesday on a budget blueprint that would pave the way for a filibuster-proof border security, defense and energy package, a key part of President Donald Trump’s legislative agenda.
    • “Once GOP leaders were certain of a critical mass of senators returning to Washington in time, they teed up a vote on the motion to proceed to the fiscal 2025 budget resolution, which was agreed to on a mostly party-line, 50-47 vote. Only a simple majority is needed to proceed and to eventually adopt the framework on a final vote, but Republicans don’t expect any Democrats to help them advance it, making every GOP vote count.  
    • “Once a budget resolution is adopted in both chambers, key congressional committees can get to work on writing the actual reconciliation bill — which is immune to a filibuster, like the budget resolution — to implement their fiscal priorities.
    • “The initial Senate plan laid out in the fiscal 2025 resolution envisions spending boosts for defense and border security, domestic energy incentives and offsets to pay for the package. It doesn’t address the 2017 tax cuts expiring at the end of the year, instead promising to come back with a second budget reconciliation process later this year to deal with the tax pieces of the GOP agenda.”

White House News

  • Fierce Healthcare tells us,
    • “A new executive order signed by President Trump aims to expand access to in vitro fertilization (IVF) and make it more affordable.
    • “The order directs the Domestic Policy Council to make policy recommendations to protect IVF access and “aggressively” reduce the associated costs for treatment. The policies should focus on ensuring reliable access to IVF and addressing areas that exacerbate the out-of-pocket and health plan costs associated with the care.
    • “These are treatments that have become unaffordable for many Americans,” Will Scharf, the White House staff secretary, said at a press conference on Tuesday.”
  • Per MedPage Today,
    • “The Trump administration’s efforts to address the causes of chronic diseases will all be based on “unbiased science,” HHS Secretary Robert F. Kennedy Jr. said Tuesday.
    • “We will convene representatives of all viewpoints to study the causes for the drastic rise in chronic disease,” Kennedy said in a speech to HHS employees. “Some of the possible factors we will investigate were formally taboo or insufficiently scrutinized — the childhood vaccine schedule; electromagnetic radiation; glyphosate; other pesticides; ultra-processed foods … SSRIs [selective serotonin reuptake inhibitors] and other psychiatric drugs; PFAS [per- and polyfluoroalkyl substances]; PFOA [perfluorooctanoic acid]; microplastics — nothing is going to be off-limits.”
    • “Whatever belief or suspicion I have expressed in the past, I’m willing to subject them all to the scrutiny of unbiased science,” Kennedy said in the speech, a portion of which was posted on Xopens in a new tab or window. “That is going to be our template — unbiased science. That’s something that will make us all proud of this agency and of our role in restoring American health.”
    • “Let’s commission research that will satisfy all the stakeholders once and for all,” he continued. “Let’s use protocols that we all agree on in advance and not alter the outcomes of studies when they’re halfway through [because] they look inconvenient. Let’s all depoliticize these issues and reestablish a common ground for action and renew the search for existential truths with no political impediments and no preconceptions.”

Postal Service News,

  • Govexec informs us,
    • “Postmaster General Louis DeJoy will soon step down as head of the U.S. Postal Service, creating an opening for the agency’s governing board to fill as it is in the midst of implementing controversial and sweeping reforms to its operations. 
    • “DeJoy has requested the USPS board begin its process to find a successor just months after telling Congress he would remain in the post “until somebody hauls me out of here.” The postmaster general has faced significant criticism since his appointment to the role in 2020 for his efforts to slow down mail delivery, raise prices and consolidate mail processing while also winning some plaudits for creating a vision he said would eliminate the agency’s financial troubles. 
    • “Postmasters general serve no fixed terms and are chosen by the board. President Biden while in office faced some calls to fire DeJoy, a long-time Republican donor who came to USPS after running a successful private sector logistics company, though he could only be removed by the board or on his own volition. 
    • “DeJoy said “much critical work” remains to implement his vision for the agency, but he decided it was time to start the process of identifying a successor.”

Food and Drug Administration News

  • Fierce Pharma relates,
    • “Two years on, Bavarian Nordic’s $380 million vaccine M&A move appears to be paying off.
    • “The Danish company’s chikungunya vaccine, Vimkunya, has now crossed the FDA finish line, heating up the competition with Valneva by countering with a label that covers a broader population.
    • ‘The FDA approved Vimkunya’s use in people who are at least 12 years old, marking the first chikungunya vaccine that can be given to those younger than 18. With the nod, Bavarian Nordic also picked up a priority review voucher (PRV) under the FDA’s tropical disease PRV program; the company plans to monetize the PRV “when appropriate,” it said in a Friday press release.”

From the judicial front,

  • The AP, via Federal News Network, reports,
    • “A federal judge refused Tuesday to immediately block billionaire Elon Musk and the Department of Government Efficiency from accessing government data systems or participating in worker layoffs. 
    • “U.S. District Judge Tanya Chutkan found that there are legitimate questions about Musk’s authority but said there isn’t evidence of the kind of grave legal harm that would justify a temporary restraining order. 
    • “The decision came in a lawsuit filed by 14 Democratic states challenging DOGE’s authority to access sensitive government data. The attorneys general argued that Musk is wielding the kind of power that the Constitution says can only be held by those who are elected or confirmed by the Senate. 
    • “The Trump administration, for its part, has maintained that layoffs are coming from agency heads, and asserted that despite his public cheering of the effort Musk isn’t directly running DOGE’s day-to-day operations himself.” 
  • Per STAT News,
    • “California officials were dealt a setback by a federal judge who ruled that a controversial law banning so-called pay-to-delay deals between pharmaceutical companies is, in part, unconstitutional and so cannot be enforced against agreements that had no link to the state.
    • “In his ruling, U.S. District Court Judge Troy Nunley determined that the state law, which was enacted in 2019, violated the Dormant Commerce Clause of the U.S. Constitution because it would extend to pay-to-delay agreements that happened outside of California and, therefore, attempted to regulate interstate commerce.”

From the public health and medical research front,

  • The Wall Street Journal offers its perspective on bird flu. “With so much H5N1 virus circulating across the U.S., scientists worry we are a few mutations away from a potential human pandemic.”
  • Beckers Hospital Review discusses hospitalizations for measles outbreaks.
  • CNN reports,
    • “The best way to stay protected against measles is to get vaccinated, according to experts. The measles, mumps and rubella (MMR) vaccine is 93% effective against measles after one dose and 97% effective against measles after two, according to the CDC.
    • “Officials’ guidance says children should get two doses of the MMR vaccine: the first dose between 12 and 15 months and the second around age 4, before starting school.
    • “When people consider their choice about vaccinating their child, it isn’t just about their own individual child, but this is a public health issue. … If we just stop thinking about the health of the population, we are going to see more and more vaccine-preventable illness, outbreaks occur,” said Dr. Christina Johns, a pediatric emergency physician at PM Pediatrics.
    • “Older children or adults can also get vaccinated if they didn’t get the vaccine as a child, she says. However, people born before 1957 are likely to have been naturally infected and thus already have immunity, according to the CDC.
    • CDC guidance also indicates that if someone is exposed to measles, getting the MMR vaccine within 72 hours could induce some protection or result in less serious illness.”
  • The National Cancer Institute blogs about “Many Men with Metastatic Prostate Cancer Are Not Getting the Recommended Treatments, Study Finds.”
  • Beckers Hospital Review tells us,
    • “Investments in primary care are declining and fewer clinicians are entering the field at a time when chronic disease rates are rising, according to a new report from researchers at the American Academy of Family Physicians. 
    • “The report, “The Health of US Primary Care: 2025 Scorecard Report — The Cost of Neglect,” points to underlying challenges contributing to a lack of access to primary care in the U.S., including insufficient funding and reimbursement rates. This marks the third edition of the scorecard report, led by researchers at the AAFP’s Robert Graham Center for Policy Studies in Primary Care. The report is co-funded by the Milbank Memorial Fund and The Physicians Foundation and is based on national and state-level data tracking primary care performance, workforce trends and reimbursement patterns.”
  • A National Institutes of Health online newsletter discusses “Dementia in the U.S. | Contact lenses slow myopia in kids | New malaria target.”
  • The HHS Inspector General released a report titled “Not All Medicare Enrollees Are Continuing Treatment for Opioid Use Disorder.”
  • Per BioPharma Dive,
    • “An experimental Duchenne muscular dystrophy gene therapy from Solid Biosciences showed potential in a small clinical trial, leading the biotechnology company to quickly raise funds on the findings.
    • “Three months after treatment with Solid’s therapy, SGT-003, the first three participants in an early-stage clinical trial produced higher-than-normal levels of a tiny protein linked to muscle function, Solid said Tuesday. No serious side effects were observed so far, the company added.
    • “Solid claims the results, while early, suggest SGT-003 could be more potent than Sarepta Therapeutics’ Elevidys, the only approved Duchenne gene therapy. The company intends to discuss an accelerated approval pathway with U.S. regulators later this year. Solid’s share price rose by as much as 79% Tuesday morning before settling back to trade up 40%. It announced a $200 million stock offering alongside the study results.”

From the U.S. healthcare business front,

  • CIGNA Healthcare announced,
    • “Specialty medications used to treat rare, chronic, and complex diseases are often administered via injection or infusion. While some patients need to receive these medications in a hospital setting, most patients can use options that are more affordable and more convenient. These include infusion centers not affiliated with hospitals, qualified physician’s offices, or administration in the patient’s home by a trained nurse. When appropriate, guiding patients to these non-hospital settings can make specialty treatment easier to access while reducing health care costs.
    • “Although some treating physicians have concerns about the quality and safety of alternative sites, new research published in the Journal of Clinical Pathways found that patients who received specialty medication treatments at non-hospital outpatient settings are less likely to experience adverse reactions or seek care at the emergency room than those treated at hospital outpatient settings. They are also less likely to be hospitalized within a week following treatment. These findings are based on a retrospective analysis of Cigna Healthcare claims data from more than 122,000 patients who received nearly 1 million injections or infusions of 72 specialty drugs between January 1, 2021, and October 31, 2023.
    • “This research clearly demonstrates that administering specialty medications in non-hospital settings is safe and effective,” said Dr. Jeff Langsam, national director of oncology and senior medical director of specialty pharmacy at Cigna Healthcare. “The convenience and comfort of these less intensive care settings also enhance the patient’s experience.”
  • Fierce Healthcare adds,
    • “CVS Health has named Ed DeVaney as president of its pharmacy benefit manager, CVS Caremark.
    • “DeVaney has served as interim president of Caremark since December 2024. The president’s role was vacated when David Joyner took over as CEO of CVS Health in October.
    • “CVS said that DeVaney joined the company in 2005 and held roles across Caremark and the company’s Aetna division. Prior to taking over as interim president, DeVaney was Caremark’s president of employer and health plans, where he led the team’s work to grow and retain its PBM customers.”
  • Beckers Health IT explains how artificial intelligence tools are being integrated into electronic health records.
  • Beckers Payer Issues discusses the healthcare stop loss market.

Happy Presidents Day

Mount Rushmore Photo by Laura Nyhuis on Unsplash

From Washington, DC

  • Milliman explains how to navigate the new mental health parity rules which are under a legal challenge before the U.S. District Court for the District of Columbia.
  • Per Fierce Pharma,
    • “Pfizer’s two-year run with the only 5-in-1 meningococcal vaccine on the U.S. market has come to an end. Now, GSK is ready to play catch-up after nabbing its own FDA approval. 
    • “The FDA approved the British drugmaker’s Penmenvy vaccine to protect people ages 10 to 25 against meningococcal serogroups A, B, C, W and Y (MenABCWY), which together cause the most invasive meningococcal disease (IMD) cases globally. The shot mixes the antigenic components of GSK’s established meningococcal vaccines Bexsero and Menveo, which target MenB and MenACWY, respectively, to offer broader coverage in fewer doses.”
  • MedPage Today adds,
    • “The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday [February 14].
    • “Like its reference counterpart, insulin aspart (Novolog), the biosimilar helps lower mealtime blood sugar spikes to improve glycemic control. The approval is for both a 3 mL single-patient-use prefilled pen and a 10 mL multiple-dose vial.
    • “For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications,” said Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research (CDER), in a statement.

From the U.S. public health and medical research front,

  • Beckers Clinical Leadership identifies America’s priciest health conditions.
  • Medscape notes,
    • “The CDC recommends everyone age 6 months or older get a flu vaccine, although so far this year, fewer adults have gotten the shot, compared to last year. The adult flu vaccination rate this season is 44%, down from 48% last season. According to the National Foundation for Infectious Diseases, “as long as influenza (flu) viruses are circulating in your community, it’s not too late to get vaccinated against flu.”
  • The New York Times offers “New Insights into Older Hearts. Heart disease is more common in people over 65, but treatments are better than ever. That can complicate decision-making for older heart patients.”
  • Consumer Reports, writing in the Washington Post, explains “How to keep your eyes healthy and your vision sharp. Cataracts, dry eyes, glaucoma and other eye problems become more common with age. Knowing the early signs and acting fast can make a difference.”
  • Per Healio,
    • There is evidence that GLP-1s can ameliorate psychiatric and neurologic symptoms.
    • More clinical trials on the direct and indirect effects of GLP-1s and their mechanisms of action are needed.
  • and
    • “American Indian and Alaska Native women face substantially higher risk for heart disease, particularly during reproductive-age years.
    • “Generational trauma, violence and racism have compounded [pregnancy] risks.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “CommonSpirit Health’s quarterly net patient revenue dipped for the first time in months.
    • “The health system saw net patient revenue of $8.9 billion in the second quarter of fiscal 2025, a 5% drop from the year-ago period, according to its earnings report released Friday. Net patient revenue, or revenue from providing healthcare services after contractual discounts, makes up most of providers’ total operating revenue and can have a big impact on the bottom line.
    • “The results were markedly different from last year, when CommonSpirit was one of several systems that saw big increases in net patient revenue due to higher utilization and improved payer rates.
  • Beckers Hospital Review shares more insights on CommonSpirit Health’s second quarter report.
  • Beckers Payer Issues discusses the adverse impact of the Inflation Reduction Act on payers.
  • Fierce Healthcare relates,
    • “As obesity rates rise across the U.S., a new study from UnitedHealthcare and the Health Action Council examines the financial costs that this growing “epidemic” may cause for employers.
    • “The report (PDF) notes that 75% of adults in U.S. are either overweight or obese, up from 50% in 1990. Obesity rates grew fastest among younger adults, according to the report.”The HAC represents about 230 self-funded employers, and, among its members, about a quarter (26%) have been diagnosed with obesity. The obese population accounts for 46% of the employers’ medical spend, according to the report.
    • “Per member per month costs for obese employees were more than double on average compared to those who were not obese, the study found. Per member per month costs for those with obesity averaged $973, compared to $421 for non-obese workers.”
  • and
    • “As both regulatory and market forces are pushing the industry toward more transparency in healthcare pricing, MultiPlan sees opportunities to be a bigger player in data and tech for providers, payers and employers.
    • “The data analytics company, which has been in the market for 45 years, launched a rebrand at the ViVE 2025 digital health conference on Monday.
    • “Rebranded Claritev, the company is focused on developing new products and technologies that provide data insights to a broader swath of the healthcare market. Providing “actionable insights” to healthcare organizations will be a key part of the company’s growth, Travis Dalton, chairman, CEO and president, told Fierce Healthcare in an interview in the lead-up to the ViVE 2025 event.”
  • MedTech Dive informs us,
    • “Medtronic has bought nano surface technology from Nanovis for use in its next-generation spine fusion implants.
    • “Nanovis, which disclosed the deal Tuesday [February 11], has developed nanotechnology to improve the speed and consistency of bone growth. The company has its own portfolio of spine devices.
    • “Medtronic will use the technology to develop PEEK interbody spine fusion devices that enhance implant fixation. The technology could help bone grow and fuse with the implant.”
  • The Wall Street Journal reports,
    • “If you need a prescription filled in the coming years, don’t be surprised if it flies in and lands in your backyard. 
    • “Hospitals and doctors are increasingly experimenting with the use of drones to deliver medications, lab tests and supplies to patients being treated at home. Some are testing whether drones can be used to deliver organs for transplant more quickly and cheaply. And in some cities, a 911 call today could set off a drone carrying a defibrillator, Narcan spray or tourniquet to the scene of an emergency ahead of the arrival of paramedics.” * * *
    • “One of the challenges in this space five to 10 years ago was that there wasn’t a really clear regulatory framework. Over the last 18 months this has solidified, especially in the U.S. There is now a clear path to scale,” says Adam Woodworth, chief executive officer of Wing, the drone-service unit of Google’s parent Alphabet GOOGL.

Thursday Report

From Washington, DC,

Capitol Hill News

  • Roll Call reports,
    • “House GOP leaders cleared an important hurdle Thursday morning after cutting a deal with Freedom Caucus holdouts on a budget resolution amendment that would lock in a mechanism to enact deeper spending cuts in exchange for bigger tax cuts.
    • “The agreement paved the way for Budget Committee approval later in the day Thursday of the fiscal 2025 blueprint needed to unlock their “big, beautiful” reconciliation bill. House Republicans want to use the filibuster-proof process to enact large pieces of their legislative agenda, including extensions of the expiring 2017 tax cuts, domestic energy production incentives, immigration enforcement and defense spending.”
  • The American Hospital Association (AHA) News lets us know, “The Senate Feb. 13 by a vote of 52-48 confirmed Robert F. Kennedy Jr. as the new secretary of the Department of Health and Human Services.” 
  • An HHS news release adds
    • “Robert F. Kennedy, Jr. today was sworn in as the 26th Secretary of the U.S. Department of Health and Human Services (HHS) in the Oval Office by Associate Justice of the Supreme Court Neil Gorsuch.
    • “Immediately following the ceremony, President Trump with Secretary Kennedy by his side, signed the “Establishing the President’s Make America Healthy Again Commission” Executive Order to investigate and address the root causes of America’s escalating health crisis, with a focus on childhood chronic disease.”
  • The Journal of Accountancy informs us,
    • “A bill to extend the deadline for an estimated 32 million small businesses to report their beneficial ownership information (BOI) as mandated by the Corporate Transparency Act (CTA) passed the U.S. House unanimously.
    • “The House passed H.R. 736, Protect Small Businesses From Excessive Paperwork Act of 2025, 408–0, on Monday. The bill, which goes to the Senate next, extends the deadline for filing BOI reports to Jan. 1, 2026. The deadline for most reports previously was Jan. 1, 2025, but the reporting requirements have been caught up in numerous court cases and are now on hold.
    • “A companion bill was introduced Tuesday in the Senate by Tim Scott, R-S.C., the chairman of the Senate Banking Committee.
    • “This is a simple solution that we’ve worked on together, and it’s one of the most pressing concerns small businesses face,” Rep. Zach Nunn, R-Iowa, who sponsored the bill, said on the House floor before the vote. “So, whether you’re a Democrat or a Republican, we all have small businesses and a hometown responsibility to fight for them today.”
    • “Both bills affect only reporting companies existing before Jan. 1, 2024. Companies formed after that date are not affected.
    • “Melanie Lauridsen, the AICPA’s vice president–Tax Policy & Advocacy, said in a LinkedIn post that the proposed deadline extension is “hopeful information” – despite the possibility of court rulings changing reporting requirements at any moment.”

White House news

  • The AHA News tells us,
    • “President Trump Feb. 13 signed an executive order establishing the Make America Healthy Again Commission, to be chaired by Department of Health and Human Services Secretary Robert F. Kennedy Jr. The commission is tasked with “investigating and addressing the root causes of America’s escalating health crisis, with an initial focus on childhood chronic diseases.” 
    • “The commission has four main policy directives to reverse chronic disease:  
      • “Empower Americans through transparency and open-source data and avoid conflicts of interest in all federally funded health research. 
      • “Prioritize gold-standard research on why Americans are getting sick in all health-related research funded by the federal government. 
      • “Work with farmers to ensure that U.S. food is healthy, abundant and affordable. 
      • “Ensure expanded treatment options and health coverage flexibility for beneficial lifestyle changes and disease prevention. 
    • “Within 100 days, the White House said the commission will produce an assessment that summarizes what is known and what questions remain regarding the childhood chronic disease crisis, and within 180 days, the commission will produce a strategy, based on the findings of the assessment, to improve the health of America’s children.”
  • For those interested, here is a link to the new DOGE website.
  • The Washington Post reports,
    • “The Trump administration on Thursday moved swiftly to fire thousands of workers and directed agency heads to terminate most trial and probationary staff — a move that could affect as many as 200,000 employees, according to four people familiar with internal conversations who, like others interviewed for this report, spoke on the condition of anonymity because they are not authorized to speak publicly.
    • “It was not immediately clear how many of those hired by the federal government within the last two years would be affected. One person familiar with the matter said some employees, such as those working on public safety and law enforcement issues, would be spared, and agency heads could exempt others.”
  • Govexec adds,
    • “Recent hires at the Office of Personnel Management were terminated on Thursday afternoon, according to three people familiar with the matter and internal communications obtained by Government Executive.
    • “The firings come as agencies across government are purging employees in their probationary status from their rolls and the Trump administration is deploying a bevy of tools to slash their workforces. 
    • “On President Trump’s first day in office, OPM instructed agencies across government to collect names of probationary employees. Those workers typically were hired within the last one-to-two years, depending on their hiring mechanism. Agencies have since gathered lists of those employees and delivered them to OPM, and some subsequently sent notices to staff reminding them of their status and their vulnerability to rapid firings. 
    • “Recent hires in probationary status do not maintain the same protections against firings as do most other federal workers, though they can still appeal to the Merit Systems Protection Board if they allege the firings took place for partisan political reasons.”

From the judicial front,

  • The Associated Press via MedPage Today relates,
    • “A federal judge on Thursday temporarily blocked President Donald Trump’s recent executive order aimed at restricting gender-affirming healthcare for transgender people under age 19.
    • “The judge’s ruling came after a lawsuit was filed earlier this month on behalf of families with transgender or nonbinary children who allege their healthcare has already been compromised by the president’s order. A national group for family of LGBTQ+ people and a doctors organization are also plaintiffs in the court challenge, one of many lawsuits opposing a slew of executive orders Trump has issued as he seeks to reverse the policies of former President Joe Biden.
    • “Judge Brendan Hurson, who was nominated by Biden, granted the plaintiffs’ request for a temporary restraining order following a hearing in federal court in Baltimore. The ruling, in effect for 14 days, essentially puts Trump’s directive on hold while the case proceeds. The restraining order could also be extended.”

From the public health and medical research front,

  • The New York Times reports,
    • “Three dairy veterinarians, including one who worked only in states with no known bird flu outbreaks in cows, had recent, undetected bird flu infections, according to a new study from the Centers for Disease Control and Prevention. The results are based on antibody testing of 150 veterinarians working in 46 U.S. states.
    • “The findings were not entirely surprising, experts said, but did suggest that the virus, known as H5N1, could be infecting cows and people in more states than have been officially reported.
    • “We do not know the extent of this outbreak in the U.S.,” said Seema Lakdawala, a virologist at Emory University. “There are clearly infections happening that we’re missing.”
    • “Since the bird flu outbreak in dairy cows was first reported last March, the virus has been confirmed in more than 950 herds in 16 states. It has also been detected in 68 people, 41 of whom had contact with sick cows. Most people have had mild symptoms.”
  • The American Medical Association lets us know “What doctors wish patients knew about UTI prevention.”
  • The National Cancer Institute released Cancer Information Highlights about “Fructose Fuels Cancer Growth | Lung Cancer Stigma | Multiple Myeloma.”
  • The National Institutes of Health posted “Research in Context: Detecting Cancer.”
  • Per MedPage Today,
    • “The blood test achieved high accuracy, with 98% specificity and 73% sensitivity for detecting pancreatic cancer.
    • “When combined with CA 19-9 biomarker testing, the sensitivity increased to 85% while maintaining high specificity.
    • “The test successfully differentiated between cancer and non-cancer pancreatic conditions using protease activity detection.”
    • “Integrating an early test for pancreatic cancer into clinical practice will be difficult, Suneel Kamath, MD, of the Cleveland Clinic, continued. Although incidence and mortality continue to increase, the cancer is much less common than breast, colon, and lung cancers. In addition to targeting high-risk populations, another possible strategy would be a one-time screening at a certain age.
    • “Early-stage pancreatic cancer still carries a poor survival rate of just 44% at 5 years,” he told MedPage Today. “The majority of people with stage I or II pancreatic cancer will die of their cancer in the first 5 years after diagnosis. For breast, colorectal, and prostate cancers, those rates are over 90%, often over 95%, so we will not screen our way into curing pancreatic cancer. We will have to find better ways to treat it once it has occurred too because early detection alone is not enough.”
  • and
    • Epidural steroid shots for back pain had mixed results, an AAN review showed.
    • The treatment demonstrated promising short-term benefits for radiculopathy patients.
    • In other situations, benefits were unclear or limited.

From the U.S. healthcare business front,

  • Beckers Payer Issues offers more observations on how “CVS is working ‘tirelessly’ to improve Aetna.”
  • Healthcare Dive points out,
    • “Tenet Healthcare brought in profits of $3.2 billion in 2024, up from $611 million in 2023, on strong same-store revenue, growth in high-acuity care and effective cost management strategies, health system executives said during an investor call Wednesday.
    • “The earnings performance was stronger than expected based on Tenet’s full year guidance, which the company updated midway through the year.
    • “Still, Tenet faced challenges during the fourth quarter and underperformed on operating revenue compared to Wall Street’s expectations. Analysts also pressed executives during the call about the health system’s plans to weather possible regulatory changes in Washington moving forward, including proposed cuts to the Medicaid program.”
  • Per Fierce Pharma,
    • “As Alnylam Pharmaceuticals approaches its highly anticipated March 23 FDA decision date for a potential expansion of Amvuttra to treat patients in an increasingly competitive indication—transthyretin amyloid cardiomyopathy (ATTR-CM)—the company is emphasizing market dynamics.
    • “The category is rapidly growing and it’s been largely underserved,” Tolga Tanguler, Alnylam’s chief commercial officer said during a conference call Thursday.” This will be a market-growth story.”
    • “After Alnylam divulged last month at the J.P. Morgan Healthcare Conference that it expects Onpattro and Amvuttra to generate between $1.6 billion and $1.7 billion in 2025, there was little suspense left in Thursday’s fourth-quarter earnings presentation about the company’s expectation for its potential launch into the new indication.”
    • “The projection compares to the ATTR franchise’s combined 2024 sales of $1.23 billion, including $970 million for Amvuttra, which nearly achieved blockbuster status in just its second full year on the market.”

Happy Lincoln’s Birthday

Our greatest President

From Washington, DC

Capitol Hill News

  • The American Hospital Association (AHA) News tells us,
    • House Republicans Jan. 12 released a budget resolution for fiscal year 2025 focusing on the Trump administration’s agenda on border security, defense, energy and taxes. The budget resolution, which acts as an outline for the reconciliation process, calls for increasing the debt ceiling by $4 trillion and allows for $4.5 trillion in spending for tax cuts. It also would allocate $200 billion for border and defense spending. The resolution instructs seven committees to come up with no less than $1.502 trillion in mandatory cuts over ten years. 
    • Notably, for health care, the bill instructs the House Energy and Commerce Committee to cut mandatory spending by no less than $880 billion. The committee has primary jurisdiction over a number of health care programs, including Medicaid, and some proposals have been circulating that would enact significant cuts to Medicaid. The House is expected to mark up its budget resolution tomorrow. 
  • Politico adds,
    • “Senate Republicans easily pushed their budget resolution out of committee on Wednesday — the first step toward being able to enact President Donald Trump’s massive domestic policy agenda.
    • “The Senate Budget Committee voted 11-10, along party lines, to approve the fiscal framework meant to tee up a package of energy, border security and defense policy through the partisan budget reconciliation process. Across the Capitol, House GOP leaders struggled at the same time to rally their own around a far more expansive plan that would pave the way for legislation that would bundle those same policies alongside trillions of dollars in tax cuts.”
  • The Senate Invoked, 53-47: Motion to invoke cloture on Executive Calendar #17 Robert F. Kennedy, Jr. to be Secretary of HHS. The Senate is expected to confirm Mr. Kennedy’s nomination as HHS Secretary Thursday morning.
  • Fierce Healthcare lays out the “top policy issues for hospitals, payers, docs and tech” on Capitol Hill this year.

White House news

  • Here is a link to the President’s February 11 executive order captioned “IMPLEMENTING THE PRESIDENT’S “DEPARTMENT OF GOVERNMENT EFFICIENCY” WORKFORCE OPTIMIZATION INITIATIVE,” which was mentioned in Tuesday’s report.
  • The American Society of Pension Professionals and Actuaries lets us know,
    • “Daniel Aronowitz has been officially nominated by the White House to become next Assistant Secretary of Labor for the Employee Benefits Security Administration (EBSA). He is the President of Euclid Fiduciary (now Encore Fiduciary), a fiduciary liability insurance underwriting company for employee benefit plans.
    • “His experience in the professional liability industry includes expertise as a coverage lawyer and underwriter.”
  • The AHA News informs us, “Tom Engels is the new administrator for the Health Resources and Services Administration, according to its website. Engels previously held the same position in the first Trump administration from 2019 to 2021.”
  • Federal News Network updates us on federal agency efforts to bring their workforces back to office.

Judicial front

  • Federal News Network reports,
    • “The Trump administration is free to continue implementing its controversial deferred resignation program after a federal court in Massachusetts dissolved a restraining order that had delayed the program’s deadline by several days.
    • “In a written opinion Wednesday afternoon, Judge George O’Toole said he had determined that the three federal unions that had challenged the program lacked the standing they’d need in order to meet the legal standard for a temporary restraining order.” * * *
    • “Wednesday’s ruling does not completely end the legal challenge — it only affects the unions’ requests for a temporary pause in the deferred resignation program while their claims work their way through the litigation process. However, in denying a temporary restraining order and preliminary injunction, O’Toole said he had determined the unions were unlikely to succeed on the merits of their case.
    • “OPM is pleased the court has rejected a desperate effort to strike down the deferred resignation program. As of 7 p.m. tonight, the program is now closed,” said McLaurine Pinover, a spokeswoman for the office. “There is no longer any doubt: the deferred resignation program was both legal and a valuable option for federal employees. This program was carefully designed, thoroughly vetted, and provides generous benefits so federal workers can plan for their futures.”
    • In fact, the Fork in the Road program closed at 7:20 pm ET Wednesday night per its website.

FDA News

  • Fierce Pharma notes,
    • “More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green light to treat large B-cell lymphoma (LBCL).
    • “The CD30-directed antibody-drug conjugate has been approved in combination with lenalidomide and rituximab for certain LBCL patients, the FDA said Wednesday. Eligible patients must have tried at least two prior lines of systemic therapy and be ineligible for an autologous hematopoietic stem cell transplant or a CAR-T therapy.
    • “Adcetris won the approval after showing it helped patients with heavily pretreated LBCL live longer in a phase 3 trial.”

From the public health and medical research front,

  • CBS News reports,
    • “For the first time since the beginning of the pandemic, more people in the U.S. died of influenza than from COVID-19 in the week ending on Jan. 25, according to weekly figures published by the Centers for Disease Control and Prevention.
    • “For the week ending on Jan. 25, nearly 1.7% of all deaths nationwide were attributed to the flu, compared to roughly 1.5% being the result of COVID-19, according to CDC data. Rates of influenza hospitalizations are more than three times higher than COVID-19 hospitalizations amid this season’s record wave of flu infections.”
  • and
    • “The U.S. confirmed at least a dozen deaths from whooping cough last year, according to preliminary figures released this week by the Centers for Disease Control and Prevention. That marks the most fatalities from the bacterial infection since a 2017 surge of the illness, which is also known as pertussis.
    • “Over the last month, pertussis infections have been rising again. While cases reported to the CDC by health departments dipped over the winter holidays, weekly infections have accelerated for a month straight since then.”
  • The New York Times adds,
    • “A worsening measles outbreak has taken root in Texas, sickening two dozen and hospitalizing nine on the western edge of the state, where childhood vaccination rates have dwindled in recent years.
    • “As of Tuesday, 22 children and two adults had been infected, all of whom were unvaccinated, local health officials said. * * *
    • “The Texas outbreak has so far been limited to residents of Gaines County, which borders New Mexico and has roughly 20,000 residents. Last year 82 percent of kindergarten students received the measles, mumps and rubella vaccine, according to state data. That figure is roughly 10 percentage points lower than the average vaccination rate in Texas public schools and far below the federal target of 95 percent for measles vaccination.”
  • Nature points out that “Dozens of new obesity drugs are coming; these are the ones to watch. Next-generation obesity drugs will work differently from Ozempic and Wegovy — aiming to deliver greater weight loss with fewer side effects.”
  • BioPharma Dive, on the other hand, lets us know “A small semaglutide trial suggests the medicine’s suppression of appetite may extend to alcohol, but larger trials are needed to establish a conclusive benefit.”
  • Per Fierce Healthcare,
    • “More than five years ago, Apple launched three medical studies to test how well its Apple Watch can track a person’s mobility and cardiovascular health, changes in hearing and women’s health and fertility.
    • “The tech company is now broadening its health research ambitions to use its devices, including iPhones, Apple Watch and AirPods along with third-party devices, for a longitudinal, virtual study to monitor changes in participants’ health, spanning a wide range of health and disease areas.
    • “Apple wants to tap into the devices and apps that individuals use every day to evaluate the connections between physical and mental health as well as social determinants, such as whether someone lives alone or with family, and how all these aspects of health factor into a person’s overall well-being.”

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “CVS Health’s profits were nearly cut in half last year as the healthcare giant wrestled with elevated medical costs in its Aetna insurance business. 
    • “The company reported net income of $4.6 billion in 2024, compared with $8.4 billion in the prior year, according to earnings results released Wednesday. 
    • “But CVS showed signs of financial improvement in the fourth quarter, beating Wall Street expectations on earnings and revenue.” 
  • Bloomberg explains,
    • “In the insurance unit, CVS spent 94.8% of premium revenue on medical care in the quarter, less than analysts expected. Investors prefer a lower number. However, CVS said in a separate filing that high use of medical services will continue to pressure the business. 
    • “The company pointed in particular to high costs in its business that manages care for patients on Medicaid, the US health program for the poor. States have been cutting Medicaid rolls since the pandemic, often culling healthier patients in the program while sicker patients remain.” 
  • Fierce Healthcare adds,
    • “CVS Health CEO David Joyner went on the defense of the pharmacy benefit management industry on the company’s Q4 earnings call Wednesday morning.” * * *
    • “One of the most powerful forces helping to offset rising healthcare costs is PBMs like Caremark,” Joyner said. “These entities remain the only part of the drug supply chain and entirely focused on lowering costs, but have erroneously been subject to deceptive rhetoric and misinformation.”
    • “Joyner noted that branded pharmaceutical manufacturers “added $21 billion of annual gross drug spend through their price actions” in January. Drugs where PBMs lack tools to negotiate prices have seen prices rise more than twice as fast as other products, he said.
    • “In addition, Joyner said that “multiple well-known economists” have projected that PBMs create $100 billion in net value each year for the healthcare system.”
  • Per the AHA News,
    • The Council for Affordable Quality Healthcare Feb. 11 released a report  highlighting how the health care industry can save $20 billion by transitioning from manual to electronic workflows.  
    • In addition, it found that the industry could save $515 million annually on electronic prior authorizations and save providers and staff 14 minutes per transaction.
  • Per Fierce Healthcare,
    • “UnitedHealth Group and Amedisys outlined plans to divest a significant number of home health and hospice locations as they seek to close their $3.3 billion merger.
    • “In a court filing issued late last week, UHG said it intends to pursue a divestiture plan that would sell off “at minimum” 128 combined home health and hospice facilities. The company said in the filing that once the divestitures are completed it will operate only 10% of home health services in the U.S. and 4% of hospice services.
    • “UnitedHealth argued that leaves plenty of competition in this space, as it will still be up against 11,000 home health agencies and more than 5,000 hospice agencies across the U.S.
    • ‘The Department of Justice sued to block the deal in mid-November, arguing that it would hamper competition across multiple home health markets.”
  • Per JAMA Open,
    • Question How have the proportion and absolute number of psychiatrists providing professional services to traditional Medicare enrollees changed as the field has grown?
    • Findings In this cross-sectional study using data from 2014 to 2022, the nationwide proportion of psychiatrists billing Medicare Part B declined from 44% in 2014 to 33% in 2022. The number of psychiatrists billing Medicare Part B declined by 3772 during a time when the total number of active psychiatrists increased by 6076.
    • Meaning These findings suggest that during a time of psychiatrist workforce growth, the proportion and number of psychiatrists accepting Medicare Part B decreased, further suggesting potential decreases in access to psychiatrist-led care for older adults and individuals with disabilities.”

Friday Report

From Washington, D.C.

  • Roll Call reports,
    • “The Senate fiscal 2025 budget resolution released Friday gives instructions to nine authorizing committees to draft a filibuster-proof reconciliation bill aimed at strengthening border control, buttressing military spending and encouraging domestic energy production.
    • “The fiscal blueprint, written by Senate Budget Chairman Lindsey Graham, R-S.C., gives the authorizing committees until March 7 to fill in the details and provide their respective pieces of the package to the Budget Committee, which will then meld them into one bill.
    • “The plan, to be marked up by the committee Feb. 12 and 13, assumes $342 billion over four years divided between border security, the Pentagon and Coast Guard: $175 billion for the border, $150 billion for defense and $17 billion for the Coast Guard.
    • “The new funding would be fully paid-for, but how they do that specifically is up to the authorizing committees charged with drafting the implementing bill. Committees given instructions to come up with the offsets are given low targets — at least $1 billion — to provide them with maximum flexibility. But the expectation is those committees will exceed those targets.”
  • and
    • “House Republican leaders emerged late Thursday from a roughly three-hour meeting without an agreement on the contours of the massive budget reconciliation package they’ve been talking about for weeks.
    • “But they planned to work through the weekend ironing out details with a goal of marking up the blueprint needed for the filibuster-proof bill early next week.
    • “Speaker Mike Johnson said he’ll be working Saturday and through Sunday’s Super Bowl taking place in New Orleans — in his and Majority Leader Steve Scalise’s home state of Louisiana. President Donald Trump, who hosted House GOP leaders for several hours to discuss reconciliation earlier in the day, is slated to attend the game Sunday.
    • “We are almost there,” Johnson said. “A couple final details that we’ve got to work out.”
  • The Washington Post reports
    • A federal judge said Friday he will temporarily bar the U.S. Agency for International Development from putting 2,200 workers on paid leave as planned by the end of the day after employee groups filed a lawsuit challenging the Trump administration’s authority to shut down the agency.
    • U.S. District Judge Carl J. Nichols said after a hastily called hearing that he will enter a “limited” order in the lawsuit, brought Thursday, and was still weighing whether to order the government to undo the decision to place an additional 500 workers on paid leave.
    • Nichols said he would explain his decision in writing Friday evening, and cautioned that his freeze would be temporary while both sides flesh out their complex but hastily sketched-out claims.
  • OPM on its Fork in the Road webpage acknowledges the federal court order extending the “deadline for the Deferred Resignation Program, the deadline for federal employees to accept the program is being extended to Monday, February 10, at 11:59 pm ET.
  • MedTech Dive tells us,
    • “The American Hospital Association (AHA) has called for the Trump administration to exempt medical devices from tariffs on imports from Canada, China and Mexico.
    • “In a letter sent to President Donald Trump Tuesday, AHA CEO Richard Pollack said disruption to the supply of devices from China would curtail hospitals’ ability to perform life-saving surgeries, protect patients and healthcare workers from contagion, and diagnose and monitor patient conditions.
    • “The AHA is particularly concerned about products that are already in short supply despite ongoing efforts to strengthen the domestic supply chain, Pollack said.”
  • The Government Accountability Office released a report on the Postal Service today.
    • “The U.S. Postal Service is consolidating some of its mail processing facilities. Before doing so, USPS must give public notice of the proposed changes and provide information on how the changes will affect costs, employees, and mail service.
    • “But we found that USPS’s process for estimating the costs of these changes doesn’t align with best practices we considered. For example, USPS doesn’t document all the assumptions and methodologies it uses to develop cost estimates. This information would help decision-makers and oversight groups better understand any risks or uncertainty involved in the estimates.
    • ‘Our recommendations address this issue.

From the public health and medical research front,

  • Fierce Pharma points out,
    • “Since 1999, Feb. 7 has marked National Black HIV/AIDS Awareness Day, drawing attention to the disproportionate impact of HIV on Black communities.
    • “For ViiV Healthcare—the HIV-focused joint venture between GSK, Pfizer and Shionogi—the day represents a dual opportunity to both celebrate progress and plan next steps, according to Randevyn Pierre, ViiV’s head of national field engagement in external affairs.
    • “It’s the moment for us to remember those who have contributed so much to this fight to end HIV/AIDS, and it’s an opportunity for us to celebrate how far we’ve come in HIV treatment, advocacy, activism, research and community work, and also to use that as evidence of how far we can go to end HIV,” Pierre said in an interview with Fierce Pharma Marketing.”
  • The Centers for Disease Control and Prevention announced
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in most areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity is declining. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • ‘RSV
      • “RSV activity remains elevated but is declining in most areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • ‘Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.”
  • The University of Minnesota’s CIDRAP informs us,
    • “Infection with the SARS-CoV-2 Omicron variant confers weak, short-term protection against reinfection, compared with the much more robust and durable protection provided by earlier variants, which highlights the need for periodic vaccine updates, a Cornell University Qatar–led study suggests.
    • ‘The researchers used a test-negative, case-control study design to compare the efficacy of SARS-CoV-2 Omicron infection against reinfection and poor outcomes in Qataris with that offered by infection with previously dominant strains such as Alpha, Beta, and Delta. COVID-positive people were matched with COVID-negative controls in a 1:2 ratio by sex, age-group, nationality, number of underlying medical conditions, vaccine doses received, week of COVID-19 test, testing method, and reason for testing.
    • “The results were published yesterday in Nature. today.”
  • and
    • “Researchers today in JAMA Network Open say children with previous COVID-19 infection have a 25% to 28% higher risk of developing new gastrointestinal (GI) tract symptoms for up to 2 years than kids who did not report SARS-CoV-2 infections.
    • “Studies in adults have shown that the risk of developing new GI symptoms, including abdominal pain, irritable bowel syndrome (IBS), and gastroesophageal reflux disease (GERD), is increased in the year following COVID-19 infection, but it is unknown if kids are at the same increased risk.” 
  • Beckers Clinical Leadership adds “Flu cases reach highest levels since 2009 pandemic: 6 respiratory virus updates.”
    • “Flu levels have surged to their highest levels since the 2009 swine flu pandemic, with influenza-related emergency department visits remaining very high across the U.S. 
    • “The flu continues to drive the most respiratory illness activity and officials warn that flu-related emergency department visits are expected to remain high in the coming weeks. “
  • The American Hospital Association News lets us know.
    • “A study by the Penn State Department of Nutritional Sciences found that low vitamin D levels in the first trimester of pregnancy are associated with higher rates of preterm birth and decreased fetal length.    
    • “More than 25% of women who are pregnant or lactating have lower than recommended levels of vitamin D,” said Alison Gernand, one of the study’s authors.   
    • “Women with higher levels of vitamin D were found to have experienced small but statistically significant increases in fetal length.”
  • The New York Times reports,
    • “Hospital and emergency room patients diagnosed with cannabis use disorder — defined as an inability to stop using cannabis even when the drug is causing harm — died at almost three times the rate of individuals without the disorder over the next five years, according to a study published on Thursday, the largest on the subject.
    • ‘Patients with cannabis use disorder were 10 times as likely to die by suicide as those in the general population. They were also more likely to die from trauma, drug poisonings and lung cancer. Those numbers suggest that cannabis use disorder is about half as dangerous as opioid addiction and slightly less dangerous than alcohol use disorder, the researchers said.
    • “A second report, published on Tuesday, found that more cases of schizophrenia and psychosis in Canada have been linked to cannabis use disorder since the drug was legalized.
    • “Many people think, ‘Oh, cannabis is not harmful — it’s organic, it’s natural; how great,’” said Dr. Laura Bierut, a psychiatrist at Washington University School of Medicine in St. Louis who is an author of an editorial accompanying the study of death risk. But the marijuana sold today is far more potent, and more harmful, than what baby boomers smoked in the 1960s and 1970s, she said.”
  • Per Healio,
    • “Central obesity measures of waist circumference and waist-to-hip ratio appear to be more accurate and consistent indicators of colorectal cancer incidence compared with BMI, according to a study published in JAMA Network Open.
  • and
    • “A blood-based biomarker test may be a reliable method for predicting or ruling out Alzheimer’s disease-related pathology and subsequently for assisting clinicians in formulating a treatment plan for patients, according to new research.
    • “The clinical integration of blood biomarkers for AD holds promise in enabling the early detection of pathology and timely intervention,” Mark Monane, MD, MBA, senior medical adviser at C2N Diagnostics, which funded the study, and colleagues wrote in Diagnostics. “The use of a blood biomarker test that is scalable and accessible as well as acceptable and equitable may address the unmet need in diagnostic testing.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lets us know,
    • “Oakland, Calif.-based Kaiser Permanente posted an operating income of $569 million (0.5% operating marin) in 2024, up from an operating income of $329 million (0.3% margin) in 2023, according to its Feb. 7 financial report. 
    • “Kaiser’s 2024 results include Risant Health, the Washington, D.C.-based nonprofit it formed to “to expand and accelerate the adoption of value-based care in diverse, multi-payer, multi-provider, community-based health system environments.” Risant closed the acquisition of its first health system, Danville, Pa.-based Geisinger, on March 31. It closed the acquisition of its second, Greensboro, N.C.-based Cone Health, on Dec. 1. 
    • “Kaiser reported operating revenues of $115.8 billion for the fiscal year ended Dec. 31, up from $100.8 billion in 2023. The system posted operating expenses of $115.2 billion, up from $100.5 billion in 2023. 
    • “The system posted a net income of $12.9 billion in 2024. Standard accounting rules required Kaiser and Risant to report the net value of unrestricted assets of the organizations that became part of Risant as one-time net income on its financial statements. A total of $6.8 billion of the $12.9 billion in the system’s net income was related to those acquisitions. The system posted a net income of $4.1 billion in 2023. 
    • “Kaiser reported capital spending of $3.7 billion in 2024, down from $3.8 billion in 2023. Its capital spending priorities in 2024 included preparations to meet California’s seismic safety standards by 2030 and supporting investments in leading-edge technologies and environmentally sustainable facilities. As of Dec. 31, Kaiser and Risant had 55 hospitals, 841 medical offices and 40 retail and employee clinics. “
  • Healthcare Dive reports,
    • “Verily, the life sciences arm of technology giant Alphabet, has reached a deal to sell its insurance subsidiary to Elevance, the payer confirmed to Healthcare Dive on Friday.
    • “The subsidiary, called Granular Insurance Company, provides stop-loss insurance for employers meant to protect them from catastrophically high medical costs.
    • “Terms of the deal were not disclosed.”
  • and
    • “A federal bankruptcy judge agreed to a deal on Thursday that places Prospect Medical’s struggling health system Crozer Health into a 30-day receivership.
    • “Under the terms, Pennsylvania regulators will provide Washington, D.C.-based FTI Consulting $20 million to act as an independent monitor and manager of Crozer while Prospect continues to search for a permanent buyer for the four-hospital health system.
    • “The deal isn’t the one Prospect originally intended to present before the Texas court. However, it will keep the lights on at Crozer for at least another 30 days.”
  • BioPharma Dive notes,
    • “Alumis and Acelyrin are merging, the biotechnology companies said Thursday afternoon, in an all-stock deal that leaves the combined company with a bigger cash balance and three drugs in clinical testing. 
    • “Per deal terms, Acelryin stockholders will receive 0.4274 shares of Alumis stock for each share they own, leaving them with about 45% of the combined company and Alumis equity holders with 55%. The new company, which will keep the Alumis name and be run by its executive team, would have $737 million in cash, enough to keep operating into 2027.  
    • “The merged entity will continue to develop Alumis’ two so-called TYK2 inhibitors, one of which is being developed for plaque psoriasis and lupus while the other is targeting neuroinflammatory conditions like multiple sclerosis. Acelyrin’s top prospect, a thyroid eye disease drug called lonigutamab, is part of the deal, too, but the program will be re-evaluated to “confirm its differentiation in a capital efficient manner,” the companies said.”

Thursday Report

From Washington, DC

Photo by Josh Mills on Unsplash

From Capitol Hill

  • The Wall Steet Journal reports
    • “House Republicans wrapped up a more than four-hour meeting at the White House saying that they had closed gaps in their own internal disagreements over extending expiring tax cuts and cutting spending, and they indicated that they were on track to hold a key committee vote next week.
    • “We had a very productive meeting at the White House,” House Majority Leader Steve Scalise (R., La.) told reporters after lawmakers streamed into the Capitol. “We are narrowing down the areas of differences.”
    • “House Republicans from different factions of the party assembled at the White House, each hoping to get Trump’s support for their proposals and resolve disputes that have slowed the party’s progress on taxes, spending and immigration.”
  • The Senate press gallery tells us Thursday evening, “The Senate is considering the nomination of Russell Vought to be Director of the Office of Management and Budget, post cloture. If all time is used, a confirmation vote would occur at 7:00 p.m. We expect several procedural votes to follow the vote on the Vought nomination.”
  • The Washington Post adds,
    • “The Senate on Thursday confirmed Russell Vought as the next director of the powerful White House budget office, installing a conservative fiscal hawk who has promised to pursue sweeping spending cuts and empower President Donald Trump to conform the budget to his political views.
    • “Republicans marshaled a 53-47 vote in support of Vought, who immediately inherits the exceedingly complicated tasks of staving off a government shutdown and preventing a catastrophic debt default — with a political clash over the two critical fiscal deadlines just weeks away.”

From the White House,

  • The Wall Street Journal lets us know,
    • “The White House is working on an executive order to fire thousands of U.S. Department of Health and Human Services workers, according to people familiar with the matter.
    • “Under the order, the Food and Drug Administration, Centers for Disease Control and Prevention and other health agencies would have to cut a certain percentage of employees. 
    • “The order could come as soon as next week, people familiar with the matter said, after workers have an opportunity to take a buyout. The terms of the order haven’t been finalized, however, and the White House could still decide against going forward with the plans.
    • “The job cuts under consideration would affect the Department of Health and Human Services, which employs more than 80,000 people and includes the National Institutes of Health and the Centers for Medicare and Medicaid Services, in addition to the FDA and CDC.
    • “The agencies are responsible for a range of functions, from approving new drugs to tracing bird-flu outbreaks and researching cancer. A loss of staff could affect the efforts depending on which workers are cut and whether they are concentrated in particular areas.
    • ‘The White House on Thursday denied that there is an executive order related to HHS coming.”

From the judicial front,

  • The Wall Street Journal informs us,
    • “A federal judge paused a Thursday deadline for federal employees to decide whether to accept an offer from the Trump administration to resign their jobs voluntarily as the president and his allies attempt to shrink the government workforce.
    • “U.S. District Judge George O’Toole in Massachusetts scheduled a hearing for Monday on whether to grant a temporary restraining order that would block the program while the litigation challenging the offer proceeds.
    • “Employees had previously been told they had until the end of the day on Thursday to decide whether to accept the offer.”

From the Food and Drug Administration front,

  • Per Cardiovascular Business,
    • “The U.S. Food and Drug Administration (FDA) is warning patients with diabetes about the risk of missing critical safety alerts when using continuous glucose monitors, insulin pumps, automated insulin dosing systems and any other similar medical devices. 
    • “While smartphones have made it easier than ever for patients to track their own insulin levels, the convenient technology is far from infallible. In fact, the FDA has received multiple reports of smartphone-compatible medical devices failing to send expected health alerts. When this happens, the agency warned, it creates a risk of patients experiencing severe hypoglycemia, severe hyperglycemia, diabetes ketoacidosis or even death.
    • “Modern medical devices, such as diabetes devices that connect to a smartphone, can provide users with the convenience and flexibility to configure alerts that are personalized to them,” Courtney Lias, director of the Office of In Vitro Diagnostic Products in the FDA’s Center for Devices and Radiological Health, said in a statement. “However, users should stay aware of alert settings and monitor these devices to ensure they continue to receive critical alerts as expected. Even if configured correctly, certain hardware or software changes can interrupt the expected operation of these critical devices, which can lead to patient harm if undetected.”
  • Per a news release,
    • “The Institute for Clinical and Economic Review (ICER) today released a Draft Evidence Report assessing the comparative clinical effectiveness and value of sonpiretigene isteparvovec (Nanoscope Therapeutics) for the treatment of advanced retinitis pigmentosa.
    • “This preliminary draft marks the midpoint of ICER’s eight-month process of assessing this treatment, and the findings within this document should not be interpreted to be ICER’s final conclusions.

From the Postal Service front,

  • Federal News Network reports,
    • “The Postal Service ended the first quarter of fiscal 2025 with a net profit — a rare moment in the black that Postmaster General Louis DeJoy says is evidence the agency is on the “right path” to overcome long-term financial challenges.
    • “USPS reported $144 million in net income for the first quarter of fiscal 2025, a dramatic reversal from the $2.1 billion net loss for the same quarter last year. The agency’s first quarter is usually its best all year.
    • “USPS, however, still anticipates ending FY 2025 with a $6.9 billion net loss.
    • “The last time USPS saw a net profit was in fiscal 2022, when it ended the year with a $56 billion net profit, ending a nearly 15-year streak of annual net losses.
    • “That sudden change, however, came from Congress passing the Postal Service Reform Act, which ended a mandate for USPS to pre-fund its retiree health benefits well into the future, and brought the agency back to a pay-as-you-go system. The legislation also forgave $57 billion in deferred payments to the retiree health fund.”

From the public health and medical research front,

  • The American Hospital Association News points out,
    • “The U.S. maternal mortality rate decreased to 18.6 deaths per 100,000 live births in 2023, down from 22.3 in 2022, according to new data from the Centers for Disease Control and Prevention. While the mortality rate decreased overall, the maternal mortality rate for Black women in 2023 was 50.3 deaths per 100,000 live births, significantly higher than rates for white (14.5), Hispanic (12.4) and Asian (10.7) women.” 
  • and
    • “The Centers for Disease Control and Prevention Feb. 6 released an advisory  about an outbreak of Ebola in Uganda caused by the Sudan virus disease. There are currently no suspected, probable or confirmed Ebola cases related to the outbreak that have been reported in the United States or outside of Uganda. The CDC recommends travelers monitor themselves for symptoms of SVD while in Uganda and 21 days after leaving.”
       
  • Healio adds
    • “Pregnant women are more likely to die of violence than any medical cause in the U.S. and are at greater risk for violent death compared with nonpregnant women, underscoring the need for intimate partner violence screening, data show. 
    • “In an analysis of CDC mortality data presented at The Pregnancy Meeting, researchers also found that domestic violence firearm legislation was associated with a reduction in homicide and firearm death in pregnancy.”
  • Modern Healthcare reports,
    • “Kaiser Permanente and Tufts University have launched a joint initiative aimed at improving nutritional and dietary health, the organizations said Thursday. 
    • “The Food is Medicine National Network of Excellence comprises Tufts University’s Food is Medicine Institute in Medford, Massachusetts, and Oakland, California-headquartered Kaiser, along with network members such as Blue Cross and Blue Shield of North Carolina, CVS Health, Devoted Health, Elevance Health, Geisinger Health and Highmark Health. 
    • “Network members will track patient outcomes following nutritional and dietary changes and use the data to instruct care delivery and promote food-is-medicine initiatives, according to a news release.”
  • Per the Health Care Cost Institute,
    • The Health Care Cost Institute (HCCI), in collaboration with West Health, conducted an analysis on the use of telehealth mental health services among people with employer-sponsored insurance (ESI). We found that telehealth played an outsized role in the delivery of mental health services starting in 2020, with over 40% of mental health visits occurring via telehealth from 2020-2022. Females, young adults, and people residing in the northeast and west coast received the highest share of mental health care via telehealth. Therapy was the most commonly received mental health service via telehealth.
  • Per AHA News,
    • The Centers for Disease Control and Prevention Feb. 6 released a report on emergency department use during the Los Angeles County wildfires that began Jan. 7. All-cause ED encounters in Los Angeles County initially decreased 9% after the start of wildfires, while wildfire-associated encounters increased eightfold. Wildfire-associated ED encounters peaked from the period of Jan. 7-12, aligning with worsened air quality deemed unhealthy for sensitive groups. The CDC said the initial decrease in all-cause visits could be due to evacuations; alterations in activity patterns; or residents seeking care in clinics, urgent care centers or EDs in neighboring counties.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “A strange thing happened weeks before the Food and Drug Administration approved the first treatment made with CRISPR gene editing, an all-but cure for certain patients with sickle cell disease. CRISPR Therapeutics, the biotech that co-developed the therapy, laid off about 50 employees. “Everyone was dumbfounded,” said a scientist who was let go.
    • “It was one early sign that, for all the public accolades, the CRISPR revolution wasn’t exactly going according to plan. 
    • The gene editing tool, wrested out of bacteria 13 years ago by a fractious group of biochemists, was supposed to change medicine. Excitement surged through boardrooms, patient communities, and the press. No less an authority than a Nobel Prize committee announced, in 2020, that CRISPR “may make the dream of curing inherited diseases come true.” Billions were spent chasing that vision, along with treatments for cancer and other non-hereditary diseases, such as HIV.
    • “Few still talk that way. They sure don’t spend that way.
    • “Over the last 16 monthslayoffs have hit nearly every major CRISPR public and private biotech. Eight public CRISPR stocks are down roughly 50% over the past year. Most are down over 75% from their 2021 peak, when near 0% interest rates and the enthusiasm around mRNA fueled a gene editing bubble. Buzzy startups have closed or merged out of existence, sometimes thunderously. In August, Tome Biosciences collapsed, just eight months after announcing $213 million in funding from biotech’s most prestigious investors and a plan to write “the final chapter in genomic medicines.” [See STAT’s updated CRISPR Tracker here.]
  • From Beckers Payer Issues, we learn that “KLAS Research, a healthcare IT data and insights company, named its “Best in KLAS” payer tools for 2025.”
  • Healthcare Dive notes,
    • “Molina reported mixed fourth-quarter results on Wednesday, beating Wall Street expectations on revenue but missing on earnings. The payer also laid out earnings guidance for 2025 that was lower than analysts had anticipated.
    • The fourth-quarter earnings miss was due to higher medical spending in Medicaid, with no help from the risk corridors that kept the worst of utilization jumps from hitting Molina’s bottom line earlier in 2024. Meanwhile, the lower earnings forecast for this year is because of implementation costs from recent contract wins in Medicaid and for individuals dually eligible for both the safety-net program and Medicare, according to the insurer.
    • “The results and 2025 outlook are “disappointing at face value,” but accretion from the contract wins could set Molina up well for 2026, J.P. Morgan analyst John Stansel said in a note Wednesday.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is expanding its plan to cut costs, announcing alongside quarterly earnings on Thursday that it will slash an additional $2 billion in annual expenses by the end of 2027
    • “The announcement builds on cutbacks Bristol Myers announced last April and that affected about 2,200 employees. Bristol Myers didn’t say how many workers will be impacted by the new initiative, but Chief Financial Officer David Elkins told analysts on a conference call that cuts will drive “operational efficiencies across multiple areas of the business.” 
    • “Bristol Myers is already facing limited generic competition for one of its highest-grossing products, the multiple myeloma drug Revlimid. But it’s also bracing for the loss of billions in yearly revenue when patents expire for its cancer immunotherapy Opdivo and blood thinner Eliquis. The planned cuts announced Thursday will help Bristol Myers become a “leaner, more focused company” along the way, CEO Chris Boerner said.”
  • and
    • “Sales of Cobenfy, a new mind-stabilizing medicine, totaled $10 million in the final months of last year, results that fell in line with analyst expectations.
    • “Bristol Myers Squibb, which acquired Cobenfy through its $14 billion purchase of Karuna Therapeutics, gave a first look at the medicine’s launch in an earnings report released Thursday. Cobenfy comes as a capsule. It received Food and Drug Administration approval on Sept. 26 as a treatment for schizophrenia, then launched onto the U.S. market in late October.
    • “By Bristol Myers’ count, the number of filled Cobenfy prescriptions had climbed to around 1,000 per week by the end of January. Chief Commercial Officer Adam Lenkowsky told investors on an earnings call that the “launch is really off to a strong start” and the company has “made very good progress achieving our access goals.”

Midweek Update

From Washington, DC

Capitol Hill News

  • The Senate Press Gallery tells us, “The Senate invoked cloture [this afternoon] on the nomination of Russell Vought to be Director of the Office of Management & Budget on a party line vote of 53-47.” 
  • Modern Healthcare reports,
    • “A package of healthcare bills including measures that targeted transparency, spread pricing and drug rebates fell off a government funding bill at the last minute after Trump objected to other aspects of the bill.
    • “But the ideas behind them remain popular, and these healthcare, business and labor interests want lawmakers to pick up where they left off by including the PBM policies in the next spending package, which Congress must pass by March 14 to prevent a partial shutdown.”

OPM News

  • The Wall Street Journal reports
    • More than 40,000 federal workers have raised their hands to resign, putting the Trump administration at risk of falling short of its target for slashing the government through voluntary measures. 
    • The Office of Personnel Management last week told workers that they have until Thursday to decide whether to take a buyout. People who do so can continue to be paid through September without working, OPM has saidUnions and a dozen attorneys general say the offer isn’t guaranteed. 
    • On a call Wednesday with agency officials, OPM officials said the number of federal workers who have accepted the resignation offer is more than 40,000, according to a person familiar with the matter. Another person confirmed the figure was above 40,000 as of Wednesday afternoon. The Trump administration is expecting numbers to rapidly increase in the final day before the deadline, a White House official said.
    • When it offered the deal last week, the White House said it expected between 5% and 10% of federal employees to accept, leading to about $100 billion in savings annually, without providing information on how the estimate was reached. Officials haven’t translated the percentage range into a specific target for the number of employees it hopes will resign. There are about two million Americans working for the federal government in civilian jobs, though some positions are exempted from the offer.

From the judicial front,

  • Federal News Network informs us,
    • “Three federal unions are asking a federal court to rule that the Trump administration’s “deferred resignation” program is illegal as currently structured, and to order the Office of Personnel Management to give federal workers at least two more months to decide whether to opt in to the unconventional workforce reduction program.
    • “In a lawsuit filed Tuesday, the American Federation of Government Employees, the American Federation of State, County and Municipal Employees and the National Association of Government Employees claim the offer — sent to most federal workers via last month’s “fork in the road” mass email — violates the Administrative Procedure Act (APA) and other federal laws. As currently designed, the program gives employees until Feb. 6 to decide whether or not to resign.
    • “In issuing the directive across the government barely a week after the new administration was sworn in, OPM did not conduct any analysis of which agencies were likely to experience high levels of resignations, the optimal number of resignations, or where staffing was already woefully insufficient such that soliciting resignations would be incontrovertibly harmful to government operations,” attorneys for the labor unions wrote.”
  • Nextgov/FCW adds,
    • “The Office of Personnel Management asked a federal judge Wednesday to dismiss a lawsuit alleging the agency illegally used a new server to send mass emails to federal employees.  
    • “The initial suit, filed in the Washington, D.C. District Court by two anonymous federal employees, claims OPM — working with Elon Musk and his Department of Government Efficiency — violated the 2002 E-Government Act by bypassing a required privacy impact assessment, or PIA, before standing up the email platform.  
    • “Specifically, the lawsuit targets emails related to the Trump administration’s workforce reduction efforts, including the “Fork in the Road” deferred resignation offer, claiming these were sent via the allegedly unauthorized server.”

From the Food and Drug Administration front,

  • Reuters points out,
    • “The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals’ (SUPN.O), opens new tab drug-device combination to treat movement-related symptoms of Parkinson’s disease, the drugmaker said on Tuesday. * * *
    • “The treatment branded Onapgo will be available in the U.S. in the second quarter.
    • “The approval brings to an end the company’s years-long effort to secure the FDA’s nod. The agency had declined to approve Supernus’ application in 2022 and 2024, with the regulator last year requesting additional information related to product quality and the device.”
  • Per a news release, “The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of suzetrigine (Vertex Pharmaceuticals) for the treatment of acute pain.” This is the non-opioid acute pain drug (brand name Journavx that the FDA approved last week.
    • “Rates of development of opioid use disorder (OUD) after short-term administration of opioids for acute pain are uncertain, as are rates of NSAID adverse effects (e.g., acute kidney injury, gastrointestinal bleeding, acute coronary syndrome) when used in the post-operative setting. There are also uncertainties in assessing the efficacy of suzetrigine because of lack of data on use of rescue medication in the Phase III trials, which studied the drug’s use after surgery, as well as the use of imputation for pain scores after rescue medication was used in the clinical trial.
    • “The above uncertainties inform ICER’s ratings that the evidence for suzetrigine for the treatment of acute pain in comparison with no systemic treatment, in comparison with opioid analgesics, and in comparison, with NSAIDs are all promising but inconclusive (P/I), meaning moderate certainty of a small or substantial net health benefit, with a small likelihood of a negative net health benefit. 
    • “The FDA approved suzetrigine for acute pain on January 30, 2025. The manufacturer announced a US price of approximately $232.50 for a one-week course of treatment for acute pain.
    • “When compared to treating with opioids, ICER expects the treatment to be cost-saving from a lifetime perspective because of cost offsets due to fewer patients developing OUD.”
  • The revised report “will be reviewed at a virtual public meeting of the Midwest CEPAC on February 28, 2025. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy. Register here to watch the live webcast of the virtual meeting.”

From the public health and medical research front,

  • The New York Times reports,
    • “Dairy cows in Nevada have been infected with a new form of bird flu that is distinct from the version that has been spreading through herds over the last year, the U.S. Department of Agriculture announced on Wednesday.
    • “The finding indicates that the virus, known as H5N1, has spilled from birds into cows at least twice — leading to these two sets of infections — and that it could continue to do so. It also suggests that the virus may pose a persistent risk to cows and to the people who work closely with them.
    • “Before last year, scientists did not know that cows were susceptible to this type of influenza.
    • “This is not what anyone wanted to see,” said Louise Moncla, an evolutionary biologist who studies avian influenza at the University of Pennsylvania. “We need to now consider the possibility that cows are more broadly susceptible to these viruses than we initially thought.”
    • * * *”So far, at least, the spread of D1.1 to cows “doesn’t change the average person’s life,” Dr. Moncla said. But it poses risks for dairy workers and the dairy industry, experts said. It also suggests the possibility that cows already infected once with B.3.13 could become ill a second time with D1.1, Dr. Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, said.
    • “It’s no longer just one virus,” he said. “This, to me, suggests that it’s going to be a lingering problem.”
  • and
    • “The idea was so tantalizing. Drugs in the GLP-1 class, which includes Wegovy and Ozempic, have proved miraculous in treating weight loss and other diseases. And some researchers hoped that the drugs could also help with some of the most difficult diseases to treat — those of the brain, like Parkinson’s.
    • “But now, at least for Parkinson’s, that hope seems dimmed. A rigorous study that randomly assigned Parkinson’s patients to take exenatide, a relative of Ozempic, showed absolutely no benefit or slowing of the course of the degenerative disease after 96 weeks.
    • “And there were no effect on patient symptoms, no effect on brain scans, no subgroup that showed any benefit. No matter how the researchers sliced the data the results were the same.
    • The study, published Tuesday in The Lancet, is bad news for the half million Americans who have been diagnosed with Parkinson’s disease. Symptoms include tremors, stiffness and difficulty with balance. Patients also may develop dementia. Treatments, including medications and deep brain stimulation, can help with symptoms. But no treatment has been shown to slow the disease’s progress.”
  • Per STAT News,
    • “Nine patients with advanced kidney cancer who received an experimental vaccine tailored to their tumors’ specific mutations mounted an immune response to their disease and remained cancer-free for three years, an early-phase clinical trial has shown. 
    • “The study, published Wednesday in Nature, demonstrates the potential of personalized vaccines to change the course of certain cancer types, but larger, longer trials are needed to confirm this approach. Cancer vaccines developed with different molecular recipes are still in their early stages, before strong conclusions can be made, experts said.”
  • Per Cardiovascular Business,
    • “Adults who regularly floss their teeth may be significantly decreasing their risk of stroke or heart rhythm issues, according to new findings to be presented at the American Stroke Association’s International Stroke Conference 2025.
    • “Researchers focused on data from more than 6,000 study participants with an average age of 62 years old. The group was followed for up to 25 years as part of the Atherosclerosis Risk in Communities study. Over the course of the study, 434 participants had a stroke and 1,291 were diagnosed with atrial fibrillation (AFib).
    • ‘Overall, flossing at least once per week was associated with a 22% lower risk of ischemic stroke, a 44% lower risk of cardioembolic stroke and a 12% lower risk of AFib. Flossing more often appeared to lead to more significant risk reductions.
    • “The difference in AFib risk was unexpected, surprising researchers.”
  • and
    • “Forty-eight percent of all U.S. adults incorrectly believe that they should be taking low-dose aspirin every day to minimize their risk of experiencing a heart attack or stroke, according to a new survey out of the University of Pennsylvania.
    • “Yes, doctors did recommend that adults take daily aspirin to protect against cardiovascular disease (CVD) in the past—but that was quite some time ago. In 2019, the American College of Cardiology American Heart Association released new guidelines saying heathy older adults should not be taking low-dose aspirin due to certain risks, including gastrointestinal bleeding. The U.S. Preventive Services Task Force even published separate recommendations in 2022 saying patients 60 or older should not be taking daily aspirin to prevent CVD, highlighting the lack of any real benefits. 
    • “Now, however, many adults still seem to think daily low-dose aspirin is beneficial, even when they are facing no other health problems. * * *
    • “Habits backed by conventional wisdom and the past advice of healthcare providers are hard to break,” Kathleen Hall Jamieson, director of the Annenberg Public Policy Center and director of this survey, said in a statement. “Knowing whether taking a low-dose aspirin daily is advisable or not for you is vital health information.”
    • “Another key takeaway from the survey was that younger patients appear to know more about the benefits and risks of taking daily low-dose aspirin when healthy. For example, 29% of healthy respondents with no family history of CVD who are between the ages of 18 and 39 understand that the risks of daily aspirin outweigh the benefits for someone in their circumstances. That is only true for 11% of adults in that same situation between the ages of 40 and 59, however, and just 7% of adults ages 60 and older.”
  • BioPharma Dive reports,
    • “Novo Nordisk is planning a new Phase 3 trial of its next-generation obesity drug CagriSema that will test different doses and longer duration of treatment, the company said Wednesday.
    • “The announcement comes six weeks after the Denmark-based company released data from another Phase 3 trial that underperformed executives’ expectations on weight loss. Other studies are ongoing, including one with results due this quarter, and Novo plans in early 2026 to ask for regulatory approval of CagriSema.
    • “Novo, which pioneered the use of GLP-1 medicines like Wegovy for weight loss, is in a tight competition with Eli Lilly. The rivalry sharpened when Lilly’s drug Zepbound showed it helped people lose more weight than Wegovy in a head-to-head trial, a finding that put greater scrutiny on Novo’s pipeline.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Healthcare access and affordability is Americans’ top public health concern, followed by ensuring safe food and water and reducing chronic disease, according to a new survey published by Gallup and Emory University’s Rollins School of Public Health. 
    • “Republicans were more likely than Democrats to list ensuring safe food and water as their top public health priority and less likely to list the Centers for Disease Control and Prevention as one of their top three sources of trusted health information.
    • “However, both Democrats and Republicans support federal action on their top priority public health concerns, with 60% of Republicans and more than 75% of Democrats indicating a preference for federal leadership over state action.”
  • The Wall Street Journal reports,
    • Novo Nordisk shares rose after the drugmaker reported strong sales growth for its blockbuster obesity and diabetes drugs and issued a forecast for full-year 2025 results that topped analysts’ expectations.
    • ‘Novo’s shares were up 3% in European trading, and its American depositary shares were up 3.4% in premarket U.S. trading Wednesday after Novo reported fourth-quarter earnings. Investors who had become concerned about an obesity market slowdown, as well as Novo’s competitive position, breathed a sigh of relief.
    • “The story continues to be about market expansion for obesity,” said David Moore, president of Novo Nordisk’s U.S. unit, on a conference call with analysts.”
  • Fierce Pharma tells us,
    • “Less than a decade since it secured its first FDA approval for a biosimilar, Amgen’s portfolio of the copycat drugs is growing and making strong contributions to the company’s top line.
    • “In 2024, when Amgen generated $33.4 billion in revenue, more than $2.2 billion came from sales of its biosimilars. It was a 16% increase from Amgen’s biosimilar sales in 2023 and the company appears ready to top that figure this year.
    • “Less than three months ago, Amgen became the first company in the U.S. to launch a biosimilar version of Regeneron and Bayer’s eye disease blockbuster Eylea. Then last month, Amgen brought to the market a knockoff of Johnson & Johnson immunology powerhouse Stelara.
    • “In the last nine weeks of last year, Amgen’s Eylea biosimilar, Pavblu, generated $31 million in sales.
    • “The current feedback from retina specialists that we’ve been talking to is very enthusiastic, very positive,” Murdo Gordon, Amgen’s global commercial operations chief, said Tuesday during a quarterly conference call. “They are pleased that Amgen is bringing yet another high-quality biosimilar in a very easy-to-use prefilled syringe.”
  • “Beckers CFO Reports informs us,
    • “Burlington, Mass.-based Tufts Medicine recorded an operating loss of $28.9 million (-4.1% operating margin) in the first quarter of 2025, down from an operating loss of $6.5 million (-0.9% margin) in the same quarter last year, according to its Feb. 3 financial report. 
    • “Tufts Medicine’s management said in the report that last year’s first quarter operating loss was reduced by “two significant one-time items.” The system received $41 million in one-time grants from the state and the federal government, and $24 million in revenue from a 340B settlement. Excluding those two items, the system would have seen an operating loss of $71.5 million in the first quarter of 2024. 
    • “Eliminating these one-time items from each fiscal year would show an improvement of $43 million,” management said in the report. 
    • “Tufts reported total operating revenue of $710.7 million in the three months ended Dec. 31, up from $701.5 million reported in the same period last year.” 
  • Per Healthcare Dive,
    • “Teladoc Health has signed a definitive agreement to acquire virtual preventive care provider Catapult Health for $65 million, the telehealth vendor said Wednesday.
    • “The deal, which is expected to close in the first quarter, will help Teladoc catch members’ health conditions early and funnel patients toward the telehealth vendor’s other offerings, including therapists and primary care providers, according to a press release.
    • “Catapult clinicians will also be able to directly enroll eligible members in Teladoc’s chronic condition management programs for diabetes, hypertension, pre-diabetes and weight management — a key area of investment for the telehealth vendor, executives said last month at the J.P. Morgan Healthcare Conference.”
  • and
    • Molina has closed its $350 million acquisition of ConnectiCare, the health insurer announced Tuesday.
    • “The deal adds $1.4 billion in annual premiums to Molina’s topline and 140,000 additional Medicare, Affordable Care Act marketplace and commercial members to the insurer’s rolls.
    • “The acquisition, which was announced last summer, also brings Molina into the state of Connecticut for the first time. ConnectiCare was previously a subsidiary of New York-based nonprofit health plan EmblemHealth.”
  • and
    • “Kroger pharmacies are once again back in Express Scripts’ network, two years after the grocer kicked the massive pharmacy benefit manager to the curb over its allegedly unsustainable pricing model.
    • “Kroger Health, the grocer’s healthcare subsidiary, said on Wednesday it had reached a new agreement with the Cigna-owned PBM that allows customers in Express Scripts’ Medicare prescription drug and Tricare plans for military members to fill prescriptions at Kroger pharmacies.
    • “The new agreement also allows Express Scripts’ commercial and Medicaid clients to add Kroger pharmacies to their networks, according to the announcement. Express Scripts customers can also receive healthcare at Kroger clinics, which offer low-acuity services like vaccinations and preventive care.”

Monday Report

Photo by Sven Read on Unsplash

From Washington, DC,

  • This afternoon, a cloture petition on the nomination of Russell Vought to be Director of the Office of Management and Budget was filed with the Senate. The next step will be a vote on the cloture motion which requires 51 votes.
  • Per a Senate news release,
    • “U.S. Senate Finance Committee Chairman Mike Crapo (R-Idaho) and Finance Committee member Michael Bennet (D-Colorado), with Ranking Member Ron Wyden (D-Oregon) and Finance Committee member Tim Scott (R-South Carolina), reintroduced the Medicare Multi-Cancer Early Detection (MCED) Screening Coverage Act that would ensure Medicare beneficiaries’ access to cutting-edge tests capable of detecting multiple types of cancer before symptoms appear.  Bipartisan companion legislation (H.R. 842) was also introduced in the U.S. House of Representatives.” * * *
    • Bill text can be found here
  • Nature adds,
    • “US Preventive Services Task Force (USPSTF) guidelines recommend single-cancer screening for select cancers (e.g., breast, cervical, colorectal, lung). Advances in genome sequencing and machine learning have facilitated the development of blood-based multi-cancer early detection (MCED) tests intended to complement single-cancer screening. MCED tests can interrogate circulating cell-free DNA to detect a shared cancer signal across multiple tumor types. We report real-world experience with an MCED test that detected cancer signals in three individuals subsequently diagnosed with cancers of the ovary, kidney, and head/neck that lack USPSTF-recommended screening. These cases illustrate the potential of MCED tests to detect early-stage cancers amenable to cure.”
  • The New York Times reports,
    • The U.S. Food and Drug Administration has given the green light to two biotechnology companies for clinical trials that will transplant organs from genetically modified pigs into people with kidney failure. If successful, these studies could lead to the broader use of cross-species transplantation, a dream of medical scientists for centuries.
    • One of the companies, United Therapeutics Corporation, will begin its trial with six patients, but that number could eventually rise to 50. The other, eGenesis, said it would begin with three patients and grow the study from there.
    • “We are entering a transformative era in organ transplantation,” said Mike Curtis, the president and chief executive of eGenesis.
  • The Government Accountability Office released a report on food safety.
    • “Millions of Americans get sick from foodborne illness every year. While many cases are mild, some cases can result in hospitalization, long-lasting complications, or even death.
    • “In this Q&A, we reported that the safety and quality of the U.S. food supply is governed by at least 30 federal laws, collectively administered by 15 federal agencies. Federal agencies have developed some agency-specific and joint goals related to reducing foodborne illness, but most of these goals have not been met.
    • “A national food safety strategy could help ensure agencies are working together in an effective and efficient manner to reduce foodborne illness.”
  • AHIP offers for public download a report on Medicare Advantage Demographics. “The most recent demographic data [released last Friday January 31] show that MA continued to be a vital source of coverage for low-income Medicare enrollees and diverse populations.”

From the public health and medical research front,

  • The New York Times considers whether the “Bird Flu Could Become Airborne? Scientists were slow to recognize that Covid spreads through the air. Some are now trying to get ahead of the bird flu.”
  • BioPharma Dive adds, “Drugmakers prep for bird flu outbreak, despite continued low risk. While the virus hasn’t made a sustained leap into humans, vaccines and treatments are being developed ahead of an outbreak.”
  • The American Medical Association lets us know what doctors wish their patients knew about Alzheimer’s Disease.
  • The Washington Post informs us,
    • “Those who go hungry or worry about getting food while pregnant are at higher risk of complications such as preeclampsia and gestational diabetes, a new analysis suggests.
    • “The paper, published in JAMA Network Open, used data from an online health survey of more than 19,300 pregnant Kaiser Permanente Northern California members between June 2020 and September 2022. Researchers did not find similar risks among those who received food assistance while pregnant.”
  • Per MedPage Today,
    • “Just over half of patients with overweight or obesity discontinued their GLP-1 receptor agonist within 1 year, with rates even higher among the subset without type 2 diabetes, according to a retrospective cohort study.
    • “Among over 125,000 patients, 53.6% discontinued their GLP-1 receptor agonist by 1 year, and these rates were significantly higher for patients without versus with type 2 diabetes (64.8% vs 46.5%), reported Ezekiel J. Emanuel, MD, PhD, of the University of Pennsylvania in Philadelphia, and colleagues.
    • “Regardless of diabetes status, every 1% of body weight loss was tied to a 3% lower risk of discontinuation, they wrote in JAMA Network Open.
    • “Of the 41,792 patients who stopped treatment and had a weight measurement at discontinuation available, 47.3% and 36.3% of those with and without type 2 diabetes, respectively, restarted their GLP-1 agent at 1 year, and 57.3% and 46.4% restarted within 2 years. For every 1% of body weight regained after discontinuing treatment, there was a 2% to 3% increased hazard of restarting treatment.
    • “The high discontinuation rate did not come as much of a surprise, as prior studies have reported GLP-1 receptor agonist discontinuation rates of up to 81%, Emanuel’s group wrote. They added that the links between weight loss and discontinuation and between weight regain and reinitiation “suggest that weight management is an important factor regardless of type 2 diabetes status.”
  • Per BioPharma Dive,
    • “Adding Pfizer’s cancer drug Braftovi to standard treatments helped people with a form of colorectal cancer live longer without their disease worsening than those who got the typical care alone in a Phase 3 trial, the company said Monday.
    • “The result confirms earlier research from the study, called Breakwater, which had shown that trial volunteers receiving Braftovi were significantly more likely to see their tumors shrink or disappear. Those data were used to support an accelerated U.S. clearance for Braftovi in colorectal cancer in December.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us,
    • “Health supply chain costs and pharmaceutical expenses are projected to rise modestly between July 2025 and June 2026, according to new research from healthcare services company Vizient.
    • “Pharmacy spend will rise 3.8%, driven in part by increased demand for specialty medications. AbbVie’s autoimmune disease drug Humira will continue to be the most popular drug by total spend, however popular GLP-1s like Ozempic, Wegovy and Mounjaro are projected to enter the top-10 list of medications by total spend.
    • “Supply chain costs will rise by approximately 2% during the period, following higher prices for raw materials, increased freight and shipping costs and tariffs on medical-surgical products, according to the report.”
  • Fierce Healthcare adds,
    • “Moody’s Ratings is downgrading the insurance industry’s credit outlook to negative as elevated medical costs continue to batter payers.
    • “Moody’s analysts noted in a report that spending in the commercial market alone is set to increase by 8% this year, the fastest rate recorded in 13 years. Spending in the individual market, meanwhile, is set to climb by 7.5%, another increase that’s higher than in recent years.
    • “Factors driving these spending hikes include inflation, prescription drug spending and higher utilization of behavioral health. Based on those trends, Moody’s projects spending in Medicare Advantage (MA) will also increase by between 5% and 7%.
    • “We are changing our outlook on the health insurance sector to negative from stable,” the Moody’s analysts wrote. “Although we expect EBITDA growth to remain in the low single digits, insurers will continue to grapple with medical costs in excess of reimbursement rates for MA and Medicaid, while commercial coverage also faces continued high medical costs.
  • Per Healthcare Dive,
    • “Cigna has released a plan it says will make healthcare more affordable and accessible for its members — including tying executive compensation to customer satisfaction — as health insurers continue to reckon with discontent with their industry since the killing of a major insurance executive late last year.
    • Cigna plans to start linking bonus awards for high-level officers to the company’s net promoter score, a measure of customer loyalty and satisfaction, the Connecticut-based insurer said Monday.
    • “Cigna will also invest in more care advocates, pare back hurdles to receiving care and make it easier for doctors to update patients on the status of prior authorization requests. Cigna also plans to release an annual “customer transparency” report starting next year with information on its business practices, including data on prior authorization requests, appeals and denials.”
  • and
    • Bankrupt Prospect Medical Holdings said Friday it intends to sell Crozer Health, its four-hospital health system based in Pennsylvania, to an unnamed consortium of nonprofit healthcare operators.
    • Attorneys for Prospect said the proposed sale is the “only viable alternative to an immediate, forced shutdown of the Pennsylvania Hospitals” in documents filed in federal bankruptcy court on Friday.
    • Prospect will appear before the bankruptcy court on Thursday to seek approval for the transaction. As of Monday morning, the hospital operator had yet to file critical details about the sale to the court, including a proposed purchase price or the names of the possible buyers. However, a press release says the deal would include all Crozer hospitals, ambulatory surgery centers, clinics and physician offices.

Friday Report

From Washington, DC,

White House News

  • Per a White House fact sheet,
    • “ELIMINATING 10 REGULATIONS FOR EACH NEW REGULATION ISSUED: Today, President Donald J. Trump signed an Executive Order to unleash prosperity through deregulation. 
    • “The Order requires that whenever an agency promulgates a new rule, regulation, or guidance, it must identify at least 10 existing rules, regulations, or guidance documents to be repealed.  
    • “The Director of the Office of Management and Budget will ensure standardized measurement and estimation of regulatory costs.
    • “It requires that for fiscal year 2025, the total incremental cost of all new regulations, including repealed regulations, be significantly less than zero.'”
  • FEHBlog observation – The White House needs to turn its attention to subregulatory guidance.

Capitol Hill news

  • Modern Healthcare reports,
    • “Doctors and some bipartisan allies on Capitol Hill advanced their campaign to boost Medicare physician reimbursements with the release of new legislation Friday.
    • “The Medicare Patient Access and Practice Stabilization Act of 2025 would give doctors a 6.6% rate increase through 2026 and be retroactive to the beginning of this year, when a 2.9% cut took effect.” * * *
    • “The next government funding bill, which must pass by March 14 to prevent a partial shutdown, is an obvious vehicle. Supporters would likely have a greater chance getting Medicare physician reimbursements into that legislation than into a broader bill with many billions in healthcare cuts that Trump and GOP leaders are drafting on a partisan track.”
  • Per a Senate press release,
    • “U.S. Senate Democratic Whip Dick Durbin (D-IL) and U.S. Senator Chuck Grassley (R-IA), a senior member and former chairman of the Senate Finance Committee, today sent a letter to the President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA) urging them to embrace their bipartisan legislation, the Drug-price Transparency for Consumers (DTC) Act, to empower patients and providers and commit to voluntarily disclosing list prices in DTC advertisements. 
    • “The Senators wrote, “The United States is one of only two developed countries in the world that permits such pharmaceutical commercials. President Trump’s nominee for Health and Human Services Secretary has expressed interest in outright banning this practice. It would be wise for drug companies to adopt commonsense solutions to address the concerns that have been raised about DTC prescription drug advertising. As you are aware, the United States Senate previously voted unanimously to pass our measure to require that pharmaceutical companies disclose their list prices in DTC ads, and it is our hope that this policy will become law this Congress. This bipartisan legislation would ensure that when patients are bombarded with information about the newest wonder drug, the price is not kept secret. President Trump previously has issued regulations to advance this policy.” * * *
    • Full text of the letter is available here.

OPM News

  • OPM issued an addendum (FEHBlog Dropbox link) to its 2026 FEHB / PSHB call letter today which implements two of the President’s executive orders.
  • Federal News Network reports,
    • “Trump administration officials are taking major steps to cut down the size of the workforce and federal programs at the Office of Personnel Management.
    • “During an internal meeting Friday morning, Trump administration officials directed OPM senior career staff to begin making plans to cut the agency’s workforce and programs by 70%. Multiple sources with direct knowledge of the meeting confirmed the details of the meeting to Federal News Network.
    • “Sources who provided information to Federal News Network on the condition of anonymity said the political leadership at the agency also directed OPM leaders to stop work on anything that is not statutorily required.
    • “Trump administration officials told agency office leaders and associate directors at OPM to prepare briefs over the weekend detailing all of their work and programs that are statutorily required. By Monday, all OPM offices are expected to give political leaders organizational staffing charts with plans for an initial 30% reduction for both federal employees and contractors.”

Postal Service news

  • Federal News Network tells us
    • “The Postal Service’s regulator warns the next phase of a 10-year reform plan would slow mail delivery for a “significant portion of the nation,” but wouldn’t save USPS enough money to justify the changes.
    • “The Postal Regulatory Commission, in an advisory opinion on key parts of the USPS “Delivering for America” plan, found upcoming changes meant to cut billions of dollars each year wouldn’t do much to help the agency regain its long-term financial footing — but would lead to “disproportionate” cuts in service across rural communities.
    • “A PRC official told Federal News Network that nearly 40% of single-piece first-class mail — including letters and postcards — would see a service downgrade under these changes — and that the impact would be even greater in rural areas.
    • “The Commission urges the Postal Service to reconsider whether the speculative, meager gains from this proposal outweigh the certain downgrade in service for a significant portion of the nation,” the PRC wrote Friday.”

FDA News

  • MedPage Today informs us,
    • “The FDA approved an oral combination of meloxicam and rizatriptan (Symbravo) to treat adults with acute migraine with or without aura, Axsome Therapeutics announcedopens in a new tab or window.
    • “Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug (NSAID) and rizatriptan is a 5-HT 1B/1D agonist (triptan). The newly approved drug uses a proprietary technology called MoSEIC to increase meloxicam’s solubility and speed of absorption after the drug is taken orally while maintaining its extended plasma half-life.
    • “A significant proportion of migraine patients experience inadequate efficacy with currently available acute treatments, leading to even greater suffering, and an increased risk of worsening of migraine pain and attack frequency,” said Richard Lipton, MD, of Albert Einstein College of Medicine in New York City, in a statement. “Results of multiple clinical trials demonstrate that Symbravo can provide rapid and long-lasting freedom from migraine pain, whether treatment is taken early in the attack while the pain is mild, or later in the attack when the pain may be severe.”

From the public health and medical research front,

  • The Centers for Disease Control and Prevention announced today
    • “Seasonal influenza activity remains elevated and continues to increase across the country. COVID-19 activity is elevated in many areas of the country. RSV activity is declining in many areas of the country.
    • “COVID-19
      • “COVID-19 activity is elevated in many areas of the country. Though wastewater levels are high, emergency department visits are at low levels, and laboratory percent positivity was similar to last week. Emergency department visits and hospitalizations are highest in older adults and emergency department visits are also elevated in young children.
      • “There is still time to benefit from getting your recommended immunizations to reduce your risk of illness this season, especially severe illness and hospitalization.
      • “CDC expects the 2024-2025 COVID-19 vaccine to work well for currently circulating variants. There are many effective tools to prevent spreading COVID-19 or becoming seriously ill.
    • “Influenza
    • “RSV
      • “RSV activity remains elevated but is declining in many areas of the country. Emergency department visits and hospitalizations are highest in children and hospitalizations are elevated among older adults in some areas.
    • “Vaccination
      • “Vaccination coverage with influenza and COVID-19 vaccines are low among U.S. adults and children. Vaccination coverage with RSV vaccines remains low among U.S. adults. Many children and adults lack protection from respiratory virus infections provided by vaccines.
  • News supplementing the CDC report
    • Health Day notes,
      • “People still see COVID-19 as an ongoing public health threat, even though the pandemic officially ended in 2023, according to a new HealthDay/Harris Poll.
      • “Nearly 3 in 4 people (72%) agree COVID is still a serious public health issue, including more than a third (35%) who strongly agree, the poll found.
      • “COVID has settled into the sort of ongoing health threat already posed by the seasonal flu, which had its turn as a pandemic back in 1918, Dr. Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said.
      • “You’ll get hundreds of thousands of people hospitalized with influenza every year,” Offit told HealthDay TV. “You’ll get tens of thousands of people who die every year from influenza. I think that’s what COVID is now. I think this virus will be with us for decades, if not longer.”
    • The University of Minnesota’s CIDRAP lets us know
      • “The nation’s flu activity continued a steady rise last week, with 44 states at the high or very high level and that national test positivity just shy of 30%, the Centers for Disease Control and Prevention (CDC) said today in its weekly update.
      • “Outpatient visits for flulike illness have been above the national baseline for 9 weeks in a row. Of samples that tested positive for flu at public health labs, nearly all were influenza A, and subtyped influenza A samples were about evenly split between the H3N2 and 2009 H1N1 strains.
      • “On the CDC’s flu activity map, most of the country is awash in shades of red that reflect high or very high activity. However, some states are shaded purple, the highest level on the activity scale. They include Southeastern states such as Louisiana, South Carolina, and Tennessee, but also several in the Northeast, including Massachusetts, New Jersey, New York, and New Hampshire.
      • “The CDC reported 16 more pediatric flu deaths, which push the season’s total to 47. The deaths occurred between the middle of December and the week ending January 25. All involved influenza A, and, of 13 subtyped samples, 7 were H1N1 and 6 were H3N2. 
      • “For deaths overall, the level remained steady, with flu making up 1.6% of all deaths last week.
      • “Emergency department (ED) visits for flu are at the very high level and are increasing in all age-groups, making up 7% of all ED visits, the CDC said in its weekly respiratory virus snapshot. Meanwhile, hospitalizations for flu remain elevated and are likewise on the rise for all age-groups.”
  • Per STAT News,
    • “Researchers confirmed that antidepressants lead to a significant reduction in generalized anxiety
    • “The long-awaited update, published by the Cochrane Database of Systematic Reviews, considered by some to be the gold-standard of evidence-based health care, considered evidence from 37 unique randomized control trials with 12,226 participants and found that these drugs are effective compared to a placebo.
    • “The drugs’ long-term impacts are muddier, said Prof. Peter Tyrer, an emeritus psychiatry professor at Imperial College London who was not involved in the study. Some patients have difficulties stopping antidepressants because of withdrawal problems. 
    • “The main reason why antidepressants were preferred to benzodiazepines (drugs that are equally effective in treating generalised anxiety) was the dependence risk, we just seem to have shifted the problem of adverse effects from one class of drugs to another,” Tyrer said. 
  • and
    • “To create one of the most advanced immunotherapies in cancer, CAR-T cell therapies, scientists engineer immune T cells to carry a synthetic protein on their surfaces. This protein, called the chimeric antigen receptor or CAR, is what gives these engineered cells such potency against certain cancers and allows them to recognize and destroy malignant cells. In a new study, scientists have found that CAR-T cells are able to donate this synthetic protein to normal T cells, essentially arming other cells in the immune system with advanced technology to kill cancer.
    • “While this finding is fascinating scientists and cancer researchers, it’s not yet clear how sharing CARs between T cells might impact CAR-T therapy efficacy or influence the design of future synthetic receptors, experts told STAT. However, the work does reveal new biology around how T cells share proteins with one another and gives bioengineers some insights into how to manipulate that process.”

From the U.S. healthcare business front,

  • Beckers Payer Issues tells us,
    • “Aetna, Blue Shield of California and Centene’s Health Net have launched a shared, value-based payment model for reimbursing primary care physicians in California.
    • “The project, led by the California Quality Collaborative and the Integrated Healthcare Association, involves 11 providers across the state, covering about 17,000 patients. The single payment model went live on Jan. 1 and aims to address primary care reimbursement challenges, improve health equity, and boost health outcomes. The model focuses on small, independent practices and could eventually expand beyond California, according to a Jan. 30 news release.
    • “Instead of each health plan using its own payment system, the three insurers use a single, shared system that rewards physicians for providing high-quality care, especially among underserved populations. The CQC will help practices implement the new system, improve care coordination, and integrate mental and physical health services. A platform called Cozeva will provide data to help physicians track their performance and close care gaps.
    • “Participating providers are here. A full model guide is available here.
  • Kauffman Hall offers an infographic about the state of rural healthcare.
  • BioPharma Dive considers the following — “After decades of research, Vertex Pharmaceuticals has an approved pain medicine. Can one of the most powerful biotechs contend with a healthcare system that’s long favored opioids?” The FEHBlog hopes so.
  • Per Fierce Pharma,
    • “One of the most important launches for Novartis in recent years is off with a bang.
    • “Following a broad FDA approval for the adjuvant treatment of HR-positive, HER2-negative early breast cancer in September, Novartis’ Kisqali grew U.S. sales by 65% year over year—or nearly 25% sequentially—to $549 million in the fourth quarter of 2024.
    • “A Novartis presentation released on Friday shows that Kisqali’s new patient starts jumped from an average of around 1,500 per month before the approval to about 2,200 in both October and November. Data for December were not yet available.”
  • and
    • “Two years after AbbVie’s loss of market exclusivity for Humira, those “How it Started and How it’s Going” memes are looking better each quarter for the Illinois drugmaker.
    • “On Friday, when AbbVie reported its quarterly earnings, the pharma giant jacked up its 2027 projected sales of Humira follow-ons Skyrizi and Rinvoq to a combined $31 billion. It is a $4 billion increase on the company’s previous guidance for the immunology duo.
    • “Chief commercial officer Jeff Stewart explained that the projection increase has come because of growing “share capture.” Skyrizi now holds 40% of the total prescription share of the biologics psoriasis market, he said.
    • “Of the $4 billion adjustment to the 2027 projection, $2 billion has been added to Skyrizi’s estimate in inflammatory bowel disease (IBD) and $500 million has been added to Rinvoq’s in the same indication.  
    • “Across the board, we’re seeing tremendous performance, particularly in IBD,” Stewart explained.”

Midweek Update

From Washington, DC,

  • Per a CMS press release issued today,
    • “Lowering the cost of prescription drugs for Americans is a top priority of President Trump and his Administration. In accordance with the statutory requirements of the Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) released the list of 15 drugs selected for the second cycle of the Medicare Drug Price Negotiation Program on January 17, 2025. As the second cycle begins under the Trump Administration, CMS is committed to incorporating lessons learned to date from the program and to considering opportunities to bring greater transparency in the Negotiation Program. CMS intends to provide opportunities for stakeholders to provide specific ideas to improve the Negotiation Program, consistent with the goals of achieving greater value for beneficiaries and taxpayers and continuing to foster innovation.”
  • The American Hospital Association (AHA) News tells us,
    • The AHA Jan. 28 voiced support for bipartisan legislation to reauthorize for five years the Dr. Lorna Breen Health Care Provider Protection Act, which provides grants to help health care organizations offer behavioral health services for front-line health care workers. Introduced yesterday by Sens. Tim Kaine, D-Va., Roger Marshall, R-Kan., Jack Reed, D-R.I., and Todd Young, R-Ind., the bill also would reauthorize a national campaign that provides hospital leaders with evidence-based solutions to support worker well-being. 
  • Federal News Network informs us,
    • “A significant majority of federal employees who took a Federal News Network survey say they don’t plan on accepting the Office of Personnel Management’s offer to resign and go on paid administrative leave.
    • “In a survey of 4,619 federal employees, more than three-quarters of respondents said they don’t intend to accept the deal OPM sent to most civil federal workers in a mass email Tuesday afternoon.” * * *
    • “More than 500 respondents — about 11% of those who took the poll — said they intend to accept the deal.
    • “Among those who expect to accept the offer, 54% said they already had plans to retire from federal service soon or leave for a job outside the federal workforce.” * * *
    • “About 70% of respondents said they don’t have enough information from OPM to make their decision either way. Many said OPM hasn’t provided enough details on what accepting the deal would mean for their health and life insurance plans, or whether it would impact their pensions.”
  • ICD10 Monitor relates,
    • “The Centers for Medicare & Medicaid Services (CMS) have issued the display copy of the Final Rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare Advantage, or MA, and the Prescription Drug Plans) established by the Patient Protection and Affordable Care Act.
    • “The Final Rule became effective as of Jan. 1, 2025. The 60-day Refund Rule is included as part of the 3,000+-page 2025 Physician Fee Schedule Final Rule. 
    • “The federal Overpayment Statute requires any person who receives or retains Medicare or Medicaid funds to which they are entitled to report and return any overpayment to the appropriate government official or contractor within 60 days after “identification” of the overpayment, per Section 1128J(d) of the Social Security Act, 42 U.S.C. § 1320a-7k(d).
    • “Failure to report and return an “identified” overpayment in a timely manner could create a false claim situation subject to the False Claims Act (FCA). The False Claims Act, among other things, addresses individuals who knowingly conceal or avoid an obligation to pay or refund money to the federal government.”

From the public health and medical research front,

  • STAT News reports,
    • In July 2022, 988 launched as the number anyone across the country could dial in a mental health crisis. It’s one entryway to a sprawling system of mental health care options, but new research shows that since then, critical crisis services have not become more available — a key objective of the nationwide rollout, designed to strengthen an underfunded, patchwork system that left many people alone in times of crisis. 
    • While calls to the national hotline have continued to increase, fewer psychiatric facilities are offering emergency psychiatric walk-in services, mobile crisis response units, and suicide prevention services, according to a study published Wednesday in JAMA Psychiatry.
    • “988 isn’t going to reach its full potential until there’s a full system of crisis services in every single community,” said Hannah Wesolowski, chief advocacy officer at the National Alliance on Mental Illness.”
  • and
    • From plant-based chocolate milk to fizzy reduced-sugar drinks courtesy of Michelle Obama, the beverage market is always introducing new offerings to appeal to kids. But new dietary recommendations from several major health organizations say that children should really stick with drinking water and plain pasteurized milk.
    • The recommendations for children ages 5-18, released Wednesday, come from the Academy of Nutrition and Dietetics, the American Academy of Pediatric Dentistry, the American Academy of Pediatrics, and the American Heart Association. 
    • Their advice is in keeping with broader draft dietary guidelines created by an advisory committee to the U.S. government at the end of last year, which also said water should be the main thing that people of all ages drink. But the report is notable in carving out specific stances on the wide range of beverage options marketed to families, including plant-based milk and drinks containing non-sugar sweeteners. 
  • Per MedPage Today,
    • Fluctuating cholesterol levels were tied to higher dementia risks in a large study of older adults.
    • Relationships were seen for variability in both total cholesterol and LDL-C levels.
    • Links with dementia were independent of baseline values or whether trends were up or down.
  • Per Healio,
    • The addition of high-dose IV vitamin C to standard chemotherapy nearly doubled overall survival for patients with advanced pancreatic cancer, according to results of a randomized phase 2 trial.
    • Vitamin C also delayed the impact of adverse events and improved quality of life.
  • Per Medscape,
    • “Low-dose aspirin reduced colorectal cancer (CRC) recurrence rates by more than half in patients with tumors harboring mutations in the PI3K signaling pathway, according to findings from the phase 3 ALASCCA trial.
    • “These results stress “the importance of upfront genomic testing” in patients with CRC, said Anna Martling, MD, PhD, from Karolinska Institutet, Stockholm, Sweden, who reported the findings at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2025 in San Francisco.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “A big-business coalition is using hospital, insurer and employer healthcare cost information to help companies negotiate the price of services and coverage for employees.
    • “The Purchaser Business Group on Health will combine healthcare price transparency data and other information from providers and insurers with claims data from five large employers to analyze the cost and quality of care across 10 markets, the group said in a Wednesday news release.
    • “We are developing a new level of transparency and analysis that does not currently exist for the commercial market,” PBGH Chief Operating Officer Won Andersen said in the news release. “The project represents a pivotal step toward enhancing transparency and accountability in healthcare spending and purchasing.”
  • Beckers Payer Issues lets us know,
    • “Express Scripts, The Cigna Group’s pharmaceutical benefit manager, will implement new policies designed to prevent members from paying the full list price for drugs. 
    • “Most Express Scripts patients spend less than $100 out-of-pocket for their prescriptions each year, but some patients in high-deductible plans may pay the full list price for medications, according to a Jan. 29 news release. 
    • “Evernorth, Cigna’s health services arm, which manages Express Scripts, will shift its standard offerings to protect patients from paying the list price for medications. The company will also implement better predictability in drug pricing for patients, especially those in high deductible plans, according to the release.” 
  • Per Fierce Healthcare,
    • “Amazon One Medical continues to build out its health system partnerships to expand its network of primary care clinics.
    • “Montefiore Health System is now partnering with the company to open up access to primary and specialty care in New York’s Westchester County and surrounding areas.
    • “Amazon, which bought primary care company One Medical in a $3.9 billion deal in 2023, will open its first primary care offices in Westchester County in affiliation with Montefiore next year, the companies announced Wednesday.
    • “The primary care office will offer same and next-day appointment availability, on-site lab services and wraparound virtual care support for members, Amazon said.
    • “This new relationship will enable patients to have increased access to seamless coordinated care through Amazon One Medical’s innovative care model and Montefiore’s high-quality network of specialists, hospitals, and facilities.
    • ‘Montefiore and Amazon One Medical will determine where to open new facilities over the next several years, executives said.”
  • The Wall Street Journal observes,
    • If obesity is a chronic disease, like kidney or heart conditions, demand for GLP-1 drugs shouldn’t ebb and flow with the seasons. But the weight-loss market is far from typical.
    • After analyzing data going back to 2016, one analyst thinks he has identified a seasonal pattern in demand for drugs such as Eli Lilly’s LLY Zepbound and Novo Nordisk’s NOVO.B Wegovy: The drugs have stellar growth in initial sign-ups in the first half of the year followed by slower gains in the second half. 
    • This pattern resembles the cyclical nature of gym memberships rather than the steady trajectory of most pharmaceutical markets, and for good reason: At the start of the year, people often make resolutions to lose weight, exercise or start new diets. It stands to reason that some of these resolutions might also lead to increased demand for weight-loss prescriptions such as GLP-1 drugs.
    • If the logic is even half-right, it could help explain Eli Lilly’s back-to-back misses [in the second half of 2024] that have confounded Wall Street.
  • MedTech Dive offers “four robotic surgery trends to watch in 2025. Intuitive Surgical will face competition this year from Medtronic and smaller companies like CMR Surgical and Moon Surgical coming to the U.S. market with robotic surgery systems.”