Monday Report

David Ermer–Uncategorized–
Photo by Sven Read on Unsplash

From Washington DC,

  • Roll Call discusses events occurring on Capitol Hill this week.
  • STAT News reports,
    • “Marty Makary, President Trump’s pick to be Food and Drug Administration commissioner, promised to step down as an adviser to various health tech, medical device, and telehealth startups if confirmed, and to sell off stock holdings in the companies as well, according to financial disclosures filed ahead of his confirmation hearing. 
    • “According to the disclosures, Makary does not hold stock in any large pharmaceutical companies, unlike some previous FDA commissioners, including the last individual to hold that office, Robert Califf. Makary’s financial ties include holdings in a telehealth company that sells compounded drugs, a clinical stage company developing drugs for tissue injury, and a medical device company focused on cataract surgery.” 
  • Govexec lets us know,
    • “Some federal agencies are continuing to fire their recently hired or newly promoted staff despite a court ruling that deemed the justification for those firings unlawful, while others are responding to that decision by rehiring those they had already terminated. 
    • “A federal judge last week said the Trump administration—through the Office of Personnel Managment—directing the mass firings of employees on their probationary periods was illegal, though the judge did not directly call for the terminations to cease or for agencies to recall those they had already let go. The ruling applied to only a handful of agencies whose employees were party to the case brought by the American Federation of Government Employees and other groups.”
  • Here’s a Dropbox link to the Court decision issued last Friday.  
  • Per a press release,
    • The Institute for Clinical and Economic Review (ICER) today posted a Special Report evaluating the evidence of two Chronic Obstructive Pulmonary Disease (COPD) treatments, Trelegy Ellipta® and Breo Ellipta®, that will be sent as its public comment submission to Centers for Medicare & Medicaid Services (CMS) as part of its work on Medicare drug price negotiations. Both of the inhaler therapies were developed by GSK.
    • Downloads: Final Report 
    • “Over 15 million people in the United States suffer from COPD. Our special report focuses on the medical evidence and value of these two inhalers, specifically for COPD,” said ICER’s President and CEO Sarah K. Emond, MPP. “We recognize that our report will be one of many inputs CMS may consider, and we hope that it will help them as they continue to build a reliable, value-based, transparent drug price negotiation process on behalf of the American people.”
  • Per Fierce Pharma,
    • “Over nearly the last three decades, Genentech has had the lone medicine on the market for the acute treatment of stroke. Monday, the Roche subsidiary added a second stroke treatment to its repertoire, gaining an FDA endorsement for TNKase (tenecteplase).
    • “The tissue plasminogen activator, clot-dissolving, thrombolytic medicine has been approved for adults with acute ischemic stroke (AIS). TNKase can be shot into the arm in five seconds, making it a faster treatment option compared to its forerunner, Activase (alteplase), which was approved for heart attack in 1987 and for stroke in 1996. Activase is administered as an IV bolus followed by a 60-minute infusion.
    • “TNKase is not a new treatment. It was approved in 2000 to reduce the risk of death from heart attack—acute ST elevation myocardial infarction—which is what happens when a coronary artery is completely blocked.
    • “Today’s approval is a significant step forward and underscores our commitment to advancing stroke treatment options for patients,” Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of global product development, said in a statement. “TNKase provides a faster and simpler administration, which can be critical for anyone who is dealing with an acute stroke.”

From the public health and medical research front,

  • The American Medical Association lets us know what doctors wish their patients knew about atrial fibrillation.
  • The Wall Street Journal reports,
    • “Emulsifiers, used to improve food texture, have been linked to health risks such as heart disease, Type 2 diabetes, and some cancers.
    • “Research suggests that emulsifiers alter the gut microbiome, leading to inflammation and potentially contributing to chronic diseases.
    • “Consumers can reduce the potential health risks of emulsifiers by avoiding ultra-processed foods and opting for certain natural emulsifiers like soy lecithin over synthetic ones like carboxymethylcellulose.”
  • Per an NIH news release,
    • “A clinical trial has found that the medication omalizumab, marketed as Xolair, treated multi-food allergy more effectively than oral immunotherapy (OIT) in people with allergic reactions to very small amounts of common food allergens. OIT, the most common approach to treating food allergy in the United States, involves eating gradually increasing doses of a food allergen to reduce the allergic response to it. Thirty-six percent of study participants who received an extended course of omalizumab could tolerate 2 grams or more of peanut protein, or about eight peanuts, and two other food allergens by the end of the treatment period, but only 19% of participants who received multi-food OIT could do so. Researchers attributed this difference primarily to the high rate of allergic reactions and other intolerable side effects among the participants who received OIT, leading a quarter of them to discontinue treatment. When the participants who discontinued therapy were excluded from the analysis, however, the same proportion of each group could tolerate at least 2 grams of all three food allergens.
    • ‘The findings were published in an online supplement to The Journal of Allergy and Clinical Immunology and presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress in San Diego on Sunday, March 2, 2025.
    • “People with highly sensitive multi-food allergy previously had only one treatment option—oral immunotherapy—for reducing their allergic response to moderate amounts of those foods,” said Jeanne Marrazzo, M.D., M.P.H., director of NIH’s National Institute of Allergy and Infectious Diseases (NIAID), the study’s funder and regulatory sponsor. “This study shows that omalizumab is a good alternative because most people tolerate it very well. Oral immunotherapy remains an effective option if treatment-related adverse effects are not an issue.”
  • Per Health Day,
    • “Many young women entering menopause suffer needlessly from symptoms related to the transition, a new study suggests.
    • “More than half of women aged 30 to 35 have already developed moderate to severe symptoms of impending menopause, researchers found.
    • “These include mood swings, delayed or absent periods, hot flashes, vaginal dryness, painful sex, heart palpitations and frequent urination.
    • “Unfortunately, most wait decades before seeking treatment, under the mistaken belief that menopause symptoms that shouldn’t appear until their 50s, researchers said.”
  • NFP adds,
    • “Mayo Clinic research reveals that menopause-related symptoms cost an estimated $1.8 billion in lost work time annually in the US, with total costs reaching $26.6 billion when medical expenses are included.
    • “Understanding how menopause affects women in the workplace has become crucial, as the study found that 13% of women experienced adverse work outcomes related to menopause symptoms, with 11% missing workdays specifically due to these symptoms. 
    • “Despite affecting approximately 17.5% of the US workforce, menopause in the workplace remains one of the most overlooked aspects of workplace health policy. With substantial financial implications, this oversight of menopause employee benefits is no longer sustainable in today’s competitive talent market.”
  • Per Fierce Pharma,
    • “AstraZeneca and Daiichi Sankyo’s Enhertu has become the first HER2-directed drug to mount a patient survival benefit in a randomized clinical trial in second-line metastatic stomach cancer, the partners said on Monday.
    • “Enhertu significantly extended the lives of patients with previously treated HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma in the phase 3 Destiny-Gastric04 study, according to the partners’ press release. For the study, investigators pitted the HER2-targeted antibody-drug conjugate against Eli Lilly’s VEGFR inhibitor Cyramza and chemotherapy.
    • “An independent data monitoring committee noted the “statistically significant and clinically meaningful” overall survival improvement during a planned interim analysis and recommended unblinding the trial, the companies said Monday. 
    • ‘The latest trial win won’t affect Enhertu’s regulatory status in the U.S. Back in 2021, the FDA approved Enhertu in stomach cancer following prior treatment with a trastuzumab (Herceptin)-based regimen. That second-line nod was based on results from the phase 2 Destiny-Gastric01 trial in a third-line setting, which showed that Enhertu reduced the risk of death by 41% versus chemotherapy alone.”
  • and
    • “Already billed as a potential blockbuster, Amgen and AstraZeneca’s Tezspire has turned in strong clinical data in chronic rhinosinusitis with nasal polyps (CRSwNP). 
    • “Tezspire showed numerically better efficacy results in CRSwNP compared with two prominent rivals in the three drugs’ separate studies. However, separate teams of analysts at William Blair and Leerink Partners stopped short of handing Tezspire the crown in the indication, citing trial design differences that likely play into the cross-trial comparisons.
    • “As Amgen and AZ previously announced, Tezspire significantly improved total nasal polyp score (NPS) and nasal congestion score (NCS) in patients with CRSwNP compared with placebo after 52 weeks in the phase 3 Waypoint study.”

From the U.S. healthcare business front,

  • Fierce Healthcare announced its Fierce 15 [healthcare innovators] of 2025.
  • BioPharma Dive informs us,
    • “AbbVie is joining the industry’s rush to develop new obesity medicines, announcing Monday a deal with Denmark-based Gubra to license a drug that could compete with experimental therapies being developed by Novo Nordisk, Eli Lilly and Zealand Pharma.
    • “Per deal terms, AbbVie will pay Gubra $350 million up front and offer up to $1.9 billion in additional payments tied to the achievement of development and sales milestones. AbbVie will assume responsibility for development and commercialization.
    • “Gubra is developing a type of drug called an amylin analog that regulates appetite and blood sugar levels. If successful, these drugs could be used as alternatives to or in combination with marketed drugs like Novo’s Wegovy and Lilly’s Zepbound to increase weight loss or reduce side effects.”
  • Modern Healthcare reports,
    • “UnitedHealth Group is taking another step to refine its prior authorization requirements as it continues to face public frustration.
    • “The healthcare giant’s insurance business, UnitedHealthcare, plans to cut nearly 10% of prior authorizations this year, the company said in a notice Saturday.
    • “As part of the initiative, the insurer said it will remove pre-approval requirements for home health services managed by its home and community division. The changes will apply to Medicare Advantage and dual special needs plans in 36 states and Washington, D.C., starting April 1.”
  • and
    • “Mayo Clinic is investing nearly $1.9 billion in its Phoenix campus as part of the Bold. Forward. Unbound. strategy being implemented across the system’s multistate footprint.
    • “The project covers 1.2 million square feet, including a new procedural building, an expanded specialty care building, 11 new operating rooms and two new patient units that support 48 beds, according to a Monday news release.
    • “A two-story indoor promenade will wrap around the front of the campus, and complementary clinical services will be clustered together in so-called care neighborhoods, according to the release. Mayo Clinic is starting the design phase this year and expects to complete the project in 2031.
    • “The project will increase the campus’ clinical space by nearly 60%, Dr. Richard Gray, CEO of Mayo Clinic in Arizona, said in the release.”
  • Beckers Hospital Review offers an interesting interview. Here’s the background:
    • “Since 2021, St. Louis-based Ascension has reduced risk-adjusted mortality by more than 20% across 88 hospitals through its Recognize and Rescue initiative, a systemwide effort to support care teams in identifying high-risk conditions and intervening quickly to prevent clinical deterioration. 
    • “Over a three-year period, the program prevented more than 4,000 deaths, outpacing a group of nearly 1,100 peer hospitals by 12%, according to findings recently published in The Joint Commission Journal on Quality and Patient Safety.
    • “This is an incredible achievement for Ascension,” Mohamed Fakih, MD, Ascension’s chief quality officer, said. 
    • “Becker’s recently spoke to Dr. Fakih to learn more about how the health system implemented Recognize and Rescue, what made it successful and how its structure can be applied to other quality initiatives.”