Daily Briefing

Around the nation: 6 deaths cause FDA to increase monitoring of new Alzheimer's drug


FDA is requiring patients taking the Alzheimer's drug Leqembi to undergo additional monitoring after routine pharmacovigilance identified six deaths early in the treatment, in today's bite-sized hospital and health industry news from Illinois, Maryland, and Texas.  

  • Illinois: Last month, the American Hospital Association (AHA) elected nine new members to its board of trustees. The members will serve three-year terms effective Jan. 1, 2026. Incoming members of AHA's board include: Debra Albert, CNO and SVP for patient care services at NYU Langone Health; Rob Allen, president and CEO of Intermountain Health; J.P. Gallagher, president and CEO of Endeavor Health; Leah Glasgo, president of UnityPoint Health; Melinda Hancock, EVP and CFO of Sentara Health; Michael Slubowski, president and CEO of Trinity Health; Pamela Sutton-Wallace, president of Yale New Haven Health; Erik Wexler, president and CEO of Providence St. Joseph Health; and Mason Van Houweling, CEO of University Medical Center. (AHA News, 8/7)
  • Maryland: FDA is requiring patients taking the Alzheimer's drug Leqembi to undergo additional MRI monitoring in their treatment after routine pharmacovigilance identified six deaths early in the treatment course. Previously, patients were required to receive MRIs approximately one week before their fifth, seventh, and 14th infusions of Leqembi. However, FDA recently identified six deaths early in the treatment course, which prompted the agency to conduct a detailed analysis of serious and fatal amyloid-related imaging abnormalities with edema (ARIA-E) outcomes before the fifth infusion. Among the six fatal cases, four of the patients developed symptoms after the third infusion, and one developed symptoms after the fourth infusion. "The four fatalities that occurred shortly following the third infusion suggest a developing process that was likely already present at the time of the infusion, given the severity of symptoms and relatively rapid onset after the third infusion," FDA said. Following the assessment, FDA called for Leqembi's prescribing information to now include MRI monitoring between the second and third doses, which could help identify patients who develop ARIA-E. (George, MedPage Today, 8/29)
  • Texas: A new Texas law regulating the use of EHRs and AI in patient care went into effect Sept. 1. Under Texas Senate Bill 1188, healthcare providers and other covered entities are required to store EHR data exclusively within the United States and limit access to individuals who are involved in treatment, payment, or healthcare operations. The law also requires covered entities to ensure parents and legal guardians have immediate access to a minor's health records unless restricted by a court order or law. The law requires healthcare providers to disclose the use of AI to patients if it is being used for diagnosis and treatment recommendations, as well as manually review any AI-generated clinical information for accuracy. Other provisions in the law include prohibiting credit scores or voter registration status from being included in medical records and establishing strict guidelines on how biological sex is documented and amended in the EHR. Affected entities are required to implement the data storage provisions by Jan. 1, 2026. Any violations may result in civil penalties between $5,000 and $250,000 depending on severity and intent. (Jeffries, Becker's Health IT, 9/2)

Top drivers of change in the neurodegenerative disease market

As occurrence of neurodegenerative disease in the U.S. has increased, advances in medicine have expanded the outlook for diagnosing, treating, and curing these diseases. We've identified four key drivers that are changing the treatment prospect and delivery of care for patients with neurodegenerative diseases.  


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