Pharmaceutical companies required to update prescribing information for chimeric antigen receptor (CAR) T-cell therapies; Texas dashboard reports a 40% increase in pediatric flu cases; a blood test shows high accuracy for Alzheimer disease biomarkers.
The FDA has directed pharmaceutical companies, such as Gilead Sciences, Johnson & Johnson, and Novartis, to incorporate a boxed warning in the prescribing information for chimeric antigen receptor (CAR) T-cell cancer therapies, according to Reuters. This decision follows reports of patients developing T-cell malignancies, including lymphoma and leukemia, after receiving CAR T treatments. While Novartis has confirmed the update for its CAR T-cell therapy tisagenlecleucel (Kymriah), other pharmaceutical companies are evaluating next steps for their respective therapies amid concerns raised by the FDA regarding the risks of T-cell malignancy associated with these cancer treatments.
The Texas Department of State Health Services has introduced a new dashboard providing real time and historical data on respiratory virus cases, focusing on the flu, respiratory syncytial virus (RSV), and COVID-19, according to CBS News. For instance, the Children's Health system in North Texas has experienced a concerning 40% rise in flu cases among children in clinics, doctor's offices, and emergency departments. The CDC reported that only 46.9% of children have received their flu vaccine this season, a figure significantly below the normal rate. While the Children's Health data show that COVID-19 and RSV cases in children are on the decline, health officials are closely monitoring the situation.
A groundbreaking study suggests that testing blood for the protein phosphorylated tau (p-tau) could provide a highly accurate screening method for Alzheimer disease, even before symptoms manifest, according to CNN. The research focused on the biomarker p-tau217, demonstrating up to 96% accuracy in identifying elevated beta amyloid levels and up to 97% accuracy in detecting tau, crucial indicators of Alzheimer disease pathology. The blood test, known as the ALZpath pTau217 assay, may offer a cost-effective and accessible alternative to current diagnostic methods, providing an opportunity for early intervention and personalized patient management.
Health Equity & Access Weekly Roundup: November 23, 2024
November 23rd 2024Americans are underinsured, even with employer-based health plans; a thorough critique of the lack of representation among Black patients in clinical trials showcases a persistent theme; systemic barriers in cardiology, breast cancer, and patent systems are examined.
Read More
FDA Accepts Resubmitted NDA for Ataluren in Nonsense Duchenne Muscular Dystrophy
November 22nd 2024The new drug application (NDA) includes data from a global placebo-controlled, 72-week study as well as findings from the STRIDE registry, an ongoing, observational, real-world study of ataluren in routine care.
Read More