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.
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