MASSACHUSETTS GENERAL HOSPITAL

FDA approves Vyloy, a zolbetuximab drug targeting CLDN18.2 protein in HER2-negative gastric/GEJ adenocarcinoma, used with chemotherapy. Clinical trials show improved survival and progression-free periods. Common side effects include nausea, vomiting, and diarrhea.

NAM elected 90 regular and 10 international members, recognizing outstanding achievements in health and medicine. New members include Carlos L. Arteaga, Nina Bhardwaj, Bob S. Carter, Stephen Jacob Chanock, George Coukos, Lisa M. Coussens, Silvia C. Formenti, Joseph Heitman, Nola M. Hylton, Reshma Jagsi, Peter Anthony Jones, Funda Meric-Bernstam, Deborah Schrag, and Mitchell J. Weiss. Victor J. Dzau, NAM President, highlighted their contributions to health equity and public health challenges.

Alzamend Neuro identified the maximum tolerated dosage of AL001, a lithium therapy for Alzheimer’s and other disorders, which avoids intensive drug monitoring. AL001, a novel lithium formulation, was well-tolerated in a Phase 1/2 trial, with a maximum tolerated dose of 240 mg lithium carbonate equivalent taken three times daily. Alzamend plans to test this dose in five Phase 2 trials for Alzheimer’s, bipolar disorder, major depressive disorder, and PTSD, in partnership with Massachusetts General Hospital.

Blood tests for Alzheimer’s could provide easier, faster diagnosis, paving the way for earlier intervention and treatment. Several tests are under development, with some showing accuracy similar to cerebrospinal fluid tests. FDA approval for such tests is expected within the next 12 months, potentially leading to earlier detection and more effective treatments.

New research in JAMA Network Open finds no significant neurodevelopmental differences in children exposed to COVID-19 in the womb at 12, 18, and 24 months. However, an accompanying editorial cautions that definitive conclusions may be premature due to limitations in screening tools and conflicting studies.

The National Academy of Medicine elected 100 new members, including 12 with Harvard affiliations, recognizing their contributions in health and medicine.

Astellas Pharma's zolbetuximab, branded Vyloy, receives FDA approval for first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma expressing CLDN18.2, offering a new targeted therapy for HER2-negative cases. Vyloy, acquired from Ganymede Pharmaceuticals, demonstrated significant improvements in progression-free and overall survival in Phase 3 trials, with common side effects including nausea, vomiting, and decreased appetite.

FDA approves Astellas Pharma’s Vylov (zolbetuximab-clzb) with chemotherapy for HER2-negative, CLDN18.2-positive gastric or GEJ adenocarcinoma. Based on Phase III SPOTLIGHT and GLOW trials, Vylov showed significant improvements in PFS and OS. Common AEs included nausea, vomiting, and decreased appetite.

The FDA approved Astellas Pharma Inc.’s VYLOY (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma. VYLOY is the first CLDN18.2-targeted therapy in the U.S., approved based on Phase 3 SPOTLIGHT and GLOW trials showing improved progression-free and overall survival. Common side effects include nausea, vomiting, and decreased appetite.

Seer, Inc. presents advancements at HUPO 2024, showcasing the Proteograph™ Product Suite's capabilities in Alzheimer’s research, population-scale plasma analysis, immune dynamics in xenotransplantation, and more. The platform enables deep, unbiased proteomic data generation at unprecedented speed and scale, driving proteomic science adoption and expansion.