MASSACHUSETTS GENERAL HOSPITAL

Zolbetuximab-clzb (Vyloy; Astellas Pharma Inc) received FDA approval for treating locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2-positive tumors. Based on phase 3 SPOTLIGHT and GLOW trials, zolbetuximab-clzb demonstrated progression-free survival benefits in combination with chemotherapy regimens. This marks the first CLDN18.2-targeted therapy for this patient population.

FDA approves zolbetuximab-clzb (Vyloy) with chemotherapy for first-line treatment of HER2-negative, Claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma. Data from SPOTLIGHT and GLOW trials showed improved progression-free and overall survival.

Astellas announces FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction cancer, based on SPOTLIGHT and GLOW trials. VYLOY is the first CLDN18.2-targeted therapy in the U.S.

A study suggests Ozempic and similar weight-loss drugs may reduce overdose and alcohol intoxication risks in substance abuse patients, though not yet FDA-approved for this use.

UniQure has dosed the first patient in its phase 1/2 EPISOD1 trial, evaluating AMT-162, an AAV vector-based gene therapy for SOD1-ALS. AMT-162 uses a miRNA to silence the disease-causing SOD1 gene, delivered via an AAVrh10 vector. The open-label, multicenter study in the US focuses on safety and efficacy, with 4 active sites and plans to activate 7 more by Q1 next year. UniQure also develops AMT-260 for temporal lobe epilepsy, with preclinical data showing potential for a good risk-benefit ratio.

Onyda XR, a liquid non-stimulant ADHD medication, became available nationwide on October 1. FDA approved it on May 24 for pediatric patients aged 6 and older, either as monotherapy or adjunctive therapy to CNS stimulants. Developed by Tris Pharma using LiquiXR® technology, Onyda XR is a centrally acting alpha2-adrenergic agonist, similar to Guanfacine and clonidine. Non-stimulant medications like Onyda XR are nearly as effective as stimulants in improving executive function, according to a May meta-analysis. Combination therapy with stimulants is increasingly popular for extended symptom coverage and reduced side effects.

GITEX GLOBAL's GITEX DIGI_HEALTH 5.0 Dubai showcased AI-driven health tech solutions, aligning with UAE's digital health market growth to $487.30 million. Focus areas included AI in healthcare, robotics, genomics, and neurology advancements, with innovations like smart contact lenses and AI-powered clinical assistants. The event also announced GITEX DIGI_HEALTH 5.0 Expo-Summit in Thailand in 2025.

A collaboration between NIAID and MGH demonstrates adenine base editors' potential to correct X-CGD mutations in stem cells, leading to a first-in-human clinical trial for the disease.

Lumicell Direct Visualization System, developed by Barbara L. Smith and Ralph Weissleder, received FDA approval in 2024 for real-time lumpectomy margin assessment, reducing the need for second surgeries and improving cancer resection accuracy.

Alzamend Neuro (Nasdaq: ALZN) regained compliance with Nasdaq's $2,500,000 minimum stockholders' equity requirement after securing a $25 million securities purchase agreement for Series A Convertible Preferred Stock, with $8 million already purchased. CEO Stephan Jackman reaffirmed plans to initiate five phase II clinical trials of AL001 in 2025 in partnership with Massachusetts General Hospital.