April 2024
Bristol Myers-backed TORL Raises $158M to Advance Antibody-Drug Conjugates (ADCs) in Clinical Trials
Bristol Myers Squibb, TORL, $158M funding, Antibody-Drug Conjugates (ADCs), Clinical Trials
EMA Dispels Link Between GLP-1 Receptor Agonists and Suicidal Ideation Risk New
EMA, GLP-1 receptor agonists, Diabetes and weight-loss drugs, Suicidal ideation risk, No causal association, Pharmacovigilance activities, Continued monitoring
FDA Approves BrainStorm’s Phase IIIb Trial Design for NurOwn in Early-Stage ALS
BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)
FDA Oncology Chief Emphasizes Equitable Standards in Confirmatory Trial Rejections at AACR24
AACR24, FDA Oncology Chief, Richard Pazdur, Confirmatory Trial Rejection, Level Playing Field, Project
AstraZeneca and Daiichi Sankyo’s Enhertu Wins Historic FDA Approval as First Tumor-Agnostic HER2-Directed Therapy
Enhertu, AstraZeneca, Daiichi Sankyo, FDA Approval, Tumor-Agnostic, HER2-Directed Therapy, Metastatic HER2-Positive Solid Tumors, Accelerated Approval, DESTINY-PanTumor02 Study, Objective Response Rate (ORR), Duration of Response (DoR)
AstraZeneca’s Lynparza Demonstrates Nearly 50% Response in Advanced Breast Cancer Patients: #AACR24 Update
AstraZeneca, Lynparza (olaparib), PARP inhibitor, Advanced breast cancer, 50% response rate, AACR24
AstraZeneca’s Imfinzi Demonstrates Survival Benefit in Limited-Stage Small Cell Lung Cancer Study
AstraZeneca, Imfinzi (durvalumab), Small Cell Lung Cancer (SCLC), Limited-stage SCLC, ADRIATIC Phase III study, Overall Survival (OS), Progression-Free Survival (PFS), Immunotherapy
Enhanced Optimization for Influenza B Strains Planned in CureVac’s mRNA Seasonal Flu Vaccine Trials
CureVac, mRNA flu vaccine, Influenza B strains, Targeted optimization, Phase 2 studies, Multivalent candidate, Improved immune response, Collaboration with GSK
Expansion of Pluvicto Use Sought by Novartis Following Positive Prostate Cancer Study Update
Novartis, Pluvicto, Broader use, Prostate cancer, PSMAfore trial, Radiographic progression-free survival (rPFS), Metastatic castration-resistant prostate cancer (mCRPC)
Sanofi Settles 4,000 Zantac Cancer Lawsuits, Faces Delaware Claims
Sanofi, Zantac, Cancer Lawsuits, Settlement, Delaware Claims, 4/000 Lawsuits, Delaware Superior Court, Daubert Ruling