Uncategorized – Page 346

FDA Approves BrainStorm’s Phase IIIb Trial Design for NurOwn in Early-Stage ALS

1 year ago talkbio0Tagged Agreement, Amyotrophic Lateral Sclerosis, BrainStorm Cell Therapeutics, Early-stage, NurOwn, SPA, Special Protocol Assessment, Trial Phase 3B, United States Food and Drug Administration

BrainStorm Cell Therapeutics, NurOwn, Phase IIIb trial, Special Protocol Assessment (SPA), FDA agreement, Early-stage ALS, Amyotrophic Lateral Sclerosis (ALS)

EMA Dispels Link Between GLP-1 Receptor Agonists and Suicidal Ideation Risk New

1 year ago talkbio0Tagged agonists, Continuous, Diabetes, Glucagon-Like Peptide-1 Receptor, Mental association, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, pharmacovigilance activities, Preventive monitoring, Suicidal ideation risk, Weight-Loss Agents

EMA, GLP-1 receptor agonists, Diabetes and weight-loss drugs, Suicidal ideation risk, No causal association, Pharmacovigilance activities, Continued monitoring

AstraZeneca and Daiichi Sankyo’s Enhertu Wins Historic FDA Approval as First Tumor-Agnostic HER2-Directed Therapy

1 year ago talkbio0Tagged Accelerated Approval, Approved, AstraZeneca, Daiichi Sankyo, DESTINY-PanTumor02 Study, Enhertu, HER2-directed therapy, Metastatic HER2-Positive Solid Tumors, Objective Response Rate, ORR, Response Duration, tumor-agnostic, United States Food and Drug Administration

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)

FDA Oncology Chief Emphasizes Equitable Standards in Confirmatory Trial Rejections at AACR24

1 year ago talkbio0Tagged AACR24, Confirmatory Trial Rejection, Level Playing Field, Oncology Chief, Pazdur, Project, United States Food and Drug Administration

AACR24, FDA Oncology Chief, Richard Pazdur, Confirmatory Trial Rejection, Level Playing Field, Project

AstraZeneca’s Lynparza Demonstrates Nearly 50% Response in Advanced Breast Cancer Patients: #AACR24 Update

1 year ago talkbio0Tagged 50, AACR24, advanced breast cancer, AstraZeneca, Frequency of Responses, Inhibitor, Lynparza, olaparib, PARP1 gene

AstraZeneca, Lynparza (olaparib), PARP inhibitor, Advanced breast cancer, 50% response rate, AACR24

Expansion of Pluvicto Use Sought by Novartis Following Positive Prostate Cancer Study Update

1 year ago talkbio0Tagged Malignant neoplasm of prostate, Metastatic castration-resistant prostate cancer, Novartis, Pluvicto, Progression-Free Survival, PSMAfore trial, Radiographic, rPFS

Novartis, Pluvicto, Broader use, Prostate cancer, PSMAfore trial, Radiographic progression-free survival (rPFS), Metastatic castration-resistant prostate cancer (mCRPC)

Enhanced Optimization for Influenza B Strains Planned in CureVac’s mRNA Seasonal Flu Vaccine Trials

1 year ago talkbio0Tagged cellular targeting, Collaboration, CureVac, Immune response, Improved, influenza B strains, mRNA flu, Optimization, Vaccines

CureVac, mRNA flu vaccine, Influenza B strains, Targeted optimization, Phase 2 studies, Multivalent candidate, Improved immune response, Collaboration with GSK

AstraZeneca’s Imfinzi Demonstrates Survival Benefit in Limited-Stage Small Cell Lung Cancer Study

1 year ago talkbio0Tagged ADRIATIC, AstraZeneca, durvalumab, Imfinzi, Immunotherapy, Limited-stage SCLC, Overall Survival, Phase 3 Clinical Trials, Progression-Free Survival, Small cell carcinoma of lung

AstraZeneca, Imfinzi (durvalumab), Small Cell Lung Cancer (SCLC), Limited-stage SCLC, ADRIATIC Phase III study, Overall Survival (OS), Progression-Free Survival (PFS), Immunotherapy