ORG
Novartis Announces 680 Layoffs in Development Group Amid Corporate Restructuring
Novartis, Layoffs, Development Group, Corporate Restructuring, 680 Jobs, Switzerland, United States, Pharmaceutical Industry
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)
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)
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
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
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
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
Merck KGaA Partners with AI Techbio Caris Discovery for ADC Discovery, Up to $1.4 Billion in Milestones
Merck KGaA, AI techbio, Caris Discovery, Antibody-Drug Conjugates (ADC), $1.4 billion milestones, ADC discovery deal
Delaware Judge Rules in Favor of Roivant Subsidiary Arbutus in COVID-19 Vaccine Patent Dispute with Moderna
Moderna, Arbutus Biopharma, Roivant Sciences, COVID-19 vaccine, Patent infringement, Judge Mitchell Goldberg, Lipid nanoparticles (LNP), Claim construction order
Basilea Secures FDA Approval for Zevtera to Treat Three Types of Bacterial Infections
Basilea Pharmaceutica, Zevtera (ceftobiprole), FDA approval, Acute bacterial skin and skin structure infections (ABSSSI), Staphylococcus aureus bacteremia (SAB), Community-acquired bacterial pneumonia (CABP), Qualified Infectious Disease Product (QIDP) status, Priority Review/ Fast Track/ and QIDP designations, Ten years of exclusivity in the US