Research Activity
FDA Launches CDER Center for Clinical Trial Innovation (C3TI) to Boost Trial Design and Efficiency
FDA, CDER (Center for Drug Evaluation and Research), C3TI (CDER Center for Clinical Trial Innovation), Clinical trial innovation, Efficiency, Drug development, Trial design, Collaboration
Neumora’s Schizophrenia Drug Study Halted by FDA Due to Preclinical Safety Signals
Neumora Therapeutics, Schizophrenia drug study, NMRA-266, Preclinical safety signals, Convulsions in rabbits, Clinical hold, Phase I trial
Enlivex Stock Plunges 50% Following Mixed Phase II Sepsis Results for Allocetra Cell Therapy
Enlivex Therapeutics, Allocetra Cell Therapy, Phase II Study, Sepsis Treatment, Stock Plummet, Mixed Results, Septic Shock, Urinary Tract Infection (UTI)
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
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’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
Diagonal Therapeutics Secures $128 Million Funding to Target Rare Diseases
Diagonal Therapeutics, Antibody biotech, $128 million funding, Rare diseases focus, Orphan disease treatment, Chronic anemia, Merck’s Winrevair related research, Blue-chip investors
Gritstone Cancer Vaccine Trial Misses Primary Endpoint, Stock Plummets
Gritstone, Personalized Neoantigen Cancer Vaccine, Colorectal Cancer, Phase 2 Study Failure, Circulating Tumor DNA (ctDNA), Progression-Free Survival (PFS), Stock Market Reaction
Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval
Bristol Myers Squibb, KRAZATI (adagrasib), Pivotal Phase 3 trial, KRYSTAL-12 study, Primary endpoint met, Progression-free survival (PFS), Overall response rate (ORR), Confirmatory trial, Non-small cell lung cancer (NSCLC), Locally advanced or metastatic, KRASG12C mutation, Accelerated approval, Continued approval contingent on clinical benefit verification, FDA assigned PDUFA goal date of June 21/ 2024
Pfizer Discontinues Phase III Trial for Sickle Cell Treatment Amid Challenges in Patient Recruitment
Pfizer, Sickle Cell Disease, Phase III Study, Inclacumab, Poor Accrual, Recruitment Challenges, THRIVE Program, ClinicalTrials.gov, Gene Therapies