Quantitative Concept – Page 53

FDA Launches CDER Center for Clinical Trial Innovation (C3TI) to Boost Trial Design and Efficiency

2 years ago talkbio0Tagged C3TI, Center for Drug Evaluation, Center for Drug Evaluation and Research, Clinical Trial Innovation, Clinical Trials, Collaboration, Drug Development, Efficiency, innovation, research, United States Food and Drug Administration

FDA, CDER (Center for Drug Evaluation and Research), C3TI (CDER Center for Clinical Trial Innovation), Clinical trial innovation, Efficiency, Drug development, Trial design, Collaboration

Boehringer Ingelheim Leverages Late-Stage Pipeline for 25 New Launches over the Next Decade

2 years ago talkbio0Tagged Administration occupational activities, approvals, boehringer ingelheim, Decade, expansion, Heart failure, Jardiance, late-stage pipeline, launches, pipeline, reshuffle

Boehringer Ingelheim, Late-stage pipeline, 25 new launches, Decade, Jardiance, Heart failure approvals, Ofev, Pipeline expansion, Management reshuffle

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

2 years 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)

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

2 years 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

Diagonal Therapeutics Secures $128 Million Series A Funding through Innovative Antibody Agonists

2 years ago talkbio0Tagged Antibody agonism, Cells, Diagonal, Funding, Rare Diseases, switches

Diagonal Therapeutics, Series A funding, Antibody agonism, Cellular “on” switches, Rare diseases

Gritstone Cancer Vaccine Trial Misses Primary Endpoint, Stock Plummets

2 years ago talkbio0Tagged Circulating, Circulating Tumor DNA, Colorectal Carcinoma, Gritstone, Personalized Neoantigen Cancer Vaccine, Phase 2 Clinical Trials, Progression-Free Survival, Stock Market Reaction

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

2 years ago talkbio0Tagged Accelerated Approval, adagrasib, Approved, bristol-myers, Clinical Benefit, Confirmatory Trial, Continuous, June 21/ 2024, KRASG12C mutation, KRAZATI, KRYSTAL-12, Locally, Metastatic to, Non-Small Cell Lung Carcinoma, ORR, Overall response rate, PDUFA, Primary Endpoint, Progression-Free Survival, squibb, United States Food and Drug Administration, Verification of Theories

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

Medicare Coverage Gap Linked to Reduced Prescription Rates for GLP-1 Weight Loss Drugs

2 years ago talkbio0Tagged Glucagon-Like Peptide 1, Health Care Costs, liraglutide, Lower prescription rates, Medicare, Mounjaro, Obesity, Saxenda, semaglutide, tirzepatide, Truveta study, Wegovy

GLP-1 drugs, Medicare coverage gap, Lower prescription rates, Obesity treatment, Semaglutide (Wegovy), Tirzepatide (Mounjaro), Liraglutide (Saxenda), Healthcare costs, Truveta study