April 1, 2024 – Talk Bio

Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges

1 year ago talkbio0Tagged Bankruptcy, Biological Factors, Chapter 11, Assets Sale, development aspects, Eiger, Infrequent, Metabolic Disease Therapy, Operational Wind Down

Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development

Bristol Myers Squibb’s KRAZATI Confirmed Effective in Pivotal Phase 3 KRYSTAL-12 Trial Following Accelerated Approval

1 year 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

Carisma Therapeutics to Lay Off Staff, Discontinue CAR-M Programs in Pursuit of Second Candidate

1 year ago talkbio0Tagged 37%, anti-HER2, Anti-mesothelin, Autologous Anti-HER2 CAR Macrophages CT-0508, CAR-macrophage, CAR-monocyte, Carisma, clinical CAR-M program, CT-1119, Dropping, layoffs, second, Workforce reduction

Carisma Therapeutics, Layoffs, Workforce reduction (37%), Dropping clinical CAR-M program, Anti-HER2 CAR-macrophage CT-0508, Anti-mesothelin CAR-monocyte candidate CT-1119, Second candidate focus

Bristol Myers Squibb’s Zeposia Misses Mark in Phase 3 Crohn’s Disease Study

1 year ago talkbio0Tagged bristol-myers, Clinical Remission Endpoint Not, Crohn Disease, ozanimod, Unmet Medical Need, YELLOWSTONE Program, Zeposia

Bristol Myers Squibb, Zeposia (ozanimod), Phase 3 Trial Setback, Crohn’s Disease, Clinical Remission Endpoint Not Met, YELLOWSTONE Program, Unmet Medical Need in Crohn’s Treatment

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

1 year 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

FDA Approves Vadadustat (Vafseo) for Anemia in Chronic Kidney Disease Patients on Dialysis and Daprodustat (Jesduvroq) for Dialysis-Dependent CKD Adults

1 year ago talkbio0Tagged Anemia, Approved, Black Box Warning, Chronic Kidney Diseases, Daprodustat, Effectiveness, Hemoglobin concentration result, Jesduvroq, Oral Medication, post-marketing safety, Safety, United States Food and Drug Administration, vadadustat, Vafseo

Anemia, Chronic Kidney Disease (CKD), Vadadustat (Vafseo), Daprodustat (Jesduvroq), Oral medication, FDA approval, Hemoglobin levels, Black Box Warning, Efficacy and safety data, Post-marketing safety data