Functional Concept
CMS to Increase Reimbursement for New Sickle Cell Gene Therapies through Outcomes-Based Agreements
CMS (Centers for Medicare & Medicaid Services), Sickle Cell Gene Therapies, Increased Reimbursement, Outcomes-Based Agreements (OBAs), Cell and Gene Therapy (CGT) Access Model, Medicaid Access, Casgevy, Lyfgenia, Fertility Preservation Services, Equitable Access, Administrative Burden Reduction
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)
Novartis Announces 680 Layoffs in Development Group Amid Corporate Restructuring
Novartis, Layoffs, Development Group, Corporate Restructuring, 680 Jobs, Switzerland, United States, Pharmaceutical Industry
Vanda’s Fanapt Secures Second FDA Approval for Treating Bipolar I Disorder
Fanapt, Vanda Pharmaceuticals, Bipolar I Disorder, Second FDA Nod, Iloperidone, Acute Treatment of Manic or Mixed Episodes
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
Eiger BioPharmaceuticals Declares Bankruptcy and Announces Operational Wind Down Following Years of Challenges
Eiger BioPharmaceuticals, Bankruptcy, Chapter 11, Assets Sale, Operational Wind Down, Rare Metabolic Disease Therapy Development
Bristol Myers Squibb’s Zeposia Misses Mark in Phase 3 Crohn’s Disease Study
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
GLP-1 drugs, Medicare coverage gap, Lower prescription rates, Obesity treatment, Semaglutide (Wegovy), Tirzepatide (Mounjaro), Liraglutide (Saxenda), Healthcare costs, Truveta study