Quantitative Concept
Sanofi Restructures US Commercial Vaccine Group Amid Cost-Saving Campaign
Sanofi, Restructuring, US Commercial Vaccine Group, Cost-Savings Campaign, Streamlined Strategic Sales Structure, Evolving Vaccine Market, Optimization for Efficiency and Effectiveness, Employee Support and Outplacement Assistance
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
Intra-Cellular’s Caplyta Triumphs in Major Depressive Disorder Phase 3 Trial, Edging Closer to FDA Filing
Intra-Cellular Therapies, Caplyta, Lumateperone, Major Depressive Disorder (MDD), Phase 3 Trial, Positive Results, Statistically Significant, Clinically Meaningful, Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression Scale for Severity of Illness (CGI-S), FDA Filing
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
Boehringer Ingelheim Leverages Late-Stage Pipeline for 25 New Launches over the Next Decade
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
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
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
Diagonal Therapeutics, Series A funding, Antibody agonism, Cellular “on” switches, Rare diseases
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