Continuous – Talk Bio

Congress Passes Slimmed-Down Continuing Resolution, Extends Telehealth Flexibilities and Includes PBM Reform

4 months ago talkbio0Tagged Continuous, Healthcare Package, Medicaid, Medicare, PBM Reform, physiologic resolution, Telehealth Flexibilities

Continuing Resolution, Telehealth Flexibilities, PBM Reform, Healthcare Package, Medicare, Medicaid

Strategic Roadmap for Biologics Manufacturing: Enhancing Efficiency and Flexibility

5 months ago talkbio0Tagged Biological Factors, biomanufacturing, bony process, Characterization, Continuous, Efficiency, Manufacturing, Modular Facilities, Pliability, Precision medicines, Regulatory Compliance, Strategic Roadmap, technology roadmap

Biologics manufacturing, Strategic roadmap, Process characterization, Flexibility and efficiency, Regulatory compliance, Biomanufacturing technology roadmap, Precision medicines, Modular facilities, Continuous manufacturing

FDA Approves Vyalev: A Breakthrough Continuous Infusion Therapy for Advanced Parkinson’s Disease

6 months ago talkbio0Tagged AbbVie, Approved, carbidopa, Continuous, Infusion procedures, levodopa, motor fluctuations, Parkinson Disease, United States Food and Drug Administration, Vyalev

Vyalev, Parkinson’s disease, continuous infusion therapy, FDA approval, AbbVie, motor fluctuations, levodopa, carbidopa

EMA Dispels Link Between GLP-1 Receptor Agonists and Suicidal Ideation Risk New

1 year ago talkbio0Tagged agonists, Continuous, Diabetes, Glucagon-Like Peptide-1 Receptor, Mental association, Multiple Acyl Coenzyme A Dehydrogenase Deficiency, pharmacovigilance activities, Preventive monitoring, Suicidal ideation risk, Weight-Loss Agents

EMA, GLP-1 receptor agonists, Diabetes and weight-loss drugs, Suicidal ideation risk, No causal association, Pharmacovigilance activities, Continued monitoring

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