Professional or Occupational Group
Navigating Complex Regulatory Landscapes: The Importance of External Support for Biotech Sponsors in IRB, IBC, DMCs, and EACs
Biotech sponsors, IRB (Institutional Review Board), IBC (Institutional Biosafety Committee), DMCs (Data Monitoring Committees), EACs (Ethics Advisory Committees), Regulatory compliance, Clinical trials, Gene therapy research, Risk management
Enhancing Flu Vaccine Uptake in the Post-Pandemic Era: Strategies and Insights
flu vaccine uptake, post-pandemic era, vaccine hesitancy, public health strategies, healthcare providers, influenza vaccination
House Oversight Chair Demands PBM Executives Correct False Testimonies
PBM Executives, False Testimonies, House Oversight Chair, James Comer, Pharmacy Benefit Managers, Congressional Hearing
US Lawmakers Demand FDA Probe into Clinical Trials Linked to China’s Military
FDA investigation, clinical trials, China’s military, US lawmakers, bipartisan scrutiny
Embracing Agility: Critical for the Role of QARA Professional
QARA Professional, Agility, Quality Assurance, Regulatory Affairs, Market Access, Innovative Therapeutic Solutions, AI, Technology, Regulatory Strategy, Leadership, Communication, Diversity, Inclusion.
FDA Approves First Engineered T Cell Therapy for Solid Tumors, Expands GSK’s Jemperli
FDA approval, engineered T cell therapy, solid tumors, GSK’s Jemperli, dostarlimab-gxly, afamitresgene autoleucel, Tecelra, endometrial cancer, synovial sarcoma
MBX Secures $63.5M in Funding Ahead of Clinical Readouts
MBX, clinical readouts, funding, engineered peptide therapeutics, hypoparathyroidism, Phase II trial
Vir Biotechnology Acquires T-Cell Engagers from Sanofi, Reduces Staff by 25% in Strategic Pipeline Shift
Vir Biotechnology, Sanofi, T-cell engagers, pipeline switch-up, staff reduction, biotech industry, pharmaceuticals
Impact of New CDC Guidelines on RSV Vaccine Makers
RSV vaccine, CDC guidelines, vaccine makers, Moderna, Pfizer, GSK, Guillain-Barré syndrome, vaccination recommendations
FDA Approves Tecelra, the First Engineered Cell Therapy for Solid Tumors, to Treat Synovial Sarcoma
Tecelra, Adaptimmune, FDA approval, engineered cell therapy, solid tumor, synovial sarcoma, MAGE-A4 antigen, TCR cell therapy