'Huge Need' For Neurotoxicity Biomarkers In Drug Development, FDA's Woodcock Says
"Perfect storm" makes it difficult to develop safety biomarkers, Woodcock tells US FDA workshop, citing lack of body charged with developing them and greater evidence required for their qualification.
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FDA's proposed review timeline to qualify biomarkers, clinical outcome assessments, and animal models can actually be pretty quick – assuming submissions clear the initial "reviewability" hurdle.
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.
Higher dose or adjuvanted seasonal flu vaccines – Fluzone, Fluad and Flubok – provide benefit over other vaccines for older adults, advisory committee concludes. Merck’s PCV15 pneumococcal vaccine and GSK’s Priorix MMR vaccine are recommended for pediatric use by ACIP.