As many in the US and around the world wait uneasily at home for a resolution to the coronavirus pandemic, one bright spot has been the suggestion by industry and government that there could be a vaccine in as soon as 18 months.
Coronavirus Vaccine: How Hard Might Development Get? Look At Chikungunya
Epidemiology complicates field efficacy trials, but US FDA advisory committee members regretfully agree that data from non-human primate passive transfer studies is compelling but potentially insufficient for chikungunya vaccines.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.
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US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
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The FDA generic drugs team’s first public workshop of the second Trump Administration ended with a request that industry amplify the value it finds from public engagement.
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Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.
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A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.