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.

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.

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EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

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.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
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The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm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.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
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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.