Regenerative Medicine Comes Of Age – In The Age Of COVID-19
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
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US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.
Wall Street is worried that a cluster of recent negative regulatory events means tougher reviews going forward. That concern is probably overdone, but a year into the COVID pandemic is a good time to take stock of how FDA is doing.
The center is partnering with Obsidian to make autologous TILs work better after being infused back into patients by using IL-15, which may be less toxic than the high-dose IL-2 currently used.