1. Pink Sheet

COVID-19’s Damage To Gene Therapy Development May Last Years

 
• By Derrick Gingery

US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.

Peter Marks at FDLI Regenerative Medicine conference screenshot
CBER Director Peter Marks said the pandemic also exasperated the backlog of pending INTERACT meetings. • Source: Screenshot

Gene therapy development and approval likely was slowed by the coronavirus pandemic, which could endanger projections for the explosion in the sector going forward.

In calendar year 2019, the US Food and Drug Administration received 243 IND applications for gene therapies, which was followed in calendar year 2020 with another 237

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