FDA Leader: We Need To Remove Surprises From Gene Therapy Development
Peter Marks Addresses Commercial And Regulatory Hurdles
Embattled gene therapy companies will take comfort from desire of FDA and EMA help smooth the process of bringing the novel treatments to market.
You may also be interested in...
PTC CEO Stuart Peltz tells Scrip that cost watchdogs are likely to look favorably on the firm’s transformational gene therapy for a distressing rare brain disorder in children who could not even lift their heads before treatment.
Former FDA principal deputy commissioner Amy Abernethy says cell and gene therapy is an area primed for improved ‘parallel conversation’ between FDA and CMS on data requirements.
After the boom of 2020 and 2021, the biotech sector is experiencing one of the deepest and longest downturns but there are hopes that catalysts could soon revive confidence.