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Another Astellas gene therapy trial paused by FDA after side effect report

June 27, 2022

Astellas paid $3 billion to acquire Audentes Therapeutics in December 2019 planning, like many of its peers, to capitalize on advances in gene therapy research. The deal came months after the FDA had approved the second gene therapy for an inherited disease, and had indicated it was preparing for an influx of applications.

Safety worries and clinical setbacks have slowed the field’s progress since, however. Last year, the FDA convened a panel of experts to discuss ways for gene therapy developers to mitigate health risks. A number of companies, among them Pfizer, UniQure and Bluebird bio, had safety concerns crop up in 2021.

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