Gene therapies for neurodegenerative diseases: Pfizer, Novartis, Biogen and others seek more from FDA
Top biopharma companies are calling on the FDA to provide more context and examples, particularly on early interactions with the agency, as part of the companies’ feedback on draft guidance from January related to developing gene therapies to treat neurodegenerative diseases.
The 15-page draft guidance outlines various considerations on manufacturing, preclinical and clinical trials for gene therapies targeting amyotrophic lateral sclerosis, Alzheimer’s disease and other neurodegenerative disorders that are notoriously difficult to treat.
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