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Latest From Lexeo Therapeutics
Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More
Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.
Unvalidated PROs In Rare Diseases: US FDA May Have To ‘Work Through’ Them, CBER’s Marks Says
Given the challenges of validating patient-reported outcome instruments specific to very rare diseases, agency is probably going to have to accept the use of unvalidated measures in some cases, Peter Marks tells American Society of Gene and Cell Therapy’s annual meeting.
Lecanemab Set A New Bar In Alzheimer’s, Now Many Drugs Are Seeking To Raise It
Drug makers are more enthusiastic than ever about the outlook for developing drugs for Alzheimer's. Scrip reports back on the latest developments at CTAD.
Accelerated Approvals Need Earlier Planning On Surrogate Endpoints, Postmarketing Trials – FDA’s Marks
Current accelerated approval provisions are the ‘sweet spot’ for balancing access and efficacy, but more attention needs to be paid by sponsors and the agency to working out regulatory pain points earlier in the development process, CBER director tells gene/cell therapy conference.
- Gene Therapy, Cell Therapy
- Other Names / Subsidiaries
- Stelios Therapeutics, Inc.
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