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Califf: Decades Of Follow-Up Necessary For Gene Therapy

FDA Commissioner Califf acknowledges that regulatory pathways for gene therapies are still being developed and that many factors outside of the modality impact agency requirements as he emphasized the need for long-term follow up due to the unknowns of gene modification.

Gene Therapy Regenerative Medicine

Califf: Decades Of Follow-Up Necessary For Gene Therapy

FDA Commissioner Califf acknowledges that regulatory pathways for gene therapies are still being developed and that many factors outside of the modality impact agency requirements as he emphasized the need for long-term follow up due to the unknowns of gene modification.

Gene Therapy Regenerative Medicine

Regenxbio: On The Cusp Of Becoming A Commercial Gene Therapy Player

Partnered with AbbVie on a wet AMD gene therapy, Regenxbio is also advancing wholly owned candidates for Duchenne muscular dystrophy and MPS I and MPS II.

Gene Therapy Business Strategies

Finance Watch: HilleVax, Belite Bio Launch First Two Biopharma IPOs In Q2

Also, Cytovia will go public via SPAC merger, Nkarta capitalized on its positive early NK cell therapy data with a $230m offering, and venture capital mega-rounds include $220m for Reify, $110m for Satellite Bio and $100m for OMass Therapeutics. 

Financing Innovation
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    • BioLife Cell Bank, Inc.
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