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Pharmaceutical Executive

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News

PharmExec
pharmexec.com > view > new-fda-draft-guidance-targets-gene-therapy-submission-burden-existing-cmc-scientific-knowledge

New FDA Draft Guidance Targets Gene Therapy Submission Burden by Allowing Use of Existing CMC and Scientific Knowledge

3+ mon, 1+ week ago   (353+ words) FDA's CBER details a framework for sponsors to apply existing CMC, nonclinical, and clinical data to genome-editing-based product development and regulatory filings. When finalized, the guidance is intended to reduce redundant testing, lower development costs, and accelerate patient access to…...

PharmExec
pharmexec.com > view > daily-new-fda-draft-guidance-targets-gene-therapy-submission-burden

Pharmaceutical Executive Daily: New FDA Draft Guidance Targets Gene Therapy Submission Burden

3+ mon, 1+ week ago   (13+ words) New FDA Draft Guidance Targets Gene Therapy Submission Burden | PharmExec PharmExec.com...

PharmExec
pharmexec.com > view > situation-we-faced-development-commercialization-maritide

The Situation We Faced: The Development and Commercialization of MariTide

11+ mon, 3+ day ago   (301+ words) Chris Spivey, Director of Industrial Relations and Strategic Partnerships for Industry Sciences One at MJH Life Sciences, and Raymond J. Deshaies, PhD, Executive Officer of Molecular Biology at the California Institute of Technology, discuss the development of MariTide, which is in…...

PharmExec
pharmexec.com > view > chiesi-group-arbor-biotechnologies-global-strategic-partnership-gene-editing-program-abo-101

Chiesi Group & Arbor Biotechnologies Announce Global Strategic Partnership Aiming to Develop Gene Editing Program ABO-101

11+ mon, 5+ day ago   (206+ words) Chiesi Group partners with Arbor Biotechnologies to advance gene editing therapies for rare diseases, focusing on primary hyperoxaluria type 1. The collaboration and license agreement includes the development and global commercialization of ABO-101 for primary hyperoxaluria type 1 and the development of…...