CGTLive’s Weekly Rewind – November 25, 2022
Review top news and interview highlights from the week ending November 25, 2022.
Welcome to CGTLive’s Weekly Rewind! We’ve compiled 5 highlights from this week’s coverage of advances in gene and cell therapies, including FDA actions, notable research, and interviews with experts across the field.
1. Omidubicel PDUFA Date Extended to May 2023
Omidubicel’s BLA was originally accepted for priority review in August of this year.
2. Terese Hammond, MD, on Investigating iNKT Cells in COVID-Associated ARDS
The director of the CCU/ICU at Saint John’s Health Center discussed unmet respiratory treatment needs in the beginning of the COVID-19 pandemic.
3. Amod Sarnaik, MD, on New Frontiers in Cell Therapy for Advanced Melanoma
Sarnaik discussed several potential areas of innovation on the horizon.
4. MPS Type IIIA Gene Therapy Trial Fails Primary Endpoint
Statistically significant improvements in cognitive development were only seen in the cohort of patients younger than 30 months.
5. Hemgenix First Gene Therapy Approved for Hemophilia B
A marketing authorization application for etranacogenedezaparvovec is currently under review by the EMA.
Conservative Management Following Treatment With DMD Gene Therapy Elevidys
May 19th 2025Ben Samelson-Jones, MD, PhD, the associate director of clinical in vivo gene therapy at Children’s Hospital of Philadelphia discussed a case he presented at the American Society of Gene and Cell Therapy’s 2025 meeting.
