CGTLive’s Weekly Rewind – 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.