Gamida Cell Ltd.
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Latest From Gamida Cell Ltd.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.
Public Company Edition: Moderna leveraged its all-time high stock price to raise $1.34bn on the same day it reported data from a Phase I trial of its COVID-19 vaccine. Several other companies also took advantage of biopharma’s rising value.
The Novartis-backed company will begin a rolling submission to the US FDA for its cord blood-derived cell therapy omidubicel in Q4 based on improved engraftment versus standard cord blood.
CAR-T therapies from Janssen, Celgene and others will get a lot of attention at the annual hematology meeting, including candidates with novel constructs and targets.
- Drug Discovery Tools
- Gene Therapy, Cell Therapy
Drug Discovery Tools