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US FDA Performance Tracker Complete Response Letters Approvals

Keeping Track: US FDA Approves Zokinvy, Defers Liso-Cel, Declines ALKS 3831 And Zimhi; Two Biosimilars Filed

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Executive Summary

The latest drug developments news and highlights from the Pink Sheet’s US FDA Performance Tracker

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Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy

The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.

Gilead Turns Back To Virology With $1.4bn MYR Acquisition

MYR’s Hepcludex obtained EU accelerated approval in July, making it the first approved therapy for hepatitis D. One analyst sees the drug as a blockbuster revenue opportunity for Gilead.

Regenerative Medicine Comes Of Age – In The Age Of COVID-19

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.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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