Regulatory Report - 2023 Archive

SECOND GLOBAL REGULATORY REPORT: 2023 H2

Highlights:

• 2960 therapies in the global pipeline (2% increase from H1 2023)
• 80 products are under regulatory review globally of which 71 products are in Phase III clinical trials
• 96 products approved globally (9% increase from H1 2023)
• 6 products received their first approvals globally including.
  • Elevydis (delandistrogene moxeparvovec-rokl)
  • Lantidra (donislecel)
  • Fucaso® (equecabtagene autoleucel)
  • CNCT19 (inaticabtagene autoleucel)
  • Casgevy™ (exagamglogene autotemcel)
  • Lyfgenia™ (lovotibeglogene autotemcel)
• Key Global Legislative/Framework Changes by US FDA,  EMA, ICH, and NZ Ministry of Environment

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FIRST GLOBAL REGULATORY REPORT: 2023 H1

Highlights:

• 87 cell and gene therapies approved globally, and 71% of them are non-genetically modified cell products.
• 81 cell and gene therapies under the late development stages (Phase III or pre-registration)
• Key Global Legislative/Framework changes by EU Commission, US FDA, Health Canada, TGA, NZ Ministry of Health, WHO
• Carvykti®, received TGA Approval for the treatment of people with multiple Myeloma
• Vyjuvek™, received FDA BLA Approval for the treatment of wounds in patients with Dystrophic Epidermolysis Bullosa

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