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Zynteglo Authorization Renewal Paused While EU Regulators Examine Safety Concerns

 
• By Neena Brizmohun

The European Medicines Agency is reviewing the safety of bluebird bio’s beta thalassaemia gene therapy, which is so far only approved in the EU and has only been used in one patient outside the context of clinical studies.

Gene therapy
Zynteglo is a gene therapy for beta thalassaemia • Source: Shutterstock

The European Medicines Agency has paused the renewal procedure for the EU conditional marketing authorization (CMA) for Zynteglo (betibeglogene autotemcel) while it continues to look into concerns over the safety of the lentiviral vector used to manufacture the beta thalassaemia gene therapy from bluebird bio.

The EMA said on 12 March that it had started reviewing Zynteglo’s safety due to concerns over a case of acute myeloid leukaemia (AML) that was diagnosed in a patient who was taking part in a Phase I/II study of bluebird's investigational drug for sickle cell disorder, LentiGlobin (bb1111). LentiGlobin and Zynteglo use the same lentiviral vector

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.