Zynteglo Authorization Renewal Paused While EU Regulators Examine Safety Concerns
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.
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No evidence has been found linking the viral vector in bluebird’s gene therapy for β-thalassemia to blood cancer, the European Medicines Agency says.
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After arbitrators set an unpalatably low price for the company, bluebird is withdrawing its Zyntgelo gene therapy from Germany. The company also announced it would be restructuring its workforce, with job losses expected.