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FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The clinical studies were placed on a partial hold in December 2021 relating to an investigation by bluebird into an adolescent patient with persistent, non-transfusion-dependent anaemia following treatment with lovo-cel.

Results from a detailed investigation of the case were presented at the American Society of Hematology Annual Meeting and Exposition earlier this month, alongside details from another case of persistent anaemia in an adult patient following treatment with the gene therapy.

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