ReutersThe U.S. Food and Drug Administration's decision ends a year-long halt on future studies and a pause in enrollment for ongoing studies of lovo-cel after one case of persistent anemia in a patient. The move also signals a more favorable regulatory environment for cell and gene therapies after a spate of clinical holds by the regulator in the last few years, said SVB Securities analyst Mani Foroohar. Bluebird said its investigation showed that patients with persistent anemia had a genetic trait called the alpha-thalassemia trait.

Source: CBC News December 20, 2022 02:28 UTC