She said the company will work on the changes in “parallel” while also qualifying and training the staff and facilities that will handle the treatments. Bluebird Bio has delayed the launch of its Zynteglo gene therapy, despite securing conditional approval from the European Medicines Agency, after it demanded a tightening of product specifications and manufacturing processes. The company said on Tuesday that regulatory delays had forced it to delay the start date for the first clinical trial in Europe by two months. It plans to enrol its first patients by the end of this year and begin treatment in early 2020.
Bluebird Bio has delayed the launch of its Zynteglo gene therapy, despite securing conditional approval from the European Medicines Agency, after it demanded a tightening of product specifications and manufacturing processes. The company said on Tuesday that regulatory delays had forced it to delay the start date for the first clinical trial in Europe by two months. It plans to enrol its first patients by the end of this year and begin treatment in early 2020.