ASH: Despite partial clinical hold, bluebird's sickle cell gene therapy remains on track

Around this time last year, when the FDA put a partial clinical hold on bluebird bio's sickle cell disease (SCD) lovo-cel for patients under the age of 18, it raised questions about the regulatory timeline of the gene therapy.

But 12 months removed from the scare—and after continued observation of lovo-cel recipients—the Massachusetts-based company says it is still on track to submit its biologics license application in the first quarter of next year, chief medical officer Rich Colvin, M.D., Ph.D., said in an interview ahead of the company’s presentation Saturday at the American Society of Hematology annual conference in New Orleans.