FDA scuttles bluebird's accelerated plans for sickle cell gene therapy, as higher CMC bar forces 1-year delay

FDA scuttles bluebird's accelerated plans for sickle cell gene therapy, as higher CMC bar forces 1-year delay

Source: 
Endpoints
snippet: 

In yet another smudge on bluebird bio’s track record for execution, the biotech is pushing back the filing for its gene therapy in sickle cell disease by a year due to a new data requirement from the FDA.