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

Submitted by admin on November 5, 2020 - 11:05am

Source:

Endpoints

News Tags:

Bluebird Bio

FDA

sickle cell disease

gene therapy

HGB-206

Headline:

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

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.

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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