BioCentury
ARTICLE | Product Development

As bluebird rejiggers EU rollout of one gene therapy, hope for near-term lifting of all clinical holds 

Zynteglo pulled from German market as pricing talks falter

April 21, 2021 1:24 AM UTC

Although bluebird believes a new diagnosis of an adverse event may help it resolve all clinical holds by mid-year, the company now finds itself recalibrating its ambitions to commercialize its Zynteglo gene therapy, at least in Europe.

Bluebird bio (NASDAQ:BLUE) is pulling Zynteglo betibeglogene autotemcel (beti-cel) from the German market after discussions over pricing reached a stalemate. But the company appears to be cautiously optimistic about the progress of its talks with health authorities elsewhere on the Continent regarding Zynteglo, which is approved in the EU to treat transfusion-dependent β thalassemia, calling discussions “productive.” Updates on those negotiations are expected in 2H21. The product has yet to generate any sales...

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