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bluebird bio (NASDAQ:BLUE), Onconova (NASDAQ:ONTX) - Why Bluebird Bio, Onconova, FSD Pharma, Immatics Are Moving Wednesday

bluebird bio (NASDAQ:BLUE), Onconova (NASDAQ:ONTX) - Why Bluebird Bio, Onconova, FSD Pharma, Immatics Are Moving Wednesday
benzinga.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from benzinga.com Daily Mail and Mail on Sunday newspapers.

Bluebird s top doctor to depart as company grapples with safety review

Bluebird s top doctor to depart as company grapples with safety review
biopharmadive.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biopharmadive.com Daily Mail and Mail on Sunday newspapers.

Bluebird says gene therapy very unlikely cause of cancer case in trial

Dive Brief: Bluebird bio on Wednesday said its experimental gene therapy for sickle cell disease is very unlikely related to a recently diagnosed case of leukemia in the one of the company s clinical trials, citing findings from an investigation into the genetic make-up of the study volunteer s tumor.  Bluebird had stopped two studies of the treatment in response to the diagnosis, which was disclosed in mid-February, and suspended sales of a related gene therapy product called Zynteglo that s approved for use in Europe.  The leukemia case, as well as the disclosure by Bluebird of cancer-like bone marrow disease in another study volunteer, renewed concerns about gene therapy safety that may be hard to quickly dispel. Bluebird s investigation into the other report of myelodysplastic syndrome remains ongoing, although the company said Wednesday it s not clear whether the participant formally meets the criteria for a diagnosis. 

Bluebird analysis finds gene therapy very unlikely to be cause of patient s cancer

Bluebird bio said independent analyses found that the gene therapy inserted its payload at a site not known to cause cancer. Based on the results, CEO Nick Leschly said the company has asked the FDA for permission to resume the three clinical trials that were placed on hold in February during the inquiry.

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