Mikael Dolsten, Pfizer CSO

FDA re­leas­es sec­ond Pfiz­er gene ther­a­py from clin­i­cal hold, as he­mo­phil­ia pro­gram gets OK to restart

The FDA has re­leased a clin­i­cal hold on Pfiz­er and Sang­amo’s he­mo­phil­ia A gene ther­a­py af­ter or­der­ing the com­pa­nies to stop the tri­al last year due to con­cerns about blood clots.

Just a week af­ter Pfiz­er an­nounced the FDA had un­leashed its gene ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy from a clin­i­cal hold — which was paused as one pa­tient died and oth­ers ex­pe­ri­enced se­vere side ef­fects  — an­oth­er one of its gene ther­a­py pro­grams has been giv­en the green light to re­sume, Pfiz­er an­nounced dur­ing its Q1 earn­ings call yes­ter­day.

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