Pfizer CEO Albert Bourla (AP Images)

Pfiz­er can restart PhI­II tri­al of Duchenne gene ther­a­py, now on track for late-2023 FDA ap­proval re­quest 

Pfiz­er’s path at get­ting a gene ther­a­py to mar­ket for pa­tients with Duchenne mus­cu­lar dy­s­tro­phy just got a lit­tle clear­er af­ter a hazy 2021 that saw a clin­i­cal hold, an amend­ed late-stage tri­al and a pa­tient death in an ear­ly-stage study.

US reg­u­la­tors will al­low the Big Phar­ma to re­sume its Phase III study dubbed CIFFREO, Pfiz­er said Thurs­day morn­ing, not­ing it has amend­ed the pro­to­col to as­sess pa­tients in the hos­pi­tal for sev­en days post-ad­min­is­tra­tion. The clin­i­cal hold lift fol­lows re­views of da­ta and pro­to­col amend­ments, Pfiz­er added.

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