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Boy Dosed with Pfizer DMD Gene Therapy Dies a Year after Phase II Trial

Boy Dosed with Pfizer DMD Gene Therapy Dies a Year after Phase II Trial
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Debra Miller , Astellas Pharma , Data Monitoring Committee , External Data Monitoring , Parent Project Muscular Dystrophy , Mikael Dolsten Pfizer , Sarepta Therapeutics , X Linked Myotubular Myopathy ,

After Patient Death, FDA Places Hold on Pfizer DMD Gene Therapy Trial

The FDA has imposed a clinical hold on a Phase Ib trial assessing Pfizer’s mini-dystrophin gene therapy candidate PF-06939926 in Duchenne muscular dystrophy (DMD), after the company acknowledged the death of a young male participant in the open-label study. ....

United States , San Francisco , Nicolek Paulk , Brianp Skorney , Guangping Gao , University Of California , University Of Massachusetts Medical School , Mary Ann Liebert Inc , Data Monitoring Committee , University Of Miami Miller School Medicine , Penelope Booth Rockwell Professor In Biomedical Research , Child Neurology Society , Li Weibo Institute For Rare Diseases Research , Horae Gene Therapy Center , World Muscle Society , Virtual Congress , External Data Monitoring , Sarepta Therapeutics , Astellas Gene Therapie Phase , X Linked Myotubular Myopathy , Miami Miller School , Penelope Booth Rockwell Professor , Biomedical Research , Massachusetts Medical School , Viral Vector Core , Rare Diseases ,