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ema-approval

Roche Restarts Phase III Trial to Pursue EMA Approval for Elevidys

Roche is launching a new Phase III placebo-controlled trial for DMD gene therapy Elevidys after the EMA rejected the treatment last year following two patient deaths. The 72-plus-week study of roughly 100 boys is designed to meet the EMA's data requirements for a regulatory re-submission. A successful outcome would

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Tag

ema-approval

Roche Restarts Phase III Trial for Elevidys to Secure EMA Approval

Roche is launching a new Phase III placebo-controlled trial for DMD gene therapy Elevidys after the EMA rejected the treatment last year following two patient deaths. The 72-plus-week study of roughly 100 boys is designed to meet the EMA's data requirements for a regulatory re-submission. A successful outcome would

2mo ago · 2 min · Business

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