Translarna – Talk Bio

Biotech Restructuring and European Regulatory Setbacks

3 weeks ago talkbio0Tagged Commission, European (ethnic group), factor IX, LifeMine, Muscular Dystrophy, Duchenne, regulatory, Translarna

LifeMine Therapeutics, layoffs, PTC Therapeutics, Translarna, Duchenne muscular dystrophy, European Commission, regulatory decision

European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment

6 months ago talkbio0Tagged CHMP, Commission, Conditional, Decision, Drug Approval, European (ethnic group), Multiple Acyl Coenzyme A Dehydrogenase Deficiency, Muscular Dystrophy, Duchenne, regulatory, Translarna

Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions

Translarna by PTC Therapeutics: Awaiting Another EU Regulatory Review for Muscular Dystrophy Treatment

11 months ago talkbio0Tagged ataluren, disease treatment, EU, European Medicines Agency, factor IX, Infrequent, Muscular Dystrophy, Muscular Dystrophy, Duchenne, regulatory approval, Translarna

PTC Therapeutics, Translarna, muscular dystrophy, EU review, regulatory approval, Duchenne muscular dystrophy (DMD), European Medicines Agency (EMA), ataluren, rare disease treatment.