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Etranacogene Dezaparvovec Significantly Improves Hemophilia B Past 2 Years

Phase 3 data presented at ASH 2023 show the gene therapy significantly reduced annualized bleeding rates and the number of total bleeds.

United statesSan diegoAmerican society of hematologyAmerican societyHemophilia bEtranacogene dezaparvovecPhase 3Mash 2023Gene therapy

CHMP issues positive opinion for CSL s etranacogene dezaparvovec

Gene therapy involves adults with haemophilia B and brings renewed hope to patients across Europe - News - PharmaTimes

Emmanuelle lecomte brissetEuropean medicines agencyEuropean commissionCommittee for medicinal products human useMedicinal productsHuman useEuropean economicLecomte brissetEtranacogene dezaparvovec

Positive CHMP Opinion Etranacogene Dezaparvovec

Positive CHMP Opinion Etranacogene Dezaparvovec
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Emmanuelle lecomte brissetEtranacogene dezaparvovecHead of global regulatory affairsEuropean unionEuropean medicines agencyEuropean commissionDrug administrationCommittee for medicinal products human useMedicinal productsHuman useEuropean economic areaSenior vice presidentGlobal regulatory affairsAnnual bleeding rate

CSL Receives Positive CHMP Opinion for Etranacogene Dezaparvovec Gene Therapy for Adults with Hemophilia B

MARBURG, GERMANY Regulatory milestone moves CSL one step closer to bringing the promise of gene therapy for hemophilia B to patients in Europe.

Emmanuelle lecomte brissetEtranacogene dezaparvovecHead of global regulatory affairsEuropean unionEuropean medicines agencyEuropean commissionDrug administrationCommittee for medicinal products human useMedicinal productsHuman useEuropean economic areaSenior vice presidentGlobal regulatory affairsAnnual bleeding rateClinical trialTransfusion medicine

CSL s Novel Gene Therapy HEMGENIX Demonstrates Durable Protection and Sustained Factor IX Activity Levels for People Living

CSL s Novel Gene Therapy HEMGENIX Demonstrates Durable Protection and Sustained Factor IX Activity Levels for People Living
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United statesBrahm goldsteinAmerican society of hematologyBehring pharmacovigilance departmentUniversity of michiganAmerican societySteven pipeVice presidentBleeding protectionLevels are demonstratedAdeno associated virus serotypeBleeding rateEtranacogene dezaparvovecAnnual bleeding rateSafety informationPharmacovigilance department

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