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BRIEF—MHRA to consider gene therapy for sickle cell disease

BRIEF—MHRA to consider gene therapy for sickle cell disease
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United kingdomEuropean medicines agencyUnited vertex pharmaceuticalsRegulatory agencyUnited states based vertex pharmaceuticalsNia tatsisOrphan drug

Milestone for gene-edited therapy exa-cel for sickle cell disease

Vertex and CRISPR Therapeutics have announced that the EMA has validated the MAA of exa-cel for the treatment of sickle cell disease.

European hematology association congressEuropean medicines agencyEuropean commissionDrug administrationVertex pharmaceuticals europeVertex pharmaceuticalsMarketing authorization applicationNia tatsisOrphan drug designationPriority medicinesBiologics license applicationNew england journal

Vertex Pharmaceuticals Incorporated: Vertex and CRISPR Therapeutics Announce Global exa-cel Regulatory Submissions for Sickle Cell Disease and Beta Thalassemia in 2022

Exa-cel will be submitted to the U.S. FDA for rolling review beginning in November, with completion of the U.S. submission package in Q1 2023 - EMA and MHRA submissions are on track for Q4 2022 - Exa-cel

United statesUnited kingdomCity ofSan franciscoSusan kimMiroslava minkovaHeather nicholsRachel eidesSusie lisaManisha paiEuropean hematology associationVertex pharmaceuticals incorporatedViacyte incTherapeutics incVertex pharmaceuticals incorporated nasdaqVertex pharmaceuticals

Vertex Pharma (VRTX) and CRISPR (CRSP) Announce Global exa-cel Regulatory Submissions for Sickle Cell Disease and Beta Thalassemia

Vertex Pharma (VRTX) and CRISPR (CRSP) Announce Global exa-cel Regulatory Submissions for Sickle Cell Disease and Beta Thalassemia
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

United statesUnited kingdomCity ofSan franciscoSusan kimMiroslava minkovaHeather nicholsSusie lisaManisha paiEuropean hematology associationVertex pharmaceuticals incorporatedViacyte incTherapeutics incVertex pharmaceuticals incorporated nasdaqVertex pharmaceuticalsDrug administration

Vertex given green light to seek US approval of CRISPR-based therapy

BioPharma

Brian abrahamsVertex pharmaceuticalsDrug administrationNovo nordiskNobel prizeNia tatsisMassachusetts based bluebirdBeam therapeuticsGene therapy

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