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EMA OKs BMS/bluebird bio’s CAR-T Abecma For Multiple Myeloma

Other EU Recommendations Include Astellas’s Roxadustat & BioMarin’s Vosoritide

 
• By Ian Schofield

A gene therapy for multiple myeloma, a new drug for achondroplasia, and the first biosimilar version of Roche’s Lucentis are among eight products recommended for EU marketing authorization this week.

Gene editing genes therapy concept with nurse and DNA lab technician medical laboratory
A gene therapy for multiple myeloma could soon be approved in Europe • Source: Shutterstock

The European Medicine Agency’s human medicines committee, the CHMP, has delivered a positive opinion on Bristol Myers Squibb Company/bluebird bio’s CAR T-cell therapy, Abecma (idecabtagene vicleucel), the first cell-based gene therapy for patients with multiple myeloma.

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New EU Filings

 
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Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

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