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Aethersys Gets Orphan Status in EU for MultiStem

Stem cell treatment intended to prevent GvHD

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The EMA’s Committee for Orphan Medicinal Products has issued a positive opinion for Athersys‘ allogeneic, multipotent adult progenitor cell, or MultiStem therapy, for the prevention of graft-versus-host disease (GvHD). The company is developing its MultiStem cell therapy as a GvHD prophylaxis in patients undergoing allogeneic hematopoietic stem cell (HSC) transplant. The MultiStem therapy for the prevention of GvHD previously received Orphan Drug Designation from the FDA Orphan drug...

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