Is an orphan medicine still an orphan once it gets on the market?

January 17, 2018 – The European Medicines Agency (EMA) will be publishing, as of today, a so-called orphan maintenance assessment report for every orphan-designated medicine which has been recommended for marketing authorisation by the Agency. The new report summarises the reasoning of the Agency’s Committee for Orphan Medicinal Products (COMP) on whether or not a medicine designated as an orphan medicine during its development still fulfils the … (leggi tutto)