ADAPTIVE LICENSING USEFUL FOR ORPHAN DRUGS, CONFERENCE HEARS

ADAPTIVE licensing methods such as that proposed by the European Medicines Agency (EMA) are indeed useful in the development of medicines for rare diseases, Martin Andrews, the senior vice-president at GSK Rare Diseases, has told the World Orphan Drugs Congress 2014.Speaking to this conference in Brussels, staged on November 14, he said that the ‘safe harbour’ dialogue provided for under EMA’s adaptive licensing pilot projects was of particular help. “Especially the fact that the discussion can be very open is incredibly valuable when you are exploring an ...


Full access to this article can be arranged with permission from the client that first ordered it. Please contact us to request access. Entries are uploaded to our archive at least one year after being published by a client – free access is restricted to International News Services journalists for background research only. The article date indicates when copy was filed to a client, not when posted to this archive. Upon client requests, International News Services will remove such articles from the archive or not upload them in the first place. They are included to demonstrate the breadth of topics undertaken by the agency and also to help promote clients’ coverage.