With expanded approval of Janssen’s psoriasis blockbuster Stelara, individual patients in the EU with Crohn’s disease have gained possible access a new treatment option. Regulators in Europe have approved use of the biologic as an alternative option for adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) have confirmed that they will incorporate the views of patients, increase international cooperation and collaborate with health technology assessment (HTA) bodies, with the aim of gaining a better understanding for orphan drug designation. The European Union (EU) orphan medicinal product regulation was started 12
The European Union’s Clinical Trials Directive has resulted in unnecessary complexity and bureaucracy that are hampering the progress of medical research by pushing up the time and costs needed to get clinical studies underway, academic and industry stakeholders from the UK and Europe argue. As European institutions reform after the summer recess, a mixed group
