EMA has revealed a final tally of 84 positive opinions on new medicines in 2018, with 42 of these being new active substances. This number is slightly down from 94 in 2017, but the number of new active substances approved in 2018 grew from 35 to 42. Amongst those approved, 21 were orphan medicines (exactly
Yvette Cleland comments on the latest Clinical Professionals Industry Analytics report, “What do we expect the impact of the EMA leaving the UK to be?” “The Dutch government’s successful bid to host the European Medicines Agency (EMA) has already faced its first hurdle, the temporary offices in which it was proposed to house some staff
EMA has accepted GW Pharmaceuticals’ request to review the MMA (Marketing Authorisation Application) of Epidiolex, or cannibidiol. The treatment is currently used on patients who suffer from seizures linked to Lennox-Gastaut syndrome and Dravet syndrome. GW Pharmaceuticals first submitted Epidiolex for review in December 2017. The successful filing of the MAA of the drug follows
As European Union leaders prepare for Brexit negotiations with the UK, Ireland has stepped up its bid to make Dublin the new home of the EU’s medicines agency. The EMA looks relatively certain to leave its current residence in east London because of Brexit, and many EU cities are eager to be chosen as the
