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Latest From Maureen Kenny
The European Medicines Agency has given the thumbs-up to Insulin lispro Sanofi, the first biosimilar version of Lilly’s diabetes drug Humalog. It has also green-lighted three more biosimilar rituximab products from Celltrion, which already has EU approval for one version of the originator product, Roche’s MabThera.
German company CO.DON is celebrating the fact that it probably won’t be long before it can start selling across Europe its key product – an advanced therapy for the repair of certain cartilage defects of the knee that’s been in use in Germany for ten years.
The many cities that want to host the European Medicines Agency when it moves from London to another member state in light of Brexit are working hard to come up with a determining factor that will make them the obvious choice. It may on the surface seem strange, but Ireland is making much of the fact that if its capital city Dublin were chosen, existing EMA staff wouldn’t need to move there.
European Medicines Agency head Guido Rasi tackles issue of Brexit in agency’s 2016 annual report, saying EMA is “core building block of the common market for medicines in the EU” that operates like “well-oiled machinery.”
Massive Reallocation of UK Rapporteurships Likely As EMA Plans For Future; UK’s Interim Role Uncertain
If Brexit means the UK no longer plays a part in the EU drug regulatory system, responsibility for the ongoing oversight of almost one in four of all the human medicines that have ever been approved under the centralized procedure will have to be reassigned from the UK to other member states. What Brexit means for the UK’s role as a key player in the regulatory system in the meantime is the subject of speculation.
AbbVie’s investigational hepatitis C treatment has become the latest therapy to get the green light under the UK’s early access to medicines scheme. The scheme enables patients to access the treatment ahead of it receiving an EU marketing authorization.