Tweeting The News: First Takes From EU Regulatory Conferences
The Pink Sheet’s London-based staff have been busy this week covering regulatory affairs conferences… and tweeting while they were there.
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The European Commission’s soon-to-be-published report on the EU Paediatric Regulation could lead to legislative changes that address some of the many problems pharma companies have with the 10-year old rules.
Europe’s medicines agency heads say they are pressing on as planned with the priorities and activities in the joint “strategy to 2020” they have with the European Medicines Agency. But this could change and, in any case, more resources are needed and agencies need to engage more to support delivery of their plan.
Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.