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Latest From Maureen Kenny
The CHMP has upheld its previous negative opinion on Sarepta’s DMD treatment Exondys, but has given a raft of positive opinions on other novel products, including Lilly’s new migraine prophylactic Emgality, Spark Therapeutics’ gene therapy Luxturna for retinal dystrophy, and Vabomere, The Medicines Co/Rempex Pharmaceuticals’ new antibiotic for severe infections.
The European Medicines Agency’s key scientific committee, the CHMP, is deciding whether a raft of new products, including Eli Lilly’s galcanezumab, should be approved for sale across the EU. Sarepta’s appeal of the CHMP’s earlier rejection of its marketing application for Exondys is also slated for a decision.
He’d rather Brexit weren’t happening, but senior European regulator Thomas Senderovitz says the national medicines agencies across the EU are on track to cope with the expected loss of the UK – a key player – from the EU pharmaceutical regulatory network. There’s no alternative, and they’re putting lots of work into preparing for it, he tells the Pink Sheet.
Clusters of excellence, competition as well as co-operation, Brexit, and aiming high. Danish Medicines Agency head Thomas Senderovitz talks national agencies and engagement in an interview with the Pink Sheet.
Thomas Senderovitz will chair the management group of the EU Heads of Medicines Agencies for at least the next two years. The Danish regulator tells the Pink Sheet of his big plans for the network.
The European Medicines Agency and drug regulators throughout the EU are having to invest huge amounts of time and effort in dealing with the fall-out from Brexit - and it hasn't even happened yet. Plans for working together on bigger issues agreed on a few years ago will likely have to change, senior regulator Thomas Senderovitz tells the Pink Sheet.