Latest From Maureen Kenny
Eiger attributes the change in status of the EU marketing authorization application for lonafarnib to the need for an inspection and the ongoing coronavirus pandemic.
Piqray is now approved for use in almost 50 countries but not only did the novel drug from Novartis for advanced breast cancer take longer to be approved in the EU than in the US, its indication is narrower in the EU. This is the first of two articles based on the European public assessment report for the PIK3 inhibitor.
The withdrawal of the EU filing for abicipar pegol will fuel speculation that Allergan parent AbbVie is indeed ditching the potential treatment for wet AMD. US regulators have already said they won't approve the drug.
There is speculation that it is the end of the road for abicipar pegol but Allergan has declined to say whether this is the case for the product that has been in development for wet AMD.
Emer Cooke seems set to take over as head of the European Medicines Agency – one of the world's most powerful regulatory bodies – before the end of the year. We report on the reaction of a range of pharmaceutical sector stakeholders to her nomination.