Latest From Maureen Kenny
Alnylam and Eiger join the select group of companies whose products have been granted fast-track status at the European Medicines Agency
The European Medicines Agency produces a monthly list of the marketing authorizations that are under review at the agency. The latest list contains just two new entries.
A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.
Novartis is hoping to address EU regulators’ concerns regarding Piqray and to persuade them that the new advanced breast cancer treatment is fit for approval.
GSK secured accelerated assessment for dostarlimab at the European Medicines Agency but there was no such good news for Merck/AstraZeneca's selumetinib. MYR Pharmaceuticals' bulevirtide has reverted to standard review timelines.
Recommending new medicines for approval and allowing sponsors of others extra time to answer outstanding questions are among the many tasks on the agenda of the March meeting of European Medicines Agency's key scientific committee, the CHMP. The meeting has been taking place, remotely, this week.