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Latest From Maureen Kenny
Members of parliament in the UK want the government to take "all necessary steps" to keep the country in the EU medicines regulatory network after Brexit. It's not that easy, though.
New medicines under evaluation at the European Medicines Agency.
Enasidenib, which last year became the first US-approved treatment for relapsed or refractory acute myeloid leukemia with an IDH2 mutation, is among a new crop of products being reviewed for marketing approval in the EU.
A listing of EU centralized approvals of new active substances, including brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Six orphan drugs – including the first two CAR-T cell therapies in the EU – may get the green light from the European Medicines Agency at its June meeting this week. Will the negative opinion handed down earlier this year on Puma Biotechnology’s Nerlynx be overturned, though?
J&J is hoping its experimental new drug for treatment-resistant depression will join the select group of products benefitting from speedy review in the EU.