Brexit: New Deadlines Kick In For Industry And ‘Reassigned’ Rapporteurs
The European Medicines Agency has announced the post-authorization procedures that the newly reassigned (co-)rapporteurs must start handling as of this month.
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EMA To Re-Prioritize Tasks To Cope With ‘Higher Than Expected’ Staff Losses
The EMA is to further refocus on its core activities to help it deal with “higher than expected” staff losses due to its relocation to Amsterdam.
BMS & Pfizer Win Funding ‘Firsts’ In England For Migraine & Heart Disease Drugs
Bristol Myers Squibb and Pfizer both asked the health technology assessment body NICE to evaluate their respective drugs, Camzyos and Vydura, for use in indications that are narrower than those for which they are – or will potentially be – approved.
New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add a new product – Tibsovo, Servier’s treatment for IDH1-mutated acute myeloid leukemia and IDH1-mutated cholangiocarcinoma.