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Review Pathway Europe Regulation

Novartis Seeks EU Fast Track For Iptacopan In Two Indications

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Executive Summary

Novartis will soon learn whether the European Medicines Agency will agree to grant its drug accelerated assessment status.

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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.

Europe's Unitary Patent System Starts Up Today

The forthcoming unitary patent system and Unified Patent Court promise to make applying for patents in Europe and litigating infringements simpler and less costly for applicants.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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