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Drug Review Europe Regulation

New EU Filings

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Executive Summary

Teclistamab, Janssen’s bispecific antibody for treating multiple myeloma, is among the latest new medicines that have been submitted for review for potential pan-EU approval.

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EU Accelerated Assessment Tracker

Janssen-Cilag's EU filing for teclistamab is being reviewed under the European Medicines Agency’s accelerated assessment procedure. The outcome of Sanofi’s request relating to nirsevimab is not yet in the public domain.

Parsaclisib & Sirolimus Gel Filed In EU For Rare Diseases

Incyte’s next-generation PI3K-delta inhibitor, parsaclisib, and Nobelpharma’s topical sirolimus gel are among the latest marketing authorization applications that have been filed in the EU.

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.

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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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