New EU Filings
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.