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Tislelizumab & Tremelimumab Among Latest Filings In EU

Executive Summary

The sponsors of two monoclonal antibody products, tislelizumab and tremelimumab, are each seeking marketing approval for more than one indication.

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New EU Filings

Tislelizumab, Novartis/BeiGene’s drug for treating esophageal and non-small cell lung cancer, is among the latest new medicines that have been submitted for review for potential pan-EU approval.

EU Accelerated Assessment Tracker

Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.

Coronavirus Notebook: EMA Starts Review Of Sanofi/GSK Vaccine, UK Boosts mRNA Lipid Production

Sanofi/GSK's vaccine is under review in the EU and the UK government has awarded a grant to a company to allow it to increase its production of a key component of mRNA vaccines. Also, EU member states have proposed ways of improving the supply and donation of COVID-19 vaccines, including for those fleeing the conflict in Ukraine. Germany’s InflaRx has reported “encouraging” results with its anti-inflammatory drug vilobelimab in seriously ill patients.

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