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Gilead’s First-In-Class Drug For Aggressive Breast Cancer On Track For EU Approval

Conditional Approval In Store For Janssen’s Non-Small Cell Lung Cancer Treatment

Executive Summary

EU reviewers have recommended five new medicines and a pneumococcal vaccine for EU-wide approval. New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

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EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from, among others, Janssen, Sanofi, Boehringer Ingelheim and Mirum.

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Gilead Awaits EMA Verdict On Trodelvy As It Whizzes Through EU Review

Sponsors of six new products, including a first-in-class treatment for unresectable locally advanced or metastatic triple-negative breast cancer, will find out this week if their products are on course to be approved for use in the EU. Also, two sponsors might be asked to address last-minute questions about their drugs.

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