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Global Pharma Guidance Tracker – August 2021

Executive Summary

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

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

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 New uses of several approved medicines have also drawn the thumbs up, while the sponsor of a cancer drug has withdrawn its product from the review process.

Orphazyme Wants More Time To Deal With Late-Stage Issues For Arimoclomol In EU

Following Orphazyme’s disappointment in the US regarding its investigational drug for an ultrarare disease, the company has said it will need more time to address outstanding issues raised by EU reviewers about the same medicine.

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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