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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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One In, One Out: Mirum Seeks New EU Indication For Maralixibat, Withdraws Another

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BeiGene’s Brukinsa Among Five Orphan Drugs Awaiting EU Approval Verdict

Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.

Switzerland Supports ‘Increasingly Important’ Decentralized Clinical Trials

A new position paper outlines several factors that sponsors must consider when planning to undertake decentralized clinical trials in Switzerland to ensure compliance with national legal and ethics requirements.

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