EMA Shortens Regulatory Path For Antibacterials Against Multidrug Resistant Pathogens

This article was originally published in The Pink Sheet Daily

08 Nov 2013
News

John Davis john.davis@informa.com

Executive Summary

Following new guidance from the European Medicines Agency, marketing approvals for antibacterials against multi-resistant bugs could be granted in Europe on expanded Phase II clinical trial data, a path that multinational Roche is keen to explore.

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EMA Shortens Regulatory Path For Antibacterials Against Multidrug Resistant Pathogens

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