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Life Sciences weekly highlights—4 October 2018

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Published on: 04 October 2018

Published by a LexisNexis Life Sciences expert

Table of contents

Disputes and regulatory enforcement
General Court dismisses action to annul EMA decision to disclose clinical study report (Amicus Therapeutics UK Ltd v European Medicines Agency)
Research and development
Horizon 2020 grant recipients asked to input information to new system
Eighth joint BIA/MHRA conference report published
New European Medicines Agency website launched
Data protection and life sciences
‘Learning healthcare system’ needed to realise full potential of real world data
International
Three new guidance documents published by FDA

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Article summary

This week’s edition of Life Sciences highlights includes analysis of the General Court’s judgment dismissing an action to annul the EMA’s decision to disclose clinical study report in Amicus Therapeutics v EMA, details of a new bespoke portal for Horizon 2020 grant recipients, and news that the FDA has published three new guidance documents.

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