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Takeda’s CMV Infection ‘Game-Changer’ Among EU Fast-Track Hopefuls

Calliditas Also Wants Accelerated Assessment For Novel Budesonide Drug

Executive Summary

Takeda, Calliditas and Bayer are set to learn whether the European Medicines Agency will grant their respective products accelerated assessment status when they file for pan-EU marketing approval.

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Gilead’s Lenacapavir, Takeda’s Maribavir Due For Oral Explanations At EMA

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EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency. 

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Novartis is one of the latest companies to fail in its attempt to have a marketing authorization application fast-tracked at the European Medicines Agency. There was better news for BioMarin. 

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