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Arimoclomol & Ipique Developers To Make Their Case For EU Approval

Orphazyme & Rotterdam Biologics Are Scheduled To Present Before The EMA This Week

 
• By Neena Brizmohun

The sponsors of two investigational drugs that have previously experienced key regulatory setbacks are set to give oral explanations to the European Medicines Agency about why they believe their products should be approved in the EU.

eye with flag
EU approval is being sought for an ophthalmic bevacizumab drug • Source: Alamy

Orphazyme and Rotterdam Biologics are due to appear before the European Medicines Agency this week to explain why their respective investigational drugs – arimoclomol and Ipique (bevacizumab) – should be approved for marketing in the EU.

Both companies have previously experienced key regulatory setbacks for their products – Orphazyme in the

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