The European Commission has mounted a robust defence of its decision not to approve an orphan drug from a French company against the advice of the European Medicines Agency's scientific committee, the CHMP, and the standing committee of member state representatives1.
European Commission defends non-approval of orphan drug amid claims of "favouritism"
The European Commission has mounted a robust defence of its decision not to approve an orphan drug from a French company against the advice of the European Medicines Agency's scientific committee, the CHMP, and the standing committee of member state representatives1.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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