Among the numerous amendments introduced by the European Parliament to the European Commission’s pharmaceutical legislative reform is a dilution of the additional regulatory data protection (RDP) available when a company is awarded a “transferable exclusivity voucher” (TEV) for the development of a “priority” antimicrobial drug.
EU Parliament Waters Down Planned Antimicrobial Voucher Scheme
In the second in a series of articles on amendments to the EU pharmaceutical reform proposals, the Pink Sheet looks at changes made by the European Parliament to the “transferable exclusivity voucher” and its ideas for a milestone payment and subscription-model scheme.

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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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