When the European Parliament adopted its position on the EU pharmaceutical package on 10 April 2024, it rejected most of its rapporteur's proposals to further reduce orphan medicine exclusivity (OME).
European Parliament Has Missed The Chance to Boost Orphan Drug Development
The European Parliament could have helped to stimulate R&D into new drugs for rare diseases if it had not stuck so closely to the European Commission’s original proposals on orphan exclusivity periods, say Baker McKenzie lawyers Els Janssens, Julia Gillert, Magda Tovar and Olha Sviatenka.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.