Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

A new chapter that will be published in the European Pharmacopoeia soon is expected to provide a comprehensive framework for the production and quality control of cell-based preparations. Meanwhile, an existing chapter has been revised to facilitate the implementation of rapid microbiological testing methods.

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.