The EU institutions are taking steps to preserve the effectiveness of existing vaccines in the face of mutations in the SARS-CoV-2 virus.
The European Commission has issued draft legislation to speed up the approval of COVID-19 vaccines that have been modified to tackling emerging variants of the SARS-CoV-2 virus.
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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.
The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.
An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.
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.
