New Therapeutic Targets & A Rich Year For Approvals: EMA’s PRIME In 2020
Last year saw the number of applications accepted onto the European Medicines Agency’s priority medicines scheme inch up and the notoriously high rejection rate for applications drop.
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Vertex and CRISPR can now get access to the advantages afforded by the European Medicines Agency’s priority medicines scheme for both of the indications they are targeting with their investigational gene therapy, CTX001.
Zydus Cadila expects to launch its DNA COVID-19 vaccine in the first quarter of fiscal 2022 but it already has more advance purchase orders than it can produce. Meanwhile, the Indian firm is confident of saroglitazar being approved for primary biliary cholangitis in the US, with the NCE also poised to become the largest contributor to India sales in three to five years.
Companies find it challenging when it comes to preparing robust quality data packages for their marketing applications for investigational products that have made it onto the European Medicines Agency’s popular priority medicines scheme.