New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, including GlaxoSmithKline's Jemperli (dostarlimab), which is the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer.
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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.
The UK drug regulator, the MHRA, has approved its first product under Project Orbis, the US-led international regulatory collaboration scheme it joined four months ago to speed up access to promising cancer medicines.
Novartis has failed to reach a reimbursement agreement to keep its first-in-class advanced breast cancer drug on the German market, but it is pressing on with plans to expand market access for the product across Europe. It is also working on securing regulatory approval to use Piqray in a broader patient population that would carve out a more meaningful place in the relevant treatment pathway.