Novartis Faces The Music Over EU Piqray Review
Green Light Possible At EMA But Scrutiny Continues
Novartis is hoping to address EU regulators’ concerns regarding Piqray and to persuade them that the new advanced breast cancer treatment is fit for approval.
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EU Indication Restricted For Novartis's Newly Approved Piqray
Piqray is now approved for use in almost 50 countries but not only did the novel drug from Novartis for advanced breast cancer take longer to be approved in the EU than in the US, its indication is narrower in the EU. This is the first of two articles based on the European public assessment report for the PIK3 inhibitor.
EU Approval Nod Possible For Novartis, Gilead/Galapagos, and Janssen
The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.
Crunch Time At EMA For Luspatercept And Glasdegib
Eight new marketing applications including ones from BMS/Acceleron Pharma and Pfizer are up for an opinion at the April meeting of the European Medicines Agency’s drug evaluation committee, the CHMP.