Novartis, D&A Pharma Prepare For High-Stake EMA Meetings
Oral explanation meetings are due to take place this week for drug sponsors who have a final chance to address questions and concerns the European Medicines Agency has about their marketing applications.
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It has taken a while but European regulators have finally followed their US counterparts and approved Piqray, making it the first targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
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.
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.