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Amgen/UCB To Appeal EMA’s 'Over Cautious' Evenity Rejection

Executive Summary

Amgen and UCB say that the European Medicines Agency’s re-examination process should allow them to clarify their position on the data supporting the marketing authorization application for their osteoporosis drug, Evenity. Meanwhile, three other drugs received a positive opinion from the EMA this week for pan-EU approval, including La Jolla’s Giapreza.

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