European CHMP Opinions and MAA Updates
Executive Summary
This is a monthly update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
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Roche Wins Two French Early Access Programs In Breast Cancer
Roche's cancer drugs, Tecentriq (atezolizumab) and Kadcyla (trastuzumab emtansine), are the latest products to be granted French temporary use authorizations for new, as yet unapproved indications.
Janssen's Imbruvica Leads CLL Market Expansion In Europe
Imbruvica is keeping ahead of potential competitors in Europe by expanding its use in patients with chronic lymphocytic leukemia and Waldenström’s macroglobulinemia.
Amgen/UCB To Appeal EMA’s 'Over Cautious' Evenity Rejection
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.