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Imminent EU CHMP Opinions: Kidney And Breast Cancer, Mastocytosis, MS, Emphysema & Hepatitis C

Executive Summary

Among products that are due for a go/no-go recommendation by the European Medicines Agency this week are new drugs for conditions such as cancer, multiple sclerosis, mastocytosis, HIV and hepatitis C.

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Rydapt set for EU approval after Novartis addresses CHMP concerns

Novartis’s new kinase inhibitor, Rydapt (midostaurin), for the treatment of AML and mastocytosis, could have got the thumbs up for EU approval in June but the committee that makes the decision, the European Medicines Agency’s CHMP, had concerns about the application. The CHMP has now issued a positive opinion for the orphan drug and formal EU approval is in sight.

Boehringer Ingelheim Limbering Up With Humira Biosimilar

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Applications for biosimilar medicines are continuing to arrive at the European Medicines Agency, with Sandoz’s versions of AbbVie’s Humira and Janssen’s Remicade having just been accepted for filing. This brings to 13 the number of biosimilars under evaluation; seven more are awaiting a marketing authorization decision from the European Commission.

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