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‘Surprised and Disappointed’ Santhera To Fight EU’s DMD Rejection

Executive Summary

Santhera has vowed to appeal against this week’s recommendation by the European Medicines Agency that the company’s application to extend Raxone’s indication to cover DMD be rejected. The agency recommended EU approval for four other drug applications seeking extended indications.

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Roche Fails Again To Convince CHMP On Ocrevus, Only Teva Gets A Thumbs Up

Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.

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