Novartis gains two positive opinions from EMA/CHMP

24 July 2015

There was good news on Friday for Swiss pharma giant Novartis (NOVN: VX) with positive opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), one for a melanoma treatment and other for a blood disorder drug.

The CHMP has adopted a positive opinion for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The European Commission will review the CHMP recommendation and is expected to deliver its final decision within three months. The decision will be applicable to all 28 EU member states plus Iceland, Norway and Liechtenstein.

And Priority Review from FDA

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