Logo

European Medicines Agency

MGI Receives CE Mark, Regulatory Clearance in Asia-Pacific Countries for Several Sequencers

The clearances pave the way to clinical applications for three of MGI's instruments but the BGI subsidiary faces legal challenges from Illumina in Europe and the US.

Myriad Projects Stronger Revenue Growth in Second Half of FY2015 Driven by CDx, Prolaris
Premium

NEW YORK (GenomeWeb) – If AstraZeneca's PARP inhibitor olaparib is granted market approval by European and US healthcare authorities in the coming months, it would enable Myriad Genetics to begin marketing BRACAnalysis as a companion test for the first time.

Myriad Opens Tumor BRACAnalysis CDx Lab in Europe

NEW YORK (GenomeWeb) – Myriad Genetics announced today that it has established a European laboratory that will offer its Tumor BRACAnalysis CDx test to guide treatment with PARP inhibitors, namely AstraZeneca's olaparib.

Europe's Rx Risk Assessment Group Recommends Keeping Iclusig Indications Unchanged
Premium

Originally published Oct. 14.

MDx/CDx Focus: EMA Okays Perjeta; Published Study on Prolaris; HER2 Tests for Kadcyla Clear FDA
Premium

EMA Approves Roche/Genentech's Perjeta Roche has garnered approval from the European Medicines Agency for its HER2-positive metastatic breast cancer drug Perjeta.