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EMA backs adjuvant use of Roche’s breast cancer ADC Kadcyla

Could face tough competition soon from a number of rivals

- PMLiVE

Novartis’ Mayzent and Roche’s Polivy lead CHMP recommendations

Sanofi Genzyme’s Lemtrada and Pfizer's Xeljanz receive label restrictions

- PMLiVE

Provention Bio wins PRIME designation for type 1 diabetes prevention drug

Meanwhile J&J partnered Crohn's drug flops in phase 2

- PMLiVE

Merck wins CHMP recommendation for Ebola vaccine

Has also been granted priority review by FDA

- PMLiVE

CHMP backs Bayer’s tumour-agnostic drug Vitrakvi

GW Pharma’s Epidyolex also on the recommended list

- PMLiVE

Brexit “having impact on EU drug development”

EMA and UK regulator both affected

- PMLiVE

AVEO warns EU approval of Fotivda could be at risk

Concerns arose with overall survival data

- PMLiVE

EMA could follow FDA’s Xeljanz blood clot warning

European agency in step with FDA after safety doubts

- PMLiVE

Big opportunities in big data, but EMA and industry just getting started

250m genomes sequenced, but data trapped in silos

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