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- PMLiVE

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EU proposes reforms to make first-in-human trials safer

New guideline revision paper “takes into account lessons learnt” from fatal Bial trial

- PMLiVE

Gilead’s Zydelig passes EMA safety review

Risk of ‘serious infections’ outweighed by cancer drug’s benefits

- PMLiVE

EMA: ‘business as usual’ – for now – after Brexit

And says it will be up to remaining EU members to decide on its future location

- PMLiVE

Ypsomed’s touch screen insulin pump for Novo Nordisk approved by EMA

mylife YpsoPump given green light for use with pump cartridge NovoRapid PumpCart

Roche Basel Switzerland

Roche’s MS drug Ocrevus awarded priority review by FDA

Comes as Swiss company files the therapy with the FDA and EMA

- PMLiVE

Teva’s asthma treatment Cinqaero set for European approval

CHMP backs the antibody therapy for eosinophilic asthma

- PMLiVE

Merck starts pivotal trials of new antibiotic combination

Continues testing after positive phase II results for relebactam addition 

- PMLiVE

EMA recruits patient voices for its management board

Continues its drive to embed patients' values within drug assessment

Gilead Sciences

Gilead, Merck get CHMP backing for new hep C combinations

Approval of Epclusa and Zepatier will see the pan-genotypic drugs compete for market share

- PMLiVE

The Medicines Company appoints Biogen’s Tony Kingsley

He will be the New Jersey firm's president and COO

- PMLiVE

Stronger together

A patient-focused strategy is high on the agenda, with a top-down approach favoured by industry leaders

Bristol-Myers Squibb (BMS) building

BMS gets two new cancer approvals in Europe

Empliciti, and Opdivo and Yervoy inhibitor combination get the green light

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