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- PMLiVE

EMA suspends generic drugs on data integrity concerns

Reports by FDA and WHO find evidence of data manipulation by Semler Research Centre

- PMLiVE

HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

EU flag

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

EMA recruits patient voices for its management board

Continues its drive to embed patients' values within drug assessment

- 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

- PMLiVE

Cell Therapy licenses heart failure therapy in Japan

EMA may grant Welsh-based biotech a marketing application in mid-2016

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