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Clinical reports

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HIV prevention pill heads July CHMP recommendations

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

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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

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EU clears AZ’s FDA-rejected diabetes combination

Approval of two-drug therapy Qtern presents first-to-market advantage in Europe

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Celgene’s Revlimid cleared for aggressive lymphoma type in EU

Analysts anticipate sales of up to $10bn for the newly-expanded drug in coming years

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Gilead’s Zydelig passes EMA safety review

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

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

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

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EC approves Bial’s Parkinson’s disease therapy

Ongentys will be given a phase roll-out in 2016 and 2017

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Amgen’s Kyprolis wins new indication in Europe

Regulators have handed the treatment a less restrictive licence in multiple myeloma 

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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

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Teva’s asthma treatment Cinqaero set for European approval

CHMP backs the antibody therapy for eosinophilic asthma

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AZ gets EU green light for new antibiotic Zavicefta

EMA approves combination drug for treatment of multidrug resistant infections

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