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- PMLiVE

Pharmathen

- 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

Shire Basingstoke

FDA finally approves Shire’s potential blockbuster Xiidra

Dry eye disease treatment wins US licence

- PMLiVE

Gilead’s Zydelig passes EMA safety review

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

EISAI

Eisai slams Cancer Drugs Fund ‘black hole’

Will consider legal action to address the ‘unfair and inequitable situation’ for UK cancer patients

- 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

- PMLiVE

FDA approves Gilead’s ‘universal’ hep C combination Epclusa

Adds a third Sovaldi-based treatment to the firm’s portfolio

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

Gilead Sciences

Gilead gets EU nod for TAF-based triple therapy for HIV

Once-daily, single-tablet Odefsey reduces risks of side effects such as renal and bone toxicity

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