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EMA gives details of new ‘future-proof’ structure

Will divide into four key areas covering R&D, medicines evaluation, business support and pharmacovigilance

- PMLiVE

Dendreon’s cancer vaccine wins EU approval

Provenge approved for use in prostate cancer three years after US recommendation

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Amgen drug misses endpoint in acute heart failure trial

Company pledges to pursue development of omecamtiv mecarbil in chronic heart failure

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EU nod for Bayer’s Stivarga as Nexavar gets US priority review

Advances pharma company’s ambitions in cancer

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Amgen and Onyx agree $10.4bn takeover deal

Deal provides indication of the premium big biopharma will pay to replenish pipelines

EMA prepares for digital signature introduction

From next month will accept digital signatures for certain procedures

- PMLiVE

Amgen buys US rights to Servier’s Procoralan

Also obtains option to develop S38844 while Servier has option to commercialise omecamtiv mecarbil in Europe

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GSK submits Votrient for ovarian cancer in Europe

Pharma company hopes for extra indication for oncology product

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EC sets up expert group on rare diseases

Will revamp EUCERD to better handle development of orphan medicines

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EMA’s head of human medicines development steps down

Patrick Le Courtois leaves regulator after 16 years

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Boehringer’s first cancer drug leads EMA recommendations

Afatinib recommended for lung cancer under brand name Giotrif

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Pfizer and Otsuka face drug rejections in Europe

EMA turns down Xeljanz for rheumatoid arthritis and delamanid for tuberculosis

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