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- PMLiVE

EMA backs drugs from Novo, Otsuka, AZ, Janssen, GSK

Nine new branded medicines recommended for use in Europe

- PMLiVE

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

Bayer symbol

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

Advances pharma company’s ambitions in cancer

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

- PMLiVE

GSK submits Votrient for ovarian cancer in Europe

Pharma company hopes for extra indication for oncology product

EU flag

EC sets up expert group on rare diseases

Will revamp EUCERD to better handle development of orphan medicines

- PMLiVE

EMA’s head of human medicines development steps down

Patrick Le Courtois leaves regulator after 16 years

- PMLiVE

Boehringer’s first cancer drug leads EMA recommendations

Afatinib recommended for lung cancer under brand name Giotrif

- PMLiVE

Pfizer and Otsuka face drug rejections in Europe

EMA turns down Xeljanz for rheumatoid arthritis and delamanid for tuberculosis

- PMLiVE

EMA: no new safety concerns with GLP-1 diabetes drugs

CHMP takes issue with study that linked the treatments to serious side effects

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