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- PMLiVE

European Ombudsman

- PMLiVE

EASD 2013: Sanofi justifies decision to withdraw US filing for Lyxumia

Takes issue with FDA's narrow risk-benefit focus

- PMLiVE

GSK’s Revolade cleared for use in hepatitis C therapy

Adds to drug’s existing thrombocytopenia indication

Roche - Basel

Roche’s Kadcyla and Bayer’s Xofigo near EU approval

Cancer drugs receive CHMP backing

- 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

AllTrials unveils manifesto for clinical trial transparency

Sets out plan for greater access to drug data

- 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

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