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- PMLiVE

etesevimab

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J&J files HIV combination in Europe

Seeks approval for fixed-dose tablet containing Prezista and Gilead’s cobicistat

- PMLiVE

Orexigen files obesity drug in EU

Company expects Contrave to show positive cardiovascular safety 

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EU launches black triangle drug monitoring scheme

New pharmacovigilance symbol will be used by all drugs needing additional monitoring

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AZ moves closer to EU approval for ovarian cancer drug

Olaparib on course to be first PARP inhibitor available for ovarian cancer

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

Takes issue with FDA's narrow risk-benefit focus

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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

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