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- PMLiVE

EMA backs Lundbeck’s Brintellix in depression

Drug recommended for approval to treat major depressive episodes in adults

- PMLiVE

Leo Pharma plans to share trial data from 2014

"It is the right thing to do" says UK managing director

- PMLiVE

EMA defends position on patient-level data

Regulator claims pharma industry fears over transparency are unfounded

- PMLiVE

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 

- PMLiVE

EU launches black triangle drug monitoring scheme

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

- PMLiVE

AZ moves closer to EU approval for ovarian cancer drug

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

- 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

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