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- PMLiVE

Clinical reports

- 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

IQWiG: Key data missing from public trial reports

German HTA body claims drug studies published in journals contain ”insufficient information"

EU flag

Pharmacists back trial transparency in Europe

European Association of Hospital Pharmacist supports EMA’s plans to improve access to study results

- 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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