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- PMLiVE

Qsiva

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AbbVie sues EMA to block Humira data release

Pharma company seeks injunction following FOI requests for raw data

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EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

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CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

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Gentium expects EMA rejection for defibrotide

Negative feedback for drug’s use in liver condition associated with stem cell transplantation

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GSK signs obesity research deal with Vanderbilt University

Follows increased push from pharma to tackle the public health challenge

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Bayer’s Diane 35 faces ban in France

Follows investigation into blood clot-related deaths

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EMA starts contraceptive safety probe

Follows French investigation into Bayer’s Diane 35

Novartis building

Novartis withdraws application for Ruvise approval in EU

Had submitted imatinib mesylate for use in hypertension

- PMLiVE

EMA publishes marketing application guidance for pharma

Aims to clarify what to include in summaries of product characteristics

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Pfizer gets CHMP backing for leukaemia drug bosutinib

Provides option for patients resistant to tyrosine kinase inhibitors

- PMLiVE

Santhera’s Raxone turned down for rare eye condition

EMA concerned about drug's ability to improve eyesight

- PMLiVE

EMA recommends suspension of Merck’s Tredaptive

Pharma company had already anticipated decision by withdrawing product worldwide

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