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- PMLiVE

Qsiva

- PMLiVE

EMA’s Pharmacovigilance Risk Assessment Committee gains new members

Filip Babylon to represent HCP organisations and Albert van der Zeijden to represent patient organisations

- PMLiVE

AbbVie sues EMA to block Humira data release

Pharma company seeks injunction following FOI requests for raw data

- PMLiVE

EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

- PMLiVE

CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

- PMLiVE

Gentium expects EMA rejection for defibrotide

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

- PMLiVE

GSK signs obesity research deal with Vanderbilt University

Follows increased push from pharma to tackle the public health challenge

- PMLiVE

Bayer’s Diane 35 faces ban in France

Follows investigation into blood clot-related deaths

- PMLiVE

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

- PMLiVE

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

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