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- PMLiVE

Protelos

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

- PMLiVE

EMA recommends suspension of Merck’s Tredaptive

Pharma company had already anticipated decision by withdrawing product worldwide

EMA launches eSubmission web tool

Will accept eCTD applications from January 15

- PMLiVE

EMA starts probe into MSD’s Tredaptive

Will investigate cholesterol drug's safety and efficacy after poor phase III results

- PMLiVE

EMA to focus on efficiency, transparency and new legislation in 2013

Regulator also plans significant staff reorganisation

Novartis building

Novartis’ Exjade gets EU approval for thalassaemia

First oral treatment for condition characterised by red blood cell problems and anaemia

- PMLiVE

EMA: move to greater clinical trial transparency ‘irreversible’

New Europe data rules could be ready by 2014

- PMLiVE

NICE backs Servier’s heart failure drug Procoralan

But recommendation includes a number of restrictions that limit NHS use of the drug

- PMLiVE

EMA publishes drug shortages plan

Globalisation of manufacturing among key issues to address

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