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- PMLiVE

adverse events

- 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

EMA publishes drug shortages plan

Globalisation of manufacturing among key issues to address

- PMLiVE

EC consults on launch timing for new pharmacovigilance symbol

Wants to know how introduction of 'black symbol' will affect pharma

Roche - Basel

Roche offers compromise in Tamiflu data debate

Comes as EMA holds workshop on clinical trial data and transparency

Novartis building

CHMP backs Novartis’ Bexsero, Exjade

European recommendations for meningitis vaccine and thalassaemia treatment

Roche - Basel

EMA launches probe into Roche’s adverse event reporting

Pharma company allegedly failed to follow pharmacovigilance procedures

- PMLiVE

Vivus fails to get European backing for obesity treatment Qsiva

EMA raises concerns about drug’s cardiovascular safety

- PMLiVE

Abbott stops kidney disease drug trial on safety concerns

Concerns about excess serious adverse events and mortality in patients taking bardoxolone methyl

- PMLiVE

Novo Nordisk files new haemophilia drug in EU, US

Seeks approval for turoctocog alfa shortly after vatreptacog alfa pulled

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