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- PMLiVE

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- PMLiVE

NICE set to approve Novartis eye drug Lucentis

Final draft guidance says treatment is cost-effective in diabetic macular oedema

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

Year-end FDA approvals for Novartis, GSK drugs

Agency gives go-ahead to Cushing’s disease treatment Signifor and raxibacumab for inhalational anthrax

- 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

Novartis calls for improvements to UK clinical trial system

Says cost of running studies in the country undermines its attractiveness

- PMLiVE

EC consults on launch timing for new pharmacovigilance symbol

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

Novartis building

Novartis to issue stark warning to UK at crisis meeting

Says UK needs to address decline in pharma R&D

Roche - Basel

Roche offers compromise in Tamiflu data debate

Comes as EMA holds workshop on clinical trial data and transparency

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