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- PMLiVE

faldaprevir

Novartis building

Novartis parts with Eisai to go it alone with COPD drugs

Ends co-promotion agreement for Onbrez, Seebri and QVA149

- 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Final draft guidance says treatment is cost-effective in diabetic macular oedema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 recommends approval for alcohol dependency drug

Lundbeck’s Selincro to be used in conjunction with psychosocial support

Sanofi reception

Blow for Sanofi as EMA turns down cholesterol drug Kynamro

Points to safety concerns related to liver toxicity and cardiovascular events

- PMLiVE

Roche’s Perjeta backed in EU for breast cancer

CHMP recommends use alongside Herceptin

- 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

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