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- PMLiVE

Mysimba

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

- PMLiVE

Takeda ends obesity alliance with Amylin

Comes more than a year after development of lead product was pulled

Novartis building

Novartis’ Exjade gets EU approval for thalassaemia

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

- 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

- 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

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