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- PMLiVE

soft tissue sarcoma

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

FDA clears six new drugs in time for the new year

Brings 2012 tally to 39 – the highest for more than 15 years

- PMLiVE

Lilly pays $29m to settle foreign bribery charges

US Securities and Exchange Commission charges centre on activities in Russia, China, Brazil and Poland

- PMLiVE

New EC anti-smoking plans include ban on flavoured tobacco

Pictorial health warnings on cigarettes and regulation for e-cigarettes also proposed

- 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

Early FDA approval for Ariad’s leukaemia drug Iclusig

Available in US three months ahead of schedule

- 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

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