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EMA

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Second approval in US for Bayer-Onyx’ Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

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EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

Roche - Basel

Roche’s Herceptin follow-up cleared in US

FDA approval for Kadcyla (formerly T-DM1) in breast cancer

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Late-stage failure for Merck’s cilengitide in brain cancer

Integrin inhibitor unable to improve overall survival in phase III trials

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CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

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Gentium expects EMA rejection for defibrotide

Negative feedback for drug’s use in liver condition associated with stem cell transplantation

Search appears on FDA’s radar once again

Warning letter to Florida company puts new slant on regulator's digital focus

- PMLiVE

GSK’s COPD drug Anoro under review in US

FDA accepts new drug application for the LAMA/LABA combination

Sanofi reception

FDA to review Sanofi’s lixisenatide for diabetes

Follows drug's European approval under brand name Lyxumia earlier this month

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OncoAssist becomes latest app to be classified as a medical device

Cancer iPhone and iPad app offers clinical decision support tools

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Global counterfeit drug business driven by crime and corruption

Institute of Medicines says international cooperation needed to tackle falsified medicines

- PMLiVE

Genzyme’s Richard Moscicki joins FDA

Provides regulatory agency with more than 20 years of industry experience

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