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- PMLiVE

Mysimba

- PMLiVE

GSK submits COPD drug in US and EU

Umeclidinium bromide intended as monotherapy for lung condition

- PMLiVE

Court blocks EMA release of pharma company data

AbbVie and InterMune successfully challenge request for trial data for Humira and Esbriet

- PMLiVE

Two new cancer drugs recommended in Europe

CHMP backing for Roche's Erivedge and Astellas' Xtandi

- PMLiVE

EMA refuses to back Pfizer’s Xeljanz in rheumatoid arthritis

Surprise after approvals in US and Japan

- PMLiVE

European drug applications ‘stable but more complex in 2012’

Despite austerity measures, EMA's annual report shows signs of biopharma resilience

- PMLiVE

EMA recommends heart risk restriction for Servier’s Protelos

Use of osteoporosis drug likely to be further tightened up

- PMLiVE

Sanofi’s four-strain flu vaccine Vaxigrip under review in EU

Pharma company also launches production of ingredient for malaria drug

- PMLiVE

Clinical trials for EMA-submitted medicines move away from US and Europe

Most trial patients for drug marketing applications to EMA now come from rest of the world

Agneta Brandt joins EMA as head of infrastructure

Joins as company prepares to move offices

- PMLiVE

EMA launches diabetes drugs safety review

Will investigate pancreatitis risks in two major drug classes

- PMLiVE

EU recommendations for Gilead, Ariad and Baxter drugs

EMA backs use of HyQvia, Iclusig and Stribild

- PMLiVE

CHMP backs oral MS drugs from Sanofi, Biogen Idec

Tecfidera and Aubagio recommended for use in Europe

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