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- PMLiVE

EMA

- 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

- PMLiVE

Otsuka’s Pletal has use restricted in Europe

EMA recommends drug only be used in limited group of patients with blood supply disorder

- PMLiVE

Black triangle monitoring warning to be used across EU

Use of symbol is part of EMA plans to strengthen pharmacovigilance

- PMLiVE

Vanda withdraws EU application for schizophrenia drug

CHMP had previously refused to back the approval of Fanaptum

- PMLiVE

EMA’s Pharmacovigilance Risk Assessment Committee gains new members

Filip Babylon to represent HCP organisations and Albert van der Zeijden to represent patient organisations

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