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- PMLiVE

adverse events

European orphan drug applications up 30 per cent

But lower than expected generics applications see EMA reduce new marketing authorisation forecast

EU flag

European pharmacovigilance changes approved

European Council formally approves new drug safety legislation

EMA recommends Lilly’s erectile dysfunction drug for enlarged prostate

Cialis would be first drug available in Europe for both ED and BPH

Almirall’s IBS drug Constella backed by CHMP

On track to become the first drug specifically approved for the condition

- PMLiVE

Vivus expects knockback from EMA for obesity drug

Setback comes despite US approval for Qsiva/Qsymia

Novartis building

CHMP backs trio of Novartis products

Including two diabetes drugs and one for non-cancerous kidney tumours

Bayer files low dose contraceptive patch for EU approval

Will offer alternative to J&J’s Evra

- PMLiVE

Sweden’s Tomas Salmonson to chair EMA’s CHMP

He replaces Eric Abadie who retired in April

- PMLiVE

EMA to consult children when reviewing paediatric medicines

Consultation launched on how best to obtain views of young people

- PMLiVE

EMA’s Stella Blackburn appointed president of International Society for Pharmacoepidemiology

Will continue as Agency’s risk management development and scientific lead

EMA wants pharma to see commercial potential in paediatric R&D

Publishes list of research needs for children’s cardiovascular medicines

- PMLiVE

MHRA’s Dr June Raine to chair new EMA pharmacovigilance committee

Pharmacovigilance Risk Assessment Committee (PRAC) will lead implementation of reforms

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