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- PMLiVE

safinamide

FDA launches safety probe into Boehringer’s Mirapex

Regulator concerned about potential heart risk link to Parkinson's disease drug

J&J files intravenous Simponi formulation in US

FDA approval would complement J&J’s current subcutaneously-administered product

- PMLiVE

J&J to launch ‘innovation centres’ in US, UK and China

Will target local life sciences partnerships in early-stage innovation

- 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

Cornerstone slumps as FDA panel votes down lead pipeline drug

US pharma company asked to conduct new trials for its hyponatremia treatment

- PMLiVE

FDA urged to give biosimilar medicines distinct scientific names

Alliance for Safe Biologic Medicines highlights safety concerns if different products have same name

- PMLiVE

FDA clears Sanofi’s oral MS drug Aubagio

Will compete with Novartis’ Gilenya

- 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

J&J responds to FDA concerns over Xarelto in ACS

Responds to regulator about missing clinical trial data

- 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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