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- PMLiVE

Gaucher disease

- 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

FDA sued for approving high dose of Eisai’s Alzheimer’s drug Aricept

Consumer rights group Public Citizen claims the high-strength dose is unsafe

Novartis building

FDA panel backs Novartis’ updated cystic fibrosis drug

New version of inhaled tobramycin therapy is simpler to use

- PMLiVE

US drug approval numbers fall despite pharma investing more in R&D

Stricter FDA policies are partly to blame for the decline says GBI Research

Pfizer gets US approval for leukaemia drug Bosulif

FDA grants the tyrosine kinase inhibitor a licence to treat chronic myelogenous leukaemia

EMA grants accelerated assessment to Ariad’s leukaemia drug

Could cut months off approval decision for ponatinib

Astellas wins US approval for prostate cancer drug Xtandi

Pharma company and its partner Medivation gain FDA licence for type of late-stage prostate cancer

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