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- PMLiVE

eosinophilic

- 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

Bayer buys Teva animal health unit

Deal valued at $145m

- 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

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