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- PMLiVE

Rare disease UK

J&J files intravenous Simponi formulation in US

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

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

Takeda completes new manufacturing facility in Russia

Expands Japanese firm’s presence in key emerging market

- PMLiVE

J&J responds to FDA concerns over Xarelto in ACS

Responds to regulator about missing clinical trial data

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

- PMLiVE

Takeda’s Revestive becomes first approved drug in Europe for short bowel syndrome

Can reduce dependency on intravenous feeding

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

- PMLiVE

COPD needs to learn risk reductions lessons from heart disease

Takeda-backed report says HCPs working in COPD need to learn from progress made by their colleagues in cardiovascular medicine

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