How the pharmaceutical industry is contributing to antimicrobial resistance Through poor practices, the pharmaceutical industry is adding to the problem of antimicrobial resistance instead of helping to solve it.…
EMA recommends treatment for rare kidney condition The European Medicines Agency has recommended the approval of tolvaptan for the treatment of a rare inherited disease, autosomal dominant polycystic kidney disease.…
EMA recommends approval for advanced lung cancer agent ceritinibThe European Medicines Agency has recommended granting a conditional marketing authorisation for ceritinib (Zykadia) for ALK-positive non-small cell lung cancer in adults with advanced disease.…
US FDA approves antibiotic combination with new beta-lactamase inhibitor The US Food and Drug Administration has approved a new intravenous antibacterial product, Avycaz, which contains ceftazidime and a new beta-lactamase inhibitor, avibactam.…
Behind the scenes of medicines regulation Sir Michael Rawlins talks about how the MHRA intends to speed up approval of innovative medicines, involve pharmacists in reclassification and address drug shortages and trade in counterfeit medicines.…
US FDA gives green light for thyroid cancer drug lenvatinib Lenvatinib will be available in the United States by the end of February 2015 after its approval was fast-tracked by the FDA.…
Infliximab biosimilars to launch in the UK as innovator product reaches patent expiryNapp Pharmaceuticals and Hospira will both launch biosimilars of Janssen Biologic’s Remicade in the UK after its patent expires on 24 February 2015.…
Hydroxyzine safety measures loom after heart risk review The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has confirmed that hydroxyzine is associated with a “small but definite risk” of serious heart rhythm anomalies.…
Drug withdrawal delays are causing avoidable deaths, investigation finds The average time it has taken for a drug to be withdrawn following deaths attributable to it has remained constant at four years since the middle of the last century.…
New antibiotics for skin infections get seal of approval from European Medicines Agency Three new antibiotics to treat serious skin infections have been recommended for approval by the European Medicines Agency.…