European Medicines Agency (EMA)

European conditional approval given for rare liver disease drug

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a new drug to treat a rare and potentially lethal liver disease for conditional marketing approval across the EU.  Obeticholic acid (Ocaliva; Intercept Pharma) has been re…

The history of antibiotic use in livestock and its contribution to antimicrobial resistance

‘One health and the politics of antimicrobial resistance’, by Laura Kahn.…

European medicines regulator sets out plans for revamped drug database

An electronic database containing information about all human medicines approved across Europe that will be accessible to the public as well as health professionals is being developed by the European Medicines Agency.…

The BMJ accuses drug company of withholding data on faulty test device in rivaroxaban trial

Janssen may have withheld data from the US Food and Drug Administration about a faulty blood testing device used in a trial of the anticoagulation drug rivaroxaban, according to the results of an investigation by The BMJ.…

Irritable bowel syndrome drug given green light for use in Europe

The European Commission has granted a marketing authorisation to a first-in-class treatment for irritable bowel syndrome (IBS) called eluxadoline (Truberzi) for use in the EU.…

Olaratumab fast-tracked for approval across EU

A new cancer drug to treat certain adult patients with rare soft tissue sarcoma is being fast-tracked for conditional approval across the EU.…

Breast cancer drug that extends life given nod by European regulator

A new breast cancer drug that could delay the progression of the disease for an extra ten months has been recommended for approval by the European Medicines Agency.…

Biosimilars and inflammatory bowel disease: a switch programme using CT-P13

How to plan and manage switching patients from a biologic to a biosimilar in inflammatory bowel disease, using the University Hospital Southampton NHS Foundation Trust’s experience as an example.…

First drug licenced in Europe for pre-exposure prophylaxis against HIV

The European Commission has approved the first drug for pre-exposure prophylaxis (PrEP) against HIV for use in Europe following a positive recommendation by the European Medicines Agency (EMA) in July 2016. Gilead Sciences has been granted a licence to market emtricitabine/tenofovir disoproxil…

Injectable asthma drug reslizumab approved by European Commission

The European Commission has approved a marketing authorisation for reslizumab (Teva Pharmaceutical Industries’ Cinqaero), an injectable treatment for use in severe asthma.  The decision follows a recommendation in June 2016 by the European Medicines Agency’s Committee for Medi…