European Medicines Agency (EMA)

Infliximab biosimilars to launch in the UK as innovator product reaches patent expiry

Napp 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The average time it has taken for a drug to be withdrawn following deaths attributable to it has remained constant at four years since the middle of the last century.…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.…

First-in-class oral drug approved for psoriasis conditions in Europe

The European Commission has authorised apremilast (Celgene’s Otezla), a first-in-class oral drug for the treatment of chronic plaque psoriasis and psoriatic arthritis in patients who have failed first-line systemic therapies.…

Drug shortages: it’s time for Europe to act

Unlike the United States, Europe has no plan for coordinated action to mitigate drug shortages.…

EMA recommends suspending licences for 700 drugs over flawed analyses by GVK Biosciences

The European Medicines Agency is recommending that the marketing authorisation be suspended for more than 700 generic products tested by GVK Biosciences.…

EMA recommends approval of liraglutide as weight loss drug

The European Medicines Agency is recommending that the prescription-only injectable drug liraglutide (Saxenda) should be granted a marketing authorisation as a weight loss product.…

EU approval of AbbVie’s hepatitis C combination therapies challenges Gilead’s Harvoni

A highly effective therapy for patients with hepatitis C is being launched by AbbVie in the EU over the next couple of months in direct competition with another treatment made by Gilead that was approved in 2014 and is now being rolled out. …

Searching social networks to detect adverse reactions

Regulators and pharmaceutical companies are monitoring social media posts for potential adverse drug reaction signals.…