The European Medicines Agency has announced the start of an in-depth safety review of Iclusig (ponatinib) in light of reports of cases of blood clots and blockages in the arteries or veins associated with the medicine’s use. ARIAD Pharmaceuticals is the manufacturer.
BTG Plc has received the go-ahead from the Food and Drug Administration to market a non-surgical procedure for the treatment of patients with varicose veins, a condition that is estimated to affect more than 30 million adults in the US from the ages of 18 to 70 years.
The Committee for Medicinal Products for Human Use has given positive opinions to seven new medicines including Gilead Sciences’ new treatment for chronic hepatitis C virus infection, sofosbuvir. The EMA issued the opinions on 22 November.
The US Food and Drug Administration has approved Olysio (simeprevir), a new therapy to treat hepatitis C virus infection developed by Janssen Research & Development LLC (Johnson & Johnson) and Medivir AB of Sweden.
The US Food and Drug Administration has approved a new indication for the Bayer/Onyx Pharmaceuticals cancer drug Nexavar (sorafenib), and also authorised a GSK vaccine for the prevention of H5N1 avian influenza.
Two US professional heart organisations have issued new guidance for the use of statins for heart disease, recommending that treatment focuses on healthy lifestyle and statins when necessary rather than routine use of low-dose statins to achieve cholesterol targets.
The European Medicines Agency has updated a regulatory guideline on antibiotic medicine development with a view to encouraging work on new agents that target multidrug resistance where patients have limited or no remaining treatment options.
Johnson & Johnson Inc and two of its subsidiaries have agreed to pay about $2 billion to the US government and state Medicaid programmes to settle a drug mis-selling case and related matters in which the company is alleged to have improperly promoted the antipsychotic drug Risperdal (risperidone) to elderly patients with dementia.
The US Food and Drug Administration has approved Roche’s Gazyva (obinutuzumab) in combination with the chemotherapy chlorambucil for patients with previously untreated chronic lymphocytic leukaemia (CLL).
UCB SA has confirmed that its underlying profitability will improve this year led by a trio of new products that address immune and central nervous system disorders. The company recently won expanded indications for one of these products, Cimzia (certolizumab pegol).