Regulation & Policy

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).

Since 2007, legislation known as the Advanced Therapy Medicinal Products Regulation (ATMP) has been in place to set regulatory standards for assessing gene, cell and tissue-engineered products. Yet in this time only four ATMPs have been approved for marketing.

The Committee for Medicinal Products for Human Use has given positive opinions to  a new drug for depression developed by H. Lundbeck A/S, and one for pulmonary arterial hypertension (PAH) by Actelion Ltd. The decisions were announced on 25 October.

The European Medicines Agency’s main scientific committee has recommended that patients with chronic hepatitis C virus infection before or after a liver transplantation be given the opportunity to be treated with the experimental drug sofosbuvir.