Regulation & Policy

The European Medicines Agency is recommending that four new drugs be allowed onto the market in Europe including a new therapy from Sanofi-Aventis for the treatment of atrial fibrillation.

The European Medicines Agency has recommended that two vaccines for influenza A (H1N1), known as swine flu, be granted a European Union-wide marketing authorisation. The vaccines are Focetria from Novartis and Pandemrix from GlaxoSmithKline.

The European Commission’s research partnership with industry aimed at finding new ways of making drug development more efficient is preparing to launch a new series of projects valued at €156.3 million

Regulators who strive to ensure the safety of medicines sometimes give different advice to companies developing drugs than do health technology assessment (HTA) bodies that rule on the cost effectiveness of the same drugs.

Geron Corporation of Menlo Park, California, has submitted further animal data to the US Food and Drug Administration on its first-in-man study of a stem cell treatment for spinal cord injury and the agency has put a clinical hold on the study.

The European Medicines Agency gave a record number of positive opinions for new medicines in 2008. However the number of applications that were rejected by the agency, or withdrawn by the applicant, also increased significantly, according to the EMEA’s 2008 annual report.

The European Medicines Agency has given positive opinions for five new medicines, including a biologic from Novartis to treat a rare auto-inflammatory disease and a new indication for Roche’s MabThera for relapsed chronic lymphocytic leukaemia.

Studies suggesting that use of the diabetes treatment, Lantus (insulin glargine), could be linked to cancer have been investigated by the European Medicines Agency which has concluded that the medicine is safe to prescribe.

The European Commission has opened antitrust investigations against Servier, one of France’s largest pharmaceutical companies, and a number of generic manufacturers for suspected breaches of EU competition law. These are the first proceedings to be brought after its 18-month pharma industry probe.

Five new medicines, including a cell-based treatment for cartilage defects, have received positive opinions from the European Medicines Agency, paving the way for the issuing of marketing authorisations by the European Commission.