There has been a recent surge in new confirmed cases of progressive multifocal leukoencephalopathy (PML) associated with the multiple sclerosis drug, Tysabri (natalizumab), with the 24th case reported to the EMEA on 25 October.
The European Medicines Agency is recommending that two new medicines, one of which is a radiopharmaceutical, be granted marketing authorisations. It has also given the go-ahead for new indications for four currently licensed treatments.
The European Medicines Agency has announced a review of the multiple sclerosis drug, Tysabri (natalizumab), in light of reports of 23 cases where patients taking the drug have developed a rare brain infection known as progressive multifocal leukoencaphalopathy (PML).
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 However the number of applications that were rejected by the agency, or withdrawn by the applicant, also increased significantly, according to the EMEA’s 2008 annual report.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.