The European Medicines Agency is recommending new marketing authorisations for three proprietary medicinal products, one of which was cleared following an appeal. The EMEA’s recommendations are usually endorsed by the European Commission, which has the power to issue authorisations.
Sanofi-Aventis has been told by the European Medicines Agency that patients taking its obesity treatment, Acomplia (rimonabant), are at risk of depression. The agency is therefore recommending the drug be pulled from the European market.
Governments in the industrialised world have revolutionized drug development over the past 25 years with the introduction of orphan legislation encouraging companies to invest in new products to treat rare diseases. Legislation in the US, Europe, Japan and elsewhere gives incentives to companies to start looking after the medical needs of patients with rare, but life-threatening diseases. The concept of ‘orphan’ derives from the fact that these patients had previously been ‘orphaned’ by the pharmaceutical industry.
The number of new applications for marketing authorisations in the first half of 2008 was steady compared with a year earlier, but requests for scientific advice increased by 28% over the same period, the European Medicines Agency said in its latest statistical overview of the pharmaceutical market.
The European Medicines Agency and the US Food and Drug Administration have agreed to expand the number of occasions on which they exchange confidential commercial data to include information about advanced-therapy medicines and medicines derived from nanotechnology as well as pharmacovigilance information.
Governments in the European Union are being urged to choose the most effective new medicines in deciding which products to subsidise under their publicly-funded health systems.
Innovation has been a widely discussed topic in Europe ever since political leaders of the European Union pledged in March 2000 to invest heavily in knowledge-based industries to create new jobs and support the region’s high standard of living. So what does spending on innovation mean for the pharmaceutical industry?
The European Medicines Agency has given positive opinions for three new medicinal products, thereby paving the way for the European Commission to issue marketing authorisations. The products are:
One of the European Commission’s biggest ever antitrust probes – an investigation into competition in the pharmaceutical industry – is drawing to a close.
The UK’s Human Fertilisation and Embryology Authority, which regulates in vitro fertilisation treatment and embryo research, has appointed six new members.