Pfizer Ltd has withdrawn its application to the European Medicines Agency to switch the classification of Viagra (sildenafil) from a prescription-only medicine to an over-the-counter medicine.
The European Medicines Agency has recommended that six new medicines be given marketing authorisations for the European Union.
Sanofi-Aventis Pharma SA has withdrawn its application to extend the indication for its cancer treatment, docetaxel, following questions from the European Medicines Agency about the design of the clinical trial used to support the proposed new use.
The European Medicines Agency has recommended that the marketing authorisation for Ionsys (fentanyl hydrochloride), an opioid analgesic produced by Janssen-Cilag International NV, be suspended because of a defect in the delivery system that could result in patients being overdosed. Janssen-Cilag is an affiliate of Johnson & Johnson.
The UK Department of Health has reached an agreement with the pharmaceutical industry to change the way in which drugs are priced and supplied to the National Health Service (NHS).
The European Commission is proposing to ban the use of great apes in scientific research in a move to tighten up the regulation of animal studies.
Sanofi-aventis has stopped all clinical trials of Acomplia (rimonabant), which until recently had been sold on 32 markets around the world as a treatment for obesity. The trials were being conducted in order to investigate new indications for the drug in diabetes and heart disease.
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.