News in Brief
The European Commission has released guidelines on how pharmaceutical companies should make applications for their medicines to be designated orphan drugs, and so benefit from the privileged marketing approvals available under EU law. The paper gives supplementary advice on how to compile documents required by the regulators. Full version: www.emea.eu.int/pdfs/human/comp/628300en.pdf
An international agreement has been signed to develop a new combination antimalaria drug. Called pyronaridine-artesunate, it will be jointly developed by the Tropical Diseases Research Programme, the Medicines for Malaria Venture and South Korea's Shin Poong Pharmaceuticals. It could be registered by early 2006.
The European Court of Justice has quashed a ban imposed in 2000 by the European Commission on certain slimming drugs. It ruled that Brussels had exceeded its powers by withdrawing a 1996 marketing authorisation for products containing amphetamine-like anorectic agents (amfepramone, clobenzorex, fenproporex, norpseudoephedrine and phentermine). The court said the EC had acted on a changed interpretation of existing data, rather than on the facts. Companies involved included Artegodan, Bruno Farmaceutici, Schuck, Laboratorios Roussel, Laboratoires Roussel Diamant, Gerot Pharmazeutika, Cambridge Healthcare Supplies and Laboratoires Pharmaceutiques Trenker.
A new subsidiary has been launched in Sri Lanka by the country's STC General Trading Co. Ltd to import cheaper generic drugs. STC Medical Ltd will start commercial operations in January, initially importing five widely used generic drugs: amoxicillin, cefalexin, enthromycin, metfomin, and atenolol. Commerce and consumer affairs minister Ravi Karunanayake praised the launch for 'bringing down retail pharmaceuticals prices through generic drugs and parallel imports.'
Aventis Pasteur has donated 30m doses of oral polio vaccine to the WHO's Global Polio Eradication Initiative, helping a campaign by 16 west African countries to vaccinate all children under five. Immunisation campaigns over the past two years have cut the number of polio-endemic countries in Africa from 20 to three.