News in brief

Latest news from the European Commission and the European Medicines Agency (EMEA)

Commission targets lab laws

The European Commission has asked the European Court of Justice to declare that special restrictions on the ownership of capital in biomedical laboratories are illegal across the EU. In a test case, Brussels is opposing laws in France that include a ban on non-biomedical firms owning more than 25% of a company operating such laboratories.

Orphan drug fees slashed

The European Medicines Agency (EMEA) has scrapped fees for small-and-medium-sized companies developing orphan drugs to encourage their production. From 1 February, EMEA has offered a "100% reduction" in marketing authorisation applications; protocol assistance and follow up; pre- and post-authorisation inspections and other activities. These reductions are available only for medicines accepted as orphans by the European Commission.

Smart capsules guided to target

An EU-funded research project called SonoDrugs is developing tiny, image-guided medicine capsules conveying doses through blood vessels to the centre of an infection or disease, after which the drugs are activated by ultrasound pulses. This new technology is initially being developed for cardiovascular disease and cancer by the Euro 10.9m project, which includes Dutch electronics giant Philips, Nanobiotix of France and Lipoid of Germany, as well as academics from the UK, the Netherlands, Germany, Cyprus, Belgium, France, Italy and Finland. A Philips note said: "By locally delivering appropriate drugs only where they are needed, these new drug delivery techniques could increase the therapeutic efficiency."

Scientists probe genetic code of C difficile

Scientists in the UK, Germany, France, Italy, the Netherlands and Slovenia are mapping the genetic code of superbug Clostridium difficile to develop effective antibiotics or even a vaccine. The bug is often present in hospitals where it is hard to destroy through disinfection and infections are hard to treat. The EU is funding this "HYPERDIFF" study with â"šÂ¬3m in grants. Its research teams will be using so-called "gene knockout technology" to isolate and study certain genes and assess their role in highly virulent strains of the bacteria. Professor Nigel Minton, of the UK's University of Nottingham, said participants would "identify their differences to..standard strains".

The European Commission has released updated guidelines on the manufacture of medicines from human blood or plasma;

The Commission has released a revised guideline on the readability of medicine labelling and packaging;

And it has asked for comments on its appointment of members representing patients' organisations at the committee for orphan medicinal products of the European Medicines Agency (EMEA);

Meanwhile, the European Medicines Agency (EMEA) has released a guideline on required clinical documentation for orally inhaled products;

And EMEA has released a guideline on clinical investigation of medicines treating hypertension; epilepsy; and alcoholism;

EMEA has also issued advice for companies requesting scientific advice or protocol assistance.