Regulation & Policy

The European Commission is proposing that pharmaceutical companies be allowed to provide prescription-drug information directly to consumers, provided this is not advertising.

A group of biotechnology company chief executives and investors has called on the UK government to contribute at least £500 million for investment in Britain’s biotech sector, which can no longer count on getting sufficient funding from private sources because of the worldwide banking crisis.

The European Medicines Agency (EMEA) will soon propose a revision of its policy for the handling of commercially confidential information so as to make more regulatory documents available to the public.

Pfizer Ltd has withdrawn its application to the European Medicines Agency to switch the classification of Viagra (sildenafil) from a prescription-only medicine to an over-the-counter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Sanofi-Aventis Pharma SA has withdrawn its application to extend the indication for its cancer treatment, docetaxel, following questions from the European Medicines Agency about the design of the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.