Regulation & Policy

European Commission proposes a relaxation of rules on drug information

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

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Location

Belgium

UK government asked to raise investment in biotech

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.

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Location

United Kingdom

EMEA to propose making more regulatory data public

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.

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Location

United Kingdom

Pfizer withdraws application to switch Viagra to OTC status

Pfizer Ltd has withdrawn its application to the European Medicines Agency to switch the classification of Viagra (sildenafil) from a prescription-only medicine to an over-the-counter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.

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Location

United Kingdom

Six new medicines given the go-ahead by the EMEA

The European Medicines Agency has recommended that six new medicines be given marketing authorisations for the European Union.

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Location

United Kingdom

Sanofi-Aventis Pharma withdraws application for new docetaxel indication

Sanofi-Aventis Pharma SA has withdrawn its application to extend the indication for its cancer treatment, docetaxel, following questions from the European Medicines Agency about the design of the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.

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Location

United Kingdom

EMEA calls for suspension of Janssen-Cilag’s pain relief drug

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.

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Location

United States

UK announces new drug pricing agreement

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).

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Location

United Kingdom

Ban proposed on the use of great apes in research

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.

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Location

Belgium

Sanofi-aventis discontinues all trials of Acomplia

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.

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Location

France

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