Regulation & Policy

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

Three proprietary drugs of US firms cleared by the EMEA

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.

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Location

United Kingdom

Sanofi-Aventis told to take obesity drug off the European market

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.

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Location

France

Editorial: the case for orphan antibiotics

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.

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Location

United Kingdom

EMEA says it is giving more advice but marketing applications are steady

The number of new applications for marketing authorisations in the first half of 2008 was steady compared with a year earlier, but requests for scientific advice increased by 28% over the same period, the European Medicines Agency said in its latest statistical overview of the pharmaceutical market.

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Location

United Kingdom

EMEA and FDA expand their cooperation

The European Medicines Agency and the US Food and Drug Administration have agreed to expand the number of occasions on which they exchange confidential commercial data to include information about advanced-therapy medicines and medicines derived from nanotechnology as well as pharmacovigilance information.

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Location

United Kingdom

EU governments urged to choose the most effective new medicines

Governments in the European Union are being urged to choose the most effective new medicines in deciding which products to subsidise under their publicly-funded health systems.

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Location

Belgium

Consensus emerging on pharmaceutical innovation in Europe

Innovation has been a widely discussed topic in Europe ever since political leaders of the European Union pledged in March 2000 to invest heavily in knowledge-based industries to create new jobs and support the region’s high standard of living. So what does spending on innovation mean for the pharmaceutical industry?

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Location

United Kingdom

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