PHARMACY

New device can recognize side effects without clinical trials

BY Adam Kraemer

GLASGOW, Scotland Scottish scientists have announced that they are developing a new way of testing experimental drugs which may limit the amount of animal/human trials needed.

A new device, the scientists say, can assess how a human cell responds to particular drugs and it records the pattern of responses, known as a signature pattern. The scientists hope to build up a huge bank of signature patterns for side-effects so that they can recognize any potential ill-effects when they test a new medicine.

The device, which they hope will be ready for use within four years, uses 1,000 sensors to “read” cells and can discover potential side effects within days, rather than through the trial-and-error of regular testing, which can take years.

The scientists said the nose could also cut the need to test on animals, as it would quickly weed out drugs which were toxic. “We hope that by being able to predict the side-effects we will be able to contribute a much better basis for making a decision on whether the drug should go forward or not,” said Professor Walter Kolch, lead researcher at the University of Glasgow.

Conversely, he said, the device will also be able to recognize the signature pattern of successful drugs, allowing researchers to use them as a basis for new, successful treatments.

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Congress passes bill giving $1.73 billion to FDA

BY Adam Kraemer

WASHINGTON Congress last week passed a consolidated appropriations bill, giving, among other things, nearly $1.73 billion to the Food and Drug Administration, more than $79 million over the president’s budget request.

In addition, the bill also gives the Center for Drug Evaluation and Research more than $682 million, of which $41.9 million is available for the Office of Generic Drugs, while the Center for Biologics Evaluation and Research would receive more than $236 million.

On Dec. 17, the House passed H.R. 2764 by a vote of 214–189, and the following day, the Senate passed a revised version by a vote of 76–17, The House agreed to send the revised version to the president, increasing 2007’s FDA funding by $145 million.

In addition, the committees encouraged the FDA to limit “to the greatest extent possible” granting financial conflict-of-interest waivers to advisory committee members, which has been a hot topic recently. While the committees were encouraged by the FDA’s announcement earlier this year that it would limit the number of waivers, they said the agency should do more.

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Cubist acquires Illumigen in potential $341.5 million deal

BY Adam Kraemer

SEATTLE and LEXINGTON, Mass. Cubist Pharmaceuticals may pay up to $341.5 million to buy Illumigen Biosciences, adding an experimental treatment for hepatitis C, a blood-borne virus that can damage the liver, to its pipeline.

Lexington, Massachusetts-based Cubist, the maker of the skin-infection drug Cubicin, will pay $9 million to acquire Seattle-based Illumigen, plus a potential $332.50 million in regulatory and drug development payments, the companies said today in a statement.

The purchase of Illumigen will add an experimental HCV treatment, called IB657, to Cubist’s portfolio of infection-fighting medicines. The HCV market, the companies said in a statement, was $2.2 billion in 2005 and is expected to reach $4.4 billion in 2010.

Cubist will make payments during the development of IB657 for hepatitis of up to $75.5 million and an additional $117 million if Cubist develops Illumigen products for other viruses, the companies said. The company will pay up to $140 million in milestone payments once products reach the market.

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