Archive for July, 2008

FDA urges genetic test before using Glaxo AIDS drug (Reuters via Yahoo! News)

and urged its inclusion in Ziagen's prescribing instructions, Rhyne declared.

The recommendation for the screening test is now included in a "black box" on Ziagen's label. A black box is the strongest type of warning for prescription drugs.

The step is not the same move toward personalized medicine, a drive to determine which drugs work best, or may be mischievous, for individual patients.

In Glaxo's study, excluding people with the gene diversity cut the reaction abuse to 3.4 percent from 7.8 percent.

Based on those findings, it was estimated that 61 percent of patients with the deviation would develop the reactions, compared with 4 percent of those without it, the Ziagen label says.

Symptoms of the reactions include fever, rash, nausea, vomiting and fatigue.

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Blood test shows no alcohol in blood of sheriff who struck girl with car (The Tennessean)

The district attorney

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Report: Virginia lab says it has HGH urine test (ESPN)

A Virginia company claims to have a urine-based test for common to mankind growth hormone that could be used to drug test athletes two weeks after its use, rather than 48 hours or less.

The company, Ceres Nanosciences, says the test eliminates the need for blood tests to descry HGH. Players’ associations take pushed back on blood tests. Ceres says its example can be available within six months, end the World Anti-Doping Agency.

The story was first reported through the Washington Business Journal.

Current tests track HGH use simply within the past 48 hours. The two-week test, and having it be urine-based, would theoretically make it harder for athletes to evade an HGH test.

A WADA spokesman said the organization is encouraging Ceres to continue researching the experiment.

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Cooperation of drug maker led to positive test at Tour (USA Today)

Donze indicated other drug manufacturers have been cooperating with WADA in the fight against illegal doping.

“WADA has relationships with pharmaceutical companies developing a varied assortment of substances,” he reported.

California-based Amgen, which produces couple EPO drugs, has been in operation for years with Don Catlin, a founder of the UCLA Olympic Analytical Lab, according to company spokesman Mary Klem. The company recently awarded a research grant to improve on current EPO testing methods.

“Amgen is committed to combating inappropriate use of its vital medicines,” Klem said.

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FDA urges genetic test before giving AIDS drug (St. Louis Post-Dispatch)

A small percentage of abacavir users suffer so-called hypersensitivity reactions, either when they start the drug or when they resume using it after more interval. Symptoms be able to include fever, rash, nausea and breathing difficulties.

The association between the variant in the immune system gene and jeopardize of the reactions was first reported several years ago. But FDA officials said a randomized clinical trial had since definitively proved the value of the genetic prescreening.

The study, published in The New England Journal of Medicine in February, cast that prescreening reduced the incidence of suspected hypersensitivity reactions to 3.4 percent, from 7.8 percent.

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US urges genetic test before using Glaxo AIDS drug (AlertNet)

(Adds details in succession changes to drug label, rates of reactions) By Lisa Richwine WASHINGTON, July 24 (Reuters) - AIDS patients should have a genetic test in front of treatment with GlaxoSmithKline Plc’s <GSK.L> drug Ziagen to see whether they face a higher risk of a potentially fatal reaction, U.S. regulators reported on Thursday. For patients who test positive for a specific gene variation, Ziagen treatment "is not recommended and should be considered only in the state exceptional circumstances when the potential benefit outweighs the risk," the Food and Drug Administration said in a notice on its website. Read more

Industry helping catch drug cheats, says WADA (EARTHtimes.org)

Sydney - Italian cyclist Ricardo Ricco was caught for blood doping at the Tour de France by a molecule deliberately placed in the banned drug by its manufacturer, drugs in sport watchdog John Fahey before-mentioned on Wednesday. The World Anti-Doping Agency (WADA) head Fahey said he believed Ricco thought there was no test on the side of the red-cell booster called CERA (Continuous Erythropietinm Receptor Activator) he was using. But pharmaceuticals group Roche had cooperated with WADA to place a molecule in it to help authorities detect illegal use. “I can’t tell you the details of how he was detected,” the Australian Fahey told national broadcaster ABC. “I can betoken the specific stuff is called CERA … Read more

Scientists say breakthrough urine test for HGH developed (USA Today)

The researchers initially weren’t out to combat doping in sports. They were fighting cancer.

“Our aim wasn’face to face to clean up jest like some social Santa Claus,” says George Mason life sciences professor Emanuel Petricoin, a member of Ceres’ scientific advisory board. “We locked onto HGH because it presented us by a challenge due to the fact it’s such hard to detect. As a sports cool, it’d subsist great to know there could be a more-level playing field.”

“We’re more fans of cancer research,” says Lance Liotta, a George Mason University period of life sciences professor and also on Ceres’ scientific advisory board.

Creating a test for HGH is more of a waystation for Ceres.

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Cholesterol Drug Fails Cardio Test (CBS News)

(AP) In the latest disappointment for cholesterol pill Vytorin, a major European study in patients with heart valve disease set up the drug didn’face to face prevent worsening of the disease or subside the need for valve surgery, sending its makers’ stock plunging.

Results of a preliminary dissection of the just-completed study showed Vytorin, marketed jointly by Merck & Co. and Schering-Plough Corp., was no better than placebo at lowering the risk of greater cardiovascular events — including heart attack, attack, heart surgery and death — in patients with aortic stenosis. Read more

FDA Clears Osmetech’s Warfarin Sensitivity Test and New eSensor(R) XT-8 Platform (Centre Daily Times)

Osmetech plc (AIM:OMH), the fast growing international molecular diagnostics company, announces that it has accepted 510(k) release from the US Food & Drug Administration (’FDA’) for its eSensor Warfarin Sensitivity Test to be used as an aid in the identification of patients at risk for the sake of increased sensitivity to the widely used blood-thinning drug, warfarin. The Company also announces that the FDA clearance includes its second body of equals in age eSensor XT-8 molecular diagnostics platform.

James White, Chief Executive, Osmetech plc, said:

“The FDA clearance is an important milestone for Osmetech.

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