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Ruling favors Merck in next Vioxx trial phase
Biotech | 2007/03/05 15:44

Merck & Co. won't have to defend against claims that the painkiller Vioxx caused a Wisconsin man's fatal heart attack during the second phase of a trial that begins today.

Judge Carol Higbee in Atlantic City on Monday rebuffed a request by Brian Hermans' family to let jurors consider whether Vioxx caused the accountant's death. The jury ruled on Friday that Hermans had been adequately warned of the drug's risks.

 
The jury also found that Merck, the third-largest U.S. drugmaker, didn't properly warn another man, Frederick Humeston. Humeston's attorney will present evidence in the trial's second phase that Vioxx caused his client's September 2001 heart attack. Merck faces 27,000 lawsuits over Vioxx, which was pulled from the market in 2004.

"We're pleased with the judge's decision," said Kent Jarrell, a Merck spokesman. "We are preparing for the second phase of the trial, where we believe the evidence will show Vioxx did not cause Mr. Humeston's heart attack."

Merck, based in Whitehouse Station, has won eight verdicts and lost four on the question of whether Vioxx caused patients' heart attacks. In the latest Atlantic City trial, jurors found that Merck warned Hermans of the risk by changing Vioxx's label in 2002.

The panel also concluded in both the Hermans and Humeston cases that Merck misrepresented the risks in marketing Vioxx, and that its handling of the drug violated New Jersey consumer laws, entitling the families to triple reimbursement for their expenses for Vioxx, plus payment of legal fees.



FDA poised to approve antibiotic for cattle
Biotech | 2007/03/04 08:59

The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the Food and Drug Administration's scientific advisers that the decision will be dangerous for people.

The drug, called cefquinome , belongs to a class of highly potent antibiotics that are among medicine's last defense against several serious human infections. No drug from that class has been approved in the United States for use in animals.

The American Medical Association and about a dozen other health groups warned the FDA that giving cefquinome to animals would probably speed the emergence of microbes resistant to that class of antibiotic, as has happened with other drugs. Those super-microbes could then spread to people.

Echoing those concerns, the FDA's advisory board last fall voted to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.

But the FDA is expected to approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented "guidance document" that codifies how to weigh threats to human health posed by proposed new animal drugs.

Industry representatives say they trust Guidance 152's calculation that cefquinome should be approved. But others say Guidance 152 makes it too difficult for the FDA to say no to some drugs because it requires that the agency show a direct link to human mortality



Nano-Tech Solutions to Detect Cancer Developed
Biotech | 2006/12/25 20:14

A team of Korean scientists said they have developed a technology to use nano-particles to draw clinical images of cells involved in cancer, which could bring a breakthrough in the early detection of the disease.

Researchers led by Cheon Jin-woo and Seo Jin-seok said in a paper published on the Internet site of Nature Medicine on Monday that their new technology allowed magnetic resonance imaging (MRI) scans to find cancer cells less than 2 millimeters in size. Conventional MRI tests could only distinguish cells of a larger size, which are found only after the cancer is further developed.

A nano-particle is a microscopic particle whose size is measured in nanometers, or one billionth of a meter. Recent scientific research has proved nano-particles to be useful in detecting tumors due to their abilities to act as imaging agents and make cells and tissues more visible in MRI scans.

The nano-particles developed by the Korean researchers could be swallowed like a pill or injected through a catheter into the human body. Their function is to detect cancer and other diseases in their early developmental stages.

Among the commonly used nano-particles in MRI imaging is CLIO, which was developed by scientists at Harvard University. In their paper in Nature Medicine, the Korean scientists claimed that their new nano-device performed better than CLIO in MRI experiments, generating a signal that was about 10 times more intense.




Australian Senate lifts therapeutic cloning ban
Biotech | 2006/11/08 09:27

The Australian Senate voted Tuesday to lift restrictions on stem cell research and permit the therapeutic cloning of human embryos. By a 34-32 vote, lawmakers approved the Prohibition of Human Cloning for Reproduction and the Regulation of Human Embryo Research Amendment Bill 2006, which also includes stricter penalties of up to 15 years in prison for anyone convicted of attempting to buy human egg, sperm or embryo faces.

Australia's parliament voted in 2002 to allow researchers to extract stem cells from extra embryos originally intended for use in in vitro fertilization, but did not permit the use of those cells in cloning. The Australian House of Representatives will consider the latest legislation later this month.



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