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ALSO NOTED: Acomplia linked to deaths in the U.K.; Does HDL really prevent heart disease?; and much more...

> While the FDA has been slammed by some drugmakers for its too-conservative approach to drug approval, it may have Read more...

ALSO NOTED: AMA joins DTC advertising fray; U.K. toughening up on pharma promos; and much more...

> We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. What we didn't expect was for the American Read more...

ALSO NOTED: The WSJ profiles the FDA's lead regulator for cancer; Living Cell raises funds; new approach to gene therapy; and m

> The argument over the FDA's role in regulating cancer therapies often comes down to one man: Dr. Richard Pazdur, a veteran oncologist and chief of the agency's oncology office. Read more...

JAMA editor won't ban authors for nondisclosure

On the advice of attorneys, the editor of the Journal of the American Medical Association says she won't ban authors who fail to disclose their financial ties to the drug industry, as a ban might spur antitrust suits. A ban "would only encourage that author to send his or her articles to another journal; it cleans our house by messing others," says Catherine DeAngelis, who has been highlighting cases of authors who fail to adhere to JAMA's disclosure rules. Critics who had been …

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Study authors failed to note ties to drug companies

In a study published last February in the Journal of the American Medical Association, a group of experts warned women that if they stopped taking their antidepression drugs they seriously raised their risk of relapse. But The Wall Street Journal notes that most of the authors have long-standing financial ties to drug companies that make antidepressants. None of those ties were revealed in the study. The authors and the drug companies say that the ties did not influence …

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Chantix outperforms Zyban in major study

New clinical studies in the Journal of the American Medical Association back up Pfizer's claims for the smoking cessation drug varenicline, which will hit the market as Chantix next month. The studies cover the results for 2,000 volunteers and found that 44 percent of the people taking Chantix continued to abstain from smoking after 12 weeks of therapy compared to 30 percent for subjects taking Zyban and 17 percent who took a placebo. Those results will give Chantix considerable …

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AMA wants moratorium on new drug ads

The American Medical Association is pushing for a moratorium on advertising new drugs, saying that there should first be a period in which doctors can learn about the new pharmaceuticals. Many in the drug industry have resisted a moratorium, insisting that advertising was a key method of educating the public.

- here's the report on the AMA from the Chicago …

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New study highlights risks of anti-TNF antibody class

A new study in the Journal of the American Medical Association concludes that people taking Abbott Laboratories' Humira or Johnson & Johnson's Remicade--both blockbuster meds--face triple the risk of cancer and double the risk of infections. While the chances of getting either cancer or an infection are still small, the study's authors conclude, these anti-TNF antibody drugs still pose threats that people should consider carefully. The drug makers responded by saying that the …

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ALSO NOTED: NitroMed raising funds; PharmaGap releases data; NexMed garners $8M; and much more...

> NitroMed is raising more than $58 million through the sale of 6.1 million shares in order to launch its first product. Report

> PharmaGap has released the first animal efficacy data for its novel lead drug compound, PhGalpha1, a selective inhibitor of Protein Kinase C-alpha. …

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Researchers link clotting drug to serious side effects

Novo Nordisk's clotting drug NovoSeven has been linked to a host of serious side effects, including deaths, strokes and heart attacks. The drug was approved by the FDA in 1999 to stop the bleeding of hemophiliacs. But physicians have also been using the drug--which costs $7,500 a dose--to treat cerebral hemorrhages. The side effects were largely concentrated among the cases involving off-label drug uses. The authors of the report at the FDA's Center for Biologics Evaluation and Research …

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