Wyeth says confident in Pristiq depression filing

(Reuters) - Gary Stiles, chief medical officer of Wyeth, told reporters
in a conference call the FDA has requested a new safety trial
of Pristiq for hot flashes due to elevated liver enzymes seen
in three women among 2,000 tested in Wyeth-sponsored trials of
the drug for a common symptom of menopause.




" liver enzymes are not an uncommon phenomenon"
in drug trials, Stiles said. He said elevated levels of the
enzymes -- which are considered a marker of potential damage to
the liver -- returned to normal levels when patients stopped
taking Pristiq.


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Neurochem's tramiprosate gets FDA fast-track

(Reuters) - TORONTO, July 24 - Neurochem Inc. said on Tuesday the U.S. Food and Drug Administration has designated its tramiprosate treatment as a fast-track product for the treatment of Alzheimer's disease.



The biotechnology company said it planned to meet with the FDA in August to discuss its Phase 3 program and provide an update on North American Phase 3 clinical trials.


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Lilly drug cuts some breast cancer risk-FDA staff

(Reuters) - Evista is already approved to treat osteoporosis in women
past menopause. The company is seeking approval to promote the
drug for the reduction in risk of invasive breast cancer in
postmenopausal women with osteoporosis and postmenopausal women
at high risk for breast cancer.




Studies provide less support for the proposed new use to
reduce the chances of invasive breast cancer in postmenopausal
women at high risk, FDA reviewers said.



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