FDA CAPSULES

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FDA CAPSULES

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February 28, 2006

CLINICAL STUDIES OF WITHDRAWN MS DRUG TYSABRI. The Food and Drug

Administration will permit clinical trials of the multiple sclerosis

treatment Tysabri to resume, though concerns remain about the drug's

potential risks. A year ago, these concerns caused the FDA to

suspend clinical trials of Tysabri, and it was taken off the market.

Tysabri, however, has shown to be beneficial for certain patients,

who will be allowed to resume treatment in controlled studies after

discussing potential risks and benefits with their doctors.

www.fda.gov/bbs/topics/news/2006/NEW01319.html

BIOMARKER INITIATIVE AIMS TO SPEED CANCER THERAPY DEVELOPMENT. The

FDA is joining with the National Cancer Institute and the Centers

for Medicare and Medicaid Services to help improve development and

delivery of new cancer therapies. The joint agreement, called the

Oncology Biomarker Qualification Initiative, will center on use of

biological indicators called " biomarkers " to develop targeted cancer

diagnostics and treatments.

www.fda.gov/bbs/topics/news/2006/NEW01316.html

NEW TREATMENT FOR SERIOUS FUNGAL INFECTIONS. The FDA has approved

Eraxis, a treatment for certain infections caused by Candida, a

fungus that can cause serious infections in hospitalized patients or

in people with compromised immune systems. The FDA calls the

treatment " a helpful addition to the available antifungal

medications that can be used in the treatment of these potentially

serious fungal conditions. "

www.fda.gov/bbs/topics/news/2006/NEW01321.html

LATEST FDA CONSUMER MAGAZINE ONLINE. The latest issue of FDA

Consumer is devoted to the 100th anniversary of the signing of the

Pure Food and Drugs Act, a milestone often viewed as the beginning

of what became the Food and Drug Administration. The issue is online

at www.fda.gov/fdac/106_toc.html.

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