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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Dendreon says SEC begins informal inquiry related to Provenge

(Reuters) - The inquiry also covers Dendreon's marketing application for Provenge, the U.S. Food and Drug Administration's review of the vaccine and related correspondence to and from the company from Jan. 1, the company said in a filing on Tuesday. In May, the biotechnology company said the FDA issued an "approvable letter" for Provenge but wanted additional clinical data and more information about chemistry, manufacturing and controls.



The company said it intends to fully cooperate with the SEC.


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Staar Surgical gets FDA warning after inspection

(Reuters) - The FDA raised eight matters of concern at the time and
found four areas of noncompliance following Staar's initial
response to the FDA. Staar said it expects to provide its
written response to the FDA on or before the July 18 deadline
cited in the warning letter.




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Shire says gets U.S. approval signal on ADHD drug

(Reuters) - "The information requested by the FDA was not unexpected,
and Shire is working with the FDA to provide a full and timely
response to the agency's request," Shire said in a statement.




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New Pfizer AIDS drug approval delayed

(Reuters) - Pfizer received a so-called approvable letter from the Food and Drug Administration for the twice-a-day pill that is the first drug designed to keep the HIV virus that causes AIDS from entering healthy immune cells. Older AIDS medicines attack the virus itself.



The company said it was in discussions with the FDA to address the agency's outstanding questions and finalize the product labeling as soon as possible.


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J&J's Cordis unit resolves issues with FDA

(Reuters) - CHICAGO, June 14 - Johnson & Johnson on Thursday said its Cordis unit, which makes cardiovascular devices, has resolved its issues with the U.S. Food and Drug Administration, clearing the way for the introduction of new products.



Cordis, best known for its Cypher drug-eluting heart stent, has been operating under a warning from the FDA since April 2004. Regulators cited problems with internal procedures, including many issues with manufacturing processes.


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US FDA panel will advise on communicating risks

(Reuters) - The new advisory committee "will bring together a broad
range of experts and views to help improve FDA's communication
of the science-based information about product risks and
benefits that the public needs to make informed decisions,"
Randall Lutter, FDA's acting deputy commissioner for policy,
said in a statement.




Fifteen voting members will sit on the panel. The FDA said
they would include experts on risk communication, social
marketing, health literacy, journalism, bioethics and other
relevant fields.


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