xolair - Peanut Allergy Information

xolair

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I thought I would post this in case anyone is interested in attending the meeting.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Pulmonary-Allergy Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the agency on FDA's regulatory issues. Date and Time: The meeting will be held on May 15, 2003, from 8 a.m. to 5 p.m. Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Kimberly Littleton Topper, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301-827-7001, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12545. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss biologics license application (BLA) 103976, XOLAIR Omalizumab (Humanized Monoclonal Antibody to Human IgE) by Genentech, Inc., for the treatment of allergic asthma. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by May 8, 2003. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 8, 2003, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kimberly Littleton Topper at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

On May 14, 2003

Oh dear. This really does sound like the proverbial rock and a hard place, doesn't it?

[url="http://money.cnn.com/2003/05/14/news/companies/xolair.reut/"]http://money.cnn.com/2003/05/14/news/companies/xolair.reut/[/url]

On May 16, 2003

all over the news, wondering what pa.com people are thinking and hearing???

On May 16, 2003

[url="http://www.nytimes.com/2003/05/16/business/16DRUG.html"]http://www.nytimes.com/2003/05/16/business/16DRUG.html[/url]

[This message has been edited by Joanne (edited May 16, 2003).]

[This message has been edited by Joanne (edited May 16, 2003).]

On May 16, 2003

Part of the problem with this drug is that it blocks the action of all IgE's present in the body in a non-selective way (non-specific antagonist). The IgE antibodies are in each of us do have a necessary biological function. Who knows what can happen if you esentially block the function of one part of your immune system for a long period of time. There are viruses that can cause cancer if left untreated. Is this what is happening? Who knows...

Disclaimer here: My company is working on a medication that would compete directly with Xolair albeit many years from now. The function of this drug would be VERY specific to asthma alone. Needless to say, if my company's drug works it would leave Xolair in the dust. Can't say more without risking my job!

Troy

On Jun 19, 2003

Good news about Xolair in today's Boston Globe: [url="http://www.boston.com/dailyglobe2/170/nation/Asthma_drug_has_promise_and_big_price+.shtml"]http://www.boston.com/dailyglobe2/170/nation/Asthma_drug_has_promise_and_big_price+.shtml[/url]

On Jul 11, 2003

Xolair will soon be distributed by Genentech to AdvancePCS, which is one of the largest pharmacy providers in the US. Hopefully, the other pharmacy providers will follow. This is so exciting.......

On Feb 27, 2004

reraising.

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