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7 replies [Last post]
By mmgshih on Sat, 04-19-03, 14:31

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


Food and Drug Administration

Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
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).

Groups: None
By Corvallis Mom on Thu, 05-15-03, 00:00

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


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By esmom on Fri, 05-16-03, 12:09

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

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By Joanne on Fri, 05-16-03, 13:21


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

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

Groups: None
By choguy on Fri, 05-16-03, 14:39

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!


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By Heather2 on Thu, 06-19-03, 16:23

Good news about Xolair in today's Boston Globe:

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By docd3122 on Fri, 07-11-03, 21:45

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.......

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By MommaBear on Fri, 02-27-04, 21:18


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