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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Icebrg who wrote (8368)5/15/2003 1:06:57 PM
From: Biomaven  Read Replies (2) | Respond to of 52153
 
Thanks, Erik - I didn't know that. So maybe the FDA will be reasonable going forward.

The FDA's original distaste for combination drugs comes from them seeing this as an attempt to extend patent life and they also saw it as taking away dosing flexibility. But of course they sometimes do approve them - KOSP's Advicor is an example, and in antibiotics there is the commonly used Bactrim (Trimethoprim-Sulfamethoxazole combo).

Peter



To: Icebrg who wrote (8368)5/15/2003 4:16:52 PM
From: Icebrg  Read Replies (1) | Respond to of 52153
 
Another drug heading towards approval.

US FDA panel backs asthma drug Xolair
Thursday May 15, 4:01 pm ET

GAITHERSBURG, Md., May 15 (Reuters) - A U.S. advisory panel on Thursday supported the injectable drug Xolair for treating asthma, the airway disease that afflicts millions of Americans.

The panel voted unanimously that Xolair's benefits outweighed its risks. Xolair is being developed by Genentech Inc. (DNA), Novartis AG (NOVZn.VX) and Tanox Inc. (TNOX).


So much for the cancer "scare" and doubts expressed about efficacy in the briefing papers. Now Genentech and partners will just have to find a way to sell the drug. I believe I saw somewhere that it will cost 1.000 USD per month to use it.

Erik