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Biotech / Medical : Incyte (INCY) -- Ignore unavailable to you. Want to Upgrade?


To: scaram(o)uche who wrote (2990)11/16/2013 3:35:43 PM
From: rkrw  Read Replies (2) | Respond to of 3202
 
I think this has actually been known for a couple of weeks....


This was from just yesterday.



Dear list members,


As some of you may already be aware, Sanofi halted their drug trial for their SAR302503 (Fedratinib) yesterday afternoon as requested by the FDA. We were just informed that a formal press release would not be issued until early Monday morning, but were asked by the Sanofi representative to give the following information to our list members.

The drug company became aware of some negative safety signals ie 4 cases of a serious condition called Wernicke-Korsakoff syndrome. This is a condition caused by a thiamine (B1) deficiency usually associated with alcohol abuse or malnutrition.
This disorder can severely effect the neurological system, and those on the drug have been ordered to stop taking it, have some blood test done right away and take thiamine supplements.

Sanofi is working with the FDA to investigate this further and will update us as they get more information.
There are presently 300 patients on this drug around the world, and 48 of those are in the US.

The company wants to be sure that everyone understands that the four reported cases could be due to some other cause and not related to Fedratinib, and that this is only a precaution until further studies have been completed.

We will post the press release as soon as we receive it.



To: scaram(o)uche who wrote (2990)11/19/2013 7:58:58 PM
From: scaram(o)uche  Read Replies (2) | Respond to of 3202
 
Anybody remember if Sanofi got anything other than fedratinib when they gobbled TargeGen?

Fun chart of the day.......

finance.yahoo.com