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Article: Encysive Submits Thelin NDA In PAH, Seeks Accelerated Review.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
Encysive Pharmaceuticals Inc. set its lead drug candidate, Thelin (sitaxsentan), on the pathway toward approval for pulmonary arterial hypertension by filing a new drug application with the FDA.
"We're submitting this NDA and we hold worldwide rights," Encysive President and CEO Bruce Given told BioWorld Today, noting that the submission represents a clear transition from the company's past as a research and development shop designed for out-licensing. "So we really are in the driver's seat here."
Two years ago, the Houston firm paid $10 million to reacquire all rights to the drug from a joint venture through which its initial ...
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... ... to unload shares in Encysive Pharmaceuticals Inc ... to "a concern that Encysive won't be able to ... secondly, he told BioWorld Today, the FDA's action ... at $4.60. (See BioWorld Today, March 28, 2006 ... competitive reasons, he said Encysive would work toward resolution ...
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