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NPS Gattex Launch Preparations Focus On Clinical Care Coordinators

 
• By Jessica Merrill

The rare-disease focused company is putting commercial plans in place for its first drug, Gattex, which could launch early next year, and is preparing to file a second NDA in mid-2013, later than expected due to requirements from FDA.

NPS Pharmaceuticals Inc.is looking beyond an FDA advisory committee meeting for Gattex (teduglutide) and laying the groundwork for what could be its first commercial drug launch early next year. The drug, developed for short bowel syndrome, an orphan indication that affects less than 15,000 patients in the U.S., is pending at FDA with a Dec. 30 action date.

First, Gattex will be scrutinized by FDA’s Gastrointestinal Drugs Advisory Committee on Oct. 16 Also see "Gattex Goes To...

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• By Sue Sutter

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• By Eliza Slawther

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Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

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