Unanimous FDA advisory panel backing for NPS Pharma's Gattex
The US Food and Drug Administration’s Gastrointestinal Drugs Advisory Committee yesterday voted unanimously to recommend approval of NPS Pharmaceuticals' (Nasdaq: NPSP) Gattex (teduglutide) for adults with short bowel syndrome (SBS).
Trading in NPS shares was suspended yesterday while the advisory panel deliberated on Gattex, but rose 19% to $10.86 last Friday after FDA staffers issued what were viewed as favorable briefing documents. The committee’s recommendation will be considered by the FDA in its review of the company’s New Drug Application for Gattex. The Prescription Drug User Fee Act (PDUFA) date for completion of the review is December 30, NPS noted.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
More Features in Pharmaceutical
| Headless Content Management with Blaze