NPS Gattex Launch Preparations Focus On Clinical Care Coordinators

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...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

More Telework, More Staff, US FDA’s Tidmarsh Plans To Alleviate Workforce Challenges

 

The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.

US Pricing Reform: New Products Offer ‘On Ramp’ To Implementation, Lilly’s Ricks Says

 
• By 

Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.

New US FDA CDER Director Pledges No Politics In Approvals, Adds Higher Ups Can Overturn

 

New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.

EU Must Up Competitiveness To Counter US Tariffs And Pricing Woes For SMEs

 

Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.

More from North America

HHS mRNA Vaccine Funding Cut Impact Limited (And One Contract Isn’t Even mRNA)

 

HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?

US FDA Requires Opioid Class Labeling Changes Despite Adcomm Advice

 
• By 

Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.