1. Pink Sheet
  2. >>R&D
  3. >>Clinical Trials

Orexigen Defines A Way To Get The Contrave PDUFA Clock Ticking

 
• By Jessica Merrill

The summary report of an interim analysis of the ongoing LIGHT clinical trial evaluating the cardiovascular safety of the obesity medicine can form the basis of a resubmission of the Contrave NDA, the company announced, shaving some time off the PDUFA clock.

Orexigen Therapeutics Inc. is anxious to see its obesity medicine Contrave (naltrexone SR/bupropion SR) reach the market after watching two competitors pass by in the neck-and-neck race to bring the first novel obesity medicines to market in 13 years. The NDA for Contrave has been stalled at FDA after the agency required Orexigen to conduct a cardiovascular outcomes study in 2011 Also see "Losing The Battle Of The Bulge: FDA Holds Up Orexigen's Contrave" - Pink Sheet, 1 February, 2011..

But the company announced some progress Jan. 7 on a proposal that will get the PDUFA clock for the application ticking a little faster. In response to Orexigen’s formal Dispute...

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
Start Free Trial

Already a subscriber?

More from Clinical Trials

US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

More from R&D

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.