Antibiotic Development: Limited Population Pathway In US Removes Barrier

Allergan's Avycaz could be indicator of how FDA will use the 21st Century Cure's new approval mechanism; experts maintain the provision does not lower FDA's standards of safety.

Antibiotic resistant bacteria closeup biofilm

By codifying the removal of regulatory barriers, the limited population pathway provision for certain antimicrobial drugs in the 21st Century Cures Act will incentivize the development of infectious disease drugs that would impact small, specific populations, experts say.

There are several reasons why drugmakers have avoided antimicrobial development – antibiotic development in particular – over the past few...

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 Approval Standards

More from Pathways & Standards

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.