Antibiotic Development Incentive Menu: Options Getting Longer
This article was originally published in RPM Report
Congress continues to look at ways to stimulate more research on anti-infectives. The list of potential incentives gets longer each time another drug category wins a new form of incentive. None of the ideas has succeeded yet in coalescing a political consensus; but potential legislative vehicles are out there.
You may also be interested in...
Antibiotic Incentive Bill Reintroduced: Industry Hopes for 2012 Enactment
The bill focuses on particularly virulent, resistant pathogens and also includes priority review designations and review of FDA guidelines.
Antibiotic Development: Where Wall Street Guidance Is Watching FDA Guidances
FDA’s effort to create a clearer path for antibiotic development has produced a series of new guidance documents. Those guidances are making some products in development look well-positioned for regulatory review, and rekindling the interest on Wall Street in specialty antibiotic firms.
Forest Labs Had Effective "Co-Sponsor" for Ceftaroline Review
FDA got a chance to show off its ability to stimulate antibiotic development during an advisory committee review of a new cephalosporin from Forest Labs. In the past, the agency has been faulted for failing to set clear targets for anti-infective trials; with ceftaroline, the agency went to the other extreme, stepping in to support an application with key re-analyses of data.