1. Pink Sheet
  2. >>R&D

War on C Difficile Is Being Fought On Multiple Fronts

 
• By Bridget Silverman

Pivotal trials are underway for two microbiota restoration therapies, a narrow-spectrum antibiotic and a vaccine; funding from non-profits and new owners have revived stalled projects at Summit, Deinove and MGB Biopharma.

Clostridium difficile bacteria isolated on black background, 3D illustration. Bacteria which cause pseudomembraneous colitis and are associated with nosocomial antibiotic resistance - Illustration

While the fight against antimicrobial resistance often produces more lamentation than new products, some long-stalled therapies for the notoriously challenging bacteria Clostridium difficile have recently shown new signs of life.

Funding from the US government, through the Biomedical Advanced R&D Agency (BARDA), helped Summit Therapeutics PLC start its Phase III trial of the antibiotic ridinilazole. The French biotech Deinove...

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 R&D

EMA Official Clarifies Benefits & Limitations Of Innovation Pathways

 
• By Eliza Slawther

A European Medicines Agency official provided an overview and update of the support the EMA offers developers of innovative products and discussed, among other things, its Innovation Task Force, Quality Innovation Group and a scientific advice pilot for clinical trials.

EU Emergency Response Authority Needs Bigger Budget To Address Health Threats, Says Industry

 
• By Eliza Slawther

The EU must renew the mandate of its Health Emergency Response Authority to support medicine stockpiles and enable agile manufacturing to combat antimicrobial resistance and chemical, biological, radiological and nuclear threats, says trade organization EUCOPE.

Canada Cuts Red Tape With Single Ethics Review For Trials Clone

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.

More from Pink Sheet

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By Lisa Takagi

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.

Drug, Biologic Policy Staff Return To US FDA, As RIF Process Hangs In Legal Limbo

 
• By Sarah Karlin-Smith

The FDA employees with reduction-in-force notice rescissions include some who work on user fee negotiations, but staff still subject to RIFs will not officially separate from the agency this week due to ongoing legal challenges.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.