CorMedix Launches Catheter Lock Product In Germany, Looks Ahead To U.S.

The company is shipping Neutrolin, a device containing an antimicrobial/antifungal agent and two anti-clotting agents, in Germany to “lock” catheters between dialysis sessions and prevent blood stream infections and clots. The New Jersey firm also is working with FDA to get the product approved in the U.S. as a specialty pharmaceutical.

It’s been a long time getting to market for CorMedix Inc.’s Neutrolin since the company licensed the product in 2008, but the product, which can prevent blood stream infections and clots in central venous catheter-using patients, is being shipped to dialysis centers in Germany now. CorMedix is also in discussions with FDA about a regulatory path forward for Neutrolin as a specialty pharmaceutical product in the U.S.

Bridgewater, N.J.-based CorMedix obtained worldwide development, manufacturing and marketing rights to Neutrolin from ND Partners LLC in February 2008 when...

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 Germany

CSL Makes Landmark National-Level Pay-For-Performance Deal In Germany For Hemgenix

 

A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.

German Ordinance To Implement HTA Reg Leaves Room For Doubt

 

A German ordinance implementing the EU Health Technology Assessment Regulation offers little clarity on how far joint clinical assessment reports should be considered by national authorities.

German, Dutch And Italian HTA Processes Not Supportive Of RWD, Say Companies

 

Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.

German Agency’s 2025 Plan Highlights EU HTA Reg, Long Covid And Smoking Cessation Drugs

 

An ordinance came into effect on 8 March to ensure that joint clinical assessments can be incorporated into the German pricing and reimbursement system.

More from Europe

Danish Probe Could Influence Rethink Of Controversial EU Urban Wastewater Rules

 

Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By 

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

New EU Filings

 

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.