Heparin

CorMedix Inc. Announces CMS Grants TDAPA to DefenCath

Retrieved on: 
Friday, April 19, 2024
FDA, CMS, ESRD, Drug, Safety, CLS, Heparin, Food, Kidney failure, CVC, HD, Incidence, Patient, Medicare

Joseph Todisco, Chief Executive Officer of CorMedix commented, “CMS determination of TDAPA eligibility for DefenCath is a critical step toward ensuring this innovative preventative drug product is available for patients in the outpatient dialysis setting.

Key Points: 
  • Joseph Todisco, Chief Executive Officer of CorMedix commented, “CMS determination of TDAPA eligibility for DefenCath is a critical step toward ensuring this innovative preventative drug product is available for patients in the outpatient dialysis setting.
  • DefenCath is contraindicated and has warnings and precautions in patients with:
    Known hypersensitivity to any drug products in DefenCath, including taurolidine, heparin or the citrate excipient or pork products.
  • If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.
  • To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin)

Retrieved on: 
Monday, April 15, 2024
FDA, CMS, Risk, Safety, CLS, Heparin, Food, Kidney failure, HD, Incidence, Patient, Medicare, Taurolidine, CVC, HCPCS, Medical device

We are proud to provide an option for adult patients who face the risk of CRBSIs.

Key Points: 
  • We are proud to provide an option for adult patients who face the risk of CRBSIs.
  • We look forward to expanding the availability of DefenCath to the outpatient setting later this year.”
    The commencement of U.S. outpatient commercialization of DefenCath is planned for July 1, 2024.
  • If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.
  • To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

CorMedix Inc. Announces Commercial Agreement With ARC Dialysis, LLC

Retrieved on: 
Monday, April 8, 2024
Dialysis, Antibiotic, CVC, Infection, Patient, NDA, Taurolidine, Heparin, ARC, FDA, Health, Medical device

CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and expects to begin commercialization of the product in the inpatient setting on April 15th.

Key Points: 
  • CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) on November 15, 2023, and expects to begin commercialization of the product in the inpatient setting on April 15th.
  • CorMedix is committed to building meaningful long-term relationships with dialysis providers that are dedicated to innovation and infection reduction.
  • ARC Dialysis, a Miami-based medium-sized dialysis organization, provides inpatient dialysis services to approximately 100 inpatient facilities, and is the operator of 18 outpatient dialysis units throughout Florida.
  • “This agreement with CorMedix for the adoption of DefenCath reinforces our commitment to innovation and patient care, and we are proud of the reputation we’ve established for ourselves as a leading dialysis provider in the southeast United States,” says Fred Dumenigo, CEO of ARC Dialysis.

Haemonetics Receives FDA Clearance for New TEG® 6s Global Hemostasis - HN Cartridge

Retrieved on: 
Thursday, April 4, 2024
6S, Heparinoid, Patient, HAE, Liver transplantation, MD, Senior, Hemostasis, Heparin, Cardiopulmonary bypass, Safety, FDA, TEG, Physician, Food, Medical device

This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.

Key Points: 
  • This new cartridge extends Haemonetics' TEG 6s viscoelastic testing capabilities to serve fully heparinized patients in adult cardiovascular surgeries/procedures and liver transplantation in both laboratory and point-of-care settings.
  • Haemonetics is planning to release the new Global Hemostasis-HN cartridge for TEG 6s system in the coming months.
  • Overall, over 5,500 clinical data points were used to demonstrate safety and effectiveness of the Global Hemostasis – HN assays.
  • "Our market-leading TEG 6s platform has helped Haemonetics make effective and efficient viscoelastic testing more accessible throughout the world," said Stewart Strong, President, Global Hospital at Haemonetics.

Sepsis Drug Pipeline Research Report 2024: Insights from 30 Companies and 35 Pipeline Drugs - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 27, 2024
Pharmaceutical, Health, Clinical Trials, Therapy, Acquisition, Blood pressure, HBV, HCV, Hepatitis B virus, Heparin, CRISPR, Infection, Escherichia coli, Melanoma, News, Cancer, Liver cancer, Discovery, Cell, Vaccine, Intensive care medicine, Adrenomedullin, ADM, COVID, Fungal infection, Patient, Protein, Clinical trial, Survival, Endothelium, NDA, Histone, Thymosin

This report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Sepsis pipeline landscape.

Key Points: 
  • This report provides comprehensive insights about 30+ companies and 35+ pipeline drugs in Sepsis pipeline landscape.
  • A detailed picture of the Sepsis pipeline landscape is provided which includes the disease overview and Sepsis treatment guidelines.
  • This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Sepsis drugs.

AcelRx Announces Rebranding With Name Change to Talphera, Inc.

Retrieved on: 
Tuesday, January 9, 2024
IDE, Dialysis, Patient, Hemofiltration, Talisman, SAN, Risk, Heparin, IRB, FDA, Renal replacement therapy, Bleeding, Pain, PMA, Pharmaceutical industry

SAN MATEO, Calif., Jan. 9, 2024 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced the rebranding of the Company, with a name change to Talphera, Inc. ("Talphera"). The rebrand decision was made to reflect the Company's strategy of developing and commercializing products to support advancing care to optimize outcomes in medically supervised settings, moving beyond the original focus on acute pain.  The Company's lead nafamostat product candidate, Niyad, is expected to have a Premarket Approval (PMA) submission to the FDA in the second half of 2024.  

Key Points: 
  • The name Talphera was derived from "Talisman", meaning a strong leader, and reflects the new "pharmaceutical era" for the Company.
  • The company's new mission at Talphera is to support healthcare providers by developing and commercializing products in medically supervised settings that deliver advances in care to patients.
  • Talphera will commence trading on the Nasdaq Global Market under the ticker symbol "TLPH" effective January 10, 2024.
  • A PMA submission for Niyad is expected to be filed with the FDA in the second half of 2024.

CorMedix Inc. Announces Partnership With The Leapfrog Group

Retrieved on: 
Monday, December 4, 2023
Patient, Policy, Food, HIT, Risk, CVC, FDA, Kidney failure, Male, Patient safety, Health, Diabetes, Nausea, Incidence, Thrombocytopenia, Hypersensitivity, Dizziness, Death, Breastfeeding, Infection, Patient safety organization, Infant, GAIN, CLS, Safety, Organization, QIDP, Female, Heparin, Vomiting, Pharmaceutical industry

BERKELEY HEIGHTS, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced an agreement with The Leapfrog Group, an independent national watchdog organization of employers and other purchasers focused on health care safety, whereby CorMedix Inc. will become a member of the Leapfrog Partners Advisory Committee.

Key Points: 
  • As a Leapfrog partner, CorMedix will advise the Leapfrog board and management on industry and policy trends and help shape the organization’s long-term strategic vision.
  • “An alliance between The Leapfrog Group and CorMedix brings together two organizations both focused on a common goal: improving patient safety and quality of care across the U.S. healthcare system,” said Joseph Todisco, Chief Executive Officer, CorMedix.
  • “CorMedix is dedicated to developing solutions that reduce the risk of healthcare associated infections, in particular catheter-related bloodstream infections (CRBSIs).
  • Every American deserves the highest quality health care, and together with CorMedix we can achieve our shared vision for excellence,” said Leah Binder, Leapfrog president and CEO.

CorMedix Inc. Announces FDA Approval of DefenCath® to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients

Retrieved on: 
Wednesday, November 15, 2023
Data, Safety, Food, Incidence, Heparin, Kidney failure, Risk, CLS, Patient, Infection, FDA, Second Continental Congress, Caregiver, Death, CVC, Disability, Hazard ratio, Congress, Kidney, Bloodstream infections, Medical device, Pharmaceutical industry

BERKELEY HEIGHTS, N.J., Nov. 15, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced that the U.S. Food and Drug Administration (FDA) has approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study.

Key Points: 
  • Joseph Todisco, Chief Executive Officer of CorMedix commented, “The approval of DefenCath marks a major advancement in reducing life-threatening infections for patients receiving hemodialysis via central venous catheters and an important milestone for CorMedix.
  • We thank all the patients, caregivers, clinical investigators, and our employees who have played an integral role in the development and regulatory approval of DefenCath.
  • In the study, a total of 806 subjects were randomized to receive either DefenCath or heparin as a CLS.
  • Patients in the DefenCath group had a lower incidence of CRBSI events compared to patients in the control group.

AcelRx Receives IDE Approval for Niyad and Advances to a Single Registration Study

Retrieved on: 
Tuesday, October 3, 2023
ACT, Bleeding, RRT, Clinical trial, Research, Trial of the century, Dialysis, Daubert v. Merrell Dow Pharmaceuticals, Inc., PMA, Publishing, Patient, Agency, Risk, Renal replacement therapy, IDE, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Heparin, First Ever, Food, Safety, Medical imaging, Pharmaceutical industry

SAN MATEO, Calif., Oct. 3, 2023 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings, today announced that it is advancing Niyad™ (a lyophilized formulation of nafamostat) into a registrational study following the recent approval of an Investigational Device Exemption (IDE) submission to the United States Food and Drug Administration (FDA).  This clinical trial will evaluate the safety and efficacy of Niyad to support a premarket approval application (PMA) expected to be submitted in the second half of 2024. The single study will consist of 166 adult patients undergoing renal replacement therapy (RRT) who cannot tolerate heparin or are at risk for bleeding.  If approved, Niyad would be the first-ever FDA-approved regional anticoagulant for the extracorporeal circuit in the U.S.

Key Points: 
  • This clinical trial will evaluate the safety and efficacy of Niyad to support a premarket approval application (PMA) expected to be submitted in the second half of 2024.
  • The single study will consist of 166 adult patients undergoing renal replacement therapy (RRT) who cannot tolerate heparin or are at risk for bleeding.
  • The primary endpoint of the study is mean post-filter activated clotting time (ACT) over the first 24 hours versus placebo.
  • Based on the feedback from the  Emergency Use Authorization request, the FDA stated that AcelRx should proceed with the clinical study.

CorMedix Inc. Announces Publication of Phase 3 LOCK IT-100 Study Data in the Clinical Journal of The American Society of Nephrology

Retrieved on: 
Friday, September 8, 2023
Kidney failure, Clinical Journal of the American Society of Nephrology, CJASN, CVC, NDA, USP, Incidence, Risk, PDUFA, FDA, Society, Heparin, Safety, Medical device

The study compared the efficacy and safety of DefenCath®, a catheter lock solution that combines taurolidine 13.5 mg/mL and heparin 1000 USP units/mL, versus heparin alone, in preventing Catheter Related Bloodstream Infections (CRBSIs) in study subjects receiving hemodialysis via central venous catheter (CVC).

Key Points: 
  • The study compared the efficacy and safety of DefenCath®, a catheter lock solution that combines taurolidine 13.5 mg/mL and heparin 1000 USP units/mL, versus heparin alone, in preventing Catheter Related Bloodstream Infections (CRBSIs) in study subjects receiving hemodialysis via central venous catheter (CVC).
  • The randomized, double-blind, active control, Phase 3 study included 795 subjects with kidney failure undergoing hemodialysis via CVC from 70 U.S. sites.
  • “The publication of these phase 3 data in a highly respected peer-reviewed nephrology publication like CJASN demonstrates the importance of these clinical results in addressing the unmet medical need of CRBSIs,” said Joseph Todisco, Chief Executive Officer of CorMedix.
  • After receiving guidance from FDA at a Type A meeting in April of 2023, the NDA for DefenCath was resubmitted.