Dialysis

Dialysis Patient Citizens Applauds Passage of Legislation Securing Affordable Treatment for All Dialysis Patients in Indiana

Retrieved on: 
Thursday, March 14, 2024

WASHINGTON, March 14, 2024 /PRNewswire/ -- Dialysis Patient Citizens (DPC), the leading advocacy organization for dialysis patients nationwide, today released the following statement applauding the passage and enactment of SB 215 in Indiana.

Key Points: 
  • WASHINGTON, March 14, 2024 /PRNewswire/ -- Dialysis Patient Citizens (DPC), the leading advocacy organization for dialysis patients nationwide, today released the following statement applauding the passage and enactment of SB 215 in Indiana.
  • Dialysis Patient Citizens (DPC) applauds the passage and enactment of SB 215 in Indiana.
  • "We are grateful to see Indiana do right by dialysis patients and provide the patient choice and healthcare coverage that all Hossiers deserve," said DPC Board President Andrew Conkling.
  • This legislation offers affordable Medigap coverage to Medicare beneficiaries of all ages, granting all dialysis patients in Indiana access to affordable care.

Akebia Therapeutics to Report Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 11, 2024

CAMBRIDGE, Mass., March 11, 2024 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to report fourth quarter and full year 2023 financial results on March 14, 2024.

Key Points: 
  • CAMBRIDGE, Mass., March 11, 2024 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to report fourth quarter and full year 2023 financial results on March 14, 2024.
  • Akebia will not host a conference call due to the proximity to the anticipated March 27, 2024 Prescription Drug User Fee Act (PDUFA) target action date for vadadustat, which is under review by the U.S. Food and Drug Administration as a treatment for anemia due to chronic kidney disease in adult patients on dialysis.

Federal Trade Commission, the Department of Justice and the Department of Health and Human Services Launch Cross-Government Inquiry on Impact of Corporate Greed in Health Care

Retrieved on: 
Tuesday, April 2, 2024

The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.

Key Points: 
  • The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.
  • Private equity firms and other corporate owners are increasingly involved in health care system transactions, and, at times, those transactions may lead to a maximizing of profits at the expense of quality care.
  • The cross-government inquiry seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care, and affordable health care for patients and taxpayers.
  • The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.
  • “This RFI will enable the agencies to accurately understand the modern market realities of the health care industry and forcefully enforce the law against unlawful deals.

Federal Trade Commission, the Department of Justice and the Department of Health and Human Services Launch Cross-Government Inquiry on Impact of Corporate Greed in Health Care

Retrieved on: 
Tuesday, April 2, 2024

The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.

Key Points: 
  • The Federal Trade Commission, the Department of Justice’s (DOJ) Antitrust Division, and the U.S. Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.
  • Private equity firms and other corporate owners are increasingly involved in health care system transactions, and, at times, those transactions may lead to a maximizing of profits at the expense of quality care.
  • The cross-government inquiry seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care, and affordable health care for patients and taxpayers.
  • The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.
  • “This RFI will enable the agencies to accurately understand the modern market realities of the health care industry and forcefully enforce the law against unlawful deals.

Crearene AG and Alzchem Group AG: Successful addition of creatine to dialysis patient treatments

Retrieved on: 
Wednesday, March 13, 2024

Crearene AG and Alzchem Group AG: Successful addition of creatine to dialysis patient treatments

Key Points: 
  • Crearene AG and Alzchem Group AG: Successful addition of creatine to dialysis patient treatments
    As part of their cooperation, Alzchem Group AG and Crearene AG announced in October 2023 that a clinical study on the use of creatine in dialysis treatments had been launched.
  • The aim is to demonstrate the technical feasibility, patient safety and dose finding of creatine-based dialysis treatment solutions.
  • Using specially purified creatine from the Alzchem Group, a University Medical Center Groningen team, led by Prof. Dr. Stephan J.L.
  • Based on the promising initial results, Alzchem Group AG and Crearene AG have extended their collaboration to develop creatine-based treatment solutions for medical applications until the end of 2025.

Kidney Foundation Marks 60th Anniversary

Retrieved on: 
Thursday, February 29, 2024

Learn more during Kidney Health Month in March

Key Points: 
  • Montreal, Quebec--(Newsfile Corp. - February 29, 2024) - When the Kidney Foundation of Canada was launched in 1964, a person with kidney failure had very little hope of survival.
  • As we work to raise awareness of these vital organs, The Kidney Foundation is reflecting on the significant progress made in the past six decades to improve the quality of life and health outcomes of kidney patients.
  • "These advances are providing new hope for people diagnosed with kidney disease and those living with kidney failure."
  • The Kidney Foundation is ramping up advocacy efforts to ensure that every Canadian has access to the care they need to prevent or delay the progression of kidney disease.

Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

Retrieved on: 
Monday, March 11, 2024

The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

Key Points: 
  • The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
  • “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
  • “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
  • The FDA has 60 days from the receipt of the application to determine whether to accept it for review.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Community Health, Inc. - CYH

Retrieved on: 
Thursday, March 7, 2024

NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Community Health, Inc. (“Community Health” or the “Company”) (NYSE: CYH).

Key Points: 
  • NEW YORK, March 07, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Community Health, Inc. (“Community Health” or the “Company”) (NYSE: CYH).
  • The investigation concerns whether Community Health and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.
  • The Firm has recovered billions of dollars in damages awards on behalf of class members.

Unicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)

Retrieved on: 
Thursday, March 7, 2024

LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).
  • OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Monday, March 4, 2024

STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • The Company enrolled 214 patients and expects topline efficacy and safety results from KOURAGE 1 Part A in the third quarter of 2024.
  • Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026.
  • Wholesalers shipped 110,700 vials to dialysis centers during the fourth quarter of 2023 (an increase of 22% vs. the third quarter of 2023), the majority of which were vials reallocated within the Fresenius network of clinics.
  • Revenues: Total revenue was $3.0 million and $3.3 million for the three months ended December 31, 2023 and 2022, respectively.