Nephrology

Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

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星期四, 三月 28, 2024
CSL Vifor, Thrombosis, Myocardial infarction, Conference, Organization, Tablet, Caregiver, Anemia, Physician, CKD, Webcast, Patient, Coronary thrombosis, Stroke, AKBA, Death, Renal Support Network, Kidney disease, Nephrology, Kidney, Chronic kidney disease, Dialysis, Division, Safety, Stanford University, Food, Hypoxia, FDA, Erythropoietin, Pharmaceutical industry

CAMBRIDGE, Mass., March 27, 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 that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo is now approved in 37 countries.

Key Points: 
  • "At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone.
  • We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients."
  • Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD1, which may be associated with many adverse clinical outcomes.
  • Today, most CKD patients are treated for anemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centers.

WVU Medicine Joins Interwell Health Network to Bring Value-Based Kidney Care to West Virginia

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星期二, 三月 26, 2024
Health, Nephrology, Disease, Partnership, CKD, Patient, Mortality, Kidney disease, Chronic kidney disease, Vacuum, Machine learning, Medicine, Nursing, Social, Government, Physician

MORGANTOWN, W.Va., March 26, 2024 /PRNewswire/ -- WVU Medicine announced today that it has entered into an agreement with Interwell Health with the goal of improving the care of patients with kidney disease.

Key Points: 
  • MORGANTOWN, W.Va., March 26, 2024 /PRNewswire/ -- WVU Medicine announced today that it has entered into an agreement with Interwell Health with the goal of improving the care of patients with kidney disease.
  • WVU Medicine nephrologists will join the Interwell network and implement its population health approach to kidney care.
  • "We are thrilled to welcome this leading group of nephrologists at WVU Medicine to our network and to our mission to reimagine kidney care," Terry Ketchersid, M.D., M.B.A., senior vice president at Interwell Health, said.
  • Visit the Interwell Health physician page to learn more about how the company supports nephrology practices in the transition to value-based care.

Leading the Charge: Anmy Mayfield Takes the Reins at WGU's Leavitt School of Health College of Nursing

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星期一, 三月 11, 2024
Refugee, Nursing, Student, College, AACN, Nurse practitioner, Education, Dream, Mentorship, Parent, Family, University, Faculty, LSH, WGU, Medical missions, Patient, Knowledge, Workforce, Community, Nephrology, American Academy

Mayfield has been with WGU for more than five years and is a champion for equity, access, and nontraditional pathways to opportunity.

Key Points: 
  • Mayfield has been with WGU for more than five years and is a champion for equity, access, and nontraditional pathways to opportunity.
  • With her team, she has led the launch and expansion of various innovative nursing programs at the university, including master’s degrees as well as postbaccalaureate and post-master’s certificates in nursing.
  • “Anmy is one of our key pillars at LSH and I feel thrilled to welcome her in the new position.
  • Her expertise in nursing, education, and equity is invaluable to the College of Nursing,” said LSH Senior Vice President and Executive Dean, Keith Smith.

SeaStar Medical-Sponsored Symposium Featuring Experts Discussing Pediatric Acute Kidney Injury and the Selective Cytopheretic Device to be Webcast Live at AKI & CRRT 2024

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星期一, 三月 11, 2024
Chronic kidney disease, FAAP, Multiple organ dysfunction syndrome, Medical director, Critical care, FDA, CKRT, SCD, Hospital, Risk, Conference, University, SeaStar, Acute kidney injury, AKI, CRRT, Nephrology, Pharmaceutical industry

DENVER, March 11, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces its sponsorship of an Industry Symposium titled “New Therapies in Pediatric Acute Kidney Injury” on March 13, 2024 at the 29th International Conference on Advances in Critical Care Nephrology – Updates in ICU Medicine: Controversies, Challenges and Solutions (AKI & CRRT 2024). The hybrid in-person and virtual conference is being held March 12-15 in San Diego.

Key Points: 
  • The hybrid in-person and virtual conference is being held March 12-15 in San Diego.
  • “Despite advancements in kidney replacement therapy, mortality rates in children with acute kidney injury (AKI) and multi-organ failure requiring continuous kidney replacement therapy (CKRT) remain at about 50%, and children who survive an AKI episode are at elevated risk of chronic kidney disease.
  • “It’s exciting to have recognized leaders in AKI and nephrology who serve on the SeaStar Medical Scientific Advisory Board participate in this symposium.
  • The discussion will highlight our technology, clinical data and the recent FDA approval of the SCD-PED, the first therapeutic device in our Quelimmune product family,” said Kevin Chung, MD, SeaStar Medical’s Chief Medical Officer.

Nuwellis, Inc. Announces Fourth Quarter and Full Year 2023 Financial Results

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星期二, 三月 5, 2024
Diuretic, Operating cost, Absorption, FDA, Growth, SCD, Cirrhosis, IDE, SeaStar, Nephrology, Webcast, Patient, Pediatrics, CRRT, CRRC, THT, Research, PIK, Pharmaceutical industry

Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.

Key Points: 
  • Fourth quarter pediatric revenue grew 35% year over year; 28% increase in utilization and a 49% increase in console sales.
  • Gross margin was 54.4% for the fourth quarter of 2023, compared to 56.9% in the prior-year period, a decrease of 250 basis points.
  • Selling, general and administrative expenses for the fourth quarter of 2023 were $3.6 million, compared to $4.7 million in the prior-year period.
  • Total operating expenses for the fourth quarter of 2023 were $5.0 million, a 15% decrease compared to $5.9 million in the prior-year period.

Kidney Month: 31 Day of Action to Equip and Empower People to Fight Kidney Disease

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星期四, 二月 29, 2024
AstraZeneca, Caregiver, American Kidney Fund, Eli Lilly and Company, AKF, Dialysis, Pfizer, Notifiable disease, Nephrology, Boehringer Ingelheim, Patient, Genetic testing, Kidney disease, Senior counsel, Disease, Kidney, Diagnosis, Research, Kidney failure, Pharmaceutical industry

During Kidney Month, AKF calls on members of the kidney community and the general public to join in solidarity in support of everyone affected by kidney disease.

Key Points: 
  • During Kidney Month, AKF calls on members of the kidney community and the general public to join in solidarity in support of everyone affected by kidney disease.
  • One of the hallmarks of Kidney Month at AKF is Kidney Action Week , which will be held March 18-22.
  • This free, virtual event will bring together patients, nephrologists, renal dieticians, caregivers and other kidney experts for a weeklong series of sessions about a variety of topics related to kidney disease, including dialysis, kidney disease prevention, kidney-friendly eating, transplant, innovations in kidney disease and more.
  • In addition, people with kidney disease have a higher chance of developing other health problems, such as heart disease.

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

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星期四, 二月 22, 2024
Fosun Pharma, Kyowa Kirin, Research, New Drug Application, Investment, Dialysis, Growth, Sale, Death, Diarrhea, Webcast, Abdominal distension, Orphan, XBR, Chronic kidney disease, Incidence, Peritoneal dialysis, Rat, Record, Calendar, ESG, CKD, Hyperphosphatemia, Safety, Human, Nephrology, IBS-C, Master of Science, Gastroenterology, FDA, Food, Social, Emeritus, Dehydration, Risk, Constipation, Society, Patient, Pharmaceutical industry

WALTHAM, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

FDA Grants Humanitarian Device Exemption Approval to SeaStar Medical’s Selective Cytopheretic Device for Pediatric Acute Kidney Injury

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星期四, 二月 22, 2024
Chronic kidney disease, Sepsis, ICU, Traction, FDA, Food, Dialysis, CKRT, SCD, HUD, Risk, Safety, SeaStar, HDE, Acute kidney injury, Patient, KRT, AKI, Mortality, Nephrology, Pharmaceutical industry

DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) Approval Order to the Selective Cytopheretic Device (SCD) Pediatric (SCD-PED) for use in children weighing 10 kilograms or more with acute kidney injury (AKI) due to sepsis or a septic condition requiring kidney replacement therapy (KRT). This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).

Key Points: 
  • This is the first product in the Company’s newly branded Quelimmune product family, and the Quelimmune pediatric device can now be commercially marketed as a Humanitarian Use Device (HUD).
  • In clinical studies, Quelimmune for pediatric AKI has been shown to reduce mortality rates and dialysis dependency in clinical studies.
  • “We appreciate the FDA’s willingness to work collaboratively with SeaStar Medical and our advisors to grant HDE approval to Quelimmune for pediatric use,” Mr. Schlorff added.
  • SeaStar Medical is currently focused on its NEUTRALIZE-AKI pivotal clinical trial to evaluate Quelimmune therapy in the larger adult AKI population, while exploring other applications for this device.

Nuwellis’ Distribution Partner, SeaStar Medical, Receives FDA Humanitarian Device Exemption for Pediatric Selective Cytopheretic Device Quelimmune™

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星期四, 二月 22, 2024
Sepsis, Humanitarian Device Exemption, Failure, Traction, Physician, FDA, Food, Dialysis, CKRT, Hospice and palliative medicine, Nephrology, Nursing care plan, SeaStar, HDE, Acute kidney injury, Patient, AKI, Mortality, Immune system

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, SeaStar Medical Holding Corporation (Nasdaq: ICU) (SeaStar Medical), has received Humanitarian Device Exemption (HDE) from the U.S. Food and Drug Administration (FDA) for Quelimmune™, its pediatric Selective Cytopheretic Device.
  • Nuwellis has an exclusive U.S. license and distribution agreement with SeaStar Medical to distribute Quelimmune and will market and distribute the device to nephrologists and intensive care physicians who are trained in pediatric extracorporeal therapy.
  • “The pediatric segment of our business has gained significant traction since the 2020 FDA clearance of our Aquadex device for pediatric patients weighing 20kg or more – growing at a compound annual growth rate (CAGR) of over 30%.
  • Clinical studies have demonstrated Quelimmune’s potential to eliminate dialysis dependency, shorten intensive care unit time, and restore the lives of critically ill pediatric patients.

Dr. Robert Huizinga Elected to the Kane Biotech Board and Appointed Executive Chair

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星期四, 二月 22, 2024
Theta, Doctor of Philosophy, Catheter, FDA, University, Food, Sigma Theta Tau, Skin care, Leadership studies, Nephrology, Executive, KNE, Management

WINNIPEG, Manitoba, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE OTCQB:KNBIF) (the “Company” or “Kane Biotech” or “Kane”) announces that at the special meeting of the shareholders of the Company held on February 20, 2024, Dr. Robert Huizinga was elected as a director of the Company.

Key Points: 
  • WINNIPEG, Manitoba, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Kane Biotech Inc. (TSX-V:KNE OTCQB:KNBIF) (the “Company” or “Kane Biotech” or “Kane”) announces that at the special meeting of the shareholders of the Company held on February 20, 2024, Dr. Robert Huizinga was elected as a director of the Company.
  • Mr. Huizinga has also been appointed by the directors of the Company as Executive Chair of the Company.
  • Dr. Huizinga has been a member of Kane Biotech’s Scientific Advisory Board since 2018.
  • “I’m excited that the Board accepted my recommendation to add Robert to the Board and to appoint him to the Executive Chair role,” said Marc Edwards, President & Chief Executive Officer.