Nephrotic syndrome

Avenacy Announces Launch of Furosemide for Injection in the U.S. Market

Retrieved on: 
Wednesday, March 20, 2024
Hospitals, Pharmaceutical, Health, Cardiology, Furosemide, Cerebral edema, Kidney, Nephrotic syndrome, Route of administration, Entrepreneurship, Diuresis, DCAT, Patient, Boxed warning, Heart, Water, Multimedia, Food, FDA, Liver, Edema, Pharmaceutical industry

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Furosemide for Injection in the United States as a therapeutic equivalent generic for Lasix® for Injection (furosemide) approved by the U.S. Food and Drug Administration.

Key Points: 
  • Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Furosemide for Injection in the United States as a therapeutic equivalent generic for Lasix® for Injection (furosemide) approved by the U.S. Food and Drug Administration.
  • View the full release here: https://www.businesswire.com/news/home/20240320953949/en/
    “The launch of Furosemide for Injection builds on the two launches announced earlier this week and further demonstrates the speed at which we are progressing the business,” said Jeff Yordon, Co-Founder and CEO of Avenacy.
  • Avenacy will begin shipping Furosemide for Injection to wholesale partners next week.
  • The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema.

VEGZELMA® (bevacizumab-adcd) receives preferred formulary status with Ventegra® for commercially insured patients

Retrieved on: 
Monday, December 11, 2023
Urine, Reproduction, Skeleton, Headache, PSA, Kidney, Erythroderma, Patient, Pharmacy, Birth, Nephrotic syndrome, MBA, Cancer, Miscarriage, Safety, Incidence, VTE, Bevacizumab, Corneal opacity, Wound healing, VEGFR2, Gastrointestinal perforation, Hemoptysis, Female, Fetus, CHF, Celltrion, Pharming, Necrotizing fasciitis, Heart failure, Fistula, Risk, Tracheoesophageal fistula, Bleeding, Organogenesis, Partnership, Rhinitis, Hypertension, Primary ovarian insufficiency, Back pain, Pregnancy, Glioblastoma, PRES, Nosebleed, Skull, FDA, ATE, VEGF, MBM, Hypertensive encephalopathy, Toxicity, Nursing, Pharmaceutical industry, Birth control, Dietary supplement, Proteinuria

Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.

Key Points: 
  • Ventegra's proprietary formulary program (which includes Formulary Shield and the Ventegra Specialty Inclusion Program) is available for access by more than 400 clients and 13 million members/patients that are enrolled with Ventegra.
  • Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, grade 4 fistula, or fistula formation involving any organ.
  • Surgery and Wound Healing Complications: In patients who experience wound healing complications during VEGZELMA treatment, withhold VEGZELMA until adequate wound healing.
  • Do not administer VEGZELMA for at least 28 days following a major surgery, and until adequate wound healing.

Mallinckrodt Presents Latest Health Economics Data on Acthar® Gel (Repository Corticotropin Injection) at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023

Retrieved on: 
Thursday, October 26, 2023
Nexus, Patient, FDA, Academy of Managed Care Pharmacy, Research, Standard of care, Cyclophosphamide, Food, Outcomes research, ClinicoEconomics and Outcomes Research, Treatment, NS, Adrenocorticotropic hormone (medication), Regulation of food and dietary supplements by the U.S. Food and Drug Administration, D20, QALY, Poster, Nephrotic syndrome, Congenital nephrotic syndrome, Adrenocorticotropic hormone, Sarcoidosis, Chlorambucil, Rituximab, Symphony, ICER, SOC, Calcineurin, AMCP, Azathioprine, Diagnosis, Proteinuria, Pharmaceutical industry, Medical imaging, Mallinckrodt

DUBLIN, Oct. 26, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, recently shared findings from Mallinckrodt's latest health economics outcomes research on Acthar® Gel (repository corticotropin injection) for patients with advanced symptomatic sarcoidosis and nephrotic syndrome (NS)1,2 at the Academy of Managed Care Pharmacy (AMCP) Nexus 2023 in Orlando, FL October 16-19, 2023.

Key Points: 
  • Patients were monitored at the end of a three-month cycle for a partial or complete response.
  • The full data manuscript from this study was published in ClinicoEconomics and Outcomes Research on October 17, 2023.
  • "We are pleased to have shared our latest health economics research on Acthar Gel.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to Acthar.

Mallinckrodt Announces Publication of Two Journal Manuscripts with Clinical and Economic Evidence for Acthar® Gel (Repository Corticotropin Injection)

Retrieved on: 
Tuesday, October 10, 2023
Narrative, RA, Adrenocorticotropic hormone, Health, Literature review, Food, Polymyositis, Dermatomyositis, MS, Abstract, Autoimmunity, Length of stay, Spasm, Clinical, Manuscript, Copyright in Historical Perspective, MOA, Nephrotic syndrome, Rheumatoid arthritis, FDA, Proteinuria, RCI, Patient, ClinicoEconomics and Outcomes Research, History, Literature, Lupus, Multiple sclerosis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Sarcoidosis, Outcomes research, Inflammation, SLE, Pharmaceutical industry, Medical device, Mallinckrodt, Adrenocorticotropic hormone (medication)

DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKTQ), a global specialty pharmaceutical company, today announced the publication of two journal manuscripts reinforcing the clinical and economic evidence supporting the efficacy, safety profile, continued use, and cost-effectiveness of Acthar Gel for appropriate patients across a range of FDA-approved autoimmune and inflammatory disease indications.1,2 

Key Points: 
  • Mallinckrodt's health economics manuscript titled "Acthar Gel (RCI): A Narrative Literature Review of Clinical and Economic Evidence" was published on June 24, 2023 in ClinicoEconomics and Outcomes Research.
  • Acthar is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.
  • Acthar Gel is approved by the U.S. Food and Drug Administration (FDA) for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.3
    Please see indications and Important Safety Information below.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical outcomes may not be solely attributable to Acthar.

Delta4 Identifies a Potential New Therapeutic Option for Focal Segmental Glomerulosclerosis (FSGS) using computational Hyper-C Drug Discovery Platform

Retrieved on: 
Monday, June 19, 2023
Doxorubicin, Clopidogrel, Nephrotic syndrome, Focal segmental glomerulosclerosis, Research, Multimedia, HIV disease progression rates, Translational research, Manuscript, Risk, Drug discovery, Computational biology, Kidney disease, Pharmaceutical industry, Medical device, Online shopping, FSGS, AI

VIENNA, June 19, 2023 /PRNewswire/ -- Delta4, a pioneering digital drug discovery company specializing in identifying new therapeutic indications for drugs with established safety profiles, has made a promising breakthrough in the search for novel treatments for Focal Segmental Glomerulosclerosis (FSGS).

Key Points: 
  • VIENNA, June 19, 2023 /PRNewswire/ -- Delta4 , a pioneering digital drug discovery company specializing in identifying new therapeutic indications for drugs with established safety profiles, has made a promising breakthrough in the search for novel treatments for Focal Segmental Glomerulosclerosis (FSGS).
  • The current therapeutic landscape for FSGS is inadequate, highlighting an urgent need for targeted therapies that focus on specific molecular pathways.
  • Delta4, leveraging its state-of-the-art proprietary AI platform, Hyper-C, combined with the expertise of its computational biologists, has generated a network-based molecular model of FSGS pathophysiology.
  • Through its advanced computational screening, Delta4 has identified clopidogrel, an anti-platelet drug, as a promising therapeutic candidate for FSGS.

HI-Bio Receives FDA Orphan Drug Designation for Felzartamab for the Treatment of Membranous Nephropathy

Retrieved on: 
Thursday, May 25, 2023
PMN, Kidney failure, Nephrotic syndrome, ODD, IMD, Cyclophosphamide, IgA nephropathy, Standard of care, Patient, Manufacturing execution system, SAN, B cell, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Disease, Pharmaceutical industry

Felzartamab is an investigational monoclonal antibody designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies.

Key Points: 
  • Felzartamab is an investigational monoclonal antibody designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies.
  • As recently announced , positive data was achieved for felzartamab in patients with PMN across two Phase 2 studies.
  • Beyond PMN, felzartamab is currently in development for IgA Nephropathy and Antibody Mediated Rejection of kidney transplants.
  • Orphan drug designation qualifies HI-Bio for certain development incentives, including tax credits for qualified clinical trials, exemption of FDA application fees and up to seven-year market exclusivity upon regulatory approval.

There is significant need for efficacious membranous nephropathy treatments for high-risk patients (MARKETVUE® REPORT)

Retrieved on: 
Wednesday, May 24, 2023
Rituximab, Nephrotic syndrome, Nephrology, Edema, Kidney disease, Proteinuria, Patient, Physician, REACH, FDA, Pharmaceutical industry

NEWTON, Mass., May 24, 2023 /PRNewswire/ -- Membranous nephropathy (MN) is a rare, autoimmune nephropathy characterized by thickening of the glomerular capillary walls. Most patients are diagnosed with an antigen-specific form of MN, with 70% testing positive for PLA2R. Symptoms include proteinuria, low albumin levels, and edema. MN is the most common cause of nephrotic syndrome and when left untreated or poorly managed, complications include:

Key Points: 
  • Nearly 1 in 5 membranous nephropathy patients never achieve remission, and nearly one-third of those that do will relapse.
  • NEWTON, Mass., May 24, 2023 /PRNewswire/ -- Membranous nephropathy (MN) is a rare, autoimmune nephropathy characterized by thickening of the glomerular capillary walls.
  • Accordingly, nephrologists report frequently measuring antibody titers in PLA2R+ patients to monitor response to treatment, especially in high-risk patients.
  • Pooja Patel, Analyst at REACH: There is a need for more treatment options, particularly for high-risk and refractory patients.

NIH Awards $4.7M to Cohen Children’s Medical Center, Feinstein Institutes to Study Nephrotic Syndrome in Children

Retrieved on: 
Wednesday, April 5, 2023
Research, Consumer, Hospitals, University, Education, Children, Clinical Trials, Science, Cardiology, Biotechnology, Neurology, Health, Cohen Children's Medical Center, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Feinstein Institutes for Medical Research, Donald, Kidney failure, Pediatrics, Nephrotic syndrome, Ear, Observational study, Anesthesiology, Diabetes, Urine, Vagus nerve, Arthritis, Inflammatory Bowel Diseases, Nephrology, Clinical trial, Cancer, Vagus nerve stimulation, MBA, Multimedia, Brain, Northwell Health, Inflammation, Biomedical engineering, Interface (computing), Kidney, Sensation, Bangladesh Technical Education Board, Paralysis, Crohn's disease, Neuroscience, Spleen, MD, Knight, Swelling, Risk, Medical Center, Water, Blood, Nervous system, Steroid, Heart rate, Pulmonary hypertension, Credit, Molecular medicine, NIH, Medical research, Kidney disease, Disease, Pharmaceutical industry, Medical imaging, Dietary supplement

View the full release here: https://www.businesswire.com/news/home/20230405005701/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230405005701/en/
    Christine Sethna, MD, was awarded two different grants to study how vagus nerve stimulation could help children with kidney disease.
  • Children with nephrotic syndrome are exposed to prolonged courses of steroids and other immunosuppressant medications which could have adverse effects.
  • The observational study will examine the nighttime blood pressure and cardiovascular outcomes in children with nephrotic syndrome at 22 different centers.
  • At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury.

NephCure Unveils New Branding Reflecting Organization's Focus on Rare Kidney Disease

Retrieved on: 
Friday, March 31, 2023
Volunteering, Nephrotic syndrome, FSGS, Research, Director of communications, Kidney disease, Patient, RKD, Kidney, Growth, Government, Health, Caregiver, Pharmaceutical industry, Dietary supplement, IgA nephropathy

KING OF PRUSSIA, Pa., March 31, 2023 /PRNewswire/ -- NephCure, formerly NephCure Kidney International, announced Friday a new visual and written brand more distinctly centered around the rare kidney disease (RKD) community they serve. With nearly a year of research and development behind it, this new brand more accurately reflects the nonprofit's unique position in the RKD space, as well as the explosive growth and transformation the RKD field has seen over the past several years.

Key Points: 
  • KING OF PRUSSIA, Pa., March 31, 2023 /PRNewswire/ -- NephCure, formerly NephCure Kidney International, announced Friday a new visual and written brand more distinctly centered around the rare kidney disease (RKD) community they serve.
  • NephCure, a nonprofit focused on finding better treatments for rare kidney disease, updates its brand identity.
  • Unique among the major kidney organizations, NephCure is squarely focused on nephrotic syndrome, FSGS, IgAN, and other rare, protein-spilling kidney diseases.
  • New Tagline: "For rare kidney disease" reflects NephCure's distinct focus on RKD, as well as their passion and focus to continuously strive to find a cure.

Aldeyra Therapeutics Advances Investigational Oral RASP Modulator ADX‑629 Into New Phase 2 Systemic Disease Trials

Retrieved on: 
Thursday, February 16, 2023
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, Edema, Pharmacology, Syndrome, Safety, RASP, Metabolism, Proteinuria, Patient, Asthma, Clinical trial, Atopic dermatitis, Skin, Therapy, Plasma, Psoriasis Area and Severity Index, Part, Nephrotic syndrome, COVID-19, Quality of life, Psoriasis, Pharmaceutical industry, Hypoalbuminemia

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome.
  • Additionally, Aldeyra announced the initiation of a Phase 2 clinical trial of ADX‑629 in atopic dermatitis.
  • Moderate Alcohol-Associated Hepatitis: Aldeyra plans to support an investigator-sponsored Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis.
  • In a Phase 2 clinical trial announced last year, ADX-629 reduced dermal flushing and improved balance time following alcohol intoxication.