Kidney

MAIWEIJIAN, First Approved Biosimilar of Denosumab (120mg) in China

Retrieved on: 
Monday, April 8, 2024
NMPA, Patient, JAMA Oncology, Denosumab, Disability, RANKL, Plasma protein binding, Nephrotoxicity, National Medical Products Administration, Safety, Pharmacokinetics, Kidney, Marketing, Pharmaceutical industry

MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.

Key Points: 
  • MAIWEIJIAN is the first denosumab biosimilar (120mg) approved for marketing in China.
  • Denosumab, due to its demonstrated good therapeutic effects, has been recommended by multiple expert consensuses or treatment guidelines.
  • Doctors and patients have a high level of recognition for denosumab.
  • 3) It has a good safety profile and is not cleared by the kidney, and patients treated with denosumab experience fewer nephrotoxic side effects.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
Monday, April 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.

How to keep your kidneys healthy – and how to spot when things are going wrong

Retrieved on: 
Tuesday, April 9, 2024
Cooking, Blood pressure, Tea, Smartphone, Exercise, Blood, Appetite, Diabetes, Drinking water, Risk, Kidney failure, Food, Kidney disease, Nausea, Cheese, Family, Kidney, Smoking, Pharmaceutical industry

To keep your kidneys healthy there are several things you can do to help yourself.

Key Points: 
  • To keep your kidneys healthy there are several things you can do to help yourself.
  • Don’t let your kidneys dry out; make sure you drink a decent amount of fluid every day.
  • Drinking water is the best way to keep your kidneys hydrated, but any fluid such as tea or fruit-flavoured drinks are fine.
  • Smoking is bad for your kidneys, as it closes up the blood vessels in the kidneys and also increases blood pressure.

Orphan designation: Adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate-aminotransferase gene Treatment of primary hyperoxaluria type 1, 21/03/2012 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, System, Primary, Calcium oxalate, Enzyme, DSM-IV codes, Cell, Disease, Abdominal pain, Patient, Committee, Knowledge, Kidney failure, Organic acid, Regulation, EMA, IRIS, Glycine, Protein, Human, AGXT, Urine, European, COMP, Urinary tract infection, European Commission, Kidney, Safety, Blood, Marketing, Liver, Medicine, Pharmaceutical industry

Orphan designation: Adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate-aminotransferase gene Treatment of primary hyperoxaluria type 1, 21/03/2012 Withdrawn

Key Points: 


Orphan designation: Adeno-associated viral vector of serotype 5 containing the human alanine-glyoxylate-aminotransferase gene Treatment of primary hyperoxaluria type 1, 21/03/2012 Withdrawn

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Eledon Pharmaceuticals Announces Use of Tegoprubart in First-ever Transplant of Genetically Modified Kidney from a Pig to a Human

Retrieved on: 
Thursday, March 21, 2024
Organ transplantation, Kidney disease, University of Minnesota, Massachusetts General Hospital, Risk, Patient, Immunosuppression, Research, Kidney transplantation, University, Kidney, Hope, Tacrolimus, Doctor of Philosophy, MD, Person, Hospital, Heart, Immune system, Calcineurin, Division, CD40L, Dentistry

IRVINE, Calif., March 21, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that tegoprubart, the company’s investigational anti-CD40L antibody, was used as a component of the immunosuppressive treatment regimen following the first-ever transplant of a kidney from a genetically modified pig to a human. The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.

Key Points: 
  • The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man living with end-stage kidney disease.
  • “Eledon has now participated in both heart and kidney xenotransplant procedures, further demonstrating tegoprubart’s broad potential in transplant.
  • Tegoprubart has been observed to be safe and well-tolerated in multiple studies and in multiple indications, including for the prevention of rejection following kidney transplantation.
  • In parallel, Eledon is running two global clinical studies evaluating tegoprubart for the prevention of organ rejection in persons receiving a de novo kidney transplant.

RespireRx Pharmaceuticals Inc. Reports Publication of Preclinical Research Results Demonstrating the Ability of CX1739, its Lead Clinical AMPAkine, to Improve Bladder Function After Spinal Cord Injury

Retrieved on: 
Wednesday, March 20, 2024
OTC Markets Group, Neurogenic bladder dysfunction, Death, Ampakine, DOI, Tetraplegia, Rat, Incidence, Bourbeau, Risk, Bruise, Patient, Research, University, Bladder cancer, Quality of life, Pleasure, EMG, Alom, Catheter, AMPA, Injury, Interim, CSO, Bangladesh Technical Education Board, Urinary tract infection, Respiration, Animal, Kidney, SCI, Rana, RespireRx

Restoration of bladder function is ranked as one of the highest priorities by individuals with SCI (Bourbeau et al., Spinal Cord 58:1216–1226; 2020).

Key Points: 
  • Restoration of bladder function is ranked as one of the highest priorities by individuals with SCI (Bourbeau et al., Spinal Cord 58:1216–1226; 2020).
  • Current treatment approaches usually require interventions such as catheterization for urinary voiding, which have their own set of risks and potentially significant set of complications.
  • The present paper, entitled “Acute ampakines increase voiding function and coordination in a rat model of SCI” (Rana, Alom et al.
  • We believe that this research has the potential to represent a novel, breakthrough in the treatment of SCI, which is badly needed.”

Scilex Holding Company Announces Seeking Approval from the FDA for Modification of the Gloperba® Label to Provide Specific Dosing Guidance for Patients with Renal Impairment and Other Circumstances Where Dose Adjustment is Needed

Retrieved on: 
Wednesday, March 20, 2024
Toxicity, Colchicine, Kidney, Risk, Gout, Patient, Rheumatology, ACR, Diarrhea, Health care, Chronic pain, American College, Dialysis, FDA, Pharmaceutical industry

For patients with severe renal impairment, the starting dose should be 0.3 mg/day.

Key Points: 
  • For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
  • For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.
  • Gloperba® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
  • For more information on Scilex Holding Company, refer to www.scilexholding.com
    For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com .