Glomerular filtration rate

Study Design and Baseline Characteristics of Prespecified, Exploratory Pooled Analysis to Investigate Effect of Finerenone on Cardio-Kidney Outcomes in Patients with CKD and Type 2 Diabetes and/or Heart Failure Shared at Heart Failure 2024 Congress

Retrieved on: 
måndag, maj 13, 2024
Research, Diabetes, Clinical Trials, Cardiology, Biotechnology, Other Health, Health, Pharmaceutical, Science, Type 2 diabetes, Patient, LVEF, HF, Finerenone, Heart failure, ESC, FACP, Chronic kidney disease, CKM, CKD, Albuminuria, Natriuresis, Bayer, EGFR, Glomerular filtration rate, History, Pharmaceutical industry

The study design and baseline characteristics of FINE-HEART, a new prespecified, exploratory pooled analysis of three Phase III trials with finerenone1, were presented today as a Late-Breaking Science Session at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC) in Lisbon.

Key Points: 
  • The study design and baseline characteristics of FINE-HEART, a new prespecified, exploratory pooled analysis of three Phase III trials with finerenone1, were presented today as a Late-Breaking Science Session at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC) in Lisbon.
  • Finerenone is marketed as Kerendia® and approved for the treatment of adults with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) in more than 70 countries worldwide, including the United States.
  • The data presented here may discuss a use outside of the approved indication.
  • FINE-HEART is designed to investigate the effects of finerenone on cardio-kidney outcomes based on data from over 19,000 patients with varying combinations of heart failure (HF), CKD and T2D across three Phase III finerenone studies – FIDELIO-DKD, FIGARO-DKD, and FINEARTS-HF.1
    Over 92% of patients included in the analysis had overlapping cardio-kidney-metabolic (CKM) conditions—78% had two (HF and CKD, HF and T2D or CKD and T2D), while 14.7% had all three.

Calliditas' Partner Everest Medicines Starts Commercial Launch of Nefecon in China

Retrieved on: 
tisdag, maj 14, 2024
Mount Everest, National Medical Products Administration, Patient, HKEX, New Drug Application, NMPA, NDA, ASN, Prevalence, Sustainability, Person, Biopsy, Incidence, Society, EGFR, Proteinuria, Glomerular filtration rate, Immunoglobulin A, Pharmaceutical industry

STOCKHOLM, May 14, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announces that its partner Everest Medicines (HKEX: 1952.HK) ("Everest") has launched Nefecon® in China.

Key Points: 
  • STOCKHOLM, May 14, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announces that its partner Everest Medicines (HKEX: 1952.HK) ("Everest") has launched Nefecon® in China.
  • There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.
  • Nefecon® was awarded conditional approval in IgAN by China's National Medical Products Administration (NMPA) in November 2023.
  • New Drug Applications (NDA) for Nefecon® were also successfully accepted for review in Taiwan and South Korea at the end of 2023.

Calliditas' Partner Everest Medicines Starts Commercial Launch of Nefecon in China

Retrieved on: 
tisdag, maj 14, 2024
Mount Everest, National Medical Products Administration, Patient, HKEX, New Drug Application, NMPA, NDA, ASN, Prevalence, Sustainability, Person, Biopsy, Incidence, Society, EGFR, Proteinuria, Glomerular filtration rate, Immunoglobulin A, Pharmaceutical industry

STOCKHOLM, May 14, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announces that its partner Everest Medicines (HKEX: 1952.HK) ("Everest") has launched Nefecon® in China.

Key Points: 
  • STOCKHOLM, May 14, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announces that its partner Everest Medicines (HKEX: 1952.HK) ("Everest") has launched Nefecon® in China.
  • There is a very significant unmet medical need for novel therapies among IgAN patients in China and other Asian countries.
  • Nefecon® was awarded conditional approval in IgAN by China's National Medical Products Administration (NMPA) in November 2023.
  • New Drug Applications (NDA) for Nefecon® were also successfully accepted for review in Taiwan and South Korea at the end of 2023.

Mineralys Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
torsdag, maj 9, 2024
Investment, Glomerular filtration rate, Safety, Conference call, Research, Heart, Aldosterone, Research and development, Insurance, Conference, Administration, EGFR, Obesity, CKD, Patient, Pivotal, SGLT2, Hypertension, Therapy, Chronic kidney disease, G&A, Pharmaceutical industry

RADNOR, Pa., May 09, 2024 (GLOBE NEWSWIRE) --  Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ending March 31, 2024, and provided a corporate update.

Key Points: 
  • ET –
    RADNOR, Pa., May 09, 2024 (GLOBE NEWSWIRE) --  Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ending March 31, 2024, and provided a corporate update.
  • General and Administrative (G&A) expenses were $4.6 million for the quarter ended March 31, 2024, compared to $2.6 million for the quarter ended March 31, 2023.
  • Total other income, net was $3.9 million for the quarter ended March 31, 2024, compared to $2.3 million for the quarter ended March 31, 2023.
  • Net loss was $31.5 million for the quarter ended March 31, 2024, compared to $12.6 million for the quarter ended March 31, 2023.

Eledon Announces Clinical Progress with Tegoprubart in the Prevention of Transplant Rejection

Retrieved on: 
tisdag, maj 7, 2024
Congress, University, Insulin, Glomerular filtration rate, Risk, Nephrotoxicity, JDRF, Immunosuppression, Death, Neurotoxicity, Viral, EGFR, Hair loss, Patient, Kidney transplantation, Fatigue, Hypertension, Toxicity, Quality of life, Calcineurin, Pharmaceutical industry

IRVINE, Calif., May 07, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the first participant in an investigator-led clinical trial has received an islet cell transplant and is being treated with a novel immunosuppression regimen including tegoprubart, the company’s novel anti-CD40L antibody, which is in development for the prevention of pancreatic islet cell transplant rejection in patients with type 1 diabetes. The study is being conducted by the research team at University of Chicago Medicine’s Pancreatic and Islet Transplant Program. Separately, the company reported updated data from its ongoing Phase 1b trial demonstrating tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated.

Key Points: 
  • The study is being conducted by the research team at University of Chicago Medicine’s Pancreatic and Islet Transplant Program.
  • Separately, the company reported updated data from its ongoing Phase 1b trial demonstrating tegoprubart successfully prevented kidney transplant rejection and was generally safe and well-tolerated.
  • Eledon is supplying tegoprubart as a cornerstone component of the immunosuppressive regimen for trial participants and tegoprubart is being evaluated for the prevention of transplant rejection in the trial.
  • Eledon is currently conducting a Phase 1b trial ( NCT05027906 ), the Phase 2 BESTOW trial ( NCT05983770 ), and a Long-Term Safety and Efficacy extension study ( NCT06126380 ) to evaluate tegoprubart for the prevention of organ rejection in patients receiving a kidney transplant.

Alpine Immune Sciences Shares Updated Clinical Data from Povetacicept in IgA Nephropathy

Retrieved on: 
onsdag, april 10, 2024
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, FDA, Congress, Immunoglobulin G, ALPN, University, Glomerular filtration rate, Proteinuria, Survival, Cytokine, MD, Hematuria, UPCR, Webcast, Immunoglobulin A, EGFR, Disease, Nephrology, Patient, WCN, Alpine, Inflammation, Multimedia, Infection, Biomarker, Exhibition, University of Leicester, Autoimmunity, BAFF, Pharmaceutical industry

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.

Key Points: 
  • Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.
  • RUBY-3 is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, where povetacicept is administered subcutaneously (SC) once every four weeks.
  • As of March 01, 2024, 41 patients with IgAN had received povetacicept 80 or 240 mg subcutaneously every 4 weeks.
  • These data strongly support the inhibition of APRIL/BAFF pathways by povetacicept and its efficacy in the treatment of IgAN as well as the need for further clinical development.

Get Your Study Enrolled - Designing Your Impairment Protocol to Prevent Challenges, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
måndag, april 22, 2024
MMS, Kidney, University, FASN, Glomerular filtration rate, UNC School of Medicine, Data analysis, MD, GFR, Doctor of Philosophy, Pharmacokinetics, Clinical pharmacology, Project management, Drug development, Associate, Division, Kidney failure, Human body

TORONTO, April 22, 2024 /PRNewswire-PRWeb/ -- As drug development progresses, regulators require clarity on how products are metabolized in the human body, and the risks associated with compounds that may linger in critical organs.

Key Points: 
  • In this free webinar, learn how renal impairment study protocols can be improved to maximize patient enrollment.
  • Making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.
  • Therefore, making informed decisions about the design of a study protocol is important, as overly complex protocols can quickly narrow the patient population.
  • Register for this webinar to understand how impairment study protocols can be improved to maximize patient enrollment.

Alport Syndrome Market to Witness Upsurge in Growth at a Massive CAGR of 69% by 2034 | DelveInsight

Retrieved on: 
onsdag, april 17, 2024
USD, Urine, ACE, Finerenone, ESRD, Kidney, Otorhinolaryngology, Nephrotoxicity, Mutation, Hearing, Diagnosis, Glomerular filtration rate, Hearing loss, Blood, Swelling, Proteinuria, Kidney failure, Cochlea, Alport syndrome, Nephrology, EU4, GFR, ADAS, Heredity, Research, Genetic counseling, Kidney disease, Novartis, ARAS, Ophthalmology, COL4A4, Patient, Kidney transplantation, LAS, Dialysis, DSM-IV codes, COL4A3, Quality of life, Genetic disorder, Gene, Pharmaceutical industry

LAS VEGAS, April 17, 2024 /PRNewswire/ -- DelveInsight's Alport Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Alport syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Points: 
  • Leading Alport syndrome companies such as Eloxx Pharmaceuticals, Chinook Therapeutics (A Novartis company), Bayer, Calliditas Therapeutics, Evotec, and others are developing novel Alport syndrome drugs that can be available in the Alport syndrome market in the coming years.
  • The disorder manifests in different forms such as autosomal recessive Alport syndrome (ARAS), X-linked Alport syndrome (XLAS), and autosomal dominant Alport syndrome (ADAS).
  • The X-linked Alport syndrome (XLAS) is the most prevalent subtype of Alport syndrome with around 11K cases in 2023 in the US while autosomal dominant Alport syndrome (ADAS) is the least prevalent subtype of Alport syndrome.
  • To know more about Alport syndrome treatment guidelines, visit @ Alport Syndrome Management

Alport Syndrome Market to Witness Upsurge in Growth at a Massive CAGR of 69% by 2034 | DelveInsight

Retrieved on: 
onsdag, april 17, 2024
USD, Urine, ACE, Finerenone, ESRD, Kidney, Otorhinolaryngology, Nephrotoxicity, Mutation, Hearing, Diagnosis, Glomerular filtration rate, Hearing loss, Blood, Swelling, Proteinuria, Kidney failure, Cochlea, Alport syndrome, Nephrology, EU4, GFR, ADAS, Heredity, Research, Genetic counseling, Kidney disease, Novartis, ARAS, Ophthalmology, COL4A4, Patient, Kidney transplantation, LAS, Dialysis, DSM-IV codes, COL4A3, Quality of life, Genetic disorder, Gene, Pharmaceutical industry

LAS VEGAS, April 17, 2024 /PRNewswire/ -- DelveInsight's Alport Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Alport syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Key Points: 
  • Leading Alport syndrome companies such as Eloxx Pharmaceuticals, Chinook Therapeutics (A Novartis company), Bayer, Calliditas Therapeutics, Evotec, and others are developing novel Alport syndrome drugs that can be available in the Alport syndrome market in the coming years.
  • The disorder manifests in different forms such as autosomal recessive Alport syndrome (ARAS), X-linked Alport syndrome (XLAS), and autosomal dominant Alport syndrome (ADAS).
  • The X-linked Alport syndrome (XLAS) is the most prevalent subtype of Alport syndrome with around 11K cases in 2023 in the US while autosomal dominant Alport syndrome (ADAS) is the least prevalent subtype of Alport syndrome.
  • To know more about Alport syndrome treatment guidelines, visit @ Alport Syndrome Management

Eledon Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Operating and Financial Results

Retrieved on: 
torsdag, mars 28, 2024
Research, JDRF, Kidney disease, Massachusetts General Hospital, Risk, Immunosuppression, Patient, Kidney transplantation, OLE, University, Tacrolimus, Glomerular filtration rate, Net, Investment, Society, Hospital, EGFR, Kidney, Safety, Pharmacokinetics, FACS, Annual general meeting, Pharmaceutical industry

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today reported its fourth quarter and full year 2023 operating and financial results and reviewed recent business highlights.

Key Points: 
  • In addition to our clinical development progress, tegoprubart was used for immunosuppression in historical kidney and heart pig-to-human xenotransplant procedures.
  • The procedure was completed on March 16, 2024, at Massachusetts General Hospital on a 62-year-old man with end-stage kidney disease.
  • Results were presented at the American Society of Nephrology Kidney Week 2023 Annual Meeting held in Philadelphia, PA in November 2023.
  • General and administrative expenses were $12.7 million for the year ended December 31, 2023, compared to $12.7 million for the year ended December 31, 2022.