Nephrology

EQS-News: Evotec and Variant Bio enter strategic partnership to discover and develop fibrosis treatments

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星期五, 五月 3, 2024
Mortality, MDAX, Nephrology, Probability, EVO, Partnership, Fibrosis, Frankfurt Stock Exchange, Science, Liver, CSO, Drug development, Drug discovery, Disease, Pharmaceutical industry

Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Variant Bio, Inc. today announced a collaboration agreement to identify a best-in-class treatment for diseases caused by fibrosis.

Key Points: 
  • Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809; NASDAQ: EVO) and Variant Bio, Inc. today announced a collaboration agreement to identify a best-in-class treatment for diseases caused by fibrosis.
  • The strategic partnership leverages Variant Bio’s cutting-edge genomic discovery capabilities and VB-Inference platform as well as Evotec’s extensive expertise in antifibrotic drug discovery.
  • This strategic framework allows Variant Bio to offset the early costs of drug development in exchange for a portion of the future upside.
  • Dr Matthias Evers, Chief Business Officer of Evotec, said: “We are excited to enter this collaboration with Variant Bio.

Ardelyx Reports First Quarter 2024 Financial Results and Provides Business Update

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星期四, 五月 2, 2024
Sale, Nephrology, Diarrhea, Investment, Safety, Risk, Food, Research, Human, Corporate development, Hyperphosphatemia, Dehydration, Incidence, Patient, Abdominal distension, Death, Growth, Rat, Pharmaceutical industry

WALTHAM, Mass., May 02, 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 first quarter ended March 31, 2024 and provided a business update.

Key Points: 
  • “The first quarter of 2024 marked an important milestone for Ardelyx as a commercial company.
  • 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 during Q1 2024 was $15.2 million, the first full quarter of sales following the product’s launch in November 2023.
  • R&D Expenses: Research and development expenses were $10.6 million for the quarter ended March 31, 2024, compared to $9.1 million for the quarter ended March 31, 2023.

Travere Therapeutics and CSL Vifor Announce European Commission Approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

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星期三, 四月 24, 2024
Nephrology, Kidney disease, Kidney, Div, Proteinuria, European Commission, Kidney failure, CHMP, Irbesartan, Immunoglobulin A, European, EGFR, Patient, CSL Vifor, CSL, Committee, Civil service commission, RAAS, Teaching hospital, Head, Therapy, CMA, SAN, Pharmaceutical industry

SAN DIEGO, April 24, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (Nasdaq: TVTX) and CSL Vifor today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • “The approval of this innovative treatment is based on data from the only head-to-head phase 3 clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.
  • In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for FILSPARI in Europe, Australia and New Zealand.

SeaStar Medical Reports 2023 Financial Results and Provides a Business Update

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星期三, 四月 17, 2024
Mortality, FDA, Nephrology, Risk, Nephron, Partnership, Hepatorenal syndrome, Acute kidney injury, ICU, White, AKI, Chronic kidney disease, Monocyte, Heart failure, SCD, Dialysis, CRRT, CKRT, KRT, Inflammation, Safety, Insurance, Clinical study design, Therapy, Clinical trial, G&A, Sepsis, University, HDE, Survival rate, Neutrophil, Acute respiratory distress syndrome, Patent, Cardiorenal syndrome, European Journal, Physician, Manuscript, Bank statement, Standard of care, Pharmaceutical industry

DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.

Key Points: 
  • DENVER, April 17, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a commercial-stage medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the 12 months ended December 31, 2023 and provides a business update.
  • “Lastly, I’m pleased that we have filed our Form 10-K for 2023, which includes restated 2022 financial statements,” said Mr. Schlorff.
  • Mr. Green brings to SeaStar Medical extensive financial experience at public medical device and therapeutics companies.
  • The Company reported cash of $176,000 as of December 31, 2023, compared with $47,000 as of December 31, 2022.

HEALWELL Subsidiaries, Khure Health & Pentavere Research Group, to Participate and Present at Upcoming Globally Recognized Medical Conferences

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星期三, 四月 17, 2024
Public, CPD, Real, Nephrology, Ophthalmology, AIDX, National Kidney Foundation, AI, Research, Health, AMIA, TSX, American Head, Conference, Artificial intelligence, Chronic kidney disease, Guideline, QC, Health information management, Oropharyngeal cancer, Patient, Faculty, Otorhinolaryngology, American Medical Informatics Association, NKF, Entertainment center, Knowledge

Pentavere will be presenting at the following medical conferences:

Key Points: 
  • Pentavere will be presenting at the following medical conferences:
    Canadian Retina Society Annual Meeting on May 3-5, 2024 in Montreal, QC.
  • American Medical Informatics Association (AMIA) Clinical Informatics Conference on May 21-23, 2024 in Minneapolis, MN.
  • Presenting Research: Using Artificial Intelligence to automate the extraction of staging criteria from the electronic health records of oropharyngeal cancer patients.
  • Thought leaders driving the future of healthcare delivery will explore practice-ready solutions to enhance patient experiences, reduce costs, and improve public health.

The United States FDA Awards Orphan Drug Designation (ODD) to NM5072 for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH)

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星期一, 四月 15, 2024
FDA, Pain, Mortality, Nephrology, Inflammation, Monocyte, Cell, Anemia, Alternative complement pathway, Safety, Ophthalmology, Red blood cell, Food, Hematology, Chelsea Handler, Dermatology, Half-life, Atypical hemolytic uremic syndrome, Blood, AP, Hyperlipidemia, Hemoglobinuria, Disease, Patient, Neurology, Fatigue, Platelet, Diagnosis, Infection, Hemolysis, Immune system, PNH, ODD, Quality of life, Chronic pain, LDH, Paroxysmal nocturnal hemoglobinuria, Pharmaceutical industry

The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.

Key Points: 
  • The United States Food and Drug Administration (FDA) has awarded orphan drug designation (ODD) to NM5072 for the treatment of anemia in PNH patients.
  • CLEVELAND, April 15, 2024 (GLOBE NEWSWIRE) -- NovelMed today announced that the Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH).
  • NM5072 is another drug in our pipeline that has received Orphan Drug Designation in the United States.
  • Among these, Paroxysmal Nocturnal Hemoglobinuria (PNH) emerges as a prominent indication for complement blockers heading towards FDA approval.

Toku Inc. Secures FDA Breakthrough Designation for Technology that Identifies Chronic Kidney Disease Risk Through the Eye

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星期二, 四月 30, 2024
Software, Research, Optical, Medical Devices, Technology, Artificial Intelligence, Science, Biotechnology, FDA, Other Science, Health, Diabetes, Health policy, Nephrology, Kidney disease, Patient, Disorder, Population health, System, National Kidney Foundation, Risk, AI, Food, Kidney failure, Death, Health care, Breakthrough, Disease, CKD, Retina, Eye, Developed country, Kidney transplantation, Dialysis, Microangiopathy, Medicare, Multimedia, Chronic kidney disease, Overalls, Pharmaceutical industry

Toku, Inc., a commercial medical device company specializing in imaging technology and AI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its MyKidneyAI technology.

Key Points: 
  • Toku, Inc., a commercial medical device company specializing in imaging technology and AI, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its MyKidneyAI technology.
  • MyKidneyAI uses AI to analyze retinal images collected at routine eye exams to detect elevated chronic kidney disease (CKD) risk in people with diabetes.
  • Toku developed MyKidneyAI to help identify individuals with diabetes who have elevated CKD risk via a simple eye exam available in eye care or primary care settings.
  • FDA's Breakthrough designation expedites the review process, shortening the time until technology reaches patients if cleared by the FDA.

Outset Medical Partners with American Nephrology Nurses Association to Support Nephrology Nursing and Patient Care

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星期一, 四月 15, 2024
Medical Devices, Other Health, Health, Health Technology, Nursing, Kidney disease, Nephrology, Policy, Kidney failure, RNS, American Journal, ANNA, Partnership, Chronic kidney disease, CKD, Patient, Dialysis, Medicine, Kidney, Chair

This collaboration underscores Outset’s dedication to supporting the nephrology nursing community and improving patient care in the realm of kidney disease.

Key Points: 
  • This collaboration underscores Outset’s dedication to supporting the nephrology nursing community and improving patient care in the realm of kidney disease.
  • Leslie Trigg, Chair and CEO of Outset, shared her thoughts on the partnership: “We enthusiastically support ANNA’s goal of empowering and educating nephrology nurses who are essential to delivering high-quality care to patients with kidney disease.
  • This partnership demonstrates our dedication to enhancing patient outcomes and supporting the vital role of the nephrology nurses who care for them.”
    ANNA emphasized the importance of collaboration with industry leaders to advance the nephrology nursing field.
  • “Outset Medical’s support, together with our other corporate partners, is important to our mission,” said Michele Kimball, ANNA Executive Director.

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

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星期三, 四月 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.

CSL Vifor and Travere Therapeutics Announce European Commission approves FILSPARI® (sparsentan) for the treatment of IgA Nephropathy

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星期三, 四月 24, 2024
Nephrology, Kidney disease, PROTECT, Proteinuria, European Commission, Kidney failure, Professor, CHMP, Irbesartan, European, EGFR, Senior, Patient, Kidney, CSL Vifor, CSL, Medicine, Committee, Civil service commission, RAAS, Teaching hospital, Clinical trial, Therapy, CMA, SAN, Pharmaceutical industry

ST. GALLEN, Switzerland and SAN DIEGO, April 24, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Commission has granted conditional marketing authorization (CMA) for FILSPARI (sparsentan) for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

Key Points: 
  • The CMA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • Nephrology and Clinical Immunology at the University Hospital, RWTH Aachen, Germany, and steering committee member for the PROTECT clinical trial.
  • "The approval of this innovative treatment is based on data from the only head-to-head phase-III clinical trial in IgAN.
  • CSL Vifor expects to launch FILSPARI in the first European markets in the second half of 2024.