CSL Vifor

EQS-News: Formycon invites to the Annual General Meeting on June 12, 2024 in Munich

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пятница, мая 10, 2024
Family, Annual general meeting, CSL Vifor, Annual, CFO, LLP, Investment, Hope, Management, London Business School, PwC, Royal Pharmaceutical Society, Bachelor of Science, Haus, Procter & Gamble, GSK, Supervisory board, Supervision, MBA, Biotechnology, Property management

Formycon invites to the Annual General Meeting on June 12, 2024 in Munich

Key Points: 
  • Formycon invites to the Annual General Meeting on June 12, 2024 in Munich
    The issuer is solely responsible for the content of this announcement.
  • Formycon invites to the Annual General Meeting on June 12, 2024 in Munich
    With Colin Bond, Dr. Bodo Coldewey and Nicholas Haggar, three new candidates with relevant industry and financial expertise stand for election
    Planegg-Martinsried, Germany – Formycon AG (FSE: FYB, "Formycon") has published the invitation to its Annual General Meeting on Wednesday, June 12, 2024.
  • The Annual General Meeting will be held as an in-person event for shareholders and their proxies from 11 a.m. (CEST) at the Haus der Bayerischen Wirtschaft in Munich.
  • The Executive Board of Formycon AG therefore proposes to the Annual General Meeting that a total of three new members be elected to the Supervisory Board.

Travere Therapeutics Reports First Quarter 2024 Financial Results

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понедельник, мая 6, 2024
FDA, Total, Risk, Ligand Pharmaceuticals, European Commission, Research, UPCR, Webcast, HCU, IND, EGFR, PDUFA, SIMD, Civil service commission, Diagnosis, PMDA, GAAP, CMA, Congress, Table, PROTECT, Priority review, Food, Abstract, FSGS, Income tax, CSL Vifor, Quarter, Medication, Therapy, SAN, Plasma, Urine, International, Safety, Proteinuria, ANNA, Immunoglobulin A, Homocysteine, Investigational New Drug, Society, Shanda, New Drug Application, Genetic, European, Disease, Patient, Quality of life (healthcare), IPR, Bank statement, Growth, Pharmaceutical industry

Net product sales for the first quarter of 2024 were $40.0 million, compared to $24.2 million for the same period in 2023.

Key Points: 
  • Net product sales for the first quarter of 2024 were $40.0 million, compared to $24.2 million for the same period in 2023.
  • Travere Therapeutics will host a conference call and webcast today, Monday, May 6, 2024, at 4:30 p.m.
  • ET to discuss company updates as well as first quarter 2024 financial results.
  • The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results.

Ligand Reports First Quarter 2024 Financial Results

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вторник, мая 7, 2024
Biotechnology, Pharmaceutical, Health, Oncology, FDA, Element, Investment, European Commission, Research, Molluscum contagiosum, CHMP, Parent, Agenus, PDUFA, Fibrosis, GAAP, CMA, PROTECT, Fast track (FDA), Priority review, Economics, Colorectal cancer, Forecasting, Liver disease, CSL Vifor, Committee, Bristol Myers Squibb, Therapy, Merck, Telephone, Safety, CASI, ASX, Immunoglobulin A, MRK, Sale, AMGN, Vikings, Gilead Sciences, Jazz Pharmaceuticals, LGND, NASH, Patient, CSL, Caregiver, Growth, Pharmaceutical industry

Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today reported financial results for the three months ended March 31, 2024, and provided an operating forecast and business updates.

Key Points: 
  • Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today reported financial results for the three months ended March 31, 2024, and provided an operating forecast and business updates.
  • “We are pleased to report another quarter of strong financial results driven by the performance of our commercial royalty portfolio.
  • Amortization of intangibles was $8.2 million for the first quarter of 2024, compared with $8.5 million for the same period in 2023.
  • Research and development expense was $6.0 million for the first quarter of 2024, compared with $6.7 million for the same period in 2023.

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

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среда, апреля 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.

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

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среда, апреля 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.

Vafseo® approved by the U.S. FDA for the treatment of anemia due to chronic kidney disease in dialysis-dependent adult patients

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четверг, марта 28, 2024
CSL Vifor, Thrombosis, Myocardial infarction, Akebia, CKD, Patient, Tablet, Public, Stroke, Death, Therapy, Nephrology, Safety, Chronic kidney disease, Dialysis, Anemia, Division, Stanford University, Food, FDA, Pharmaceutical industry

Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia.

Key Points: 
  • Vafseo is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) developed by Akebia.
  • "As we continue to deliver on our promise for patients and public health, we are eager to closely collaborate with our partners to make this new oral treatment option available to patients."
  • Results from the INNO2VATE program were published in the New England Journal of Medicine: (N Engl J Med 2021; 384:1601-1612); (N Engl J Med 2021; 384:1589-1600).
  • See the Important Safety Information section below, including BOXED WARNING regarding increased risk of death, myocardial infarction, stroke, venous thromboembolism and thrombosis of vascular access.

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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четверг, марта 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.

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

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вторник, марта 19, 2024
CSL Vifor, University, Research, Exercise, Classification, Health professional, Risk, Patient, Public, Palpitations, Health care, NYHA, News, Periodic breathing, Cardiovascular Research, Quality of life, Health Canada, Woman, Heart failure, Anemia, Fatigue, Hospital, Dietary supplement

Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.

Key Points: 
  • Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.
  • "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency."
  • Iron deficiency affects one in every two hospitalized patients with heart failure5.
  • * The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms.

Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

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понедельник, марта 11, 2024
Angiotensin, SAN, European Commission, EMA, Erosion (morphology), Committee, New Drug Application, PROTECT, FDA, Food, Dialysis, Shanda, Hope, Risk, Civil service commission, Therapy, CHMP, CSL Vifor, EGFR, Patient, Immunoglobulin A, Kidney disease, Disease, Kidney, CMA, Proteinuria, Pharmaceutical industry

The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

Key Points: 
  • The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
  • “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
  • “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
  • The FDA has 60 days from the receipt of the application to determine whether to accept it for review.

4BIO Capital Strengthens Advisory Board and Investment Team

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понедельник, марта 11, 2024
Eli Lilly, University, Advisory board, AstraZeneca, Philosophy, Doctor of Philosophy, GSK, CSL, Growth, Sale, Government, Vaccine, Therapy, CSL Vifor, Associate, VVMF, Admiration, NSW, Pharmaceutical industry

LONDON, 11 March 2024 – 4BIO Capital (“4BIO” or “the Group”), an international venture capital firm unlocking the treatments of the future by investing in advanced therapies and other emerging technologies, announces today the appointments of biopharmaceutical industry veteran Abbas Hussain and world-leading vectorology expert Leszek Lisowski, PhD MBA to its Advisory Board.

Key Points: 
  • LONDON, 11 March 2024 – 4BIO Capital (“4BIO” or “the Group”), an international venture capital firm unlocking the treatments of the future by investing in advanced therapies and other emerging technologies, announces today the appointments of biopharmaceutical industry veteran Abbas Hussain and world-leading vectorology expert Leszek Lisowski, PhD MBA to its Advisory Board.
  • Along with the appointment of Abbas and Leszek, 4BIO is also pleased to announce the promotion of Dr Natalie Johnston to Principal.
  • I am honoured to be joining the 4BIO Capital Advisory Board alongside such esteemed members and look forward to working closely with the entire team to support the firm’s portfolio companies and identify the disruptive companies of the future.”
    Leszek Lisowski, newly appointed Advisory Board member added: “I have watched the 4BIO Capital team’s success over the last 8 years with admiration and I am excited to support them as an Advisory Board member.
  • Fostering the development of our team is core to 4BIO’s philosophy, ensuring we have the very best talent to help drive tomorrow’s innovation.