Warfarin

Cadrenal Therapeutics Receives FDA Orphan Drug Designation for Tecarfarin for Prevention of Thromboembolism and Thrombosis in Patients with LVADs, RVADs, Biventricular Assist Devices, and Total Artificial Hearts

Retrieved on: 
Tuesday, April 9, 2024
ODD, Warfarin, Thrombosis, VADS, Risk, Vitamin K antagonist, New Drug Application, Patient, Apixaban, Stroke, Anticoagulant, Splenic infarction, Death, Therapy, Bleeding, LVAD, FDA, VKA, Pharmaceutical industry

PONTE VEDRA, Fla., April 9, 2024 /PRNewswire/ -- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing tecarfarin, a late-stage novel oral and reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients with rare cardiovascular conditions, announced today that the United States Food and Drug Administration (FDA) has granted tecarfarin Orphan Drug Designation (ODD) for the prevention of thromboembolism and thrombosis in patients with an implanted mechanical circulatory support device (left ventricular assist device (LVAD), right ventricular assist device (RVAD), collectively known as ventricular assist devices (VADs), biventricular assist device, and total artificial heart).

Key Points: 
  • "This second orphan drug designation highlights the expanded need for tecarfarin where existing anticoagulation therapies are inadequate," said Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.
  • "We are dedicated to advancing tecarfarin through clinical development options as swiftly as possible."
  • Since its adoption in 1983, the Orphan Drug Act has helped countless individuals living with these conditions gain access to life-enhancing and life-saving therapies.
  • The designation is made to promote safe and efficacious products for the treatment of rare conditions.

Findings Presented at ACC.24 Showed XARELTO® (rivaroxaban) Reduced the Risk of Clinically Significant Bleeding and Net Adverse Clinical Events or Rehospitalization

Retrieved on: 
Monday, April 8, 2024
Cardiology, Abstract, Harvard Medical School, Warfarin, NACE, Rivaroxaban, Ventricular fibrillation, Data analysis, Risk, Patient, Stroke, Research, CSB, American College, Clinical trial, PCI, Bleeding, Johnson & Johnson, Percutaneous coronary intervention, Pharmaceutical industry

NEW BRUNSWICK, N.J., April 8, 2024 /PRNewswire/ -- Johnson & Johnson announced today a new analysis of data from the PIONEER AF-PCI clinical trial demonstrating that XARELTO® (rivaroxaban) was associated with a reduced risk of clinically significant bleeding (CSB), and net adverse clinical events (NACE; a composite of clinically significant bleeding [CSB] or major adverse cardiovascular event [MACE]) or rehospitalization compared to warfarin among both elderly and non-elderly patients with nonvalvular atrial fibrillation (AF) undergoing percutaneous coronary intervention (PCI), a nonsurgical procedure designed to relieve narrowing or occlusion of the coronary artery.1,2 These data were featured in an oral presentation today at the American College of Cardiology 73rd Annual Scientific Session & Expo (ACC.24) in Atlanta, Georgia (Abstract #906-04).

Key Points: 
  • "Despite advances in cardiovascular care, patients with nonvalvular AF continue to be at risk of potentially life-threatening cardiovascular events, especially older patients considered difficult to treat due to multiple factors, including age and co-morbidities," said C. Michael Gibson*, M.D., CEO, of the nonprofit Baim Institute and professor of Medicine, Harvard Medical School.
  • "A significant challenge in managing nonvalvular AF in older individuals undergoing PCI is determining a treatment that balances the prevention of stroke with the risk for bleeding.
  • Results from the PIONEER AF-PCI trial reinforce the need to continue to research this complex and fragile elderly patient population."
  • "With this new exploratory analysis at ACC.24, we're pleased to bring the latest research to healthcare providers that adds to the growing body of clinical evidence in older adults."

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Retrieved on: 
Tuesday, February 13, 2024
Acquisition, Warfarin, CSL Behring, Depreciation, Research, Ministry, Messenger, CIDP, Marketing, CSL, Growth, Plasmapheresis, Primary immunodeficiency, Von Willebrand disease, Antibody, S&M, Immunodeficiency, ASX, Income tax, Haemophilia, HAE, Ministry of Health, CSL Vifor, Hereditary angioedema, Plasma, COVID, Patient, Webcast, Phase, Diagnosis, G&A, CC3, Pressure, CSL Limited, Vaccine

MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Retrieved on: 
Tuesday, February 13, 2024
Acquisition, Warfarin, CSL Behring, Depreciation, Research, Ministry, Messenger, CIDP, Marketing, CSL, Growth, Plasmapheresis, Primary immunodeficiency, Von Willebrand disease, Antibody, S&M, Immunodeficiency, ASX, Income tax, Haemophilia, HAE, Ministry of Health, CSL Vifor, Hereditary angioedema, Plasma, COVID, Patient, Webcast, Phase, Diagnosis, G&A, CC3, Pressure, CSL Limited, Vaccine

MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.

Key Points: 
  • Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3.
  • Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand.
  • HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by  patient diagnosis rates.
  • However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year.

Cadrenal Therapeutics to Present at the Biotech Showcase on January 8, 2024 Alongside the J.P. Morgan Annual Healthcare Conference

Retrieved on: 
Thursday, January 4, 2024
Assistive technology, Conference, NASDAQ Biotechnology Index, Anticoagulant, Partnership, Metabolism, Risk, Death, Biotechnology, Warfarin, Bleeding, Antiphospholipid syndrome, APS, Atrial fibrillation, Phạm, Therapy, ESKD, Stroke, Splenic infarction, Kidney disease, Ventricular fibrillation, Patient, Apixaban, Pharmaceutical industry

"Tecarfarin provides a more stable anticoagulation than warfarin due to its metabolism, thereby decreasing the risk of stroke and bleeding."

Key Points: 
  • "Tecarfarin provides a more stable anticoagulation than warfarin due to its metabolism, thereby decreasing the risk of stroke and bleeding."
  • To arrange a meeting with management, please contact your Biotech Showcase representative or Lytham Partners at [email protected] .
  • The ceremony will feature healthcare companies within the Nasdaq Biotechnology Index, highlighting them as companies pioneering the future.
  • The conference takes place each year in San Francisco during the course of one of the industry's largest gatherings and busiest weeks.

Octapharma Announces Availability of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, January 3, 2024
Phase, Coagulation, Food, Emergency medicine, Risk, Vitamin K, PCC, Hemostasis, FDA, Warfarin, Bleeding, INR, Massachusetts General Hospital, Hospital, Thrombophilia, MD, Doctor of Philosophy, Factor X, Factor IX, Clinical trial, Prothrombin time, Trial of the century, Coagulation factor VII, Octapharma, VKA, Patient, Safety, Harvard Medical School, Thrombin, Pharmaceutical industry

PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.

Key Points: 
  • The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
  • Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers.
  • "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future.
  • Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk.

American Regent Introduces Levocarnitine Injection, USP; FDA-Approved, "AP" Rated, and Therapeutically Equivalent to Carnitor®¹

Retrieved on: 
Tuesday, October 10, 2023
Urine, INR, Kidney disease, ESRD, Vomiting, Carnitine, Milk, Nursing, Safety, Pregnancy, Edema, Dialysis, Nausea, FDA, Warfarin, Drinking fountain, Gastritis, Child, Seizure, Anaphylaxis, Patient, Vaccine, Pharmaceutical industry, Dietary supplement

Consider the risks and benefits of re-administering levocarnitine to individual patients following a severe reaction.

Key Points: 
  • Consider the risks and benefits of re-administering levocarnitine to individual patients following a severe reaction.
  • Studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine.
  • You are encouraged to report adverse drug events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.
  • You are encouraged to report adverse drug events (ADEs) to American Regent:
    ADEs may also be reported to the FDA:

Octapharma USA Presents Factor Concentrates for Perioperative Bleeding Symposium for ASA Annual Meeting Attendees

Retrieved on: 
Tuesday, October 10, 2023
Annual general meeting, Thrombophilia, Algorithm, American Society of Anesthesiologists, Disease, Food, VKA, Bleeding, PST, MD, Society, Mortality, Factor, Hospital, FDA, Food and Drug Administration, Warfarin, Toronto General Hospital, PCC, FC, Octapharma, Duke University, Hemostasis, The Reconstruction (1970 film), ASA, Moscone Center, Toronto, Patient, Nightclub, Dentistry, Pharmaceutical industry, Fibrinogen, Research

PARAMUS, N.J., Oct. 10, 2023 /PRNewswire/ -- Octapharma USA will sponsor the scientific symposium, Factor Concentrates for Perioperative Bleeding – Global Perspectives, Sunday, October 15th in conjunction with the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco.

Key Points: 
  • PARAMUS, N.J., Oct. 10, 2023 /PRNewswire/ -- Octapharma USA will sponsor the scientific symposium, Factor Concentrates for Perioperative Bleeding – Global Perspectives, Sunday, October 15th in conjunction with the American Society of Anesthesiologists (ASA) Annual Meeting in San Francisco.
  • The symposium will address current gaps in research related to factor concentrates, including prothrombin complex concentrates (PCC) and fibrinogen concentrates (FC), for perioperative bleeding management.
  • Kamrouz Ghadimi, MD, MHSc, Department of Anesthesiology, Duke University, will discuss, "Perioperative Coagulopathic Bleeding – Definition, Treatment Algorithms, and POC Testing, Oh My!"
  • The role of factor concentrates and blood products for management of bleeding in surgery;
    The latest research and current practice guidelines for factor concentrates in perioperative bleeding; and
    Individualized bleeding management strategies in cardiac surgery, with patient case presentations.

Artivion Announces Presentation of Real World Data from Post Market Study of On-X® Aortic Heart Valve Replacement Patients Treated with Low Dose Warfarin

Retrieved on: 
Thursday, October 5, 2023
Annual general meeting, European Association for Cardio-Thoracic Surgery, NYSE, INR, Real, EACTS, Thrombosis, Warfarin, Patient, LOR, Aortic valve, Medical imaging

ATLANTA, Oct. 5, 2023 /PRNewswire/ -- Artivion, Inc. (NYSE: AORT), a leading cardiac and vascular surgery company focused on aortic disease, today announced data from its On-X Aortic Heart Valve Low INR post-market study presented in a Late-Breaking Science session at the 37th European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Vienna, Austria. Real world interim results for all patients confirm that the On-X Aortic Valve remains safe and effective with low-dose warfarin.

Key Points: 
  • Real world interim results for all patients confirm that the On-X Aortic Valve remains safe and effective with low-dose warfarin.
  • Professor Aung Oo, Clinical Lead for Aortovascular Surgery at Barts Heart Centre, London, England, presented an abstract titled, Real World Experience of 510 On-X Aortic Valve Replacement Patients Treated with Low Dose Warfarin.
  • The abstract included at least 1-year and up to 5 years of clinical data on study participants, with median follow up time of 3.4 years.
  • Notably, the data reflected an improvement in outcomes compared to the On-X Aortic Low INR IDE Study (IDE Study) data first published in 2014.

UK Fine Art Company Thriving in Soaring Global Fine Art Market

Retrieved on: 
Monday, October 2, 2023
Online, Christie, Internet, Culture, Millennials, Sale, Movement, Creativity, Christie's, Beauty, Collection, Investment, Museum, Fine art, Growth, Imagination, Auction, Financial services, Cryptocurrency, Entertainment, Warfarin

Waran's Fine Art, a new London-based rising star on the scene, is poised to capitalise on the thriving arts industry.

Key Points: 
  • Waran's Fine Art, a new London-based rising star on the scene, is poised to capitalise on the thriving arts industry.
  • The global art market is currently expanding rapidly as we continue to recover from the economic storm wrought by the pandemic.
  • As a rapidly growing UK fine art company, Waran's Fine Art are delighted to be playing their part in this international success story.
  • Waran's Fine Art believe that fine art assets should be available to all, and invite art collectors, investors and enthusiasts to explore their curated collection of fine art pieces, which includes works from renowned artists as well as the best of emerging talents.