VKA

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.

Cadrenal Therapeutics Appoints Jeff Cole as Chief Operating Officer in Advance of Tecarfarin Phase 3 Pivotal Trial

Retrieved on: 
Thursday, February 8, 2024
Principal, Kidney disease, Corporate development, Ventricular fibrillation, Therapy, OTC, University, Vitamin K antagonist, Financial management, Antiphospholipid syndrome, ESKD, Patient, Atrial fibrillation, APS, PwC, Intellectual property, VKA, Management

In this role, Mr. Cole will be responsible for the Company's manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.

Key Points: 
  • In this role, Mr. Cole will be responsible for the Company's manufacturing and supply chain operations, intellectual property, commercialization strategies, and supporting partnering activities for tecarfarin.
  • Mr. Cole brings over 25 years of experience in global pharmaceutical manufacturing and commercial operations, finance, and corporate development to the Company.
  • His experience will serve Cadrenal well as we advance our tecarfarin clinical program and evaluate partnering opportunities," commented Quang Pham, Founder, Chairman and Chief Executive Officer of Cadrenal Therapeutics.
  • "I look forward to leveraging my experience to advance tecarfarin to the market and help those underserved patient groups."

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.

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Medical Subject Headings, Marketing, Acute coronary syndrome, Thrombolysis, Artery, Moyamoya disease, INN, Risk, ABCD2, ATC, Myocardial infarction, Bleeding, International, Blood, ASA, Brain, NIHSS, Language, Heart, TIA, Vitamin K, Vascular disease, Percutaneous coronary intervention, European Medicines Agency, VKA, Preventive healthcare, Tablet, ADP, Select, Chest pain, Aspirin, Patient, Anatomy, IIA, Atrial fibrillation, Generic drug

Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Clopidogrel Viatris (previously Clopidogrel Taw Pharma), clopidogrel, Date of authorisation: 16/10/2009, Revision: 27, Status: Authorised

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.

Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, July 26, 2023
Embolism, Factor IX, Bleeding, Health, Prothrombin time, Factor X, Stroke, Food and Drug Administration, Clinical trial, Thrombophilia, VKA, Octapharma, PCC, INR, Coagulation, Warfarin, Hemostasis, Patient, Protein C, Risk, Physician, Coagulation factor VII, Vitamin K, Trial of the century, Phase, FDA, Thrombin, Food, Safety, Pharmaceutical industry, Medical imaging

Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.

Key Points: 
  • Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.
  • The Phase III, randomized, double-blind, multicenter study was performed at 24 sites in the U.S. and Europe and randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103).
  • We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients' coagulation."
  • Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro ®.

Thrombosis Research Institute (TRI) Shares Six New GARFIELD-AF And RIVER Real-world Data Analyses At ESC Congress 2021

Retrieved on: 
Monday, August 30, 2021
People, Congress, Blood, United States Preventive Services Task Force, Science, Task force, Observational study, European Union, AF, Teaching hospital, Rivaroxaban, European Society of Cardiology, Risk, Solution, Union, Tim Crow, Stroke, University, Associate, Thrombus, Diabetes, Chronic fatigue, Safety, Death, Adult, Recurrence, Patient, Thrombosis, Brain, Heart failure, Atrial fibrillation, Center, Incidence, Diagnosis, United, Ventricular fibrillation, VKA, Mortality, Population, TRI, Database, Physician, Prevalence, Warfarin, ESC, NOAC, Pharmaceutical industry, Medicine, Canal, Liquor, Medical imaging, Hospital

LONDON, Aug. 30, 2021 /PRNewswire/ -- The Thrombosis Research Institute (TRI) has six atrial fibrillation e-posters – four from the GARFIELD-AF Registry and two from the RIVER Registry – at the European Society of Cardiology (ESC) Congress 2021, which is taking place virtually from 27th to 30thAugust 2021.

Key Points: 
  • "We are delighted once again to have a strong showing at ESC Congress 2021," said Rt.
  • One of the RIVER posters looks at dosing, and shines a light on the issue of non-recommended dosing in patients based on renal function.
  • All of the TRI e-posters are available for registered participants to view on the ESC Congress 2021 Research Gateway platform at any time 'on demand'.
  • Our pioneering research programme, across medical disciplines and across the world, continues to provide breakthrough solutions in thrombosis.

Thrombosis Research Institute (TRI) Shares Six New GARFIELD-AF And RIVER Real-world Data Analyses At ESC Congress 2021

Retrieved on: 
Monday, August 30, 2021
People, Congress, Blood, United States Preventive Services Task Force, Science, Task force, Observational study, European Union, AF, Teaching hospital, Rivaroxaban, European Society of Cardiology, Risk, Solution, Union, Tim Crow, Stroke, University, Associate, Thrombus, Diabetes, Chronic fatigue, Safety, Death, Adult, Recurrence, Patient, Thrombosis, Brain, Heart failure, Atrial fibrillation, Center, Incidence, Diagnosis, United, Ventricular fibrillation, VKA, Mortality, Population, TRI, Database, Physician, Prevalence, Warfarin, ESC, NOAC, Pharmaceutical industry, Medicine, Canal, Liquor, Medical imaging, Hospital

LONDON, Aug. 30, 2021 /PRNewswire/ -- The Thrombosis Research Institute (TRI) has six atrial fibrillation e-posters – four from the GARFIELD-AF Registry and two from the RIVER Registry – at the European Society of Cardiology (ESC) Congress 2021, which is taking place virtually from 27th to 30thAugust 2021.

Key Points: 
  • "We are delighted once again to have a strong showing at ESC Congress 2021," said Rt.
  • One of the RIVER posters looks at dosing, and shines a light on the issue of non-recommended dosing in patients based on renal function.
  • All of the TRI e-posters are available for registered participants to view on the ESC Congress 2021 Research Gateway platform at any time 'on demand'.
  • Our pioneering research programme, across medical disciplines and across the world, continues to provide breakthrough solutions in thrombosis.

VEON appoints Artashes Davtyan as CEO of Beeline Uzbekistan

Retrieved on: 
Monday, March 8, 2021
Telenor, VEON, Companies, Telecommunications, Alfa Group, Beeline, VEON, VKA, Yandex

AMSTERDAM, March 8, 2021 /PRNewswire/ -- VEON Ltd. (NASDAQ: VEON) (Euronext Amsterdam: VEON), a leading global provider of connectivity and internet services, announces the appointment of Artashes Davtyan as CEO of Beeline Uzbekistan, effective 15 March 2021.

Key Points: 
  • AMSTERDAM, March 8, 2021 /PRNewswire/ -- VEON Ltd. (NASDAQ: VEON) (Euronext Amsterdam: VEON), a leading global provider of connectivity and internet services, announces the appointment of Artashes Davtyan as CEO of Beeline Uzbekistan, effective 15 March 2021.
  • Artashes joins Beeline Uzbekistan with a wealth of commercial and leadership experiencefrom international FMCG companies including Gillette, PepsiCo and Mars, and most recently Yandex where he was Head of Private Label in its digital retail delivery business, Yandex.Lavka.
  • Kaan Terziolu, VEON's co-CEO, commented: "We welcome Artashes to the VEON family and are confident that his impressive track record of leading FMCG and digital businesses will be a great fit for the customer-first mindset of our Group.
  • Forward-looking statements are inherently subject to risks and uncertainties, many of which VEON cannot predict with accuracy and some of which VEON might not even anticipate.