Anticoagulant

TRIA™ Polymer Surgical Valves Surpass 200 Patient Life Years

Retrieved on: 
Tuesday, April 16, 2024
Biotechnology, Surgery, Medical Devices, Health, Cardiology, Doctor of Philosophy, FDA, Sale, Anticoagulant, University, DCGI, Biomedical engineering, Trial of the century, TRIA, Biomedicine, TAVR, Patient, Hemodynamics, Calcification, Quality of life, Cardiovascular disease, Medical device

Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced that its TRIA valves have surpassed 200 patient life years in human recipients.

Key Points: 
  • Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced that its TRIA valves have surpassed 200 patient life years in human recipients.
  • TRIA valves are intended to improve the lifetime management of heart valve disease in patients.
  • The novel polymer material enables TRIA valves to be robotically produced, minimizing manpower and process, and maximizing product quality and precision.
  • The TRIA valves have demonstrated excellent and stable hemodynamics clinically and have restored patient quality of life without requiring long-term use of anticoagulants.

EISAI TO PRESENT DATA ON ROBUST NEUROLOGY PORTFOLIO AT THE 76th AMERICAN ACADEMY OF NEUROLOGY® (AAN) ANNUAL MEETING

Retrieved on: 
Friday, April 12, 2024
Amyloid, Angioedema, Brain, Anticoagulant, Neuroimaging, Patient, Vascular malformation, Lecanemab, Siderosis, Dementia, Cell, Seizure, ARIA, Risk, Aspirin, Focal neurologic signs, Nausea, Cerebral edema, Dizziness, Paracetamol, Arthralgia, Cerebral amyloid angiopathy, Effectiveness, Genetic testing, Intraparenchymal hemorrhage, Observation, Confusion, Alzheimer's disease, Intracerebral hemorrhage, Status epilepticus, Vomiting, Incidence, Aneurysm, Anaphylaxis, Headache, Hypersensitivity, Hypertension, MRI, Magnetic resonance imaging, Chills, Neuron, Bronchospasm, Fatal, Hypotension, Tissue plasminogen activator, Edema, Fever, Excipient, Pharmaceutical industry

Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Key Points: 
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E.
  • There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.

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.

Foldax, Inc. Signs Manufacturing Agreement with Dolphin Life Science India LLP to Expedite Upcoming Commercial Availability

Retrieved on: 
Tuesday, February 27, 2024
Research, Medical Devices, Engineering, Chemicals, Plastics, Health Technology, Cardiology, Manufacturing, Biotechnology, Health, Science, Anticoagulant, Cardiovascular disease, CDSCO, Sale, RHD, Calcification, Mitral valve, Patient, Anatomy, LLP, Failure, DCGI, TRIA, Medical device

Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.

Key Points: 
  • Foldax® Inc., a pioneer in the development of innovative, polymer heart valves, today announced a manufacturing agreement with Dolphin Life Science India LLP to enable in-country manufacturing of the TRIA™ polymer mitral surgical heart valve outside of the U.S. for the first time.
  • The TRIA mitral valve is designed specifically to accommodate the anatomy and pressures of the mitral position.
  • Dolphin Life Science India LLP is an expert in manufacturing medical devices.
  • The company is registered with India’s regulatory bodies, the Drugs Controller General of India (DCGI), and the Central Drugs Standard Control Organization (CDSCO).

Roche launches three new Factor Xa inhibitor coagulation tests to meet growing patient need

Retrieved on: 
Monday, February 12, 2024
Essential medicines, CE, Rivaroxaban, VTE, Anticoagulant, INR, Roche, Edoxaban, Direct factor Xa inhibitors, PAD, Stroke, Moyamoya disease, Risk, CAD, Ventricular fibrillation, Health, Patient, Labs, Coronary thrombosis, Diagnosis, Laboratory, Coronary artery disease

"Diseases such as CAD and PAD can have serious consequences and urgently need better diagnosis and treatment.

Key Points: 
  • "Diseases such as CAD and PAD can have serious consequences and urgently need better diagnosis and treatment.
  • "These numbers and our growing understanding of these diseases are leading to a sharp rise in global demand for direct oral anticoagulants.
  • We want to help labs meet this increased need for testing to better inform patient care.
  • These tests can be used for both assessing the anti-Xa activity of heparin therapy as well as the three authorised Factor Xa inhibitors.

Medicines360 and DKT WomanCare Announce Strategic Partnership to Expand Access to the Hormonal IUD Avibela™

Retrieved on: 
Wednesday, January 31, 2024
SAN, Nausea, Clinical trial, Perforation, Birth, Fibroid, Internal bleeding, Liver failure, Infection, Artery, Pelvic pain, DKT International, Jaundice, Anticoagulant, Blood pressure, Ovarian cyst, Woman, Acne, Organization, Partnership, Endometritis, Angioedema, History, Abscess, Contraindication, DKT, Peritonitis, Rash, Coagulopathy, Dyspareunia, Inflammatory cytokine, Adhesion, Vomiting, Bacterial vaginosis, Headache, Bowel obstruction, IUS, Uterus, STI, Breast cancer, Miscarriage, Patient, Fertility, Sepsis, Marketing, Risk, Stroke, Organ, Streptococcus, Hormone-sensitive cancer, Liver tumor, Cyst, Intrauterine device, GAS, Pregnancy, PID, Social marketing, Vaginitis, Migraine, Myocardial infarction, Health, Brain, Birth control

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.

Key Points: 
  • "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.
  • “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception.
  • As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies.
  • Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market.

Verseon Gains US Patent Protection for Compounds that Could Eliminate Bleeding Risks of Current Anticoagulants

Retrieved on: 
Wednesday, January 24, 2024
Risk, Stroke, Bleeding, Protease, Patent, Patient, Verseon, Splenic infarction, Anticoagulant, Cardiovascular disease, CSO, Pharmaceutical industry

FREMONT, Calif., Jan. 24, 2024 /PRNewswire/ -- Verseon is pleased to announce that the USPTO has issued a new patent, "Thrombin Inhibitors, Formulations, and Uses Thereof," that further extends intellectual property protection for Verseon's novel class of thrombin inhibitors. These anticoagulant compounds promise to open new and safer treatment options for many of the world's 400+ million cardiovascular disease patients.

Key Points: 
  • These anticoagulant compounds promise to open new and safer treatment options for many of the world's 400+ million cardiovascular disease patients.
  • Unlike current anticoagulants, Verseon's Precision Oral Anticoagulants (PROACs) covered by this patent exhibit a unique mechanism of action that does not increase the risk of bleeding yet prevents the formation of the dangerous blood clots behind heart attacks and strokes.
  • Because these compounds are also highly selective against other serine proteases, they are expected to cause fewer side effects.
  • "We are pleased by the USPTO's decision to grant additional patent protection for our PROACs," said Verseon's CSO David Kita.

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.

Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Date of authorisation: 26/04/2019, Revision: 17, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Patient, Medical Subject Headings, Marketing, Protein, Agency, INN, Fever, Risk, IIA, Allergy, ATC, Destiny of X, Fondaparinux, Blood, Bleeding, International, Ageing, Language, Thrombosis, Stroke, European Medicines Agency, Anticoagulant, Select, Side effect, Anatomy, Rivaroxaban

Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Date of authorisation: 26/04/2019, Revision: 17, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Ondexxya, andexanet alfa, Date of authorisation: 26/04/2019, Revision: 17, Status: Authorised

Foldax Completes Enrollment in India Clinical Trial Evaluating TRIA™ Polymer Surgical Mitral Heart Valve

Retrieved on: 
Monday, November 27, 2023
Health, Hospitals, General Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Sale, Woman, Calcification, Safety, Hope, Anatomy, Heart, Surgery, Clinical trial, Patient, Anticoagulant, Casciaro, Rheumatic fever, MD, TRIA, Human, Growth, TCT, Columbia University, Mitral valve, Failure, Female, Physician, Life, Medical device, Medical imaging

Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve.

Key Points: 
  • Foldax® , Inc., a leader in the development of innovative, polymer heart valves, today announced completion of enrollment in the Indian clinical trial of the TRIA™ polymer surgical mitral heart valve.
  • The TRIA mitral valve is designed specifically for the anatomy and pressures of the mitral position.
  • “We are excited to see early promising results from the TRIA polymer mitral valve,” said Kaushal Pandey, MD, with P.D.
  • “The blood flow dynamics are excellent, and the polymer material properties are formulated to resist calcification, one of the main causes of tissue valve failure.”
    The Indian TRIA surgical mitral valve study is a prospective multicenter clinical trial.