ISTH

New asundexian Phase III study to include patients with atrial fibrillation ineligible for oral anticoagulant treatment

Retrieved on: 
Friday, November 10, 2023
Research, FDA, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, OAC, International Society, Safety, ESKD, Executive Committee, Risk, Thrombosis, Patient, Atrial fibrillation, Stroke, Bleeding, Trial of the century, Kidney disease, Physician, Pharmaceutical industry, Birth control, ISTH, Hemostasis, Medicine, Bayer

Bayer today announced it expanded its Phase III OCEANIC clinical development program for the investigational drug asundexian (BAY2433334) by initiating a third clinical study, OCEANIC-AFINA.

Key Points: 
  • Bayer today announced it expanded its Phase III OCEANIC clinical development program for the investigational drug asundexian (BAY2433334) by initiating a third clinical study, OCEANIC-AFINA.
  • OCEANIC AFINA is a Phase III study investigating asundexian as a potential treatment option in patients (≥65 years of age) with atrial fibrillation (AF) at high risk for stroke or systemic embolism who are deemed ineligible for oral anticoagulation (OAC) treatment due to an increased risk of bleeding.
  • OCEANIC-AFINA complements OCEANIC-AF, an ongoing Phase III study investigating the efficacy and safety of asundexian for the prevention of stroke or systemic embolism in people with AF.
  • “It is our vision to support patients with atrial fibrillation, including those, that up to now were deemed as not eligible for treatment with OACs.

World Thrombosis Day encourages public to "Move Against Thrombosis" to celebrate 10 years of raising awareness worldwide

Retrieved on: 
Friday, October 13, 2023
Foot, Coronary thrombosis, ISTH, Thrombosis, Death, International Society, Tenderness, Chest pain, Pelvis, Uterus, Organization, VTE, DVT, Hospital, Travel, Pregnancy, Calf, Heart rate, Cancer, Movement, Blood, Thrombus, Pulmonary embolism, International Society on Thrombosis and Haemostasis, Patient, Walking, Leg, Deep vein thrombosis, Vein, Ankle, Risk, Birth control

World Thrombosis Day engages 5,000 partner organizations from 120 countries to advance understanding of the treatment and prevention of blood clots.

Key Points: 
  • World Thrombosis Day engages 5,000 partner organizations from 120 countries to advance understanding of the treatment and prevention of blood clots.
  • For its 10th anniversary year, the campaign encourages people to Move Against Thrombosis with simple movements to increase blood flow.
  • Thrombosis can develop in, or travel to, blood vessels throughout the body, often causing symptoms that can be mistaken for other conditions.
  • Incorporating movement in blood clot prevention inspired World Thrombosis Day's Move Against Thrombosis theme.

World Thrombosis Day encourages public to "Move Against Thrombosis" to celebrate 10 years of raising awareness worldwide

Retrieved on: 
Friday, October 13, 2023
Foot, Coronary thrombosis, ISTH, Thrombosis, Death, International Society, Tenderness, Chest pain, Pelvis, Uterus, Organization, VTE, DVT, Hospital, Travel, Pregnancy, Calf, Heart rate, Cancer, Movement, Blood, Thrombus, Pulmonary embolism, International Society on Thrombosis and Haemostasis, Patient, Leg, Deep vein thrombosis, Vein, Ankle, Risk, Birth control

World Thrombosis Day engages 5,000 partner organizations from 120 countries to advance understanding of the treatment and prevention of blood clots.

Key Points: 
  • World Thrombosis Day engages 5,000 partner organizations from 120 countries to advance understanding of the treatment and prevention of blood clots.
  • For its 10th anniversary year, the campaign encourages people to Move Against Thrombosis with simple movements to increase blood flow.
  • Thrombosis can develop in, or travel to, blood vessels throughout the body, often causing symptoms that can be mistaken for other conditions.
  • Incorporating movement in blood clot prevention inspired World Thrombosis Day's Move Against Thrombosis theme.

FDA Grants Orphan Drug Designation to GC Biopharma's Drug Candidate for Thrombotic Thrombocytopenic Purpura

Retrieved on: 
Friday, October 6, 2023
Congress, Antibody, Food, ISTH, Autoantibody, International Society, Brain, Thrombosis, Thrombotic thrombocytopenic purpura, Heart, Mortality, Half-life, FDA, Marketing, International Society on Thrombosis and Haemostasis, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, TTP, Disorder, ADAMTS13, PDUFA, Patient, Pharmaceutical industry

YONGIN, South Korea, Oct. 5, 2023 /PRNewswire/ -- GC Biopharma Corp. announced today that GC1126A, its drug candidate for Thrombotic Thrombocytopenic Purpura (TTP), received an Orphan Drug Designation on September 27 from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • YONGIN, South Korea, Oct. 5, 2023 /PRNewswire/ -- GC Biopharma Corp. announced today that GC1126A, its drug candidate for Thrombotic Thrombocytopenic Purpura (TTP), received an Orphan Drug Designation on September 27 from the U.S. Food and Drug Administration (FDA).
  • When designated as an orphan drug, there are incentives such as tax credits for clinical development costs and exemptions from PDUFA user fees Initial Pediatric Study Plan.
  • Speaking on this achievement, GC Biopharma stated, "We are dedicated to collecting data to develop a Best-in-Class treatment for such rare disorders.
  • We remain committed to our mission of providing patients with new treatment options by continuously developing innovative drugs."

Precision BioLogic's Factor VIII Deficient Plasma with VWF Now FDA-Cleared for Sale in U.S.

Retrieved on: 
Monday, September 18, 2023
Factor VIII, Haemophilia, Research, Biologic, ISTH, Von Willebrand factor, Plasma, VWF, Traction, Hemostasis, VIII, FDA, Vaccine, EU, NS

The latest in Precision BioLogic's family of factor deficient plasmas, CRYOcheck Factor VIII Deficient Plasma with VWF is intended for use in clinical laboratories to identify factor VIII (FVIII) deficiency in human plasma and aid in the management of hemophilia A.

Key Points: 
  • The latest in Precision BioLogic's family of factor deficient plasmas, CRYOcheck Factor VIII Deficient Plasma with VWF is intended for use in clinical laboratories to identify factor VIII (FVIII) deficiency in human plasma and aid in the management of hemophilia A.
  • CRYOcheck Factor VIII Deficient Plasma with VWF comes in a convenient frozen format, which eliminates reconstitution errors and reduces preparation time.
  • CRYOcheck Factor VIII Deficient Plasma with VWF launched in Canada, the EU, UK, Australia and New Zealand in 2021.
  • "CRYOcheck Factor VIII Deficient Plasma with VWF offers labs a readily available and reliable alternative to congenital FVIII deficient plasmas.

KalVista Pharmaceuticals Provides Operational Update and Fiscal Year Financial Results

Retrieved on: 
Friday, July 7, 2023
Biotechnology, Diabetes, Health, Pharmaceutical, Clinical Trials, Attack, International Society of Sculptors, Painters and Gravers, Hereditary angioedema, Clinical trial, NDA, ODT, EAACI, G&A, Research, European Academy of Allergy and Clinical Immunology, Angioedema, ISTH, Thrombosis, Public expenditure, Congress, HAE, Patient, PMDA, Mouse, KALV, FDA, Safety, D, Pharmaceutical industry, Lancet

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2023.

Key Points: 
  • KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today provided an operational update and released financial results for the fiscal year ended April 30, 2023.
  • “We have made a great deal of progress over the last fiscal year in the development of sebetralstat,” said Andrew Crockett, Chief Executive Officer of KalVista.
  • Research and development expenses were $80.3 million for the fiscal year ended April 30, 2023, compared to $70.2 million for the prior fiscal year.
  • General and administrative expenses were $30.6 million for the fiscal year ended April 30, 2023, compared to $26.4 million for the prior fiscal year.

U.S. Food and Drug Administration Approves BioMarin's ROCTAVIAN™ (valoctocogene roxaparvovec-rvox), the First and Only Gene Therapy for Adults with Severe Hemophilia A

Retrieved on: 
Thursday, June 29, 2023
Injection, Large, Partnership, University, Bleeding, Gene, BioMarin Pharmaceutical, Pediatrics, Safety, European Medicines Agency, ABR, Clinical trial, Pathology, Haemophilia, Mutation, Coagulopathy, Antibody, Government, Acquisition, Patient, Physician, Risk, SAN, VIII, HTC Global Services, FDA, Haemophilia A, Conference, Pharmaceutical industry, Rare-earth element, Medical device, Birth control, Nursing, ISTH, Webcast

SAN RAFAEL, Calif., June 29, 2023 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery, today announced that the United States Food and Drug Administration (FDA) approved ROCTAVIAN™ (valoctocogene roxaparvovec-rvox) gene therapy for the treatment of adults with severe hemophilia A (congenital factor VIII (FVIII) deficiency with FVIII activity

Key Points: 
  • The one-time, single-dose infusion is the first approved gene therapy for severe hemophilia A in the U.S. ROCTAVIAN was first approved by the European Medicines Agency in August 2022.
  • When severely deficient in amount, the condition puts people with hemophilia A at risk for painful and potentially life-threatening bleeds, which can occur spontaneously.
  • ROCTAVIAN is designed to replace the function of the mutated gene, allowing people with severe hemophilia A to produce their own FVIII and thereby limit bleeding episodes.
  • "We are proud to now offer adults with severe hemophilia A, a one-time, single-dose treatment option.

Anthos Therapeutics Supported Global Survey of 3000+ Patients Prescribed Anticoagulants Detailing Impact of Patient-Relevant Bleeding (PRB) Presented at ISTH 2023

Retrieved on: 
Monday, June 26, 2023
PRB, Partnership, Bleeding, National Blood Clot Alliance, Health care, Quality of life, International Society on Thrombosis and Haemostasis, Emotion, NBCA, Anthos, Anticoagulant, Bruise, American Foundation for Children with AIDS, DSM-IV codes, Patient, Physician, Thrombosis, Therapy, International Society, Skin, Pharmaceutical industry, Birth control, ISTH

CAMBRIDGE, Mass., June 26, 2023 (GLOBE NEWSWIRE) -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, presented new data in collaboration with two internationally recognized patient advocacy groups, detailing the impacts of patient-relevant bleeding (PRB) on individuals prescribed anticoagulants. The oral presentation, Patient-Relevant Bleeding Events Among Patients Taking Anticoagulant Medication, was presented yesterday at ISTH – The International Society on Thrombosis and Haemostasis’ annual meeting, being held in Montreal, June 24-28, 2023.

Key Points: 
  • The oral presentation, Patient-Relevant Bleeding Events Among Patients Taking Anticoagulant Medication, was presented yesterday at ISTH – The International Society on Thrombosis and Haemostasis’ annual meeting, being held in Montreal, June 24-28, 2023.
  • More than 3,000 adult patients were recruited in partnership with StopAfib.org and the National Blood Clot Alliance (NBCA), to participate in an anonymous, online global survey with their members, designed to better understand so-called “minor” bleeding problems experienced by patients who take anticoagulants.
  • “We partnered with Anthos because they are putting patients first, such as through this patient survey.
  • This forward-thinking survey explores the impact of patient-relevant bleeding events on lifestyle, emotional and mental well-being, and adherence,” said Tarin Patrikis, Deputy Director of the National Blood Clot Alliance.

Press Release: ALTUVIIIO late-breaking data at ISTH demonstrates highly effective bleed protection in children with severe hemophilia A with once-weekly dosing

Retrieved on: 
Sunday, June 25, 2023
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XTEND-Kids data confirm the efficacy and safety profile of ALTUVIIIO with simple, weekly 50 IU/kg dosing for both adults and children

Key Points: 
  • XTEND-Kids data confirm the efficacy and safety profile of ALTUVIIIO with simple, weekly 50 IU/kg dosing for both adults and children
    Paris, June 25, 2023.
  • These data confirm that a once-weekly 50 IU/kg dose of ALTUVIIIO provides highly effective bleed protection in both children and adults and can be used across clinical scenarios.
  • Achieving high-sustained factor activity with once weekly dosing means a freedom from the tradeoffs between treatment burden and efficacy we often see in treating severe hemophilia A.
  • The most common treatment-emergent adverse events (>10%) were SARS-CoV-2 test positive, upper respiratory tract infection, and fever (pyrexia).

Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK-755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Retrieved on: 
Sunday, June 25, 2023
Health, Clinical Trials, Research, Science, Pharmaceutical, Cardiology, Biotechnology, PK, Abstract, Priority review, Hematology, Head, European Medicines Agency, TAK, Confidence, Pharmacokinetics, Cmax, University College Hospital, Abdominal pain, Female, EMA, Congress, Incidence, Thrombocytopenia, Patient, TTP, Mortality, Ageing, Thrombosis, FDA, Headache, Safety, BLA, International Society on Thrombosis and Haemostasis, SD, International Society, TSE, Disease, Pharmaceutical industry, Takeda, Toll, ISTH, ADAMTS13

In the pivotal trial, no patient had an acute TTP event while receiving TAK-755 prophylactic treatment.

Key Points: 
  • In the pivotal trial, no patient had an acute TTP event while receiving TAK-755 prophylactic treatment.
  • In the pivotal trial, treatment-emergent adverse events (TEAEs) were reported in 10.3% of patients ages 12-68 receiving TAK-755 compared to 50% of patients receiving plasma-based therapy.
  • (Presentation Number: OC 14.4)
    Results were presented today in three oral presentations delivered at the International Society on Thrombosis and Haemostasis (ISTH) 2023 Congress.
  • The FDA has accepted and granted Priority Review for Takeda’s Biologics License Application (BLA) for TAK-755 for the treatment of cTTP.