ISTH

World Thrombosis Day Campaign Activates Global Awareness Efforts on Evidence-Based Prevention of Blood Clots for Ninth Consecutive Year

Retrieved on: 
Thursday, October 13, 2022

CHAPEL HILL, N.C., Oct. 13, 2022 /PRNewswire/ -- Today is World Thrombosis Day, a global awareness campaign led by the International Society on Thrombosis and Haemostasis (ISTH), recognized annually on October 13 to bring awareness to conditions caused by thrombosis, commonly known as a blood clot(s), that are responsible for one in four deaths worldwide. 

Key Points: 
  • "Blood clots are often overlooked because their symptoms can resemble those of many other conditions," shared Professor Beverley Hunt, MD, OBE, Chair of the World Thrombosis Day Steering Committee.
  • World Thrombosis Day shares these key tips to help prevent blood clots:
    Know the signs and symptoms of a blood clot.
  • "We encourage everyone across the globe to get involved in World Thrombosis Day to increase public awareness and education about blood clots," said Professor Flora Peyvandi, MD, ISTH President.
  • To learn more about blood clots and to participate in World Thrombosis Day, visit www.worldthrombosisday.org and follow #WTDay22 on social media.

World Thrombosis Day Campaign Activates Global Awareness Efforts on Evidence-Based Prevention of Blood Clots for Ninth Consecutive Year

Retrieved on: 
Thursday, October 13, 2022

CHAPEL HILL, N.C., Oct. 13, 2022 /PRNewswire/ -- Today is World Thrombosis Day, a global awareness campaign led by the International Society on Thrombosis and Haemostasis (ISTH), recognized annually on October 13 to bring awareness to conditions caused by thrombosis, commonly known as a blood clot(s), that are responsible for one in four deaths worldwide. 

Key Points: 
  • "Blood clots are often overlooked because their symptoms can resemble those of many other conditions," shared Professor Beverley Hunt, MD, OBE, Chair of the World Thrombosis Day Steering Committee.
  • World Thrombosis Day shares these key tips to help prevent blood clots:
    Know the signs and symptoms of a blood clot.
  • "We encourage everyone across the globe to get involved in World Thrombosis Day to increase public awareness and education about blood clots," said Professor Flora Peyvandi, MD, ISTH President.
  • To learn more about blood clots and to participate in World Thrombosis Day, visit www.worldthrombosisday.org and follow #WTDay22 on social media.

Press Release: Strong execution in Q2 drives full-year 2022 guidance upgrade and delivers rich R&D news flow in Immunology and Rare Disease

Retrieved on: 
Thursday, July 28, 2022

Applying average July 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated between +7.5% to +8.5%

Key Points: 
  • Applying average July 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated between +7.5% to +8.5%
    Our performance in the second quarter was again marked by higher sales across our key growth drivers and outstanding financial results leading us to upgrade our business EPS guidance for the full-year.
  • Notably, we saw significant growth momentum from our Specialty Care business, mainly driven by Dupixent.
  • While we continue to increase our investment in R&D, we delivered important pipeline milestones such as the approval of Dupixent in its fourth disease indication, Eosinophilic Esophagitis.
  • Earlier this month, we had the opportunity to showcase at ISTH the transformative potential of efanesoctocog alfa, the first factor replacement therapy for hemophilia A to receive FDA Breakthrough Therapy Designation.

BioMarin Presents Findings from Studies of Valoctocogene Roxaparvovec, Investigational Gene Therapy, at the International Society on Thrombosis and Haemostasis (ISTH) 2022 Congress July 9-12, Including 4 Oral and 2 Poster Presentations

Retrieved on: 
Monday, July 11, 2022

SAN RAFAEL, Calif., July 11, 2022 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that it presented four oral presentations and two poster presentations on valoctocogene roxaparvovec, an investigational gene therapy for the treatment of adults with severe hemophilia A, at the International Society on Thrombosis and Haemostasis (ISTH) 2022 World Congress from July 9-12 in London.

Key Points: 
  • "With each passing year, the breadth of data supporting valoctocogene roxaparvovec increasingly demonstrate the positive impact gene therapy treatment may provide people with severe hemophilia A.
  • A final approval decision, typically consistent with the CHMP recommendation, is expected from the European Commission in Q3 2022.
  • Individuals with the most severe form of hemophilia A make up approximately 50 percent of the hemophilia A population.
  • These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements.

New Data From Phase III HAVEN 6 Study Reinforce Favorable Safety and Efficacy Profile of Genentech’s Hemlibra (emicizumab-kxwh) in People With Moderate or Mild Hemophilia A

Retrieved on: 
Monday, July 11, 2022

The data presented at ISTH this year underscore Genentechs commitment to addressing gaps in care for hemophilia A, thereby ensuring that broader populations can potentially benefit from Hemlibra.

Key Points: 
  • The data presented at ISTH this year underscore Genentechs commitment to addressing gaps in care for hemophilia A, thereby ensuring that broader populations can potentially benefit from Hemlibra.
  • In addition to HAVEN 6, data from the CHESS II (Cost of Haemophilia across Europe: a Socioeconomic Survey-II) and CHESS PAEDs studies will also be presented at ISTH 2022.
  • These data show most adults with moderate or mild hemophilia A and more than half of children with moderate hemophilia A may not receive preventative treatments.
  • HAVEN 6 is a Phase III, multicenter, open-label, single-arm study evaluating the safety, efficacy, pharmacokinetics and pharmacodynamics of Hemlibra in people with moderate or mild hamophilia A without factor VIII inhibitors.

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Retrieved on: 
Monday, July 11, 2022

CAMBRIDGE, Mass., July 11, 2022 /PRNewswire/ -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis (ISTH) Congress in London, UK.

Key Points: 
  • The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs.
  • "Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients.
  • We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need."
  • "The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward."

Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer

Retrieved on: 
Monday, July 11, 2022

CAMBRIDGE, Mass., July 11, 2022 /PRNewswire/ -- Anthos Therapeutics, a clinical-stage biotechnology company developing innovative therapies for cardiovascular and metabolic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational Factor XI inhibitor, abelacimab, for the treatment of thrombosis associated with cancer. The company will also be announcing this important milestone today at a session of the ongoing 2022 Congress of the International Society on Thrombosis and Haemostasis (ISTH) Congress in London, UK.

Key Points: 
  • The Fast Track Designation process is designed to facilitate the development and expedite the review of treatments for serious medical conditions, thereby, addressing unmet medical needs.
  • "Fast track designation by the FDA is a significant milestone for abelacimab and Anthos Therapeutics, but more importantly represents another hopeful step forward for patients.
  • We look forward to working closely with the FDA on our clinical trial program to bring once-monthly abelacimab to patients in need."
  • "The hemostasis sparing potential of FXI inhibitors, such as abelacimab, may represent an important treatment advance in how we manage patients moving forward."

Positive Initial Clinical Data from the B-LIEVE Dose-Confirmation Trial for FLT180a in Hemophilia B Presented at the International Society on Thrombosis and Haemostasis Congress

Retrieved on: 
Sunday, July 10, 2022

LONDON, July 10, 2022 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today announced the presentation of safety and initial efficacy data from the first cohort of the Phase 1/2 dose-confirmation B-LIEVE trial for FLT180a, the company’s AAVS3-based gene therapy candidate for people with hemophilia B, at the International Society on Thrombosis and Haemostasis (ISTH) Congress being held in London, July 9-13, 2022.

Key Points: 
  • Dosing of cohort two was completed in June, with early results showing a similar initial response to FLT180a.
  • All patients continue to have expression levels above baseline, and no patient has experienced a bleed or required FIX supplementation.
  • These include, but are not limited to, seeking a partner that would enable the continuation of FLT180a through Phase 3 development.
  • A Phase 1/2 dose-confirmation trial of FLT180a called B-LIEVE to finalize a dose for a Phase 3 pivotal trial is in progress.

Octapharma shares new data at ISTH 2022 in its mission to meet the challenges faced by people with bleeding disorders

Retrieved on: 
Monday, July 4, 2022

The data will be featured in eleven poster presentations and two Supported Symposia during this major international meeting.

Key Points: 
  • The data will be featured in eleven poster presentations and two Supported Symposia during this major international meeting.
  • Octapharma is proud to be a Gold Supporter of the ISTH 2022 Congress.
  • Safety and pharmacokinetics of a subcutaneous recombinant FVIII (OCTA101) in adult patients with severe haemophilia A. Presenting Author: Sigurd Knaub
    PB0559.
  • "Despite advances in the field, managing emergency bleeding and bleeding disorders still comes with considerable challenges.

Octapharma shares new data at ISTH 2022 in its mission to meet the challenges faced by people with bleeding disorders

Retrieved on: 
Monday, July 4, 2022

The data will be featured in eleven poster presentations and two Supported Symposia during this major international meeting.

Key Points: 
  • The data will be featured in eleven poster presentations and two Supported Symposia during this major international meeting.
  • Octapharma is proud to be a Gold Supporter of the ISTH 2022 Congress.
  • Safety and pharmacokinetics of a subcutaneous recombinant FVIII (OCTA101) in adult patients with severe haemophilia A. Presenting Author: Sigurd Knaub
    PB0559.
  • "Despite advances in the field, managing emergency bleeding and bleeding disorders still comes with considerable challenges.