Factor I deficiency

DGAP-News: Biotest AG: Biotest achieves an improved adjusted EBIT by 9.8% of EUR 32.4 million in the first half of 2022

Retrieved on: 
Thursday, August 11, 2022

Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to 8.8 million in the first half of the 2022 financial year, compared to 5.8 million in the first half of the previous year.

Key Points: 
  • Earnings before interest, taxes, depreciation and amortisation (EBITDA) amounted to 8.8 million in the first half of the 2022 financial year, compared to 5.8 million in the first half of the previous year.
  • EBIT in the first half of the year 2022 mounted to - 9.1 million and was thus below the previous year's value of - 8.5 million.
  • In the current half year, this includes expenses for the Biotest Next Level project in the amount of 41.5 million (same period of the previous year: 38.0 million).
  • The Biotest Group's total earnings after tax in the first half of 2022 were -19.9 million (same period of the previous year: -18.2 million).

Cerus Corporation Announces CMS Has Granted New Technology Add-On Payment for INTERCEPT Fibrinogen Complex

Retrieved on: 
Tuesday, August 3, 2021

Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for INTERCEPT Fibrinogen Complex within the Medicare Hospital Inpatient Prospective Payment System (IPPS).

Key Points: 
  • Cerus Corporation (Nasdaq: CERS) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has granted a new technology add-on payment (NTAP) for INTERCEPT Fibrinogen Complex within the Medicare Hospital Inpatient Prospective Payment System (IPPS).
  • The NTAP was granted under CMS alternative NTAP pathway, which recognizes the transformative nature of products granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA).
  • The U.S. FDA granted approval of the INTERCEPT Blood System for Cryoprecipitation, which is used to produce INTERCEPT Fibrinogen Complex for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency, in November 2020.
  • INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

DGAP-News: Biotest AG: Biotest accelerates fibrinogen phase III study with additional patient group

Retrieved on: 
Wednesday, April 7, 2021

In order to compensate the fibrinogen deficiency and to effectively stop bleeding, Biotest has developed the fibrinogen concentrate BT524.

Key Points: 
  • In order to compensate the fibrinogen deficiency and to effectively stop bleeding, Biotest has developed the fibrinogen concentrate BT524.
  • The AdFIrst study is a prospective, randomized, active-controlled, multicenter phase III study that investigates the efficacy and tolerability of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency.
  • With the AdFIrst study in acquired fibrinogen deficiency, Biotest is further expanding its development program for the fibrinogen concentrate BT524.
  • The AdFIrst study is a prospective, active-controlled, multicentre phase III study investigating the efficacy and safety of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency.

BT524: A Human Fibrinogen Concentrate Purified from Human Plasma - Global Emerging Insight and Market Forecast Report 2021-2030 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 16, 2021

The "BT524 - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "BT524 - Emerging Insight and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering.
  • BT524 is a human fibrinogen concentrate purified from human plasma.
  • "BT524- Emerging Insight and Market Forecast - 2030" the report provides comprehensive insights about an investigational product for Hypofibrinogenemia in 7 Major Markets.
  • Further, it also consists of future market assessments inclusive of the market forecast, SWOT analysis, market competitors, and other emerging therapies.

Hypofibrinogenemia Epidemiology Forecast to 2030: Focus on United States, Japan, Germany, Spain, Italy, France, and the United Kingdom - ResearchAndMarkets.com

Retrieved on: 
Monday, December 21, 2020

Hypofibrinogenemia - Epidemiology Forecast to 2030 delivers an in-depth understanding of the Hypofibrinogenemia, historical and forecasted epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan.

Key Points: 
  • Hypofibrinogenemia - Epidemiology Forecast to 2030 delivers an in-depth understanding of the Hypofibrinogenemia, historical and forecasted epidemiology in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom) and Japan.
  • The Hypofibrinogenemia epidemiology division provides insights about the historical and current patient pool along with the forecasted trend for every seven major countries.
  • The disease epidemiology covered in the report provides historical as well as forecasted Hypofibrinogenemia epidemiology segmented as the Total Cases of Hypofibrinogenemia, Type-Specific Cases of Hypofibrinogenemia (as congenital and acquired), and Acquired Hypofibrinogenemia cases.
  • The epidemiology segment also provides the Hypofibrinogenemia epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

Octapharma USA Presents Research on Congenital & Acquired Bleeding Disorders at ASH Annual Meeting

Retrieved on: 
Thursday, December 3, 2020

Octapharma USA will present multiple clinical research posters focused on the efficacy and safety of fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use in the treatment of congenital and acquired bleeding disorders during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, a virtual medical congress to be held December 5 8.

Key Points: 
  • Octapharma USA will present multiple clinical research posters focused on the efficacy and safety of fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use in the treatment of congenital and acquired bleeding disorders during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, a virtual medical congress to be held December 5 8.
  • Additionally, Octapharma will present fibryga research evaluating the products hemostatic efficacy in acquired fibrinogen deficiency, a condition affecting non-surgical and surgical bleeding patients, including cardiac surgery, post-partum hemorrhage and trauma patients.
  • Octapharma is determined to advance clinical research and treatment options for people with life-threatening bleeding disorders, including Factor 1 deficiency and other rare conditions, said Octapharma USA President Flemming Nielsen.
  • A favorable safety profile was seen for the treatment of patients with congenital afibrinogenemia with fibryga.

National Hemophilia Foundation Revises Treatment Guidelines for Factor 1 Deficiency to Include Octapharma’s fibryga®

Retrieved on: 
Wednesday, October 7, 2020

The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.

Key Points: 
  • The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga , Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.
  • View the full release here: https://www.businesswire.com/news/home/20201007005220/en/
    The National Hemophilia Foundation (NHF) has revised its treatment recommendations for congenital fibrinogen (Factor 1) deficiency to include fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use.
  • We are committed to providing life-saving treatment options to people with rare bleeding disorders, including Factor 1 deficiency.
  • Fibrinogen replacement therapies for Factor 1 deficiency include fibrinogen concentrates or cryoprecipitate.

2020 Insights on the Hypofibrinogenemia Industry to 2030 - Market Insights, Epidemiology, and Forecast - ResearchAndMarkets.com

Retrieved on: 
Monday, September 7, 2020

The "Hypofibrinogenemia - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hypofibrinogenemia - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The Hypofibrinogenemia market report provides current treatment practices, emerging drugs, and their market share of the individual therapies, current and forecasted Hypofibrinogenemia market size from 2017 to 2030 segmented by seven major markets.
  • The Report also covers current Hypofibrinogenemia treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
  • The Hypofibrinogenemia market report gives a thorough understanding of Hypofibrinogenemia by including details such as disease definition, symptoms, causes, pathophysiology, and diagnosis.

Octapharma USA Sponsors ASA Symposium on Fibrinogen Supplementation in Surgical Patients

Retrieved on: 
Tuesday, November 5, 2019

Octapharma USA sponsored a scientific symposium, Fibrinogen Supplementation in Surgical Patients New Perspectives in Acquired Fibrinogen Deficiency, at the recent American Society of Anesthesiologists Annual Meeting.

Key Points: 
  • Octapharma USA sponsored a scientific symposium, Fibrinogen Supplementation in Surgical Patients New Perspectives in Acquired Fibrinogen Deficiency, at the recent American Society of Anesthesiologists Annual Meeting.
  • The symposium addressed the global perspectives on patient blood management with respect to fibrinogen replacement in acquired bleeding and treatment options for acquired fibrinogen deficiency (AFD).
  • The studies presented at the symposium are important contributions to build on the current published research and growing clinical experiences with fibrinogen concentrates for managing bleeding in surgical patients, said Jerrold Levy, M.D.
  • These two important clinical trials investigating the use of fibryga in acquired fibrinogen deficiency have identified fibrinogen concentrate as a potential alternative to cryoprecipitate during severe surgical bleeding, said Octapharma USA President Flemming Nielsen.

Octapharma’s fibryga® Receives European Label Extension to Treat Acquired Fibrinogen Deficiency (AFD)

Retrieved on: 
Tuesday, November 5, 2019

Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries.

Key Points: 
  • Octapharma announced today that the human fibrinogen concentrate fibryga has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries.
  • The approval extends the market authorisation for fibryga, which is already approved for use in patients with congenital fibrinogen deficiency.
  • Fibryga is a highly purified, dual pathogen-inactivated, lyophilised human fibrinogen concentrate for intravenous infusion, with a rapid, convenient reconstitution device for effective correction of fibrinogen deficiency.
  • However, patients treated with fibryga experienced more rapid and pronounced replenishment of plasma fibrinogen levels and blood clot firmness.