VWF

Octapharma USA: FDA Grants Expanded Approval to wilate® as the First VWF Concentrate for Prophylaxis in All Types of VWD

Retrieved on: 
Tuesday, December 5, 2023

PARAMUS, N.J., Dec. 5, 2023 /PRNewswire/ -- Octapharma USA announced the expansion of the U.S. Food and Drug Administration (FDA) approval for wilate®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection. The approved label now includes routine prophylaxis aimed at reducing the frequency of bleeding episodes in adults and children aged 6 and older with any type of von Willebrand disease (VWD), the most prevalent bleeding disorder in the United States. Wilate® is the first von Willebrand factor (VWF) concentrate indicated for prophylactic treatment across all forms of VWD, marking a significant milestone in the field.

Key Points: 
  • Wilate® is the first von Willebrand factor (VWF) concentrate indicated for prophylactic treatment across all forms of VWD, marking a significant milestone in the field.
  • "The approval of wilate® for VWD prophylaxis is a welcome new treatment option that can be life-saving for many patients.
  • Increased use of VWF prophylaxis in VWD patients may lead to improved patient care and a reduced burden of disease."
  • In tandem with this approval, Octapharma USA extends its commitment to patient care through the Factor My Way patient support program.

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

Retrieved on: 
Monday, September 18, 2023

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.

BreathMo®: The New Generation ECMO system Revealed at ASAIO Conference

Retrieved on: 
Saturday, July 22, 2023

Extracorporeal Membrane Oxygenation (ECMO) provides essential support for intensive care unit (ICU) patients, 60% of whom develop heart or respiratory failure with a mortality rate of 23-75%.

Key Points: 
  • Extracorporeal Membrane Oxygenation (ECMO) provides essential support for intensive care unit (ICU) patients, 60% of whom develop heart or respiratory failure with a mortality rate of 23-75%.
  • The limitation of the existing ECMO systems exposed the need for medical device manufacturers to upgrade ECMO devices equipped with advanced functions.
  • BreathMo®, China's homegrown maglev ECMO system that addresses the unmet medical needs of Chinese patients.
  • To bridge clinical gaps in China, magAssist has developed a new generation ECMO system, BreathMo®.

BreathMo®: The New Generation ECMO system Revealed at ASAIO Conference

Retrieved on: 
Friday, July 21, 2023

Extracorporeal Membrane Oxygenation (ECMO) provides essential support for intensive care unit (ICU) patients, 60% of whom develop heart or respiratory failure with a mortality rate of 23-75%.

Key Points: 
  • Extracorporeal Membrane Oxygenation (ECMO) provides essential support for intensive care unit (ICU) patients, 60% of whom develop heart or respiratory failure with a mortality rate of 23-75%.
  • The limitation of the existing ECMO systems exposed the need for medical device manufacturers to upgrade ECMO devices equipped with advanced functions.
  • BreathMo®, China's homegrown maglev ECMO system that addresses the unmet medical needs of Chinese patients.
  • To bridge clinical gaps in China, magAssist has developed a new generation ECMO system, BreathMo®.

Global Von Willebrand Disease (VWD) Treatment Market Report 2023: Increasing Public Awareness Related to VWD Drives Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, June 12, 2023

On the basis of type of VWD, von Willebrand disease treatment market can be segmented as Type 1 VWD, Type 2 VWD and Type 3 VWD.

Key Points: 
  • On the basis of type of VWD, von Willebrand disease treatment market can be segmented as Type 1 VWD, Type 2 VWD and Type 3 VWD.
  • The types of therapeutic treatments used against von Willebrand disease are Desmopressin (DDAVP), hormone replacement therapy, contraceptives, anti-fibrinolytic or clot-stabilizing drugs, and fibrin sealants.
  • The key factor responsible for growth of von Willebrand disease is increasing public awareness related to VWD which is fueling the diagnosis rate in North America and Europe.
  • North America was observed as the largest market for von Willebrand disease treatment followed by Europe.

Octapharma USA Requests FDA Approval for wilate® VWD Prophylaxis Supplement

Retrieved on: 
Thursday, February 23, 2023

"We look forward to working with the FDA on this sBLA for wilate® prophylaxis in children and adults," said Octapharma USA President Flemming Nielsen.

Key Points: 
  • "We look forward to working with the FDA on this sBLA for wilate® prophylaxis in children and adults," said Octapharma USA President Flemming Nielsen.
  • "People with VWD urgently need treatment alternatives for von Willebrand disease prophylaxis.
  • Octapharma is committed to delivering life-saving therapies to the bleeding disorders community and medical providers."
  • Patients in WIL-31 received wilate® prophylaxis, two to three times per week at a dose of 20-40 IU/kg, for 12 months.

Vega Therapeutics launches and unveils its first-in-class antibody therapy for von Willebrand disease at ASH Annual Meeting

Retrieved on: 
Tuesday, December 6, 2022

Vega was spun out of its parent company, Star Therapeutics , to advance the discovery and development of antibody therapies for patients with blood disorders, starting with von Willebrand disease (VWD).

Key Points: 
  • Vega was spun out of its parent company, Star Therapeutics , to advance the discovery and development of antibody therapies for patients with blood disorders, starting with von Willebrand disease (VWD).
  • Vega will disclose the first public information about VGA039 in a podium presentation on December 12th at the ASH Annual Meeting in New Orleans.
  • In VWD, defective or low amounts of von Willebrand factor (VWF) leads to insufficient platelet adhesion and unstable clot formation.
  • Vega Therapeutics is a clinical stage biotechnology company developing novel, first-in-class therapies for rare blood disorders with overlooked patient needs, starting with von Willebrand disease (VWD).

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.

DGAP-News: Andera Partners supports TargED Biopharmaceuticals in €39 million Series A financing to bring groundbreaking thrombolytic treatment to patients

Retrieved on: 
Tuesday, February 22, 2022

TargED's lead product, Microlyse, is a first-in-class proprietary clot-busting compound which binds to a protein present in all forms of thrombosis.

Key Points: 
  • TargED's lead product, Microlyse, is a first-in-class proprietary clot-busting compound which binds to a protein present in all forms of thrombosis.
  • Microlyse is the first compound to achieve targeted enzyme delivery, using a single domain antibody (VhH), directly to blood clots.
  • Andera Partners' mission is to work alongside companies and their managers to support them in achieving strong and sustainable growth.
  • TargED Biopharmaceuticals B.V. is a biotechnology company that develops first-in-class biological drugs to improve treatment of thrombosis.