Coagulation factor VII

Octapharma Announces Availability of Balfaxar® For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, January 3, 2024
Phase, Coagulation, Food, Emergency medicine, Risk, Vitamin K, PCC, Hemostasis, FDA, Warfarin, Bleeding, INR, Massachusetts General Hospital, Hospital, Thrombophilia, MD, Doctor of Philosophy, Factor X, Factor IX, Clinical trial, Prothrombin time, Trial of the century, Coagulation factor VII, Octapharma, VKA, Patient, Safety, Harvard Medical School, Thrombin, Pharmaceutical industry

PARAMUS, N.J., Jan. 3, 2024 /PRNewswire/ -- Octapharma USA has announced Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) is now available. The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.

Key Points: 
  • The new non-activated four factor prothrombin complex concentrate (4F-PCC), approved by the U.S. Food and Drug Administration (FDA) this summer, is indicated for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
  • Octapharma has the Balfaxar® production flexibility to ensure consistent supply for hospitals and medical providers.
  • "Octapharma has the production flexibility to ensure consistent supply for hospitals and medical providers now and in the future.
  • Balfaxar® met the primary endpoint of hemostatic efficacy in patients on a vitamin K antagonist undergoing urgent surgery with significant bleeding risk.

Global Rare Hemophilia Factors (I, II, VII) Market Size, Share & Trends Analysis Report 2023-2030 - ResearchAndMarkets.com

Retrieved on: 
Friday, October 27, 2023
Health, Genetics, FDA, Child, Plasma, Second Continental Congress, Orphan Drug Act of 1983, Health care, Haemophilia, ODA, Hand, Treatment, Congress, Prevalence, VII, Coagulation factor VII, Personal protective equipment, Coagulation, Infection, Quality of life, Growth, COVID-19, Factor VII deficiency, Patient, Diagnosis, Speciality chemicals, Pharmaceutical industry, Tisagenlecleucel, Safety, Cryoprecipitate

The "Rare Hemophilia Factors Market Size, Share & Trends Analysis Report By Type (Factor I, Factor II, Factor VII), By Treatment (Factor Concentrates, Fresh Frozen Plasma, Cryoprecipitate), By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Rare Hemophilia Factors Market Size, Share & Trends Analysis Report By Type (Factor I, Factor II, Factor VII), By Treatment (Factor Concentrates, Fresh Frozen Plasma, Cryoprecipitate), By Region, And Segment Forecasts, 2023 - 2030" report has been added to ResearchAndMarkets.com's offering.
  • The global rare hemophilia factors market is poised for substantial growth, targeting a USD 499.5 million market size by 2030, accompanied by a noteworthy compound annual growth rate (CAGR) of 6.9% from 2023 to 2030.
  • Prophylactic treatment is recommended for individuals with severe rare hemophilia factor disorders to prevent bleeding episodes and enhance their quality of life.
  • This intensified focus on patient safety measures is expected to have enduring benefits for rare hemophilia factor administration.

Global Rare Hemophilia Factors Market Analysis Report 2023-2030 - Tailored Factor Concentrates Gain FDA Approval, Fueling Rare Hemophilia Factors Market Growth

Retrieved on: 
Tuesday, October 3, 2023
Orphan Drug Act of 1983, Fresh frozen plasma, Infection, Hand, Prevalence, Personal protective equipment, Health care, COVID-19, Quality of life, Haemophilia, Coagulation, Second Continental Congress, Congress, Plasma, ODA, VII, Patient, Child, Coagulation factor VII, Factor VII deficiency, Growth, Diagnosis, FDA, Treatment, Speciality chemicals, Pharmaceutical industry, Safety, Tisagenlecleucel

The global rare hemophilia factors market is poised for substantial growth, targeting a USD 499.5 million market size by 2030, accompanied by a noteworthy compound annual growth rate (CAGR) of 6.9% from 2023 to 2030.

Key Points: 
  • The global rare hemophilia factors market is poised for substantial growth, targeting a USD 499.5 million market size by 2030, accompanied by a noteworthy compound annual growth rate (CAGR) of 6.9% from 2023 to 2030.
  • The surge in the market is primarily attributed to the increased availability of tailored factor concentrates securing regulatory approvals, notably from the U.S. FDA.
  • Additionally, the rising adoption of prophylaxis treatment among patients is expected to be a significant growth driver in the coming years.
  • Prophylactic treatment is recommended for individuals with severe rare hemophilia factor disorders to prevent bleeding episodes and enhance their quality of life.

Octapharma's Prothrombin Complex Concentrate, Balfaxar®, Receives FDA Approval For Warfarin Reversal in Urgent Surgery & Invasive Procedures

Retrieved on: 
Wednesday, July 26, 2023
Embolism, Factor IX, Bleeding, Health, Prothrombin time, Factor X, Stroke, Food and Drug Administration, Clinical trial, Thrombophilia, VKA, Octapharma, PCC, INR, Coagulation, Warfarin, Hemostasis, Patient, Protein C, Risk, Physician, Coagulation factor VII, Vitamin K, Trial of the century, Phase, FDA, Thrombin, Food, Safety, Pharmaceutical industry, Medical imaging

Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.

Key Points: 
  • Balfaxar® helps restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.
  • The Phase III, randomized, double-blind, multicenter study was performed at 24 sites in the U.S. and Europe and randomized 208 patients to Balfaxar® (N=105) or control 4F-PCC (N=103).
  • We are confident Balfaxar® will be a welcomed treatment for physicians who need to quickly restore patients' coagulation."
  • Balfaxar®, a lyophilized powder for reconstitution, will be provided with sterile water for injection and the new transfer device, nextaro ®.

Juha Punnonen, M.D., Ph.D. Joins Hinge Bio as Chief Development Officer

Retrieved on: 
Wednesday, May 31, 2023
Coagulation factor VII, Hinge, University, Therapy, Senior, Internal medicine, Pediatrics, Principal investigator, TPO, University of Turku, Antibody, Doctor of Philosophy, MD, Patient, Merck, R, Merck & Co., Pharmacology, Health, IND, Biology, SPG, Nursing, Maxygen

BURLINGAME, Calif., May 30, 2023 /PRNewswire/ -- Hinge Bio, Inc., a privately-held biotechnology company, today announced that Juha Punnonen, M.D., Ph.D. has joined the company as Chief Development Officer. Dr. Punnonen brings over 20 years of experience as a biopharmaceutical executive with a track record in building and managing R&D teams from early-stage research to development in oncology and immuno-oncology. He will lead Hinge Bio's preclinical and clinical strategy and development of product candidates generated by the company's GEM-DIMER™ technology.

Key Points: 
  • BURLINGAME, Calif., May 30, 2023 /PRNewswire/ -- Hinge Bio, Inc., a privately-held biotechnology company, today announced that Juha Punnonen, M.D., Ph.D. has joined the company as Chief Development Officer.
  • He will lead Hinge Bio's preclinical and clinical strategy and development of product candidates generated by the company's GEM-DIMER™ technology.
  • "We are thrilled to welcome Juha to Hinge Bio," said Barry Selick, Ph.D, Chief Executive Officer of Hinge Bio.
  • "I am excited to join Hinge Bio to advance GEM-DIMER candidates to development," said Dr. Punnonen.