Recombinant factor VIIa

Hemab Therapeutics Announces First Drug Candidate: HMB-001, a Novel Bispecific Antibody with Potential for Treatment of Rare Bleeding Disorders

Retrieved on: 
Friday, February 4, 2022
CEO, Patient, Therapy, Thrombosis, Communication, Glycoprotein IIb/IIIa, Coagulopathy, MD, Hematology, Bleeding, Biotechnology, Tissue factor, Research, Hemostasis, HealthCap, Haemophilia, Partnership, Recombinant factor VIIa, Education, Association, Life, Doctor of Philosophy, GT, Novo Holdings A/S, Multimedia, Professor, European Association for the Study of the Liver, Pharmaceutical industry

COPENHAGEN, Denmark and BOSTON, Feb.4, 2022 /PRNewswire/ --Hemab Therapeutics, a biotechnology company developing next-generation therapeutics for serious, underserved bleeding and thrombosis disorders, today unveiled its lead candidate, HMB-001, a novel bispecific antibody with potential for the treatment of Glanzmann Thrombasthenia (GT) and other rare bleeding disorders.

Key Points: 
  • COPENHAGEN, Denmark and BOSTON, Feb.4, 2022 /PRNewswire/ --Hemab Therapeutics, a biotechnology company developing next-generation therapeutics for serious, underserved bleeding and thrombosis disorders, today unveiled its lead candidate, HMB-001, a novel bispecific antibody with potential for the treatment of Glanzmann Thrombasthenia (GT) and other rare bleeding disorders.
  • "Patients suffering with rare bleeding and clotting disorders deserve the same advancements in care that hemophilia patients have experienced for decades," said Benny Sorensen, MD, PhD, President and CEO of Hemab.
  • At the conference, Hemab highlighted data from studies exploring the mechanism of action for HMB-001 in cynomolgus monkeys and experiments with platelets from GT patients.
  • "The data show it may have broad applicability across multiple bleeding disorders, enabling subcutaneous and long-term prophylactic treatment."

New Data for Genentech’s Hemlibra (emicizumab-kxwh) Reinforce Safety Profile in People With Hemophilia A

Retrieved on: 
Monday, July 19, 2021
Biotechnology, Pharmaceutical, Health, Clinical trials, Blood, Branches of biology, Coagulation system, Anatomy, Haemophilia, Recombinant proteins, Factor VII, International Society on Thrombosis and Haemostasis, Haemophilia A, Factor V, Emicizumab, Recombinant factor VIIa, Hemlibra, hemophilia A, Genentech in hemophilia, Genentech, HEMLIBRA, HEMOPHILIA A, GENENTECH IN HEMOPHILIA, GENENTECH

The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, July 17-21.

Key Points: 
  • The data were presented at the virtual International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress, July 17-21.
  • These results provide further confidence in Hemlibras favorable safety profile in people with hemophilia A with factor VIII inhibitors, who have historically faced significant treatment challenges.
  • Nearly one in three people with severe hemophilia A develop factor VIII inhibitors, antibodies that bind to and block the efficacy of replacement factor VIII.
  • Hemlibra has been approved in more than 100 countries worldwide for the treatment of people with hemophilia A with factor VIII inhibitors.

Catalyst Biosciences Receives FDA Fast Track Designation for Subcutaneous MarzAA for the Treatment of Episodic Bleeding in Factor VII Deficiency

Retrieved on: 
Monday, June 28, 2021
Drugs, Orphan drugs, Fast track, Food and Drug Administration, Life sciences, Recombinant factor VIIa, Priority review, Health care, Breakthrough therapy, Drotrecogin alfa

A drug candidate with Fast Track designation is eligible for greater access to the FDA as well as a priority review and rolling review of the marketing application.

Key Points: 
  • A drug candidate with Fast Track designation is eligible for greater access to the FDA as well as a priority review and rolling review of the marketing application.
  • Receiving a second Fast Track designation is another important milestone in our MarzAA development program.
  • FDA granted Fast Track Designation for MarzAA for the SQ treatment and control of episodic bleeding in subjects with Hemophilia A or B with inhibitors in December 2020.
  • Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, an SQ administered next-generation engineered rFVIIa for the episodic treatment of bleeding in subjects with rare bleeding disorders.

Catalyst Biosciences Announces First Patient Dosed in Marzeptacog Alfa (Activated) Phase 1/2 Study in Factor VII Deficiency, Glanzmann Thrombasthenia and Hemophilia A treated with Hemlibra

Retrieved on: 
Tuesday, May 18, 2021
Branches of biology, Coagulation system, Health sciences, Pharmacy, Body fluids, Glycoproteins, Recombinant factor VIIa, Factor VII, Coagulation, Glanzmann's thrombasthenia, Haemophilia A, Pharmacodynamics

MarzAA is a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa).

Key Points: 
  • MarzAA is a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa).
  • MAA-202 is a Phase 1/2 open-label study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and efficacy of SQ MarzAA for treatment of bleeding in FVII deficiency, Glanzmann Thrombasthenia, and Hemophilia A with inhibitor patients receiving Hemlibra\xc2\xae prophylaxis.
  • "We look forward to providing updates on the MarzAA clinical development program, including reporting interim data from MAA-202 later this year.
  • The Company does not assume any obligation to update any forward-looking statements, except as required by law.\n'

Catalyst Biosciences to Present at the Truist Securities Life Sciences Summit

Retrieved on: 
Thursday, May 13, 2021
Coagulation system, Branches of biology, Factor VII, Recombinant factor VIIa, Coagulation, Forward-looking statement, Protease

b'SOUTH SAN FRANCISCO, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced that members of its executive management team will participate in a fireside chat at the Truist Securities Life Sciences Summit at 1:00 pm ET on Monday, May 17, 2021.\nTo access a live webcast of the presentation, please click https://kvgo.com/life-sciences-summit/catalyst-biosciences-may-2021 .

Key Points: 
  • b'SOUTH SAN FRANCISCO, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced that members of its executive management team will participate in a fireside chat at the Truist Securities Life Sciences Summit at 1:00 pm ET on Monday, May 17, 2021.\nTo access a live webcast of the presentation, please click https://kvgo.com/life-sciences-summit/catalyst-biosciences-may-2021 .
  • Our protease engineering platform has generated two late-stage clinical programs, including MarzAA, a subcutaneously (SQ) administered next-generation engineered coagulation Factor VIIa (FVIIa) for the treatment of episodic bleeding in subjects with rare bleeding disorders.
  • Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements.
  • The Company does not assume any obligation to update any forward-looking statements, except as required by law.\n'

Global Hemophilia A Market to 2030 - Insights, Epidemiology and Forecast - ResearchAndMarkets.com

Retrieved on: 
Thursday, March 11, 2021
General Health, Pharmaceutical, Health, Coagulation system, Branches of biology, Proteins, Recombinant proteins, Cofactors, Factor VIII, Factor VII, Recombinant factor VIIa, Haemophilia

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

Key Points: 
  • The "Hemophilia A - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • The Hemophilia A market report provides current treatment practices, emerging drugs, Hemophilia A market share of the individual therapies, current and forecasted Hemophilia A market size from 2018 to 2030 segmented by seven major markets.
  • The current market for Hemophilia A includes Recombinant factor VIII (short and long-acting), Plasma-derived products, bypassing agents, bi-specific antibody, and a few others.
  • To understand the future market competition in the Hemophilia A market and Insightful review of the key market drivers and barriers.

LFB Announces that the European Medicines Agency (EMA) Has Accepted for Filing the Marketing Authorization Application for eptacog beta (activated), a Recombinant Coagulation Factor VIIa

Retrieved on: 
Monday, March 1, 2021
Biotechnology, Other Health, Hospitals, Health, Pharmaceutical, Coagulation system, Life sciences, Branches of biology, Anatomy, Peripheral membrane proteins, Biotechnology, Acute-phase proteins, Factor VII, Biopharmaceutical, Recombinant factor VIIa, Coagulation, Thrombin

LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa).

Key Points: 
  • LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa).
  • An exclusive license for the commercialization of SEVENFACT in the USA has been granted to HEMA Biologics, a joint venture between LFB and US WorldMeds.
  • Created in France in 1994, LFB is today one of the leading European companies providing plasma-derived and recombinant medicinal products to healthcare professionals.
  • Exploratory in vitro evaluation of thrombin generation of eptacog beta (recombinant human FVIIa) and emicizumab in congenital haemophilia A plasma.

Catalyst Biosciences Presents Crimson 1 Phase 3 Study Design at the 62nd Annual American Society of Hematology Conference

Retrieved on: 
Monday, December 7, 2020
Coagulation system, Branches of biology, Blood, Factor VII, Recombinant factor VIIa, Coagulation, Hemostasis, Hematology

SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) presented a poster today at the 62nd Annual American Society of Hematology (ASH) meeting, held virtually December 5-8, 2020, highlighting its Phase 3 Study, Crimson 1.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) presented a poster today at the 62nd Annual American Society of Hematology (ASH) meeting, held virtually December 5-8, 2020, highlighting its Phase 3 Study, Crimson 1.
  • The study will evaluate Marzeptacog alfa (activated) or MarzAA, the Companys subcutaneously administered next-generation engineered coagulation Factor VIIa (FVIIa).
  • The study will enroll approximately 60 subjects to treat 244 eligible bleeding episodes with each treatment.
  • The primary endpoint for the trial is the percentage of treated bleeds resulting in effective hemostasis at the 24-hour timepoint.

Catalyst Biosciences Announces Poster Presentation at the 62nd Annual American Society of Hematology Conference

Retrieved on: 
Thursday, November 5, 2020
Coagulation system, Branches of biology, Blood, Factor VII, Recombinant factor VIIa, Coagulation, Hematology

SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced a trials in progress poster presentation on Marzeptacog alfa (activated) or MarzAA, the Companys subcutaneously administered next-generation engineered coagulation Factor VIIa (FVIIa), at the upcoming 62nd Annual American Society of Hematology (ASH) meeting being held virtually December 5-8, 2020.

Key Points: 
  • SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Catalyst Biosciences, Inc. (NASDAQ: CBIO) today announced a trials in progress poster presentation on Marzeptacog alfa (activated) or MarzAA, the Companys subcutaneously administered next-generation engineered coagulation Factor VIIa (FVIIa), at the upcoming 62nd Annual American Society of Hematology (ASH) meeting being held virtually December 5-8, 2020.
  • In late 2020, Catalyst Biosciences plans to dose the first patient in Crimson 1, its Phase 3 study of MarzAA for treatment of episodic bleeding in Hemophilia A and B with inhibitors.
  • Catalyst is a research and clinical development biopharmaceutical company focused on addressing unmet medical needs in rare hematologic and complement-mediated disorders.
  • The Company does not assume any obligation to update any forward-looking statements, except as required by law.

Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients

Retrieved on: 
Monday, October 19, 2020
FDA, Pharmaceutical, Genetics, Health, Blood, Branches of biology, Haemophilia, Recombinant proteins, Coagulation system, Proteins, Cofactors, Factor VIII, Octapharma, Haemophilia A, Recombinant factor VIIa, Acquired haemophilia, Haemophilia A, Nuwiq®, Octapharma

Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ, Octapharmas human cell line-derived recombinant factor VIII (FVIII).

Key Points: 
  • Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ, Octapharmas human cell line-derived recombinant factor VIII (FVIII).
  • The updated PI includes immunogenicity data from the NuProtect study in previously untreated patients (PUPs).
  • FVIII inhibitor development is the most serious treatment complication in previously untreated patients (PUPs) with severe haemophilia A.
  • The updated NUWIQ PI includes data from the NuProtect study, which was the largest prospective study of a single FVIII product in true PUPs.