Coagulation system

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.

Cure HHT Announces Two New Treatment Centers for Rare Disease in Indianapolis, Indiana and Ann Arbor, Michigan

Retrieved on: 
Friday, July 23, 2021

HHT affects 1 in 5,000 people, and is as common as Cystic Fibrosis, perhaps the best known of the rare diseases.

Key Points: 
  • HHT affects 1 in 5,000 people, and is as common as Cystic Fibrosis, perhaps the best known of the rare diseases.
  • Thanks to a new program proposed by Cure HHT and funded by the Centers for Disease Control (CDC), Cure HHT was able to collaborate with the American Thrombosis & Hemostasis Network (ATHN) to train Hemophilia Treatment Center (HTC) staff, identify the subspecialists necessary to provide HHT care, and establish a patient referral and treatment program for HHT patients.
  • The first two such HHT-HTC Centers are now operational and accepting patients at the Michigan Medicine Hemophilia and Coagulation Disorders Program (Ann Arbor, Michigan), and the Indiana Hemophilia & Thrombosis Center (Indianapolis, Indiana).
  • "The Indiana Hemophilia & Thrombosis Center is excited to announce our partnership with Cure HHT as an HHT-HTC Treatment Center.

Novo Holdings co-leads Hemab's US$ 55M Series A to Advance Next Generation Therapeutics for Bleeding and Thrombosis Disorders

Retrieved on: 
Thursday, July 22, 2021

Dr Sorensen brings a wealth of patient-centred R&D experience in many therapeutic areas including thrombosis and hemostasis.

Key Points: 
  • Dr Sorensen brings a wealth of patient-centred R&D experience in many therapeutic areas including thrombosis and hemostasis.
  • The pipeline will initially focus on underserved people living with rare bleeding disorders such asGlanzmann's Thrombasthenia (GT), with plans to expand intomore common disorders of hemostasis and thrombosis.
  • Jrgen Sberg Petersen, Partner at Novo Holdings, and Camilla Petrycer Hansen, Principal at Novo Seeds will continue as Chairman and Independent Director on the Board.
  • Hemab is an emerging biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders.

Hemab Raises US$ 55M Series A to Advance Next Generation Therapeutics for Bleeding and Thrombosis Disorders

Retrieved on: 
Thursday, July 22, 2021

COPENHAGEN, Denmark and BOSTON, July 22, 2021 /PRNewswire/ --Hemab ApS ("Hemab"), a biotech company developing next generation therapeutics for serious underserved bleeding and thrombosis disorders, today announces the successful closing of a US$ 55M Series A financing.

Key Points: 
  • COPENHAGEN, Denmark and BOSTON, July 22, 2021 /PRNewswire/ --Hemab ApS ("Hemab"), a biotech company developing next generation therapeutics for serious underserved bleeding and thrombosis disorders, today announces the successful closing of a US$ 55M Series A financing.
  • The pipeline will initially focus on underserved people living with rare bleeding disorders such as Glanzmann's Thrombasthenia (GT),with plans to expand into more common disorders of hemostasis and thrombosis.
  • This financing will enable us to accelerate the development of innovative therapeutics for long underserved patients with serious bleeding and thrombosis disorders.
  • Hemab is an emerging biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders.

Novo Holdings co-leads Hemab's US$ 55M Series A to Advance Next Generation Therapeutics for Bleeding and Thrombosis Disorders

Retrieved on: 
Thursday, July 22, 2021

COPENHAGEN, Denmark and BOSTON, July 22, 2021 /PRNewswire/ -- Novo Holdings, a leading international life science investor, today announces that it has co-led alongside HealthCap and RA Capital Management a US$ 55M Series A financing in Hemab ApS ("Hemab"), a biotech company developing next generation therapeutics for serious underserved bleeding and thrombosis disorders.

Key Points: 
  • Dr Sorensen brings a wealth of patient-centred R&D experience in many therapeutic areas including thrombosis and hemostasis.
  • The pipeline will initially focus on underserved people living with rare bleeding disorders such asGlanzmann's Thrombasthenia (GT), with plans to expand intomore common disorders of hemostasis and thrombosis.
  • Jrgen Sberg Petersen, Partner at Novo Holdings, and Camilla Petrycer Hansen, Principal at Novo Seeds will continue as Chairman and Independent Director on the Board.
  • Hemab is an emerging biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders.

Hemab Raises US$ 55M Series A to Advance Next Generation Therapeutics for Bleeding and Thrombosis Disorders

Retrieved on: 
Thursday, July 22, 2021

COPENHAGEN, Denmark and BOSTON, July 22, 2021 /PRNewswire/ -- Hemab ApS ("Hemab"), a biotech company developing next generation therapeutics for serious underserved bleeding and thrombosis disorders, today announces the successful closing of a US$ 55M Series A financing. The investment was led by Novo Holdings, HealthCap and RA Capital Management.

Key Points: 
  • The pipeline will initially focus on underserved people living with rare bleeding disorders such as Glanzmann's Thrombasthenia (GT),with plans to expand into more common disorders of hemostasis and thrombosis.
  • The financing will also enable Hemab to further build the team and expand its operational footprint in Denmark and the US.
  • This financing will enable us to accelerate the development of innovative therapeutics for long underserved patients with serious bleeding and thrombosis disorders.
  • Hemab is an emerging biotech company developing next generation therapeutics for serious, underserved bleeding and thrombosis disorders.

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

Retrieved on: 
Monday, July 19, 2021

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.

New TAVALISSE® Data Analyses To Be Presented at International Society on Thrombosis and Haemostasis (ISTH) 2021 Congress

Retrieved on: 
Wednesday, July 14, 2021

All ePosters will be made available online during the Poster Networking Session on the conference website on Saturday, July 17, 2021, at 4:00 p.m. Eastern Time.

Key Points: 
  • All ePosters will be made available online during the Poster Networking Session on the conference website on Saturday, July 17, 2021, at 4:00 p.m. Eastern Time.
  • Incidence of bleeding events and use of rescue therapy continually decreased in these 58 patients over the first year of treatment with fostamatinib.
  • Findings include:
    A reduced need for office visits due to oral administration, easy titration, and low incidence of thrombocytosis.
  • Fostamatinib's unique mechanism of action provide increased hemostasis and may reduce the risk of thrombosis.

Hemophilia Clinical Landscape Market Report 2021: Hemlibra will Continue to Capture Market Share from Replacement Factors in the Hemophilia-A Space - ResearchAndMarkets.com

Retrieved on: 
Monday, July 12, 2021

Hemophilia is a rare, inherited X chromosome-linked bleeding disorder in which deficiencies in clotting factors prevent blood from clotting normally.

Key Points: 
  • Hemophilia is a rare, inherited X chromosome-linked bleeding disorder in which deficiencies in clotting factors prevent blood from clotting normally.
  • There are two types of hemophilia, A and B, with similar signs and symptoms but different genetic defects.
  • The publisher estimates that in 2018, there were approximately 180,750 diagnosed prevalent cases of hemophilia A and 35,950 diagnosed prevalent cases of hemophilia B worldwide.
  • Hemlibra has captured market share from a host of replacement factors and EHLs and is set to achieve market leader status over the forecast period.

Sigilon Therapeutics Announces Clinical Hold on SIG-001 Phase 1/2 Study in Hemophilia A

Retrieved on: 
Friday, July 9, 2021

The clinical hold was initiated following the Companys submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.

Key Points: 
  • The clinical hold was initiated following the Companys submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.
  • The third patient, who received the highest dose of study drug, developed inhibitors to Factor VIII (FVIII) a well-known complication of FVIII therapy.
  • All three patients enrolled in this study will continue to be followed per study protocol, while the company investigates the SAE.
  • Sigilon Therapeutics seeks to develop functional cures for chronic diseases through its Shielded Living Therapeutics platform.