Bleeding

Organizations Collaborate to Develop International State-of-the-Art Guidelines on the Diagnosis and Management of von Willebrand Disease

Tuesday, January 12, 2021 - 6:07pm

This inherited condition results in the decreased production, absence, or abnormal function of the clotting protein von Willebrand factor.

Key Points: 
  • This inherited condition results in the decreased production, absence, or abnormal function of the clotting protein von Willebrand factor.
  • Symptoms may vary from patient to patient or in a single patient over the course of his or her life.
  • Primary care providers, pediatricians, obstetricians, and gynecologists who observe unusual bleeding often refer their patients to a hematologist for further testing and management.
  • "Working as part of the incredible team that developed the guidelines in diagnosis of VWD was hugely rewarding and inspiring."

Amydis Announces Successful Completion of Pre-IND Meeting with the FDA for the Development of AMDX-2011P, a First-in-Class Retinal Tracer for the Diagnosis of Amyloid Angiopathy

Monday, January 11, 2021 - 12:00pm

Amydis has reached agreement with the FDA on both nonclinical and clinical plans.

Key Points: 
  • Amydis has reached agreement with the FDA on both nonclinical and clinical plans.
  • CAA is a major cause of spontaneous intracerebral hemorrhage in people older than 55 and an important contributor to age-related cognitive decline.
  • I am keenly aware of the challenges CAA patients face in the diagnosis and treatment of disease.
  • I believe that diagnosis of CAA through the eye would be a tremendous step forward for the field.

Soleo Health Among First to Offer HEMA Biologics’™ SEVENFACT®, a Newly Released Treatment for Bleeding Disorders

Monday, December 21, 2020 - 1:00pm

Soleo Health is among the first to offer the drug to patients, providers and payors.

Key Points: 
  • Soleo Health is among the first to offer the drug to patients, providers and payors.
  • SEVENFACT is designed to bypass the presence of an inhibitor that some patients produce against the clotting factor concentrates they have used as a treatment, thereby helping to treat their bleeding disorders.
  • Several options have been made available for bleeding disorders in recent years, yet there were no new treatments for inhibitor-related bleeding.
  • SEVENFACT affords the Company an opportunity to offer additional treatment to help better serve our bleeding disorders population, an area where we have garnered significant expertise, and to offer yet another beneficial treatment, said Craig Vollmer, chief commercial officer at Soleo Health.

Novo Holdings Creates New Rare Bleeding Disorder Company, Hemab

Monday, December 14, 2020 - 8:00am

COPENHAGEN, Denmark, Dec. 14, 2020 /PRNewswire/ -- Novo Seeds, the early stage investment and company creation team of Novo Holdings, announced today that it has invested in a new portfolio company Hemab ApS (Hemab), which is focused on the development of bispecific antibodies for the treatment of rare bleeding disorders.

Key Points: 
  • COPENHAGEN, Denmark, Dec. 14, 2020 /PRNewswire/ -- Novo Seeds, the early stage investment and company creation team of Novo Holdings, announced today that it has invested in a new portfolio company Hemab ApS (Hemab), which is focused on the development of bispecific antibodies for the treatment of rare bleeding disorders.
  • Hemab was co-founded by Johan Faber and Sren Bjrn, who until 2018, held leadership positions within hemophilia drug research and development at Novo Nordisk A/S.
  • Hemab has secured an exclusive license to certain intellectual property to develop a product within hemophilia and other rare bleeding disorders from Novo Nordisk A/S and an exclusive license to Genmab A/S's proven bispecific DuoBodyplatform technology, which enables the company to further develop novel therapies for ultra rare bleeding disorders.
  • With the hands-on support of Novo Seeds we have a strongfoundation to realize our ambitions for patients with rare bleeding disorders."

Novo Holdings Creates New Rare Bleeding Disorder Company, Hemab

Monday, December 14, 2020 - 8:00am

COPENHAGEN, Denmark, Dec. 14, 2020 /PRNewswire/ -- Novo Seeds, the early stage investment and company creation team of Novo Holdings, announced today that it has invested in a new portfolio company Hemab ApS (Hemab), which is focused on the development of bispecific antibodies for the treatment of rare bleeding disorders.

Key Points: 
  • COPENHAGEN, Denmark, Dec. 14, 2020 /PRNewswire/ -- Novo Seeds, the early stage investment and company creation team of Novo Holdings, announced today that it has invested in a new portfolio company Hemab ApS (Hemab), which is focused on the development of bispecific antibodies for the treatment of rare bleeding disorders.
  • Hemab was co-founded by Johan Faber and Sren Bjrn, who until 2018, held leadership positions within hemophilia drug research and development at Novo Nordisk A/S.
  • Hemab has secured an exclusive license to certain intellectual property to develop a product within hemophilia and other rare bleeding disorders from Novo Nordisk A/S and an exclusive license to Genmab A/S's proven bispecific DuoBodyplatform technology, which enables the company to further develop novel therapies for ultra rare bleeding disorders.
  • With the hands-on support of Novo Seeds we have a strongfoundation to realize our ambitions for patients with rare bleeding disorders."

Arch Therapeutics to Present at the 13th Annual LD Micro Main Event Conference

Friday, December 11, 2020 - 12:50pm

FRAMINGHAM, Mass., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel self-assembling wound care and biosurgical devices, announced today that it will be presenting at the 13th annual LD Micro Main Event investor conference.

Key Points: 
  • FRAMINGHAM, Mass., Dec. 11, 2020 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel self-assembling wound care and biosurgical devices, announced today that it will be presenting at the 13th annual LD Micro Main Event investor conference.
  • Chief Executive Officer, Terrence W. Norchi, MD, is scheduled to present on Tuesday, December 15 at 11:40 AM ET.
  • The Main Event will feature a new format, with companies presenting for approximately 10 minutes followed by questions from a panel of investors and analysts.
  • Arch Therapeutics, Inc. is a biotechnology company developing a novel approach to stop bleeding (hemostasis), control leaking (sealant) and manage wounds during surgery, trauma and interventional care.

Takeda Presents Real-World Evidence at ASH 2020, Demonstrating Its Long-Standing Commitment to Personalizing Treatments for Rare Bleeding Disorders

Monday, December 7, 2020 - 2:00pm

Takeda Pharmaceutical Company Limited ( TSE: 4502/NYSE:TAK ) (Takeda), today presented five hematology poster presentations and four abstracts at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition that underscore its commitment to advancing treatments for rare bleeding disorders.

Key Points: 
  • Takeda Pharmaceutical Company Limited ( TSE: 4502/NYSE:TAK ) (Takeda), today presented five hematology poster presentations and four abstracts at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition that underscore its commitment to advancing treatments for rare bleeding disorders.
  • Real-world evidence (RWE) from studies across rare bleeding disorders demonstrate the crucial role understanding patterns of care and the patients holistic experience outside of rigorous clinical studies play in advancing patient-centric treatment in bleeding disorders.
  • Several of Takedas studies presented at ASH generate real-world evidence to better understand clinical management of treatment and associated disease outcomes in hemophilia A and VWD.
  • Patient preferences for hemophilia A treatments: A discrete choice experiment, (poster #1623) measured patients preferences for different hemophilia A treatments, including emerging treatments such as gene therapy.

Study by Intermountain Researchers to Determine If Blood Thinners Prevent Clots, Illness Severity in COVID-19 Patients

Thursday, December 3, 2020 - 10:16pm

Intermountain researchers are specifically seeking to determine whether a dose of either aspirin or the anticoagulant, apixaban, will prevent the formation of potentially deadly blood clots in patients who are COVID-positive but are not sick enough to be hospitalized.

Key Points: 
  • Intermountain researchers are specifically seeking to determine whether a dose of either aspirin or the anticoagulant, apixaban, will prevent the formation of potentially deadly blood clots in patients who are COVID-positive but are not sick enough to be hospitalized.
  • This study is looking to see if patients who are less critically-ill from COVID benefit from taking very common medications to prevent the development of blood clots.
  • Researchers will be tracking blood clots, hospitalization, mortality rates, as well as bleeding complications over that same period of time.
  • Intermountain researchers hope to enroll several hundred patients in the study, which will run through March 2021.

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

Thursday, December 3, 2020 - 2:03pm

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.

TISSIUM Receives FDA Investigational Device Exemption for Vascular Sealant

Tuesday, November 17, 2020 - 1:00pm

TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, announced today it has received approval from the U.S. Food and Drug Administration for its Investigational Device Exemption application for its vascular sealant.

Key Points: 
  • TISSIUM, a privately-owned medtech company developing biomorphic programmable polymers for tissue reconstruction, announced today it has received approval from the U.S. Food and Drug Administration for its Investigational Device Exemption application for its vascular sealant.
  • TISSIUMs vascular sealant is designed to address the issue of quickly achieving hemostasis and preventing post-operative bleeding following peripheral vascular surgeries, while also offering biocompatibility and a simple preparation and application process for surgeons.
  • In this application, the configuration of TISSIUMs polymer complements sutures as a sealant for a fully effective surgical closure.
  • We are pleased to receive this approval from the FDA as it represents a key milestone that accelerates the development of our vascular indication and triggers the further expansion of our broad platform, said Christophe Bancel, CEO of TISSIUM.