Transfusion medicine

Rallybio Announces Clinical Proof-of-Concept Results for RLYB211, an Anti-HPA-1a Polyclonal Antibody for the Prevention of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT), Published in the Journal of Thrombosis and Haemostasis

Retrieved on: 
Thursday, April 6, 2023

FNAIT is a rare and life-threatening bleeding disorder in which maternal alloantibodies directed against fetal platelets can lead to devastating outcomes for the fetus/neonate.

Key Points: 
  • FNAIT is a rare and life-threatening bleeding disorder in which maternal alloantibodies directed against fetal platelets can lead to devastating outcomes for the fetus/neonate.
  • There are currently no approved therapies for the prevention or treatment of FNAIT.
  • The findings were published in the Journal of Thrombosis and Haemostasis, the official journal of the International Society on Thrombosis and Haemostasis.
  • “We are pleased that these clinical results were published in the Journal of Thrombosis and Haemostasis, indicating that RLYB211 markedly accelerated the elimination of HPA-1a-positive platelets.

QuidelOrtho Announces the Formation of the International QuidelOrtho Women’s Leadership Network (QWLN)

Retrieved on: 
Tuesday, March 28, 2023

QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, celebrates Women’s History Month by announcing that the QuidelOrtho Women’s Leadership Network (QWLN) has been formed, creating an enhanced network with 14 global leaders supporting 16 chapters around the world.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq: QDEL) (“QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, celebrates Women’s History Month by announcing that the QuidelOrtho Women’s Leadership Network (QWLN) has been formed, creating an enhanced network with 14 global leaders supporting 16 chapters around the world.
  • In 2022, Quidel Corporation and Ortho Clinical Diagnostics united as QuidelOrtho.
  • Leaders from both companies’ women’s leadership networks came together to form QWLN, a global women-led organization amplifying the mentoring, empowerment, achievement and visibility of women.
  • Because Women’s History Month was created to highlight the achievements women have made throughout history, it is the perfect time to share information about this expanding network.

QuidelOrtho Receives De Novo FDA Authorization for Sofia® 2 SARS Antigen+ FIA

Retrieved on: 
Wednesday, March 8, 2023

The Sofia 2 SARS Antigen+ FIA is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance.

Key Points: 
  • The Sofia 2 SARS Antigen+ FIA is the first rapid antigen test that detects COVID-19 to be awarded FDA market clearance.
  • The Sofia 2 SARS Antigen+ FIA is intended for use by trained clinical laboratory personnel and individuals trained in point-of-care settings and proficient in performing tests using Sofia 2 instruments.
  • “As the first company to introduce a rapid antigen test for COVID-19 when the FDA granted Emergency Use Authorization for the Sofia SARS Antigen FIA in May of 2020, we are pleased to again be the first to receive De Novo FDA clearance for our Sofia 2 SARS Antigen+ FIA,” said Douglas Bryant, president and CEO of QuidelOrtho Corporation.
  • “With this De Novo authorization, Sofia becomes the predicate device upon which subsequent devices of the same type and intended use will be compared.

QuidelOrtho to Participate in the Raymond James 44th Annual Institutional Investor Conference

Retrieved on: 
Thursday, March 2, 2023

QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in vitro diagnostics technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that members of its management team are scheduled to participate in the Raymond James & Associates’ 44th Annual Institutional Investors Conference in Orlando, Florida, on March 7, 2023.

Key Points: 
  • QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in vitro diagnostics technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that members of its management team are scheduled to participate in the Raymond James & Associates’ 44th Annual Institutional Investors Conference in Orlando, Florida, on March 7, 2023.
  • Douglas Bryant, president and chief executive officer, will present in a fireside chat format scheduled for 11:35 a.m.
  • ET / 8:35 a.m. PT.

Cerus Corporation Announces Record Fourth Quarter and Full-Year 2022 Financial Results

Retrieved on: 
Tuesday, February 28, 2023

Product gross margin for the fourth quarter of 2022 was 55.7% compared to 51.1% for the fourth quarter of 2021.

Key Points: 
  • Product gross margin for the fourth quarter of 2022 was 55.7% compared to 51.1% for the fourth quarter of 2021.
  • SG&A expenses for the fourth quarter of 2022 totaled $23.2 million, compared to $22.0 million for the fourth quarter of 2021.
  • R&D expenses for the fourth quarter of 2022 were $18.6 million, compared to $15.6 million for the fourth quarter of 2021.
  • Net loss attributable to Cerus Corporation for the fourth quarter of 2022 was $13.6 million, or $0.08 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $9.1 million, or $0.05 per basic and diluted share, for the fourth quarter of 2021.

National Comprehensive Cancer Network Announces Collaboration with Blood Cancer Experts in Poland

Retrieved on: 
Monday, February 27, 2023

PLYMOUTH MEETING, Pa., Feb. 27, 2023 /PRNewswire/ -- Today, the National Comprehensive Cancer Network® (NCCN®)—a not-for-profit alliance of leading United States cancer centers—announced a new collaboration with the Institute of Hematology and Transfusion Medicine in Poland (IHIT), and the Alliance For Innovation—Polish-American Foundation (AFI). The three organizations have signed an agreement enabling clinicians to share their established expertise and international experience in order to improve quality of care and outcomes for patients with hematologic malignancies in Poland and around the world.

Key Points: 
  • New international agreement builds on existing work to improve cancer care and outcomes worldwide by adapting and implementing evidence-based guidelines for Poland and beyond.
  • PLYMOUTH MEETING, Pa., Feb. 27, 2023 /PRNewswire/ -- Today, the National Comprehensive Cancer Network® ( NCCN ®)—a not-for-profit alliance of leading United States cancer centers—announced a new collaboration with the Institute of Hematology and Transfusion Medicine in Poland ( IHIT ), and the Alliance For Innovation—Polish-American Foundation ( AFI ).
  • "The Institute of Hematology and Transfusion Medicine in Poland is the leading medical and research hospital in Poland for hematology; it serves as a national clinical and diagnostic reference center.
  • The initial work with Poland launched in 2021 ; to date, the groups have co-developed Polish NCCN Guidelines Adaptations for:

National Comprehensive Cancer Network Announces Collaboration with Blood Cancer Experts in Poland

Retrieved on: 
Monday, February 27, 2023

PLYMOUTH MEETING, Pa., Feb. 27, 2023 /PRNewswire/ -- Today, the National Comprehensive Cancer Network® (NCCN®)—a not-for-profit alliance of leading United States cancer centers—announced a new collaboration with the Institute of Hematology and Transfusion Medicine in Poland (IHIT), and the Alliance For Innovation—Polish-American Foundation (AFI). The three organizations have signed an agreement enabling clinicians to share their established expertise and international experience in order to improve quality of care and outcomes for patients with hematologic malignancies in Poland and around the world.

Key Points: 
  • New international agreement builds on existing work to improve cancer care and outcomes worldwide by adapting and implementing evidence-based guidelines for Poland and beyond.
  • PLYMOUTH MEETING, Pa., Feb. 27, 2023 /PRNewswire/ -- Today, the National Comprehensive Cancer Network® ( NCCN ®)—a not-for-profit alliance of leading United States cancer centers—announced a new collaboration with the Institute of Hematology and Transfusion Medicine in Poland ( IHIT ), and the Alliance For Innovation—Polish-American Foundation ( AFI ).
  • "The Institute of Hematology and Transfusion Medicine in Poland is the leading medical and research hospital in Poland for hematology; it serves as a national clinical and diagnostic reference center.
  • Together, we can make sure more people with blood cancers receive region-appropriate treatment based on the latest evidence and expert consensus."

Priothera cleared to begin Japanese arm of pivotal Phase 3 study with mocravimod in patients with Acute Myeloid Leukemia undergoing allogeneic Hematopoietic Cell Transplant

Retrieved on: 
Monday, February 27, 2023

The double-blind, placebo-controlled study assesses relapse-free and overall survival of two dose levels of mocravimod in comparison to placebo.

Key Points: 
  • The double-blind, placebo-controlled study assesses relapse-free and overall survival of two dose levels of mocravimod in comparison to placebo.
  • Dr. Teshima, M.D., commented: “AML is the most common acute leukemia in Japan accounting for approximately 70% of all myeloid leukemias.
  • Despite advances in the use of HCT in Japan, patients are still at risk of relapse with resulting poor prognosis.
  • Mocravimod has shown a clinically relevant benefit in an early clinical study in patients with hematologic malignancies undergoing allogeneic HCT.

QuidelOrtho Reports Fourth Quarter and Full Year 2022 Financial Results

Retrieved on: 
Wednesday, February 15, 2023

GAAP diluted earnings per share (EPS) for the fourth quarter of 2022 decreased to $0.45, compared to $6.85 for the fourth quarter of 2021.

Key Points: 
  • GAAP diluted earnings per share (EPS) for the fourth quarter of 2022 decreased to $0.45, compared to $6.85 for the fourth quarter of 2021.
  • GAAP operating income for the fourth quarter of 2022 was $86.5 million, compared to $376.7 million for the fourth quarter of 2021, and GAAP operating margin was 10% and 59% for the fourth quarters of 2022 and 2021, respectively.
  • Adjusted diluted EPS for the fourth quarter of 2022 decreased to $1.76, compared to $5.12 for the fourth quarter of 2021.
  • Adjusted EBITDA margin for the fourth quarter of 2022 was 28.3%, compared to 45.6% for the fourth quarter of 2021.

European Authorities Approve Lyophilized S/D Treated Plasma OctaplasLG® for Pre-Hospital Transfusion

Retrieved on: 
Thursday, February 2, 2023

Octapharma AG today announced that European medical authorities have approved the lyophilised presentation of the well-established octaplasLG® - pharmaceutically-licensed S/D treated plasma for transfusion.

Key Points: 
  • Octapharma AG today announced that European medical authorities have approved the lyophilised presentation of the well-established octaplasLG® - pharmaceutically-licensed S/D treated plasma for transfusion.
  • The line extension, which will be marketed in Europe as a powder and solvent for solution for infusion, offers new and potentially life-saving treatment options in pre-hospital and emergency settings.
  • Trauma results in 4.4 million deaths worldwide annually6, with uncontrolled bleeding being the major cause of potentially preventable death.
  • Trauma-induced coagulopathy (TIC) is an early abnormal response characterised by hypocoagulation, in addition to acute blood loss, shock, hypothermia and metabolic acidosis, that begins soon after injury.