Transplantation medicine

Gamida Cell to Present at the BTIG Virtual Biotechnology Conference

Retrieved on: 
Tuesday, August 3, 2021

Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 10, 2021 at 3:00 p.m.

Key Points: 
  • Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for blood cancers and serious blood diseases, today announced that the company will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Tuesday, August 10, 2021 at 3:00 p.m.
  • In the fourth quarter of 2021, Gamida Cell is targeting a BLA submission for omidubicel, the first potential approval of a cell therapy for blood cancer patients in need of an allogeneic bone marrow transplant.
  • Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases.
  • For additional information, please visit www.gamida-cell.com or follow Gamida Cell on LinkedIn or Twitter at @GamidaCellTx.

Global Hematopoietic Stem Cell Transplantation Market to 2027 - Size, Share, Outlook, and Opportunity Analysis - ResearchAndMarkets.com

Retrieved on: 
Tuesday, August 3, 2021

The "Hematopoietic Stem Cell Transplantation (HSCT) Market - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Hematopoietic Stem Cell Transplantation (HSCT) Market - Size, Share, Outlook, and Opportunity Analysis, 2019 - 2027" report has been added to ResearchAndMarkets.com's offering.
  • The global hematopoietic stem cell transplantation market is expected to witness significant growth during the forecast period owing to the increasing prevalence of leukemia and lymphoma.
  • Hematopoietic stem cell transplantation is a procedure in which multipotent hematopoietic stem cells sourced from peripheral blood cells, bone marrow, or umbilical cord blood are transplanted into the patient.
  • Hematopoietic stem cell transplantation is commonly used in the treatment of lymphoma (Hodgkin, Non-Hodgkin), leukemia, multiple myeloma, thalassemia, sickle cell anemia, and osteoporosis.

Emmes Announces New Role for the Blood and Marrow Transplant Clinical Trials Network

Retrieved on: 
Monday, August 2, 2021

The study is part of an expanded portfolio of projects conducted under the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).

Key Points: 
  • The study is part of an expanded portfolio of projects conducted under the Blood and Marrow Transplant Clinical Trials Network (BMT CTN).
  • The Blood and Marrow Transplant Clinical Trials Network (BMT CTN) conducts rigorous multi-institutional clinical trials of high scientific merit, focused on improving survival for patients undergoing hematopoietic cell transplantation and/or receiving cellular therapies.
  • The CIBMTR(Center for International Blood and Marrow Transplant Research) is a research collaboration between the National Marrow Donor Program (NMDP)/Be The Match and the Medical College of Wisconsin (MCW).
  • The CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of transplant centers, and a unique and extensive clinical outcomes database.

TransMedics Receives FDA Clearance of OCS Lung Solution for Cold Preservation of Lungs

Retrieved on: 
Thursday, July 29, 2021

ANDOVER, Mass., July 29, 2021 /PRNewswire/ -- TransMedics Group, Inc. ("TransMedics") (Nasdaq: TMDX), a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of its OCS™ Lung Solution for use in transplants using cold storage techniques. The solution, which is also cleared as a component of the company's OCS Lung System, is indicated for hypothermic flushing, storage and transportation of donor lungs for transplantation. 

Key Points: 
  • The solution, which is also cleared as a component of the company's OCS Lung System, is indicated for hypothermic flushing, storage and transportation of donor lungs for transplantation.
  • The OCS Lung System is approved in the U.S. and the Company's OCS Heart System and OCS Liver System are currently under review by the FDA after receiving positive votes by the FDA's relevant advisory panels in April and July respectively.
  • The OCS Lung Solution is a colorless, sterile, pyrogen-free, colloid-based extracellular low potassium solution for cold flushing, storage and transport of donor lungs for transplantation.
  • The solution is cleared by FDA for use in transplants using TransMedics' OCS Lung System for warm perfusion as well as in transplants using cold storage techniques as a standalone product.

Orthofix Announces US Launch and First Patient Implants with New fiberFUSE Strip – An Advanced Fiber Bone-Graft Solution Containing Cancellous Bone

Retrieved on: 
Wednesday, July 28, 2021

(NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the launch and first patient implants with the fiberFUSE Strip , an advanced demineralized fiber bone-graft solution containing cancellous bone.

Key Points: 
  • (NASDAQ:OFIX), a global medical device company with a spine and orthopedics focus, today announced the launch and first patient implants with the fiberFUSE Strip , an advanced demineralized fiber bone-graft solution containing cancellous bone.
  • View the full release here: https://www.businesswire.com/news/home/20210728005105/en/
    Image of the Orthofix fiberFUSE Strip, an advanced demineralized fiber bone-graft solution containing cancellous bone.
  • We are pleased to introduce this next-generation formulation in the fiberFUSE allograft line, said Kevin Kenny, President of Orthofix Global Spine.
  • The fiberFUSE Strip delivers a high-quality advanced bone-graft option in a convenient, easy-to-use strip preparation.

LifeNet Health features revolutionary biologics for wounds at APMA Annual Scientific Meeting

Retrieved on: 
Wednesday, July 28, 2021

As the only biologic of its kind to include the entire trophoblast layer, Matrion replicates the natural thickness and structure of the placental membrane.

Key Points: 
  • As the only biologic of its kind to include the entire trophoblast layer, Matrion replicates the natural thickness and structure of the placental membrane.
  • Like Matrion, Dermacell AWM is decellularized with LifeNet Health's patented Matracell technology to remove donor cells and create a biohospitable scaffold for cellular infiltration and re-vascularization.
  • LifeNet Health helps save lives, restore health, and give hope to thousands each year.
  • For more information about LifeNet Health, go to www.lifenethealth.org .

CareDx Launches ACROBAT Study to Potentially Change Care Paradigm for Stem Cell Transplant Patients

Retrieved on: 
Monday, July 26, 2021

The ACROBAT study is a prospective, multicenter, observational cohort study to evaluate the use of AlloHeme, a microchimerism tool to predict post-transplant relapse in patients with allogeneic hematopoietic cell transplants (HCT), also known as bone marrow or stem cell transplants.

Key Points: 
  • The ACROBAT study is a prospective, multicenter, observational cohort study to evaluate the use of AlloHeme, a microchimerism tool to predict post-transplant relapse in patients with allogeneic hematopoietic cell transplants (HCT), also known as bone marrow or stem cell transplants.
  • AlloHeme is an innovative testing solution that utilizes Next-Generation Sequencing technology to measure the relative amount of donor and recipient cells after a stem cell transplant.
  • Monitoring for changes in chimerism over time using AlloHeme has the potential to significantly change patient surveillance and care in the underserved HCT patient population.
  • CareDx has led the way in improving the standards of care in solid organ transplant and cell therapy monitoring, and now we enter into the stem cell transplant field with this first patient enrolled in ACROBAT, said Reg Seeto, CEO and President of CareDx.

REZUROCK™ (belumosudil) Tablets Approved to Treat Adult and Pediatric Patients 12 Years and Older With Chronic Graft-Versus-Host Disease After Failure of at Least Two Prior Lines of Therapy

Retrieved on: 
Wednesday, July 21, 2021

Onco360 is honored to be selected as a specialty pharmacy provider for REZUROCK in partnership with Kadmon, said Benito Fernandez, Chief Commercial Officer, Onco360.

Key Points: 
  • Onco360 is honored to be selected as a specialty pharmacy provider for REZUROCK in partnership with Kadmon, said Benito Fernandez, Chief Commercial Officer, Onco360.
  • The recent approval of REZUROCK represents the first FDA-approved therapy for chronic GVHD patients who have failed multiple alternative treatment options.
  • As a provider of this key treatment, Onco360 is committed to supporting the highly specialized needs of chronic GVHD patients.
  • According to the National Comprehensive Cancer Network (NCCN) Guidelines for Hematopoietic Cell Transplantation (HCT), chronic GVHD is the leading cause of non-relapse mortality following allogeneic HCT.

Global Graft Vs Host Disease Clinical Trial Pipeline Research Report 2021: Phase 3, Phase 2, Phase 1, Preclinical Research, and Discovery Stage - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 21, 2021

The "Global Graft Vs Host Disease Clinical Trial Pipeline Highlights - 2021" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Graft Vs Host Disease Clinical Trial Pipeline Highlights - 2021" report has been added to ResearchAndMarkets.com's offering.
  • Graft Vs Host Disease Pipeline Highlights - 2021, provides the most up-to-date information on key pipeline products in the global Graft Vs Host Disease market.
  • It covers emerging therapies for Graft Vs Host Disease in active clinical development stages including early and late stage clinical trials.
  • The report provides Graft Vs Host Disease pipeline products by clinical trial stages including both early and late stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage.

U.S. Food and Drug Administration Expands Indication for PROGRAF® for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients

Retrieved on: 
Tuesday, July 20, 2021

NORTHBROOK, Ill., July 20, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention of organ rejection in adult and pediatric lung transplant recipients.

Key Points: 
  • "The current approval expands the indications for PROGRAF from liver, kidney and heart transplants to adult and pediatric patients who receive a lung transplant in combination with other medicines to help prevent organ rejection."
  • The FDA granted Orphan Drug Designation (ODD) to PROGRAF for the prevention of rejection after lung transplant in September 2019.
  • PROGRAFis a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, heart or lung transplants, in combination with other immunosuppressants.
  • PROGRAF is a prescription medicine used with other medicines to help prevent organ rejection in people who have had a kidney, liver, heart or lung transplant.