Transplantation

Thermo Fisher Scientific Develops COVID-19 Antibody Assay Targeting Transplant Community

WEST HILLS, Calif., Aug. 10, 2020 /PRNewswire/ — Thermo Fisher Scientific continues to expand its response to the COVID-19 pandemic, developing a new serological assay targeted towards transplant candidates and recipients that can detect antibodies directed against COVID-19 (SARS-CoV-2). The assay will be provided under the company’s One Lambda brand …

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Roche Announces FDA Authorization for the first Epstein-Barr Virus Quantitative Test on the cobas 6800/8800 Systems to Improve Care for Transplant Patients

Basel, 5 August 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has authorized the cobas® EBV test. This is the first quantitative in vitro diagnostic test for Epstein-Barr virus (EBV) DNA in the United States. This authorization gives healthcare professionals …

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City of Hope’s Triplex Vaccine Reduces Rate of CMV Complications in Transplant Recipients by 50% and Spurs Immunity Against the Virus

DUARTE, Calif.–(BUSINESS WIRE)–Patients who underwent a stem cell transplant and received the Triplex vaccine to prevent a type of herpes virus – cytomegalovirus (CMV) – from duplicating out of control were 50% less likely to develop health complications related to the virus than patients who did not take Triplex, according …

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Akari’s Nomacopan Granted Orphan Drug Designation for Hematopoietic Stem Cell Transplantation-Associated Thrombotic Microangiopathy

NEW YORK and LONDON, Aug. 30, 2019 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced that the U.S. Food and Drug Administration (FDA) has …

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Tonix and Massachusetts General Hospital Partner to Develop TNX-1500 for Treatment and Prevention of Organ Transplant Rejection

NEW YORK, Aug. 21, 2019 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the signing of a research collaboration agreement with Massachusetts General Hospital (MGH), a teaching hospital of Harvard Medical School, to develop TNX-1500, a humanized monoclonal antibody …

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Study Demonstrates Ability to Predict Early Rejection in Kidney Transplant with FractalDx Portfolio Technology

NEW YORK, June 7, 2019 /PRNewswire/ — Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that positive study results have been published in the Journal of Clinical Investigation (JCI) Insight1.  These results show FractalDx portfolio technology can accurately predict early acute …

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Novartis Presents Histology Data with Iscalimab Suggesting the Extended Survival of Transplanted Organs May Be Possible

Basel, June 6, 2019 – Novartis announced today new early stage histology data in kidney transplantation, suggesting that with investigational compound iscalimab (CFZ533) it may be possible to prolong the durability of transplanted kidneys as well as to potentially improve long-term outcomes for kidney transplant patients[1]. “Extending the life of transplanted kidneys …

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Takeda’s Ninlaro Fails to Meet Primary Endpoint in Phase 3 Trial in Patients with AL Amyloidosis

CAMBRIDGE, Mass. & OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) today announced that the Phase 3 TOURMALINE-AL1 clinical trial in patients with relapsed or refractory systemic light-chain (AL) amyloidosis did not meet the first of two primary endpoints. Treatment with NINLAROTM (ixazomib) in combination with dexamethasone did not demonstrate …

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FDA Approves Incyte’s Jakafi for the Treatment of Patients with Acute Graft-Versus-Host Disease

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication. “For the first time, patients …

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Mallinckrodt Reports Top-Line Results from Proof-of-Concept Study of Nitric Oxide Gas in Ex-Vivo System of Human Lung Transplants

STAINES-UPON-THAMES, United Kingdom, April 18, 2019 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced top-line results from its company-sponsored, proof-of-concept study of nitric oxide gas (gNO) with ex-vivo lung perfusion compared to lung perfusion alone in human lung transplants. The study’s primary objectives were …

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