Tag Archives: transplantation

June, 2018

21 June
Kalytera Provides Update on its Cannabis-Based Therapy for Prevention and Treatment of GVHD

SAN FRANCISCO and TEL AVIV, Israel, June 21, 2018 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the “Company” or “Kalytera”) today provided an update on its lead clinical development program evaluating cannabidiol (“CBD”) for the prevention and treatment of acute graft versus host disease (“GVHD”). GVHD is a …
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26 April
FDA Grants Breakthrough Therapy Designation to Omeros’ Therapy for High-Risk HSCT-Associated Thrombotic Microangiopathy

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ: OMER) today announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is …
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24 April
FDA Approves Sanofi’s Thymoglobulin for Prevention of Acute Kidney Transplant Rejection

BRIDGEWATER, N.J., April 24, 2017 /PRNewswire/ — Sanofi today announced that the U.S. Food and Drug Administration (FDA) approved Thymoglobulin® [anti-thymocyte globulin (rabbit)], for use in conjunction with concomitant immunosuppression in the prophylaxis, or prevention, of acute rejection in patients receiving a kidney transplant. Kidney disease is the ninth leading cause …
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5 April
FDA Accepts AbbVie and Janssen’s sNDA for Imbruvica for Treatment of Chronic Graft-Versus-Host-Disease

NORTH CHICAGO, Ill., April 4, 2017 – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced a supplemental New Drug Application (sNDA) was accepted for review by the U.S. Food and Drug Administration (FDA) for ibrutinib (IMBRUVICA®) in chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic …
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10 February
Study Finds Genetic Profiling Can Guide Stem Cell Transplantation for Patients with Myelodysplastic Syndrome

A single blood test and basic information about a patient’s medical status can indicate which patients with myelodysplastic syndrome (MDS) are likely to benefit from a stem cell transplant, and the intensity of pre-transplant chemotherapy and/or radiation therapy that is likely to produce the best results, according to new research …
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2 January
Incyte Announces First Patient Treated in Pivotal Clinical Trial Program for Jakafi for GVHD

December 30, 2016 04:15 PM Eastern Standard Time WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the first patient has been treated in the REACH-1 pivotal Phase 2 trial evaluating ruxolitinib (Jakafi®) in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD). “We are very …
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22 December
Alexion’s Soliris Fails to Meet Primary Endpoint in Mid-Stage Study in Kidney Transplant Patients

December 21, 2016 04:04 PM Eastern Standard Time NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) today reported results from the PROTECT Study, a Phase 2/3 registration trial of eculizumab (Soliris®) for the prevention of delayed graft function (DGF) after kidney transplantation in adult recipients of a deceased donor kidney. …
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18 November
Alexion Announces that Data from Global aHUS Registry Shows Reduced Risk with Soliris

NEW HAVEN, Conn.–(BUSINESS WIRE)–Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced today that researchers presented new data from an analysis of patients enrolled in the Global atypical Hemolytic Uremic Syndrome (aHUS) Registry, demonstrating that initiation of Soliris® (eculizumab) prior to kidney transplant reduces the risk of dialysis post-transplant in patients with aHUS. Specifically, …
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19 October
Merck’s Antiviral Drug Letermovir Meets Primary Endpoint in Late-Stage Trial

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine, met its primary endpoint. The global, multicenter, randomized, placebo-controlled study evaluated the efficacy and safety of letermovir for …
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22 February
Celldex Presents Preliminary Cohort Data from Pilot Study of its CDX-301

HAMPTON, N.J., Feb. 20, 2016 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today presented new clinical data on CDX-301 (recombinant human Flt3 ligand), a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells. An open label, pilot study of CDX-301, alone and in combination with Mozobil (plerixafor), …
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