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Transplantation

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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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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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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AbbVie’s Imbruvica Benefits Treatment-Resistant GVHD Patients in Mid-Stage Study

NORTH CHICAGO, Ill., Dec. 6, 2016 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced positive results from a Phase 2 study (PCYC-1129) evaluating ibrutinib (IMBRUVICA®) in patients with chronic graft-versus-host-disease (cGVHD), a serious and debilitating potential consequence of stem cell or bone marrow transplant,1 who failed prior systemic …

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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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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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Discovery Could Provide New Prevention, Treatment Option for Organ Transplant Rejection

PITTSBURGH, Aug. 24, 2016 – An international team led by researchers from the University of Pittsburgh School of Medicine found that targeting certain donor cells lowered the risk of organ rejection in mice that underwent kidney and heart transplants. The study results, published today in Nature Communications, could lead to …

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FDA Grants Breakthrough Therapy Designation for Imbruvica for Chronic Graft-Versus-Host-Disease

RARITAN, N.J., June 29, 2016 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy Designation (BTD) for ibrutinib (IMBRUVICA®): as monotherapy for the treatment of patients with chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy, Janssen Research & Development, …

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FDA Grants Breakthrough Therapy Designation to Incyte’s Jakafi for GVHD

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq: INCY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for ruxolitinib (Jakafi®) for the treatment of patients with acute graft-versus-host disease (GVHD). There are currently no approved treatments for patients with acute GVHD. Breakthrough Therapy Designation is designed …

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FDA Grants Orphan Drug Exclusivity to Spectrum’s Evomela in Multiple Myeloma

HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) has granted 7 years of Orphan Drug Exclusivity for …

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