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Cases of Encephalopathy Force the FDA to Place Clinical Hold on Studies of Bellicum’s Lead Candidate BPX-501

HOUSTON, Jan. 30, 2018 (GLOBE NEWSWIRE) — Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders, today announced that the Company has received notice from the U.S. Food and Drug Administration (FDA) that U.S. studies of BPX-501 have been placed on a clinical hold following three …

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Astellas and Vical’s Investigational Cytomegalovirus Vaccine Fails in Late-Stage Trial in Hematopoietic Stem Cell Transplant Recipients

TOKYO and SAN DIEGO, Jan. 22, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Vical Incorporated (NASDAQ: VICL) announced today that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) recipients, did not meet its primary or …

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FDA Approves Merck’s Prevymis for Prevention of Cytomegalovirus Infection in HSCT Patients

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck & Co., Inc. (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved PREVYMIS™ (letermovir) once-daily tablets for oral use and injection for intravenous infusion. PREVYMIS is indicated for prophylaxis (prevention) of cytomegalovirus (CMV) …

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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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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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Merck’s Letermovir Demonstrates Positive Results in Late-Stage CMV Study

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck & Co., Inc. (NYSE:MRK), known as MSD outside the United States and Canada, today announced results of the pivotal Phase 3 clinical study of letermovir, an investigational antiviral medicine for the prevention of clinically-significant cytomegalovirus (CMV) infection in adult (18 years and older) CMV-seropositive recipients of an …

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FDA Expands Approval of Revlimid as a Maintenance Treatment for Patients with Multiple Myeloma Following auto-HSCT

SUMMIT, N.J.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ:CELG) today announced that the U.S. Food and Drug Administration (FDA) has expanded the existing indication for REVLIMID (lenalidomide) 10 mg capsules to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant (auto-HSCT). The expanded indication makes REVLIMID …

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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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