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FDA Grants QIDP and Fast Track Designations to Cidara’s Rezafungin Prophylaxis Development Program

SAN DIEGO–(BUSINESS WIRE)–Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing novel anti-infectives including immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted both Qualified Infectious Disease Product (QIDP) and Fast Track designations for the company’s prophylaxis (prevention) development program for lead antifungal product candidate, rezafungin …

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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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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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FDA Lifts Clinical Hold on US Studies of Bellicum’s BPX-501

HOUSTON, April 11, 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 U.S. Food and Drug Administration has lifted the clinical hold on studies of BPX-501 in the U.S. The decision follows consultation with the FDA and agreement on amendments …

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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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