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Hematopoietics

Takeda’s Maribavir Beats Valcyte in a Phase 2 Study as a Potential Treatment of Cytomegalovirus Infection

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the New England Journal of Medicine has published results of a Phase 2, randomised, 12-week, open-label study of TAK-620 (maribavir), an investigational, orally bioavailable antiviral compound being evaluated in patients with cytomegalovirus (CMV) infection after undergoing hematopoietic cell transplant or solid …

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Gamida Cell and the CIBMTR Announce Collaboration to Advance Research for Life-Saving Cellular Therapy

BOSTON & MILWAUKEE–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, and the CIBMTR® (Center for International Blood and Marrow Transplant Research®) today announced the entry into a research agreement to collect and analyze health outcomes data in patients with hematologic malignancies who receive an allogeneic hematopoietic …

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FDA Grants Fast Track Designation to Akari’s Nomacopan for Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy

NEW YORK and LONDON, Aug. 14, 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 and/or leukotriene systems are implicated, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast …

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CRISPR Therapeutics and Vertex Announce Progress in Clinical Development Programs for the Investigational CRISPR/Cas9 Gene-Editing Therapy CTX001

ZUG, Switzerland and CAMBRIDGE and BOSTON, Mass., Feb. 25, 2019 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP) and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today reviewed recent progress in the clinical development programs for CTX001, an investigational, autologous, CRISPR/Cas9 gene-edited hematopoietic stem cell therapy being evaluated for patients suffering from severe hemoglobinopathies. The companies …

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FDA Grants Orphan Drug Designation to Omeros’ OMS721 for Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy

SEATTLE–(BUSINESS WIRE)–Omeros Corporation (NASDAQ:OMER) today announced that OMS721 has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA). OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin …

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FDA Lifts Clinical Hold on Vertex/CRISPR Therapeutics’ Investigational Gene Therapy CTX001 for the Treatment of Sickle Cell Disease

ZUG, Switzerland and BOSTON and CAMBRIDGE, Mass., Oct. 10, 2018 (GLOBE NEWSWIRE) — CRISPR Therapeutics (NASDAQ:CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, and Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold and accepted the Investigational New Drug application (IND) for CTX001 for the treatment of …

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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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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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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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FDA Approves the Cleveland Cord Blood Center’s Clevecord for Stem Cell Transplants

CLEVELAND, Sept. 12, 2016 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration (FDA) has issued a biologics license to the Cleveland Cord Blood Center (CCBC) for CLEVECORD™, a stem cell product (HPC, Cord Blood) derived from umbilical cord blood. Under this license, CCBC is authorized to manufacture CLEVECORD, for use …

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