Home / Hematopoietics

Hematopoietics

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

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 …

Read More »

FDA Approves Spectrum Pharmaceuticals’ Evomela for Injection

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) has granted approval of EVOMELA for use in two indications: 1) use as a …

Read More »

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), …

Read More »

Chimerix’s Lead Candidate Misses Primary Endpoint in Late-Stage Study

DURHAM, N.C., Dec. 28, 2015 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its Phase 3 SUPPRESS trial of brincidofovir in patients undergoing hematopoietic cell transplantation (HCT) did not achieve its primary endpoint for the prevention …

Read More »

FDA Grants Breakthrough Therapy Status to Atara and MSK’s T Cell Therapy

Atara Biotherapeutics, Inc. and partner Memorial Sloan Kettering Cancer Center (MSK) announced that they have received Breakthrough Therapy designation for its promising T cell therapy. The companies said that the US Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Atara’s optioned cytotoxic T lymphocytes activated against Epstein-Barr Virus …

Read More »