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Transplantation

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 …

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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), …

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Illumina Acquires Conexio Genomics

Building on Illumina’s work to develop next-generation sequencing (NGS) solutions for the HLA typing market, Illumina recently announced its acquisition of Conexio Genomics, a world leader in the development of HLA typing solutions. “The addition of Conexio products and people solidify our HLA capabilities and demonstrate Illumina’s ongoing commitment to …

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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 …

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Organ Transplant Drug Linked to Increased Risk of Rare Lymphoma

A study led by Johns Hopkins researchers has linked the immunosuppressive drug mycophenolate mofetil (MMF) to an increased risk of central nervous system (CNS) lymphoma in solid organ transplant patients. But the same study also found that another class of immunosuppressive drugs, called calcineurin inhibitors (CNIs), given alone or in …

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Shire’s Cinryze Receives Fast Track Status from the FDA for AMR in Kidney Transplant Patients

Lexington, MA – October 13, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CINRYZE® (C1 esterase inhibitor [human]) for intravenous administration in subjects with Antibody Mediated Rejection (AMR) in renal …

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FDA Accepts and Grants Priority Review to Seattle Genetics’ sBLA for Adcetris for Post-Transplant Consolidation Therapy

The US Food and Drug Administration (FDA) has accepted for filing Seattle Genetics’ supplemental Biologics License Application (BLA) for Adcetris (brentuximab vedotin) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression. Additionally, the agency granted Priority Review for …

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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 …

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