Specialty Pharma Journal Specialty, Precision & Technology
TOKYO, Nov. 28, 2018 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) approved XOSPATA® (generic name: gilteritinib) for the treatment of adult patients who have relapsed or refractory (resistant to treatment) Acute Myeloid Leukemia …
Tag Archives: leukemia
November, 2018
April, 2018
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5 April
FDA Accepts AstraZeneca’s Application for its Investigational Hairy Cell Leukemia Drug
Zene AstraZeneca and MedImmune, its global biologics research and development arm, today announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell …
January, 2018
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5 January
Tumor Suppressor Gene Variants Identified as Cancer ‘Double Whammy’ for Leukemia Patients
Newly identified germline variations in a key tumor suppressor gene predispose individuals to develop leukemia as children and leave them with a 1-in-4 chance of developing a second cancer later. TP scientists led the study, which appears today in the Journal of Clinical Oncology. Researchers sequenced the TP53 tumor suppressor gene in 3,858 children …
December, 2017
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27 December
Study Explores Impact of Obesity on Bone Marrow Cells
CINCINNATI, Dec. 27, 2017 /PRNewswire-USNewswire/ — New research published in the Journal of Experimental Medicine highlights the pernicious effect of obesity on the long-term health of blood-making stem cells (hematopoietic stem cells). Published Dec. 27, the study was led by researchers at the Cincinnati Children’s Cancer and Blood Diseases Institute. …
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20 December
FDA Approves Pfizer’s Bosulif for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for BOSULIF® (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). The sNDA was reviewed and approved under the …
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7 December
Foundation Medicine to Present New Data Supporting FoundationOne®Heme to Advance Personalized Medicine in Blood Cancers
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Foundation Medicine, Inc. (NASDAQ:FMI) today announced that new data generated with FoundationOne®Heme, its comprehensive genomic profiling (CGP) assay for hematologic malignancies and sarcomas, will be presented at the American Society of Hematology (ASH) Annual Meeting. Data from a broad range of blood cancers, including acute myeloid leukemia (AML), myeloproliferative …
November, 2017
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27 November
High Levels of Natural Immune Suppressor Correlate with Poor Survival in the Most Common Leukemia
AUGUSTA, Ga. (Nov. 27, 2017) – Patients diagnosed with the most common form of leukemia who also have high levels of an enzyme known to suppress the immune system are most likely to die early, researchers say. High levels of this enzyme, indoleamine 2,3 dioxygenase, or IDO, at diagnosis also …
October, 2017
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11 October
FDA Grants Fast Track Designation to Astellas’ Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia
TOKYO, Oct. 10, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of gilteritinib for adult patients with FLT3 mutation-positive (FLT3+) relapsed or refractory acute myeloid leukemia …
September, 2017
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19 September
AbbVie Announces Positive Results from Late-Stage Relapsed/Refractory Chronic Lymphocytic Leukemia Study
NORTH CHICAGO, Ill., Sept. 18, 2017 /PRNewswire/ — AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the Phase 3 MURANO study of VENCLEXTA™/VENCLYXTO™ (Venetoclax) Tablets in combination with Rituxan® (rituximab) met its primary endpoint. Results showed that VENCLEXTA/VENCLYXTO in combination with Rituxan prolonged progression-free survival (PFS) in patients with relapsed/refractory (R/R) chronic …
August, 2017
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3 August
Jazz’s Vyxeos Receives FDA Approval for Treatment of Certain Poor Prognosis Acute Myeloid Leukemia
DUBLIN, Aug. 3, 2017 /PRNewswire/ — Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has approved Vyxeos™ (daunorubicin and cytarabine) liposome for injection for the treatment of adults with two types of Acute Myeloid Leukemia (AML), a rapidly progressing and life-threatening blood cancer. …