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KING OF PRUSSIA, Penn. — Global biotechnology leader CSL today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the...
SUZHOU, China – CStone Pharmaceuticals (“CStone”, HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and Jiangsu Hengrui Pharmaceuticals (“Hengrui”, SHSE: 600276) today announced a strategic partnership and exclusive licensing agreement on anti-CTLA-4 mAb CS1002 in the Greater China region. This strategic partnership marks...
Tsukuba, Japan — Nonfunctional pancreatic neuroendocrine tumors, while rare, are primarily treated through surgery. The presence or absence of lymph node metastasis considerably influences the selection of surgical and other treatment approaches. Particularly controversial is the necessity of surgery for tumors smaller than 2 cm as current clinical guidelines provide...
Longitudinal circulating tumor DNA (ctDNA) analysis can predict disease recurrence and guide adjuvant treatment in patients with resected non-small cell lung cancer (NSCLC), according to a study published in Nature Communications. ctDNA positivity — both after surgery and after adjuvant therapy — was significantly associated with worse recurrence-free survival (RFS), researchers...
SEATTLE – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”) seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L). CTI had previously announced the...
CINCINNATI — Shortly after Ryan Dempster and his wife, Jenny, welcomed daughter Riley into the world on April 1, they learned their daughter suffers from DiGeorge syndrome, a rare congenital disease that prevents her from swallowing and digesting food. Dempster has commuted to Childrens Memorial Hospital over the last seven...
Ryan Dempster, a pitcher for the Chicago Cubs, recently opened up to the Chicago Tribune about his new-born daughter and her fight with DiGeorge Syndrome. In the interview, the professional baseball player admitted that the experience has “been rougher than anything I can imagine.” The syndrome is caused by a...
CAMBRIDGE, Mass. — Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that...