CAMBRIDGE, Mass. — Crossbow Therapeutics, Inc., a biotechnology company focused on advancing T-Bolt™ therapies, a novel class of antibody therapeutics that mimic T-cell receptors (TCR-mimetics), today announced the nomination of its first development candidate, CBX-250, a first-in-class, potent, and specific T-cell engager (TCE) for the treatment of myeloid leukemia. Researchers from...
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King of Prussia, Pennsylvania – CSL Behring has released promising 3-year results from the pivotal HOPE-B study, confirming the sustained long-term durability and safety of etranacogene dezaparvovec-drlb (Hemgenix®) in individuals with hemophilia B. The data, demonstrating prolonged elevated factor IX activity levels following a single infusion, were recently presented at...
KING OF PRUSSIA, Pa. — CSL Behring, a business unit of global biotechnology leader CSL, today announced the availability of 4- and 5-gram vial sizes for ZEMAIRA® [Alpha1-Proteinase Inhibitor (Human)]. Previously available only in a 1-gram vial, the 4- and 5-gram packaging is significant for the Alpha-1 community as it...
HATTERSHEIM AM MAIN, Germany – At this year’s fully virtual International Congress of the European Respiratory Society (ERS 2021), CSL Behring will be hosting a highly significant and topical virtual symposium on 6 September 2021, from 20:00 – 21:30 CEST. Focusing on what we have learnt about the impact of global Covid-19 pandemic...
ST. GALLEN, Switzerland — CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgAN with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). IgAN is a...
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...