Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma™, a biosimilar to Stelara® (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD). The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma™ presentation, which includes 45mg/0.5mL, 90mg/...
Kioxia Corporation today announced that its 2.5-inch KIOXIA CM7 Series Enterprise PCIe® 5.0 NVMe™ 2.0, KIOXIA CD8P Series Data Center PCIe 5.0 NVMe 2.0 and KIOXIA CD8 Series Data Center PCIe 4.0 NVMe 1.4 SSDs have been successfully tested for compatibility and interoperability with the Adaptec® SmartRAID 4300 Series RAID storage accelerator card from Microchip Technology Inc. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/2025121746108...
RHI Magnesita, the leading global supplier of high-grade refractory products, systems, and solutions, has strengthened its operations in the Middle East, Türkiye, and Africa (META) region by setting up a new business unit headquartered in Dubai with ambitions to propel further growth and expansion in the region. The company inaugurated its new regional office yesterday, marking a key milestone in its growth journey and underscoring a long-term commitment to customers across the region. This pre...
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced new data on sonrotoclax, a next-generation investigational BCL2 inhibitor, demonstrating meaningful clinical benefit as monotherapy and in combination across B-cell malignancies. These data were featured at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida. The five presentations highlight durable responses in heavily pretreated patients with r...
The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY® (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and com...
Takeda (TSE:4502/NYSE:TAK) today announced positive topline results for the two pivotal Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). The studies demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA) 0/1 and P...