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...

Reply [EXM, STAR: REY] announced today it has been recognized once again as a Microsoft Azure Expert Managed Services Provider (MSP). The renewal reaffirms Reply’s proven expertise and consistent track record in delivering high-quality cloud solutions and services on the Microsoft Azure platform, powered by the deep technical expertise of its specialized companies – Cluster Reply, Solidsoft Reply and Valorem Reply. This press release features multimedia. View the full release here: https://www....

Regnology, a leading provider in regulatory, risk, tax, and finance reporting, as well as supervisory technology, today announced it has signed an exclusive agreement for the acquisition of Moody’s Regulatory Reporting & ALM Solutions business, inclusive of solutions for Basel III compliance, IFRS9 impairment accounting, large bank asset-liability management (ALM), Solvency II insurance reporting, and prudential and statistical regulatory reporting across more than 50 jurisdictions. By int...