AURORA, Colo., and ZAGREB, Croatia – Taiga Biotechnologies, a cell-based immunotherapy company, announced today that the Company has completed the site initiation session for the first site to participate in the TBX-2400-01 clinical trial, a Phase 1/2 study to evaluate the safety and early efficacy of TBX-2400 in acute myeloid leukemia...
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PRINCETON, N.J. — Taiho Oncology, Inc. announces publication of the final results from the pivotal ASCERTAIN clinical trial of fixed-dose oral decitabine and cedazuridine (INQOVI®) compared to intravenous decitabine in adults with intermediate and high-risk myelodysplastic syndromes (MDS) including chronic myelomonocytic leukemia (CMML). The ASCERTAIN trial was the first Phase 3...
CAMBRIDGE, Mass. & HYDERABAD, India — Takeda (TSE:4502/NYSE:TAK) and Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company, today announced a strategic partnership to accelerate access to QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) multi-dose vials (MDVs). These doses will ultimately be made available for procurement by governments...
OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. This...
OSAKA, Japan & CAMBRIDGE, Mass. – Takeda (TSE:4502/NYSE:TAK) today announced topline data from its SKYLINE and SKYWAY studies. SKYLINE (TAK-935-3001) was a multicenter, randomized, double-blind Phase 3 study that evaluated soticlestat (TAK-935) plus standard of care versus placebo plus standard of care in patients with refractory Dravet syndrome (DS).1 Soticlestat...
OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced positive topline results from a Phase 2, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP). Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody (mAb)...
OSAKA, Japan – Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis,[1] one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021. Several...
TORONTO – Takeda Canada Inc. has entered into a contract with Canadian Blood Services (CBS) for GLASSIA® (alpha-1 proteinase inhibitor) resulting from CBS’s request for proposal for hereditary deficiency of Alpha-1 Antitrypsin Deficiency (Alpha-1). Glassia has been approved to be listed on the CBS Plasma Protein and Related Products (PPRP) formulary...
OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced positive topline results from a randomized, double-blind, placebo-controlled, multiple dose Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R) agonist, in patients with narcolepsy type 1. Narcolepsy is a chronic, rare neurological disorder of central hypersomnolence with significant...
OSAKA, Japan & CAMBRIDGE, Mass. – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced updated data from the Phase 1/2 trial of mobocertinib (TAK-788) orally administered in patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer (mNSCLC) who received prior platinum-based chemotherapy. The...