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...
treatment News
OSAKA, Japan & CAMBRIDGE, Mass. – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced that a safety signal has emerged in Phase 2 studies of TAK-994, an investigational oral orexin agonist. As an immediate precautionary measure, the company has suspended dosing of patients and has decided to stop both Phase 2...
OSAKA, Japan & CAMBRIDGE, Mass. — Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved FRUZAQLA™ (fruquintinib), an oral targeted therapy for adults with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS...
OSAKA, Japan – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE). HAE is a rare genetic...
OSAKA, Japan and CAMBRIDGE Massachusetts – The FDA on Thursday approved Takeda’s recombinant ADAMTS13, now to be marketed as Adzynma, for the treatment of the rare blood disorder congenital thrombotic thrombocytopenic purpura—the biopharma company’s second approval in as many days. Adzynma is indicated as an intravenous prophylactic and on-demand therapy...
OSAKA, Japan & CAMBRIDGE, Mass. – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has approved EXKIVITY (mobocertinib) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20...
OSAKA, Japan & CAMBRIDGE, Mass. — Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved GAMMAGARD LIQUID® [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). It can be...
OSAKA, Japan & CAMBRIDGE, Mass. – Takeda (TSE:4502/NYSE:TAK) today announced new interim data from the Phase 1b, open-label, proof-of-concept study of subcutaneous mezagitamab (TAK-079), an anti-CD38 monoclonal antibody with disease-modifying potential, in primary immunoglobulin A (IgA) nephropathy. Data from the study showed that kidney function (eGFR) remained stable in patients...
Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs MILAN, Italy — Johnson & Johnson (NYSE: JNJ) announced today new results from...
JERSEY CITY, N.J. — Tanabe Pharma America, Inc., the wholly owned subsidiary of Tanabe Pharma Corporation, today announced positive topline efficacy and safety results from the global Phase 3 clinical trial, also known as the INSPIRE study, of investigational dersimelagon (MT-7117), a selective melanocortin-1 receptor (MC1R) agonist, being developed for...