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TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it filed a regulatory application with the Ministry of Health, Labour and Welfare (MHLW) on August 29 for the anti-cancer agent/humanized anti-VEGF*1 monoclonal antibody Avastin® for Intravenous Infusion 100mg/4mL, 400mg/16mL [generic name: bevacizumab (genetical recombination)] for neurofibromatosis type 2 (NF2), a new indication...
The filing is based on the results from an investigator-initiated Japanese phase II clinical study evaluating Tecentriq in combination with carboplatin and paclitaxel, the standard chemotherapy regimen for unresectable thymic carcinoma as first-line treatment Designated as an orphan drug, making it eligible for priority review If approved, Tecentriq would become...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it launched “LUNSUMIO® for intravenous infusion 1 mg” and “LUNSUMIO® for intravenous infusion 30 mg” (generic name: mosunetuzumab (genetical recombination)) (hereafter, LUNSUMIO), antineoplastic agent / anti-CD20/CD3 humanized bispecific antibody for the treatment of patients with relapsed or refractory follicular lymphoma who have...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for the anti-cancer agent/humanized anti-PD-L1 monoclonal antibody Tecentriq® Intravenous Infusion [generic name: atezolizumab (genetical recombination)] for an additional indication of unresectable thymic carcinoma. Tecentriq received orphan drug designation...
TOKYO, Japan — Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare for “Evrysdi® Tablets 5mg,” a new formulation of the spinal muscular atrophy (SMA) treatment Evrysdi [generic name: risdiplam]. Evrysdi is currently the only orally administered treatment for...
SAN DIEGO, Calif. — Cidara Therapeutics Inc. (Nasdaq: CDTX), a biotechnology company developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the...
PALO ALTO, Calif. & PHILADELPHIA – Ciitizen, a healthcare technology company that helps patients get full control of their medical records to access better treatment options including participation in research and clinical trials, and the STXBP1 Foundation, a patient advocacy group dedicated to finding a cure for STXBP1 Disorders, today announced...
SOUTH SAN FRANCISCO, Calif. – Circle Pharma, Inc., a macrocycle drug discovery and development company focused on intractable cancer targets, announced that it has raised $66 million in an oversubscribed Series C financing. The financing was co-led by The Column Group and Nextech Invest. All investors from the prior round...