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...
treatment News
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 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...
Duchenne muscular dystrophy is a rare genetic muscle disorder with poor life prognosis, which is difficult to cure and significantly reduces independent living and quality of life due to muscle weakness Approval based on results from clinical studies including a global Phase III clinical study (EMBARK) Approval for ambulatory patients...
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...
CRANFORD, N.J. — Citius Oncology, Inc. (“Citius Oncology”) (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), today announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of...
SHANGHAI and BOSTON – Citrine Medicine, a China-based rare disease therapeutics company, today announced that it has received a clinical trial waiver from the National Medical Products Administration (NMPA) in China for Wakix® (pitolisant), a narcolepsy drug approved in the European Union and the United States for the treatment of narcolepsy in adult patients with and without...
LOS ANGELES, Calif. — Treating prostate cancer with immunotherapy is currently difficult to do. But results from a first in-human phase 1 trial using a chimeric antigen receptor (CAR) T cell therapy developed by researchers from City of Hope®, one of the largest cancer research and treatment organizations in the...
LOS ANGELES, Calif. — An international Phase 3 clinical trial found that metastatic colorectal cancer patients with a rare genetic tumor mutation called KRAS G12C experienced superior progression-free survival rates compared to standard of care when offered a combination treatment of KRAS inhibitor sotorasib and monoclonal antibody panitumumab. City of...