Greater Asia News
Astellas Announces U.S. FDA Grants Priority Review for Zolbetuximab Biologics License Application
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the company's Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody, for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.
FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer's disease (AD).
Temasek-backed Tessa Therapeutics to cease operations after failure to raise funding
TESSA Therapeutics, one of the top-funded biotech startups in Singapore, will soon enter liquidation after failing to find investors to continue funding the development of its cancer treatment cell therapies.
Guardant Health announces reimbursement approval of Guardant360® CDx liquid biopsy test in Japan
Guardant Health, Inc. (Nasdaq: GH) announced today that it has been informed it will receive national reimbursement approval from the Japanese Ministry of Health, Labor and Welfare for its Guardant360® CDx liquid biopsy test for comprehensive genomic profiling for patients with advanced or metastatic solid tumor cancers.
SK bioscience- Government Pharmaceutical Organization Sign Memorandum of Understanding to Strengthen Vaccine Infrastructure in Thailand
SK bioscience announced that the company has signed a Memorandum of Understanding (MOU) with the Government Pharmaceutical Organization (GPO), a state pharmaceutical enterprise in Thailand, to strengthen Thailand's vaccine infrastructure.
Shionogi Further Extends Infectious Disease Innovation Platform with Planned Acquisition of Qpex Biopharma, Inc.
Shionogi Inc. will acquire Qpex Biopharma, Inc.
LYMPHOMA THERAPY NOW APPROVED FOR AUSTRALIAN PATIENTS With Diffuse Large B-cell Lymphoma
SINGAPORE, June 27, 2023 /PRNewswire/ -- Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce that a new therapy to treat the most common type of non-Hodgkin lymphoma in adults – diffuse large B-cell lymphoma – is now approved for use in Australia.
MEDICAL IP Received US FDA 510(k) Clearance for DeepCatch, AI Software for Whole-Body Composition CT Quantification
MEDICAL IP (CEO Joon S. Park), an AI-based digital twin company, announced that CT-based automatic body composition analysis AI software DeepCatch received US FDA 510(k) Clearance.
Kalos Medical Receives Korean MFDS Innovative Medical Device Designation for DENEX Hypertension Treatment System
Kalos Medical Inc. announced that South Korea’s Ministry of Food and Drug Safety designated the company’s DENEX hypertension treatment system as an Innovative Medical Device.
Immuno-oncology company Biosyngen opens new cell therapy GMP facility in Singapore
Biosyngen, an immune-oncology company with technology targeting the unmet medical needs in solid tumour and lymphoma treatment, today announced the official opening of its latest Good Manufacturing Practice (GMP) facility in Singapore.
