Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare opportunity to collect prospective human data in an active filovirus emergency.
For decades, treatment options for osteoarthritis have followed a familiar path: As cartilage deteriorates and pain worsens, conservative therapies eventually give way to joint replacement surgery. Australian regenerative medicine company Integrant Pty Ltd. wants to change that trajectory. Rather than replacing damaged joints, the Sydney-based company is building a platform designed to regenerate cartilage and preserve joint function by combining biologics, medical devices and artificial intelligence.
Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody mezagitamab (TAK-079) is showing benefits beyond platelet restoration, with new data suggesting the candidate may improve quality of life for patients with chronic immune thrombocytopenia (ITP) and sustain those gains after treatment ends.
South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics.
Mindrank AI Ltd. completed a $52 million series B round to advance MDR-001, its AI-discovered oral small-molecule GLP-1 receptor agonist, which is in phase III trials for obesity in China.
The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.
Astrazeneca plc has added a dual PDE3/4 inhibitor candidate to its chronic obstructive pulmonary disease (COPD) portfolio via a deal worth up to $2.1 billion with Chia Tai Tianqing Pharmaceutical Group Co. Ltd., a Sino Biopharmaceutical Ltd. subsidiary.
Drug Farm Biotechnology Co. Ltd. closed a $55 million series D round to advance its AI-developed alpha-protein kinase 1 (ALPK1) inhibitor, DF-003, in a phase III trial for ROSAH syndrome, a rare genetic disease that can lead to blindness.
Regulatory snapshots for biopharma and med tech in Asia-Pacific, including global submissions and approvals, and other regulatory decisions and designations: Forus, Leads Biolabs, Pharmaessentia, SL Science.
Biopharma and med-tech happenings in Asia-Pacific, including deals and partnerships, and other news in brief: Accurkardia, Baiyunshan Xihe Health, Biocytogen, Everest Medicines, Fosun Diagnostics, Hanchorbio, Inxmed, LG Chem, OTR, Pegbio, Proteina, Rani, Samsung Bioepis, Sanyou, Travere, Virax Biolabs, Wellysis, Whitehawk.