Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions. Read More
Changchun Bcht Biotechnology Co. Ltd. has obtained marketing approval for its live attenuated zoster vaccine in China, making it the first approved shingles vaccine developed by a Chinese company. An injectable of 0.5 ml per dose, it is designed for adults ages 40 and older and will go up against GSK plc’s Shingrix vaccine. Read More
Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease. Read More
The ruling Communist Party of China increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance. Read More
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay. Read More
In a blow to Aussie regenerative medicine company Regeneus Ltd., Japan’s Kyocera Corp. has pulled out of a licensing deal for Regeneus’ lead mesenchymal stem cell (MSC) therapy, Progenza, for osteoarthritis of the knee for the Japan market. Read More
Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle. Read More
Sirnaomics Ltd. is gearing up to start either an expanded phase IIb or a phase III clinical trial for its lead siRNA candidate, STP-705, for the treatment of two non-melanoma skin cancers: squamous cell carcinoma in situ and basal cell carcinoma. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Biophytis, Daiichi Sankyo, Ocumension, Oricell, Qurient, Sciwind. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Carsgen, Cidara, Healion, Qurient, Roche, TB Alliance, Tonix, Wuxi XDC, Ymmunobio. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Abbisko, Alpha, Arcturus, Ascletis, Eisai, Greenlight, Help, Huidagene, Junshi, Mesoblast, Pfizer, Pharmala, Zai Lab. Read More
