Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Bellerophon, Bioxytran, CSL Vifor, Everest Medicines, Hinova Pharmaceuticals, Inmagene, Medicinova, Takeda.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Advanz, Aeon, Alvotech, Asieris, Atyr, Chong Kun Dang, Inmune, Kyorin, Merck, Nimbus, Novavax, Revir, Synaffix, Takeda, Thermo Fisher Scientific, Wellmarker.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Certa, Daewoong, Eiger, Essex, Immutep, Immvira, Innocare, Kintor.
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.
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.
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.
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.
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.
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