Australia’s Therapeutic Goods Administration (TGA) is proposing that devices be subject to good clinical practices (GCP) inspections, and it is proposing two approaches to achieve that goal.
The University of Sydney is investing AU$478 million (US$326.5 million) to build a leading biomedical precinct to fast-track research and shorten the time between discovery and development of transformative therapies.
Taiwan’s Brim Biotechnology Inc. announced a capital raise of $18 million to advance its lead candidate, regenerative peptide therapy BRM-421, to phase III trials for dry eye syndrome. It’s designed to offer relief from dry eye symptoms by stimulating proliferation and differentiation of stem cells to repair damage to the cornea. “Our goal is restoration and repair of the damage caused by DES,” said Brim founder and CEO Haishan Jang.
Australian radiopharmaceutical company Advancell Co. Ltd. closed an AU$18 million (US$12.4 million) series B round that will take its lead targeted alpha-emitting radiotherapy, ADVC-001, for metastatic prostate cancer to the clinic by the end of 2022.
Takeda Pharmaceutical Co. Ltd.’s dengue fever vaccine, Qdenga, was approved in Indonesia Aug. 23, making it the first global approval for the tetravalent vaccine. The approval marks Takeda’s first marketed vaccine outside of Japan. Indonesia’s National Agency for Drug and Food Control approved the vaccine for prevention of dengue disease caused by any serotype in individuals 6 years to 45 years of age.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Women with endometriosis may soon be able to take a simple blood test to determine if they have the condition thanks to a new test being developed by Proteomics International Pty Ltd. that detects up to 78% of women with endometriosis.
Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.
Founded in 2014, Bertis Co. Ltd. is developing proteomics-based diagnostics and biomarkers by combining artificial intelligence/machine learning (AI/ML) algorithms with high-performance mass spectrometry technology. Using this technology, it is able to quantify extremely small amounts of protein.
Takeda Pharmaceutical Co. Ltd.’s dengue fever vaccine, Qdenga, was approved in Indonesia Aug. 23, making it the first global approval for the tetravalent vaccine. The approval marks Takeda’s first marketed vaccine outside of Japan. Indonesia’s National Agency for Drug and Food Control approved the vaccine for prevention of dengue disease caused by any serotype in individuals 6 years to 45 years of age.
