PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines.
Via Surgical Ltd. has secured an investment from Taiwanese manufacturer Catcher Technology Co. Ltd. to bring its Fastouch deployable suture fixation system that assists hernia repair to Asia.
TORONTO – The University of Toronto (U of T) is collaborating with Kawasaki, Japan’s Fujitsu Laboratories Ltd. to dramatically streamline radiation treatment plans for Gamma Knife brain tumor radiosurgery. Together, they are leveraging Fujitsu's Digital Annealer described as quantum-inspired computing technology to create treatment plans for complex surgical procedures in minutes, while maintaining accuracy and minimizing dosage to surrounding healthy tissue.
HONG KONG – SK Bioscience Ltd.’s shares soared as much as 30% in their KOSPI board debut on Thursday. The 22.95 million shares on offer opened at ₩130,000 (US$115.08) and were trading at ₩169,000 by the close of the trading day, raising ₩1.5 trillion, or $1.33 billion. SK Bioscience had priced the shares at the top of the ₩49,000 to ₩65,000 range.
HONG KONG –Uni-Bio Science Group Ltd. and Dotbio Pte. Ltd. formed a partnership to develop therapeutics for patients with retinal diseases, such as age-related macular degeneration, diabetic macular edema, retinal vein occlusion and myopic choroidal neovascularization.
In the “The World for Asia, Asia for the World” panel discussion at the virtual Wuxi Healthcare Forum, investors and executives took note of the region’s digital capabilities for reducing R&D costs and timelines, while also calling for more harmonization on the regulatory front to empower R&D in Asia.
As the World Trade Organization (WTO) debate intensified this week over a demand to waive patent protections for COVID-19 vaccines and therapies, the group’s new director-general, Ngozi Okonjo-Iweala, urged members to “walk and chew gum” at the same time by working with “companies to open up and license more viable manufacturing sites now in emerging markets and developing countries. We must get them to work with us on know-how and technology transfer now.”
From the time it paused inspections of drug manufacturing sites a year ago due to the COVID-19 pandemic, the FDA conducted only three foreign “mission-critical” inspections in fiscal 2020. Those were in Canada, Germany and India, according to a new U.S. Government Accountability Office report.
HONG KONG – The Korea Advanced Institute of Science and Technology (KAIST) is making headway with its 3D holotomography technology, which enables a more accurate and systematic way to view cell-to-cell interactions. This could be a game changer for assessing cell therapy.
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