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.
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.
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.
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.
KARACHI, Pakistan – Trypanophobia is a debilitating extreme fear of needles and syringes that prevents both children and adults from receiving sometimes life-saving medical care. The condition can lead patients to resist or deny simple procedures like an intravenous drip or even essential vaccinations. The condition has taken on an added significance in the fight against COVID-19 because of its impact on vaccination campaigns.
HONG KONG – Rokit Healthcare Inc. is working toward its goal of listing on the Korean stock exchange by July or August 2021. The Seoul, South Korea-based company will issue 12 million shares and targets setting the price range as early as July 2021. KB Securities Co. Ltd. and Mirae Asset will serve as organizers for the IPO.
HONG KONG – Looking to improve treatment outcomes for Alzheimer’s patients, Shanghai-based Luye Pharma Group has inked a deal to hand the Japanese rights for its leading treatment to Japan’s Towa Pharmaceutical Co. Ltd. Made through Luye’s subsidiary Luye Pharma Switzerland AG, the agreement gives Towa the exclusive rights for the development and commercialization of the Rivastigmine multi-day transdermal patch (Rivastigmine MD) in Japan.
HONG KONG – Vuno Inc. saw its shares soar on their first day of trading on the Kosdaq board with a $33.4 million IPO. The shares closed at ₩32,150 (US$28.89) on Feb. 26. Vuno had priced the 1.8 million new shares on offer at ₩21,000, exceeding its desired range of ₩15,000 to ₩19,500 and raising ₩37.8 billion, or $33.4 million, to boot.
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