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.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA grants de novo for Biofire multianalyte assay; No injuries or deaths associated with Acist Kodama recall; Supreme Court to hear assignor estoppel case; Cardiac rehab bill resurfaces in U.S. House.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biofire, Boston Scientific, Braintale, Catalyst, Life Spine, Stimdia.
Keeping you up to date on recent developments in diagnostics, including: Data flaws sink current AI models for COVID-19 diagnosis; Smartphone-based gaze may provide a scalable, digital biomarker of mental fatigue; AI developed to predict disease based on genetic mutations; High blood fats, sugars alter antigen processing.
Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices.
Combining research on emerging technologies with an accelerator program and a dedicated equity fund, the European Commission (EC) launched the European Innovation Council March 18 to invest in promising research and to scale up innovative startups and small- and medium-size businesses.
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