PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.
HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer (NSCLC) from the country’s Ministry of Food and Drug Safety (MFDS) on May 7.
The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.
Researchers in Guangzhou, China, have developed a nanoparticle-based lateral flow immunoassay that quickly and accurately detects antibodies to the SARS-CoV-2 virus that causes COVID-19. The current test, which works in a similar manner to a pregnancy test, detects IgG antibodies in blood in less than 10 minutes. A proof-of-concept study appeared in Analytical Chemistry this week.
PERTH, Australia – Australia is taking several measures to increase diagnostic testing for COVID-19 and rolling out a national surveillance app as it prepares to relax social distancing measures and get back to work.
KARACHI, Pakistan – With limited resources, a growing outbreak and a tech savvy population, Pakistan is reaching into a diverse bag of tricks to find ways to battle COVID-19. Part of these efforts include at least one artificial intelligence (AI)-based diagnostic product as well as molecular diagnostic assays.
HONG KONG – The South Korean Ministry of Health and Welfare (MHW) is seeking a manager for its new ₩100 billion (US$81.63 million) private equity fund, which aims to help domestic biotech and medical device companies expand into overseas markets.
Leo Pharma A/S, of Ballerup, Denmark, has eyed a stronger company presence in Asia during the past year and took a giant step to achieving it by signing a worldwide exclusive licensing agreement with Oneness Biotech Co. Ltd., of Taipei, Taiwan, and Microbio Shanghai Co. Ltd. to develop and commercialize FB-825 for treating atopic dermatitis and allergic asthma.
BEIJING – After its masks and test kits were said to be sent back by Western countries due to complaints over poor quality, China this week required only NMPA-approved companies export their products and stepped up regulations to ensure quality.