BEIJING – China was the first country to face serious disruptions in clinical trials caused by COVID-19, and policy advocates in the country moved quickly to identify lessons for future outbreaks.
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally.
Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aegea Medical, Biolase, Biofire Defence, Biomérieux, Diacarta, Helius Medical Technologies, Mesa Biotech.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3M, Affinity Health Partners, Allogene Therapeutics, Bellaseno, Curemetrix, Decipher Biosciences, Fiat Chrysler Automobiles, Ford Motor, GE Healthcare, Genmark Diagnostics, Global Center for Medical Innovation, Heat Biologics, Intervenn Biosciences, Iqvia, Letsgetchecked, Maxcyte, Nano-X Imaging, No Borders, Nuclein, Pathsensors, Protex, Q2 Solutions, Qiagen, Quest Diagnostics, Tamarin Health, Vero Biotech, Zoll.
HONG KONG – As the number of COVID-19 confirmed cases and deaths continue to rise globally, South Korea’s focus on testing has attracted international attention. Two diagnostic kits made by domestic companies Seegene Inc.and Kogene Biotech Co. Ltd. are currently preparing to apply for U.S FDA approval.
Trying to build out a new med-tech product category is a time-consuming and costly endeavor. Senseonics Holdings Inc. has long pursued the vision of extended-use, implantable continuous glucose monitoring. Since it was founded in 1996, the Germantown, Md.-based company has already spent roughly half a billion dollars to get there.
Everlywell Inc. stepped back from its announcement that consumers could access at-home testing for COVID-19 starting on March 23, 2020, following a U.S. FDA update that cautioned against fraudulent at-home tests.
