HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.

PERTH, Australia – Epi-Minder Pty. Ltd. has completed an oversubscribed series A round of AU$18 million (US$12.89 million) that will see its Minder epilepsy monitoring device enter a pivotal trial to support marketing applications in Europe and the U.S. The smartphone-enabled device promises to improve on wearables and other tools – such as patient diaries – that have proven to be unreliable.

BEIJING – Three-year-old startup Everest Medicines Ltd. (1952.HK) sold 63 million shares at HK$55 apiece to raise HK$3.49 billion (US$451 million) on the Hong Kong Stock Exchange on Oct 9. Shares were oversubscribed by 654 times in Hong Kong.

Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.

PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.

PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) is seeking industry feedback on further strengthening reforms for adverse events and postmarket regulations for medical devices.

The Lung Cancer Genomic Screening Project for Individualized Medicine in Asia (LC-SCRUM-Asia) has partnered with Thermo Fisher Scientific Inc. to speed molecular profiling in two major studies. The project now uses Waltham, Mass.-based Thermo Fisher’s Ion Torrent Genexus system and Oncomine Precision assay as the sole system for conducting next-generation sequencing (NGS) to improve personalization of therapeutic approaches and better understand drug resistance in non-small-cell lung cancer (NSCLS).