In the shadow of COVID-19, experts at the BIO Asia-Taiwan conference on Wednesday warned of present and future challenges for the biotech industry. Changes in manufacturing logistics and financial distress will continue to cause concern for the industry.
PERTH, Australia – The U.S. FDA gave the thumbs up to Australia’s Micro-X Ltd. for its Rover mobile X-ray system. The 510(k) application was cleared in just five weeks. The concept for the Rover was originally developed under a contract with the Australian Department of Defense to prove that Micro-X’s technology could fulfill an unmet need for a full performance, digital medical X-ray imager that was light enough to be used in deployed medical facilities.
Diagnostic firm AnchorDx Medical Co. Ltd. is now working with the Lung Cancer Initiative at Johnson & Johnson in a four-year lung cancer study that aims to enable early detection and diagnosis of the disease in China. The study takes place at six hospitals in the country and is expected to be completed in December 2024.
Emerging companies continue to have a bigger role in pushing biotech innovation, and their presence is more important than ever, given the race for a COVID-19 solution. Those companies’ role in global R&D and new drug approvals was stressed by experts at the current BIO Asia-Taiwan conference.
HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials.
HONG KONG – Shanghai-based I-Mab Biopharma Co. Ltd. expects to begin clinical trials for the world’s first and only claudin18.2 and 4-1BB bispecific program in a year.
HONG KONG – China and U.S.-based pharmaceutical company Antengene Corp. has closed a $97 million series C financing round, with proceeds mainly directed toward funding the continuing clinical development of its pipeline of hematology and oncology therapies.
HONG KONG – Incheon, South Korea-based Celltrion Inc. will start manufacturing its COVID-19 treatment for clinical trials and commercial distribution, even though it’s only reached phase I. The phase I trials testing the in-house antiviral antibody treatment CT-P59 began on July 17, the same day the company received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for its investigational new drug application on the back of positive preclinical results.
NEW DELHI – Bangalore-based Biocon Ltd. has received the Indian drug regulator's approval for restricted emergency use of its psoriasis biologic, itolizumab, to treat patients with severe cases of COVID-19 in need of ventilator support.
Hong Kong – Korea’s Ministry of Food and Drug Safety (MFDS) is looking to establish an international common set of guidelines for AI medical devices after its election to the first Chair of Artificial Intelligence Medical Devices (AIMDs) at a meeting of the International Medical Device Regulators Forum (IMDRF).
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