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HONG KONG – Olix Pharmaceuticals Inc. has entered an extensive research collaboration to test its RNAi therapeutic, OLX-104C, with Fimanac, PCI Biotech Holding ASA’s delivery technology for nucleic acid-based therapies, with the aim of reducing off-target effects while treating androgenic alopecia, or hair loss.
Shenzhen Pregene Biopharma Co. Ltd. has outlicensed its internally developed anti-BCMA CAR T-cell therapy candidate, PRG-1801, to Indian pharma giant Dr. Reddy's Laboratories Ltd. in a $162.5 million deal to develop and commercialize it in India. The candidate, which is being developed by Pregene to treat relapsed/refractory multiple myeloma, is now in a phase I trial in China after anIND approval in March 2020.
PERTH, Australia – The FDA granted Oncores Medical Pty. Ltd. breakthrough device designation for its quantitative micro-elastography (QME) imaging system. The hand-held imaging tool helps surgeons differentiate between cancerous and healthy tissue in real time at the point of surgery, and it could substantially improve outcomes in breast-conserving surgery (BCS) and reduce repeat operations for women with breast cancer.
HONG KONG – The Vietnamese Ministry of Health (MoH) has published a draft decree intended to refine the legal framework for regulating medical devices in the country. Released under the title Official Dispatch No. 2271/BYT-TB-CT, the draft document consolidates the amendments made to the current decree and introduces new sections addressing clinical trials, the Essential Principles for Safety and Efficiency of Medical Devices, and advertising.
HONG KONG – The revisions for China’s Regulations for Supervision and Administration of Medical Devices, which promise harsher penalties and post-market enforcements, will come into effect on June 1, 2021. The revisions see authorities take a more progressive and aggressive approach to the regulatory enforcement of medical device products in China.
HONG KONG – Olix Pharmaceuticals Inc. has entered an extensive research collaboration to test its RNAi therapeutic, OLX-104C, with Fimanac, PCI Biotech Holding ASA’s delivery technology for nucleic acid-based therapies, with the aim of reducing off-target effects while treating androgenic alopecia, or hair loss.
To encourage more innovative medical devices to enter the market faster, China has revised its regulation to allow third parties to manufacture devices, foreign devices that are not yet approved overseas to be imported to the country, and to shorten the regulatory process. The new regulation will take effect on June 1. The 2021 version of the Regulation on Supervision and Administration of Medical Devices introduced a few important changes, echoing Beijing’s call to spur health care innovation. The last update was in 2014.
HONG KONG – South Korea’s securities exchange operator, Korea Exchange Inc., has relaxed the procedure for tech companies, including biopharma firms, to list on its KOSDAQ board. Under the simplified listing standard, which came into effect on April 26, companies with a market capitalization of ₩500 billion (US$449.26 million) and above will now need to submit only one assessment, with a result of “A” or higher, from a professional evaluation agency.
PERTH, Australia – After gaining European clearance for its Eugeni COVID-19 rapid antigen test, Anteotech Ltd. reported a A$12 million (US$9.3 million) capital raise to launch its first global product that will help screen travelers, making it easier and safer to open borders. The Brisbane, Australia-based company was largely unheard of before the COVID-19 pandemic hit, but it has emerged as one of the few companies that has developed a low-cost, high sensitivity rapid COVID-19 test.
HONG KONG – Researchers at The Chinese University of Hong Kong (CUHK) have developed an artificial intelligence (AI)-based system for the automated, rapid and accurate detection of COVID-19 infections in chest computed tomography (CT) images. The system can provide immediate results, without the need for clinicians to interpret images. It could be potentially used in radiology imaging departments in hospitals.
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