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 – As it advances into its first full year of commercialization in China, Zai Lab Ltd. raised $857.5 million through the sale of American depositary shares (ADS) and ordinary shares, exceeding its initial aim of $750 million.
HONG KONG – Canbridge Pharmaceuticals Inc. signed a collaboration and licensing agreement that could be worth $591 million, gaining global rights to develop, manufacture and commercialize gene therapy candidates from Logicbio Therapeutics Inc. for the treatment of Fabry and Pompe diseases. The candidates are based on Logicbio’s adeno-associated virus (AAV) sL65, the first produced from its Saavy capsid development platform.
HONG KONG – Lutris Pharma Ltd., a company taking on the dermal toxicity common to cancer therapy with EGFR inhibitors, has begun testing its lead product, the B-Raf inhibitor LUT-014, in a phase II trial targeting reduction of acne-like lesions associated with the class. Partial results are expected by the end of 2021.
HONG KONG – As it advances into its first full year of commercialization in China, Zai Lab Ltd. raised $857.5 million through the sale of American depositary shares (ADS) and ordinary shares, exceeding its initial aim of $750 million. “We continue to execute with speed and excellence across all areas of our platform,” Samantha Du, the CEO of Zai Lab, told BioWorld. That includes business development, clinical development – “we currently have 40-plus ongoing and planned trials this year” – along with commercial expansion and global pipeline advancement.
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.
HONG KONG – Canbridge Pharmaceuticals Inc. signed a collaboration and licensing agreement that could be worth $581 million, gaining global rights to develop, manufacture and commercialize gene therapy candidates from Logicbio Therapeutics Inc. for the treatment of Fabry and Pompe diseases. The candidates are based on Logicbio’s adeno-associated virus (AAV) sL65, the first produced from its Saavy capsid development platform.
HONG KONG – Laboring under the burden of a new wave of COVID-19 infections that have raised its case total to 15.3 million, second only to the U.S., India is ramping up its vaccination efforts by opening up COVID-19 vaccine availability to citizens 18 years or older from May 1, according to the Ministry of Health and Family Welfare. However, ensuring a steady vaccine supply for the world's second most populous country, with nearly 1.4 billion people, might prove to be an issue. So far, India has administered just over 124 million COVID-19 vaccine doses.
HONG KONG – A professor at the Chinese University of Hong Kong (CUHK) claims that retinal eye scanning can help to improve early detection of autism and treatment outcomes for children. Benny Zee, a professor at CUHK, has developed a method to identify children at risk of autism and get them into treatment programs sooner.
