PERTH, Australia – As D-Day approaches for the European Medical Device Regulations (MDR), Australia is also nearing completion of implementing its own medical device reforms, which closely mirror the EU MDR. “We had to look at aligning as close as possible with the EU system, but we’ve had to align with a moving, incomplete and delayed target, and the TGA asked us to move ahead of the EU reforms,” said John Skerritt, deputy secretary, Health Products Regulation for the Therapeutic Goods Administration (TGA), during the recent Ausmedtech virtual conference.
BEIJING, China and SANTANDER, Spain – Antengene Corp. and Calithera Biosciences Inc. entered a worldwide exclusive license agreement to develop and market the CD73 inhibitor CB-708 (ATG-037), as part of a push to use the small-molecule inhibitor to grab significant market share in Asia Pacific and global markets.
Amid the trend of investors partnering with Western biotech companies to set up China-focused joint ventures, San Diego-based Kinnate Biopharma Inc. has joined Orbimed Asia Partners, Orbimed Private Investments and Foresite Capital to establish a JV in Shanghai to move its preclinical kinase inhibitor candidates forward in greater China.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
Seychelles has seen rising numbers of COVID-19 cases despite 61% of its population being fully vaccinated as of May 8, calling into question the effectiveness of the COVID-19 vaccines used by the island nation.
HONG KONG – Dia Imaging Analysis Ltd. has teamed up with Sonoscape Medical Corp. to deliver cardiac ultrasound artificial intelligence (AI) solutions. The partnership aims to reduce the variability associated with manual or visual analysis, and increase efficiency and accuracy throughout the analysis process. As a result, China-based Sonoscape's ultrasound devices will be offering a layer of automated AI-based analysis to support the clinician’s decision-making process, courtesy of Dia's AI-based cardiac solutions.
Seychelles has seen rising numbers of COVID-19 cases despite 61% of its population being fully vaccinated as of May 8, calling into question the effectiveness of the COVID-19 vaccines used by the island nation.
PERTH, Australia – The launch of Australia’s first medical device development and manufacturing facility in Melbourne is set to fast-track new treatments for people with conditions such as epilepsy, Parkinson’s disease, hearing loss, stroke and diabetes.
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.
RSS
