HKSH Medical Group (HKSH) has adopted droplet digital polymerase chain reaction (ddPCR) for minimal residual disease (MRD) monitoring to track the status of patients with leukemia.
Tianjin Usights Ophthalmology Technology Co. Ltd.’s ophthalmic fiberoptic microcatheter system has been approved by the NMPA for marketing for minimally invasive glaucoma surgery (MIGS) in China. Tianjin, China-based Usights claims this is the first homegrown products for MIGS in China that has been approved.
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.
Rainmed Medical Ltd.'s coronary angiography-derived fractional flow reserve system (caFFR system) was approved by Australia’s TGA for precision diagnosis of coronary artery diseases.
Sino Medical Sciences Technology Inc. received marketing approval from China’s NMPA for its drug eluting stent system to improve vascular stenosis in patients with localized ischemic heart disease. The product is designed to improve the speed of wound healing and accelerate the recovery of vascular endothelium after stent implantation. It fits vessels with a diameter of 2.25 mm to 4.00 mm and a lesion length of less than or equal to 40 mm.
PT Etana Biotechnologies Indonesia secured a series B financing of undisclosed value, led by Chinese investors that include Jack Ma’s Yunfeng Capital and Highlight Capital. The funds will be used to strengthen the company's pipeline and to expand its local manufacturing capacity.
Worg Pharmaceuticals Co. Ltd. raised nearly ¥400 million (US$55.6 million) in its series B financing. Founded in 2018, the company is developing immunotherapies to treat allergic and autoimmune diseases and other indications based on its two technology platforms, Pcfit and Apitope.
South Korea's LG Chem Ltd., seeking new growth opportunities in the life sciences and a concrete footprint in the U.S., has proposed an all-cash acquisition of Aveo Pharmaceuticals Inc., with a deal value of $519.2 million.
South Korea’s drug regulator should consider revising orphan drug definitions or allow more new innovative drugs to be excluded from pharmacoeconomic assessments, which are required for new drugs to be reimbursed under Korea’s single-payer system, the European Chamber of Commerce in Korea said.
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