HONG KONG – Olive Healthcare Inc., a South Korean biotech startup, said its abdominal fat scanner Bello has received an FDA approval to sell the device in the U.S. The company said it plans to launch the scanner in the country this December, after a market test. The miniature device is portable with a weight of 3.8 oz (107 g), measuring 3.9 inches (10 centimeters) long, 3.1 inches wide and 1.9 inches high.

TAIPEI, Taiwan – Asian capital continues to play a key role in funding biotech development regionally and globally through private investments, M&A deals or IPOs. And 2018 was a particularly exciting one for cross-border investments and health care IPOs, said speakers at the BIO Asia conference. The total deal value of global biopharma IPOs and M&A deals hit a record $49 billion in 2018.

HONG KONG – The trade feud between South Korea and Japan has worsened since the beginning of July, when the Japanese government said it would impose new regulations on exports to Korea. The new policies are mostly applied to elements of semiconductor technology but also includes some pharmaceutical components and devices, leading to concerns that the regulations will affect Korea's pharmaceutical sector.

HONG KONG – Sinomab Bioscience Ltd., a Hong Kong clinical-stage antibody firm, said its application for a Hong Kong IPO was accepted by the stock exchange, making it the 16th biopharma to submit an application under the new rules of the Hong Kong Exchange (HKEX).

HONG KONG – Biocure Technology Corp., a Canadian biopharmaceutical company focusing on biosimilar products, is advancing a CAR T product through its South Korean subsidiary, Biocurepharm Inc., thanks to a recently closed private placement.

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny.

PERTH, Australia – The majority of comments were positive for the Therapeutics Goods Administration's proposal for regulating in vitro diagnostic companion diagnostics (IVD CDx) to ensure the devices receive appropriate premarket scrutiny. Currently, Australia does not have a framework for companion diagnostics. Until now, the TGA has assessed the associated therapy and companion diagnostic separately, which does not always allow comprehensive evaluation of the benefits and risks of using the therapy and device together, the TGA said.

HONG KONG – Prestige Biopharma Pte. Ltd., a Singapore-headquartered pharmaceutical company under the Prestige Group, has agreed to grant exclusive license to U.K.-based multinational company Mundipharma International Ltd. for distribution and sale of its trastuzumab biosimilar, Tuznue, in western European markets, including France, Spain, Norway, Sweden, Denmark, Finland, Portugal, Switzerland and Austria.

PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from stakeholders on whether it was necessary to implement a formal good clinical practices inspections program in Australia. Many comments questioned how inspectional findings from a proposed pilot program would be released, but most agreed that a formal inspections program would raise compliance and enhance international competitiveness.

HONG KONG – To improve public health care in Brazil, Bioneer Corp., a South Korean biotech, and Brazilian government-run Institute of Technology on Imunobiologicals (Bio-Manguinhos) will focus on business development and R&D of in vitro diagnostics and new drugs.