BEIJING – With home-grown artificial intelligence (AI) medical devices under priority review, mainland China is quickly putting together a regulatory framework to more rapidly tap into the power of AI to develop devices and drugs.
NEW DELHI – Artificial intelligence (AI) is increasingly gaining a foothold in India's health care landscape, with investors pouring money into the new technology, companies developing products and regulators looking to come up with much-needed rules. India's Ministry of Health has reached out to the public for consultation on its national digital health blueprint that seeks to propel digital health care, including the use of AI in the biotech and medical technology sectors.
TAIPEI, Taiwan – Budding Taiwanese startup Elixiron Immunotherapeutics Inc. closed a $10.5 million series A1 financing to further expand its technology platform and drive its drug candidates toward clinical development.
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.