HONG KONG – Tokyo-based Cureapp Inc. has received the Ministry of Health, Labour and Welfare (MHLW)’s green light to manufacture and sell Cureapp SC [Smoking Cessation] Nicotine Addiction Treatment App and CO Checker, its therapeutics app to aid patients who are quitting smoking.

An Australian study led by University of Melbourne scientists has identified a previously unknown role for the hepatokine, sparc-related modular calcium-binding protein 1 (SMOC1), in suppressing hepatic glucose production. The investigators reported their results in the Sept. 2, 2020, edition of Science Translational Medicine.

NEW DELHI – A COVID-19 diagnostic test kit developed by the Indian Institute of Technology (IIT) in New Delhi is the latest to join a growing pool of low-cost kits domestically developed in a country where the number of cases topped 2 million in August and continues to rise. The push to develop test kits domestically is part of a national effort to shake off a heavy dependence on imports of medical devices, including diagnostic kits.

PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity.

PERTH, Australia – Sydney-based Cochlear Ltd. reported its first loss in 25 years due to the COVID-19 pandemic and a patent battle loss in the U.S. For fiscal year 2020, which ended June 30, Cochlear reported a AU$238 million (US$170 million) loss in sales, down 186% from last year’s profit of AU$276 million.

PERTH, Australia – An independent review of recent reforms to Australia’s Therapeutic Goods Administration (TGA) advertising framework confirmed that the changes to the new advertising code resulted in improvement, with the new code being clearer and easier to understand. The advertising reforms are part of larger regulatory reforms implemented to increase the pathways for marketing approval for drugs and devices while reducing regulatory red tape and redundancies.

PERTH, Australia – With 1 in 3 patients with type 2 diabetes likely to develop diabetic kidney disease (DKD), Perth-based Proteomics International Laboratories Ltd. has developed a blood-based diagnostic test that can predict the onset of DKD, enabling patients to get treatment sooner to prevent the onset of the disease.

HONG KONG – China’s Arctic Vision (Shanghai) Biotechnology Co. Ltd. has entered an exclusive deal with New York’s Eyenovia Inc. to develop and commercialize ophthalmic formulations that are delivered using the latter’s first-in-class microdosing spray technology. Under the deal, Arctic Vision will commercialize Eyenovia’s Micropine and Microline formulations in Greater China and South Korea in exchange for $45.75 million in upfront payments and additional milestone and royalty payments.

HONG KONG – Incheon, South Korea-based Celltrion Inc. is planning to launch two of its three rapid test kits in the U.S. as it plays its part in the global fight against the COVID-19 pandemic. Celltrion said Aug. 12 that its Sampinute COVID-19 Antigen MIA and Diatrust COVID-19 IgG/IgM rapid test kits will launch in the U.S. by the third week of August.

The COVID-19 pandemic has exerted a massive effect on procedure volumes across the globe, but concerns over supply chains have prompted political officials in Washington to encourage domestic production of drugs. That approach is also in play in a number of nations in the Asia-Pacific region, said Sana Siddiqui of Decision Resources Group, who noted that Beijing wants hospitals in China to ensure that 70% of devices used there are domestically manufactured by 2025.