HONG KONG –Stempeutics Research Pvt Ltd. received the green light from the Drug Controller General of India (DCGI) to launch its Stempeucel therapy to treat critical limb ischemia (CLI) due to Buerger’s disease and atherosclerotic peripheral arterial disease.
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.
HONG KONG Researchers from the Massachusetts Institute of Technology’s (MIT) research enterprise in Singapore, known as Singapore-MIT Alliance for Research and Technology (SMART), have found a way to not just reverse antibiotic resistance but also increase sensitivity in some bacteria, using hydrogen sulfide.
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.
HONG KONG – Following positive phase II data on Hanmi Pharmaceutical Co. Ltd.’s once-weekly GLP-1/glucagon receptor dual agonist, efinopegdutide, in nonalcoholic steatohepatitis (NASH), the Seoul-based company has exclusively licensed the drug to Kenilworth, N.J.-based Merck & Co. Inc. for the indication.
HONG KONG – Osaka, Japan-based Ono Pharmaceutical Co. Ltd. has obtained positive top-line data in its phase III study of a combination of Opdivo (nivolumab, Bristol Myers Squibb Co.) and bevacizumab in lung cancer patients.