With COVID-19 taking a toll on the U.S. FDA’s inspection program, warning letters stemming from drug facility inspections have been few and far between for the past two years. Aurobindo Pharmaceutical Ltd., of Hyderabad, India, was one of the exceptions.
TOKYO – Japan’s Pharmaceuticals and Medical Device Agency (PMDA) is refocusing its efforts to strengthen ties with Asian counterparts as COVID-19 and market trends show a clear need for faster drug development, approval and accommodation for ailments more common in the region.
South Korea’s Ministry of Food and Drug Safety (MFDS) has greenlighted Novavax Inc.’s Nuvaxovid, making it the first protein-based COVID-19 vaccine to be approved for commercial use in the country. The regulatory win for Novavax adds to emergency use authorizations (EUA) for the product, also known as NVX-CoV2373, in India, Indonesia and the Philippines, as well as an emergency use listing from the World Health Organization. On Jan. 12, the company said it expects to submit an EUA request to the FDA after one month.
SCG Cell Therapy Pte. Ltd. has acquired rights to human induced pluripotent stem cell technology from Singapore’s Agency for Science, Technology and Research (A*STAR)’s Accelerate Technologies Pte. Ltd. to support the development of natural killer (NK) cell therapies for leukemia, liver cancer, gastric cancer and other solid tumors.
Computational technology and high-quality data will help scientists to improve R&D and find better treatments for human diseases, according to experts at the Wuxi Global Forum 2022.
Prism Biolab Co. Ltd. has added Genentech Inc., a unit of Roche Holding AG, to the list of users for its peptide mimetic small-molecules library after signing a multitarget research collaboration and licensing agreement. Under the agreement, Tokyo-based Prism Biolab will open its Pepmetics Library, a library of peptide mimetic small molecules, to screen against targets selected by Roche and Genentech.
Inveniai LLC and Kyowa Kirin Co. Ltd. have expanded their partnership a second time, inking their most recent multiple drug discovery agreement. The multiyear deal will see the duo discover novel targets and treatments for therapeutic areas across Kyowa Kirin’s portfolio and areas of interest using Inveniai’s artificial intelligence (AI) platform.
Sirnaomics Ltd. became the first RNA therapeutics company to list on the Hong Kong Stock Exchange (HKEX) with a $64 million initial public offering. Its shares (HKEX:2277) have since surged, rising to HK$93.90 ($12.04) on Jan. 4 following their debut at HK$65.90 per share.
PERTH, Australia – Australia should be at the front of the line among developed nations when it comes to innovative drugs and devices, but health policies must evolve to respond to changes in technology and global trends, Johnson & Johnson (J&J) said. Although Australia’s health policy has served the country well, tensions in the system are becoming seismic shifts that mirror international trends, J&J said in a recent report on Australia’s health system.
India’s Department of Pharmaceuticals (DOD) released draft guidelines to boost research and development in its pharmaceutical and medical device industries. The document touched on the reasons for a dedicated R&D and innovation policy, which involved reducing import dependence, increasing the speed of biologic and biosimilar development cycles, and tackling infrastructural challenges.