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.
Samsung Biologics Co. Ltd. has agreed to buy out Biogen Inc.’s stake in the joint venture Samsung Bioepis Co. Ltd. for $2.3 billion. Biogen will receive $1 billion in cash at closing and $1.25 billion in deferred payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is also expected to receive up to $50 million upon achievement of certain commercial milestones.
South Korea’s Gwangju Institute of Science and Technology (GIST) has completed a preclinical study for a noninvasive therapy for Alzheimer’s disease. The "ultrasound-based gamma entrainment” technique involves syncing up gamma waves, or brain waves above 30 Hz, with an external oscillation of a given frequency. This happens naturally by exposing a subject to a repetitive stimulus, such as sound, light, or mechanical vibrations.
Samsung Biologics Co. Ltd. has agreed to buy out Biogen Inc.’s stake in the joint venture Samsung Bioepis Co. Ltd. for $2.3 billion. Biogen will receive $1 billion in cash at closing and $1.25 billion in deferred payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is also expected to receive up to $50 million upon achievement of certain commercial milestones.
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.
Beijing Microkpro Medical Instrument Co. Ltd. has received marketing approval for its artificial cornea from China’s NMPA. Miok Keratoprosthesis is the world’s first artificial cornea made of 100% non-biological materials and does not require co-implantation of donor corneas, according to Microkpro Medical.
Targetingone Corp. Ltd.’s new testing kit based on digital polymerase chain reaction (dPCR) techniques has received approval from China’s NMPA. It is the first dCPR-based testing kit to receive the country’s class III medical device registration certificate. The Beijing-based company collaborated with Tsinghua University, several hospitals and the Chinese Center for Disease Control and Prevention (CDC) participated to research and develop the testing kit.
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.
Peijia Medical Ltd. has acquired exclusive rights to Jenavalve Technology Inc.’s transcatheter aortic valve replacement (TAVR) products for the treatment of aortic regurgitation (AR) and aortic stenosis (AS). Suzhou, China-based Peijia is now able to develop, manufacture, and commercialize the TAVR products in Greater China.
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