HONG KONG – Starting March 5, Japan's regulator suspended a subsidiary of Novartis AG from manufacturing or selling drugs, citing a string of unreported negative side effects patients suffered after using the company's drugs.
HONG KONG – Paving the way for further growth of a $2 billion sector, the CFDA has published final regulatory guidelines for biosimilars. Included are standards for research, development and evaluation. Most importantly, the CFDA also gave clear instruction on the pathway, categorization and application material needed for biosimilar registrations.
HONG KONG – Known already as the first China-manufactured biologic used in U.S. trials, HIV candidate ibalizumab (TMB-355) won FDA breakthrough therapy designation, which could substantially accelerate the product's launch.
HONG KONG – Known already as the first China-manufactured biologic used in U.S. trials, HIV candidate ibalizumab (TMB-355) won FDA breakthrough therapy designation, which could substantially accelerate the product's launch.
HONG KONG – China surpassed the U.S. and Japan in 2013 to become the No. 1 patent-filing country in the world with more than 600,000 applications in 2013. A significant chunk of that activity was in the general pharmaceutical space, with more than 20,000 patents filed.
HONG KONG – China surpassed the U.S. and Japan in 2013 to become the No. 1 patent-filing country in the world with more than 600,000 applications in 2013. A significant chunk of that activity was in the general pharmaceutical space, with more than 20,000 patents filed.
HONG KONG – Shanghai-based Cellular Biomedicine Group Inc. (CBMG), having gotten its start in autologous stem cells has strengthened its position in another area of regenerative cellular therapy, cancer immuno-oncology, with the acquisition of chimeric antigen receptor T-cell (CAR T) technology and data from the People's Liberation Army General Hospital (PLAGH) in Beijing.
HONG KONG – South Korea's Ministry of Food and Drug Safety (MFDS) has approved the country's first tissue-specific osteoarthritis drug, which its manufacturer hopes will soon grab 10 percent of the Korean arthritis market.
TAIPEI, Taiwan – Biologic drugs are so difficult to make that they are almost impossible to counterfeit, but that does not mean that they are immune to the onslaught of fake products. And yet clamping down on fake biologics can be hard and expensive to do, not to mention that simply identifying fake products after they have been used can be quite difficult.
