HONG KONG – Alexion Pharmaceuticals Inc.'s blockbuster drug, Soliris (eculizumab), was granted a rapid approval by China's drug regulator, the National Medical Products Administration (NMPA, formerly CFDA), for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Read More
The first China-discovered and developed treatment for colorectal cancer (CRC), fruquintinib, won approval from the National Medical Products Administration of China, marking Hutchison China Meditech Ltd.'s (Chi-Med) first approval for an innovative medicine. The drug, a small-molecule inhibitor of VEGF receptors to be marketed as Elunate, is now approved for the treatment of metastatic CRC patients who have failed at least two prior systemic antineoplastic therapies. Read More
Otsuka Pharmaceutical Co. Ltd., of Tokyo, completed the acquisition of Waltham, Mass.-based Visterra Inc. for about $430 million in an all-cash transaction. Visterra will operate as a subsidiary of Otsuka America Inc. Read More
Sumitomo Dainippon Pharma Co. Ltd., of Osaka, Japan, appointed Hiroshi Noda senior director, regulatory compliance and quality assurance management, Izuru Miyawaki senior director, preclinical research unit and director, toxicology group I, preclinical research unit, and Hiroyuki Nishii senior director, Ibaraki and Ehime plants; each appointment effective Oct. 1. Read More
HONG KONG – China-based Hansoh Pharmaceutical Group Co. Ltd. has filed for an IPO in Hong Kong, making it the 11th biopharma company to seek a listing on the Hong Kong Stock Exchange (HKEX) since May and following Ascentage Pharma Group International's IPO a week earlier. Read More
HONG KONG – Hong Kong-based gene therapy company Reflection Biotechnologies Ltd. received orphan drug designation from the U.S. FDA for its gene therapy, RBIO-101, to treat Bietti's crystalline dystrophy (BCD), an inherited eye disease affecting about 100,000 patients worldwide. Read More
HONG KONG – South Korea's JW Pharmaceutical Corp. out-licensed its atopic dermatitis candidate, JW-1601, to Danish medical dermatologist Leo Pharma A/S, which has rights to develop and commercialize the drug worldwide, except in South Korea. Read More
HONG KONG – Some outward-looking Indian drugmakers may be benefiting from the cheapest rupee ever, but others, which hedged their currency bets, could take a hit. Read More
BOSTON – To explain best practice in making cross-border investments, especially those in China, Biopharm America panelists quickly seized upon the metaphor of groping to form a romantic relationship. Read More
An Australian study has discovered several new lipid molecules that may represent new biomarkers and/or potential therapeutic targets for atrial fibrillation (AF) and heart failure (HF). Read More