The FDA hit Kyowa Hakko Bio Co. Ltd. with a warning letter citing API quality and data issues at the company's facility in Hofu-shi, Japan. Employees retested or manipulated data after obtaining out-of-specification or other unacceptable test results, according to the letter. Read More
A novel means of modeling sporadic amyotrophic lateral sclerosis (SALS) using motor neurons derived from induced pluripotent stem (iPS) cells should provide new insights into the pathology of the disease, researchers reported in the Aug. 20, 2018, edition of Nature Medicine. Read More
HONG KONG – China purged about 40 provincial and local officials, including top staff of China's drug watchdog, after a meeting of the Politburo Standing Committee, led by President Xi Jinping, who pledged to punish rabies vaccine maker Changchun Changsheng Bio-technology Co., of Jilin Province, for stirring up fears for public health. Read More
PERTH, Australia – After reporting positive data at the American Society of Clinical Oncology (ASCO) meeting for its Akt inhibitor in estrogen receptor (ER)-positive breast cancer, Melbourne-based Prescient Therapeutics Pty Ltd. is poised to carve out a niche for itself across a variety of cancers. Read More
HONG KONG – The latest Chinese biopharma company to join the listing spree in Hong Kong was Suzhou-based Ascentage Pharma Group International, which last week filed its application to list on the Hong Kong Stock Exchange (HKEX). Read More
HONG KONG – Roche Holding AG was granted a rapid approval from the China National Drug Administration (CNDA) for Alecensa (alectinib). The drug was greenlighted as a monotherapy treatment for patients with anaplastic lymphoma kinase (ALK)-positive, advanced non-small-cell lung cancer (NSCLC). Read More
HONG KONG – Taiwan Liposome Co. Ltd. said its lead product candidate TLC-599, to treat osteoarthritis pain, has demonstrated promising results in its phase II study, making it a potential best-in-class intra-articular steroid for its duration of action. Read More
