PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) received mixed comments from industry on two related draft guidances for reporting adverse events for biologics and for adopting an EU guideline on good pharmacovigilance practices. Read More
HONG KONG – Chinese biotech company Hybio Pharmaceutical Co. recently received approval from the CFDA to conduct clinical trials for its generic version of GLP-1 analogue liraglutide. Read More
HONG KONG – YL Biologics Ltd. has inked a licensing deal to distribute a biosimilar for the treatment of anemia by Korea's CJ Healthcare Ltd. in Japan. The drug, CJ-40001, is CJ Healthcare's version of Amgen Inc.'s Aranesp (darbepoetin alfa). Read More
SHANGHAI – On June 1 of this year, China's new Cybersecurity Law came into effect, tightening the government's grip on the transfer and security of data collected in China. Now that the law is in place, industry regulators are expected to hammer out specific rules that will come out in 2018. There are signs that drugmakers, and those collecting clinical trial data, could face some tough constraints making it difficult for patient data to leave the country. Read More
HONG KONG – Generon Corp. (Shanghai) Ltd. has reached an agreement with the FDA under a special protocol assessment (SPA) regarding the second pivotal global phase III study design of its chemotherapy-induced neutropenia (CIN) treatment. Read More
Samsung Biologics, of Incheon, South Korea, said the FDA has licensed the first monoclonal antibody drug substance at its second plant. The company is now able to manufacture commercial biologics drug substance in addition to its first plant, which has 30,000 liters of capacity. The second plant has 152,000 liters of capacity. Read More
