HONG KONG – A year and a half after reports of illegal vaccine sales prompted investigation by China's CFDA, a recent recall involving vaccines of substandard quality has further eroded public trust in the country toward drug safety and raised concerns of the government's loophole-ridden supervision of the space.
HONG KONG – Beigene Ltd. is advancing its small-molecule Bruton's tyrosine kinase (BTK) inhibitor BGB-3111 into two more global clinical trials, further exploring the efficacy of the drug candidate in treating B-cell cancers.
HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) said the phase III trial of its oral vascular endothelial growth factor (VEGF) inhibitor fruquintinib has begun. Named FRUTIGA, the randomized, double-blind, placebo-controlled, multicenter study is to test fruquintinib's efficacy and safety in combination with chemotherapy paclitaxel for the treatment of advanced gastric cancer, or gastroesophageal junction adenocarcinoma, in China.
HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) said the phase III trial of its oral vascular endothelial growth factor (VEGF) inhibitor fruquintinib has begun. Named FRUTIGA, the randomized, double-blind, placebo-controlled, multicenter study is to test fruquintinib's efficacy and safety in combination with chemotherapy paclitaxel for the treatment of advanced gastric cancer, or gastroesophageal junction adenocarcinoma, in China.
HONG KONG – Neuraly Inc., a startup from Johns Hopkins School of Medicine and South Korea-based 1st Biotherapeutics Inc. agreed to co-develop brain penetrant c-Abl inhibitors for Parkinson's disease with aims to file an investigational new drug (IND) application with the FDA next year.
HONG KONG – For the first time in 16 years, China is planning to implement an updated version of its drug administration law. The CFDA also is set to revise the country's provisions for drug registration in efforts to upgrade its health care industry. Major proposed changes to the drug administration law – which covers both pharmaceuticals and medical devices – are intended to reduce regulations in line with other major markets.
HONG KONG – Neuraly Inc., a startup from Johns Hopkins School of Medicine and South Korea-based 1st Biotherapeutics Inc. agreed to co-develop brain penetrant c-Abl inhibitors for Parkinson's disease with aims to file an investigational new drug (IND) application with the FDA next year.
