HONG KONG – China's leading vaccine maker, Sinovac Biotech Ltd., has postponed its 2016 annual report while it investigates allegations made by U.S. investment management company Geoinvesting LLC that its CEO may have been involved in bribing a CFDA official to speed up drug approvals.
HONG KONG – Aslan Pharmaceuticals Pte Ltd., an oncology-focused biotech company headquartered in Singapore, is set to commence a global pivotal study to treat biliary tract cancer with its lead product, varlitinib (ASLAN-001), after getting clearance from the FDA.
HONG KONG – In a nationwide effort to combat clinical trial data fabrication, China's Supreme People's Court and the CFDA have simultaneously proposed new actions and regulatory changes.
HONG KONG – In a nationwide effort to combat clinical trial data fabrication, China’s Supreme People’s Court and the CFDA have simultaneously proposed new actions and regulatory changes.
HONG KONG – The CFDA recently accepted a clinical trial application (CTA) to conduct phase I and phase III trials of rituximab biosimilar JHL1101, submitted by JHL Biotech Inc., a startup based in Zhubei City, Taiwan, and Wuhan, China. If successful, the biosimilar will be key to improving drug access in the country for patients with non-Hodgkin lymphoma (NHL).
HONG KONG – The global market for traditional Chinese medicine (TCM) is growing rapidly as researchers make strides in applying modern drug development techniques to TCM development. However, regulatory hurdles for TCM clinical trials are slowing down progress.
HONG KONG – The CFDA recently accepted a clinical trial application (CTA) to conduct phase I and phase III trials of rituximab biosimilar JHL1101, submitted by JHL Biotech Inc., a startup based in Zhubei City, Taiwan, and Wuhan, China. If successful, the biosimilar will be key to improving drug access in the country for patients with non-Hodgkin’s lymphoma (NHL).
HONG KONG – The global market for traditional Chinese medicine (TCM) is growing rapidly as researchers make strides in applying modern drug development techniques to TCM development. However, regulatory hurdles for TCM clinical trials are slowing down progress.
