Updated on 11 October 2015
Registered Ongoing Clinical Trial: 6501
• China issued new guidelines for clinical research companies to conduct trial in China that include submission of dossier filed anywhere for CFDA review, inspection of non-chinese sites and thorough inspection and credibility of clinical research investigators.
• WuXi Pharma Tech collaborated with Foundation Medicine to provide genomic profiling to biopharma companies conducting clinical trials in China
• WuXi PharmaTech inked deal with gene therapy expert, ReGenX Bio, to hammer out a manufacturing process for the company's potential one-time treatments. Under the deal, WuXi is lending its expertise in biologics manufacturing to help ReGenX establish a production process for treatments that use a safe human virus to insert corrective genes into the body
• Sihuan Pharmaceuticals inked a deal with Covance that would provide clinical and research services to develop Sihuan's product pipeline of cardiovascular, metabolic and infectious diseases, oncology and urology. As per the deal, Sihuan will be provided with drug development and regulatory expertise, in efforts to achieve dual or multiple filings for regulatory approvals such as investigational new drug (IND) applications and new drug applications (NDA) in China and internationally
• Sydney-based CRO, Novotech, expanded its Hong Kong operations with permanent office to meet the increasing demand in the research market. With its new operation, Novotech is focusing on Phase I trials in Hong Kong, partnering with local universities to host early-stage studies on in-development drugs