CFDA issues guides on device trials, inspections; ASLAN works with ACT Genomics;

> China's Food and Drug Administration has published new rules on record keeping to strengthen oversight of clinical trials for medical devices. The rules include investigational review board (IRB) review and also issued a notice on unannounced inspections that take effect as of Sept 1, aimed at alleged serious violations of quality management or inadequate adverse event monitoring. Moreover, it establishes guidance on the conduct of such inspections. Release

> Singapore-based ASLAN Pharmaceuticals said it will work with Taiwan's ACT Genomics on detailed genomic studies of better-than-expected therapeutic responses. The company cited a positive reaction during a clinical trial of ASLAN001 in which one bile duct cancer patient showed 87% tumor shrinkage over a prolonged period of time. Release (PDF)

> Regeneron Pharmaceuticals ($REGN) and Sanofi ($SNY) said a Phase III trial of Praluent (alirocumab) in Japan met its primary endpoint, with a 64% greater reduction from baseline in low-density lipoprotein cholesterol for patients when added to current standard of care. Release

> Talks between Zhejiang Hisun Pharmaceuticals and French drugmaker Sanofi are underway over a commercial deal to for diabetes therapies in China that could include local manufacturing and other development projects. Release (Chinese language)

> China's FDA has issued a tender for a national drug regulatory information system and related project data management subsystem. Release (Chinese language)

> Australia's Therapeutic Goods Administration said a three-year transition period for filing a request for reclassification into Class III of marketed total and partial hip, knee or shoulder joint replacements ended on June 30. That means companies that have not submitted reclassification applications must stop marketing such devices and submit marketing authorization applications. Release

> Japan's Pharmaceutical and Medical Devices Agency has published an English-language version of its precautions for drugs covering fiscal 2015. Release

> Japan's Pharmaceutical and Medical Devices Agency has published an English-language version of the Ministry of Health, Labor and Welfare's Pharmaceuticals and Medical Devices Safety Information for fiscal 2015. Release

> China's Mindray Medical International ($MR) said it would buy the remaining stake in Wuhan Dragonbio Surgical Implant it does not own for approximately $72.6 million. Release