Japanese companies agree to discontinue regenerative cell therapy pact after high-profile Phase II failure, but SanBio will move ahead with development and Dainippon will hold onto ex-partner stake for now.

SmartMonitor battery pack troubles dog Philips Children’s Medical Ventures; maker of GenStrip glucose test strips cited for QS and MDR reg violations; the Portable Exchange Deionization System was labeled to meet the requirements of an outdated ANSI/AAMI standard. Nine quality-related warning letters were listed by FDA from Aug. 12 through Sept. 11.

A closer look at components of Japan’s distribution system reveals a vastly improved network than previous years.

As the Japanese government tries to boost generics utilization, Pfizer and Mylan plan to leverage combined strengths to become a market leader by 2015.