For the first time since they’ve had access to U.S. capital, biopharma and med-tech companies based in China and Hong Kong are having to comply with the same accountability standards companies in the U.S. and other countries must follow as a condition of trading on U.S. markets.

It’s that time of year when the U.S. Trade Representative asks for help as it prepares its list of notorious markets for counterfeiting and piracy.

Japan’s Healios K.K. is in discussions with Japan’s Pharmaceutical and Medical Devices Agenc about the regulatory path forward for its Multistem somatic stem cell products, for which it conducted phase II/III trials in ischemic stroke and a phase II trial in acute respiratory distress syndrome.

If the U.S. Supreme Court agrees to hear Teva Pharmaceuticals USA Inc. vs. Glaxosmithkline LLC, it could be one of the biggest biopharma cases on the court’s calendar in the coming year. But that’s still an if. Whether the patent infringement case involving a so-called “skinny label” makes it to the high court’s docket depends on which interpretation of the underlying question the court accepts.