Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement.

It’s not always obvious whether a claim found in a patent is obvious to a “person having ordinary skill” while the patent is still in prosecution, but that lack of clarity came back to bite Best Medical International Inc., of Springfield, Va. The U.S. Court of Appeals for the Federal Circuit has ruled that a patent for conformal radiotherapy held by Best included three claims that would have been obvious to this mythical person of ordinary skill, handing a win to Stockholm-based Elekta AB, maker of the Gamma Knife radiotherapy system.

While it will need a “reasonable period of time” to do so, Turkey said Aug. 29 that it intends to establish a level playing field for foreign and domestic drug producers in accordance with the recommendations and rulings of World Trade Organization dispute arbitrators.

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.