PERTH, Australia – With the Brexit split now official, Australia’s Therapeutic Goods Administration is trying to figure out the impact to its life sciences industry and the new trade relationships that will take effect after the transition period ends.
HONG KONG – Tessa Therapeutics Pte Ltd.’s CD30 CAR T-cell therapy has been granted a regenerative medicine advanced therapy designation by the U.S. FDA based on data from two independent phase I/II trials.
With trauma patients and those suffering from bleeding disorders, being able to quickly assess a person’s bleeding risk can be lifesaving, but most current tests to measure clotting ability are laboratory-based and don’t provide immediate results. To that end, the U.S. FDA has granted Cleveland-based Xatek Inc. breakthrough device designation for its Clotchip portable blood clotting sensor.
BOGOTA, Colombia – Argentina is the latest member of an international medical devices regulatory group. Joining the group could help the country speed up approvals and help the market for medical technology improve.
Against the backdrop of the global spread of COVID-19, India announced restrictions Tuesday on the export of 26 active pharmaceutical ingredients (APIs) and formulations of those ingredients.