PERTH, Australia – The FDA granted Melbourne-based Neuren Pharmaceuticals Ltd. and San Diego, California-based Acadia Pharmaceuticals Inc. a rare pediatric disease designation for trofinetide for treatment of Rett syndrome, a rare neurodevelopmental congenital central nervous system disorder.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: American Clinical Laboratory Association, DNA Technologies, Texas Instruments, Dialog Semiconductors, Telink Semiconductors.
With an eye toward helping those with early stage hepatocellular carcinoma (HCC), Basel, Switzerland-based Roche Group has won a breakthrough device designation from the U.S. FDA for the Elecsys GALAD score. When combined with ultrasound, the Elecsys GALAD score aims to help provide more accurate information for clinicians to treat patients at an earlier stage.
HONG KONG - India has made amendments to the export policy of certain active pharmaceutical ingredients (APIs) and the formulations based on some specific APIs. In a note dated March 3, India’s Directorate General of Foreign Trade compiled a list of now restricted APIs and formulations that were previously free to export. It ranged from paracetamol and erythromycin salts to progesterone and vitamin B1, 6 and 12.
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.