Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Ascentage, Berg, Enterome, Horizon, RDIF, Reneo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aditxt, Arch, Betterlife, Clinuvel, Exacis, Gemphire, GSK, Hutchison China Meditech, Intensity, Interna, Jeune, Kaleido, Krystal, Neurobo, Nobelpharma, Probiogen, Servier, Valence.
LONDON – Astrazeneca plc promised to publish the primary analysis of the phase III U.S. trial of its COVID-19 vaccine by the morning of March 25, after chastisement from the data safety monitoring board (DSMB) for using “outdated” information in the interim results published on March 22.
Although artificial intelligence (AI) seems to be making only incremental headway in the world of medical technology, Brainscope Co. Inc., continues to advance its AI offerings with the launch of the Concussion Index (CI). This algorithm, used with the company’s disposable headset, has been demonstrated to reduce the need for cranial CT scans by 30%, making this a double win for patients and for health care spending in the U.S.
CAJICA, Colombia – The COVID-19 pandemic has exposed the weaknesses of Mexico’s techno-vigilance system, along with a chronic lack of reporting of inventories and adverse effects related to medical devices in use. These weaknesses were exposed during previous pandemics but the country’s antiquated tracking and reporting system has not changed.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainscope, Optellum, Ortho Clinical Diagnostics, Shape Memory Medical.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Electrocore, Coherent, Fusion Robotics, Lumentum, Oxford Biodynamics, Predictmedix, Silvert Médical, Smartcone Technologies, Symp2pass, Thermo Fisher Scientific, Todos Medical.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Australian manufacture of Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S), which is being manufactured by CSL Ltd.