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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Cansino, Incyte, Insmed, JCR, Merck, Protagonist, RDIF, Zealand.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Augustine, Celonic, Cipla, Cure, Curevac, Devpro, Evelo, Eyenovia, Eversana, Fairjourney, Hepion, Hoth, Immunome, Intervivo, Iontas, JSR, Lead Discovery, Life Edit, Lyell, Maze, Mindset, Novo Nordisk, Organicell, Plus, Point, Sangamo, Scholar Rock, Siga, Tallac, Viracta, Xoma, Zenas.
The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.
LONDON – Positive interim data from the U.S. trial of Astrazeneca plc’s COVID-19 vaccine have added yet more evidence it is effective in older adults and quelled concerns about serious thrombotic events that led countries in Europe to pause use of the vaccine earlier this month. Overall, the vaccine showed 79% efficacy in preventing symptomatic COVID-19, and was 100% effective in preventing serious disease and hospitalization. The effect was comparable across different ethnicities and age groups, with 80% efficacy in participants over 65 years of age. The analysis is based on 141 cases of COVID-19 infection.
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