Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Ascentage, Cantargia, Incyte, Innovent, Lion, Novavax, Psybio, Serum, Wake.
LONDON – A large-scale analysis of U.S. data shows that 57% of patients with a recorded diagnosis of COVID-19 subsequently presented to their physicians with symptom(s) of long COVID. In 37% of those patients, the symptoms were not reported until three to six months after they contracted COVID-19, indicating they are not persisting acute symptoms.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agnovos Healthcare, Asahi Kasei Pharma, Asensus Surgical, Augmedix, Avantgen, Elbit Systems of America, Global Wholehealth Partners, Google, KMC Systems, Lumiradx, Pan Probe Biotech, Relievant Medsystems, Siemens Healthineers.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Electrocore, Endologix, Enlightenvue, Foldax, Nexstim.
When the White House COVID-19 Response Team announced its booster program in August, it justified the broad use of a third vaccine dose with antibody studies and real-world data from Israel.
LONDON – Industry-sponsored clinical research in the U.K. took a big hit in the pandemic and is still struggling to catch up – and to capitalize on innovative trial designs and delivery approaches that were so successful in speeding up COVID-19 studies.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim Immunotech, Astrazeneca, Eisai, Gilead, Humanigen, I-Mab, Iterum, Lipocine, MRM, Pfizer, Regeneron, Revelation, Sanofi, Viiv, Zogenix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altimmune, Artios, Dicerna, Ena Respiratory, First Wave, Graybug, Mind Medicine, Oncoinvent, Pfizer, Sanofi, Seagen, Translate, Valneva.
PERTH, Australia – As Australia prepares to reopen the country after strict lockdown measures, the TGA is making a new regulation to allow companies to supply their COVID-19 rapid antigen self-tests for home use beginning Nov. 1. “There’s light at the end of the tunnel for Australians on a number of fronts,” said Health Minister Greg Hunt in a Sept. 28 press conference.
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