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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ANP Technologies, Breathesuite, Koya Medical, Medtronic, Nanowear, Nonagen, Seaspine, Selux Diagnostics.
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.
Horseshoe or Rhinopolus bats in Laos carry coronavirus species with a near-identical receptor binding domain to SARS-CoV-2, according to a paper posted on the preprint server Research Square by investigators from the Pasteur Institutes of Paris and Laos.
Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Astellas, Atara, BMS, Eisai, Genetx, Immunoforge, JW, Kintor, Lipidor, Moderna, Opko, Takeda, Transcenta, Ultragenyx, Vifor.
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