The U.S. Recover program, set up in July 2022 to identify the causes of long COVID, find biomarkers of disease and discover new therapeutic targets, is now preparing to move to its next phase and begin testing potential treatments in a multi-arm, randomized, placebo-controlled trial. But with 200 different symptoms, and limited understanding of relevant system-level pathological targets, there are significant hurdles to be overcome.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aptorum, BMS, Merck, Ractigen, Valeo.
In a striking demonstration of how the success of mRNA vaccines against COVID-19 has opened up the potential of the technology in cancer, mice that cleared a tumor after a single administration of an mRNA vaccine, also cleared a second tumor without receiving further immunization. This display of potent immunogenicity formed part of a head-to-head study of three different mRNA technology platforms in human papillomavirus (HPV)-16 associated tumors.
Shares of Veru Inc. hit a 52-week low March 3 after the U.S. FDA declined to grant an emergency use authorization (EUA) for sabizabulin for use in hospitalized adults with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome. The decision comes as little surprise, given the negative advisory panel vote in November, but the agency’s wording might suggest potential use for the microtubule disruptor in the future.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Alvotech, Astrazeneca, Checkpoint, Genenta, Intellia, Santhera, Serda, Valneva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amniotics, Biovie, BMS, Brim, Inovio, Janssen, Organogenesis, Poolbeg, Sanofi, Sobi.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Boomerang Medical, Convatec, Cordx, Neuro20.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amo, Asklepios, Biophytis, Glaukos, Orchard, PDS, Priothera, Replimune, Springworks.
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