Taking strides from its start as a Seoul National University laboratory, South Korea’s Cellid Co. Ltd. said July 24 that the MFDS approved an IND for the global phase III trial for its omicron variant-targeting COVID-19 vaccine called AdCLD-CoV19-1 OMI. Approval from the MFDS comes two months after Cellid filed the IND on May 23 for its adenovirus vector platform vaccine “capable of responding quickly to virus mutations,” the company said.
Anbio Biotechnology Ltd. launched the Anbio AF-100S, an automated, compact and affordable fluorescent immunoassay (FIA) solution that it hopes will transform the field of clinical diagnostics and empower healthcare providers. The AF-100S FIA is a handheld point-of-care immunodiagnostic solution that provides rapid, accurate and reliable results for a wide range of analytes.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advent, Astria, Biophytis, Excision, Hutchmed, Ipsen, Junshi, Pharmala.
A day after a U.S. House committee, on a party-line vote, advanced two bills to reauthorize emergency preparedness programs, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 17-3 July 20 to send its bipartisan reauthorization of the Pandemic and All Hazards Preparedness Act to the Senate floor with a do-pass recommendation.
Immunic AG has identified deuterated dihydroorotate dehydrogenase (DHODH) inhibitors containing a carboxylic acid bioisostere. They are reported to be useful for the treatment of Crohn’s disease, influenza, lupus erythematosus, multiple sclerosis, psoriasis, rheumatoid arthritis, SARS-CoV-2 infection (COVID-19) and cancer, among others.
The most in-depth study to date of the genetic risk factors for long COVID has identified 73 genes that are highly associated with severe or fatigue-dominant forms of the disease. Many of these genes also are known to be associated with other disorders, including myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and neurodegenerative, autoimmune, cardiovascular and metabolic diseases.
Since its emergence in late 2019, SARS-CoV-2 has killed nearly 7 million people. But at the same time, many infections, in particular in children and young adults, are asymptomatic with rapid viral clearance from the body. It remains unclear why many individuals are able to successfully clear infection without major complications while others develop severe disease, even without known risk factors for severe COVID-19 outcomes.
Now, a new study involving nearly 30,000 individuals has found that variation in the human leukocyte antigen (HLA) loci may underlie processes mediating asymptomatic infection. The findings were reported in the July 19, 2023, online edition of Nature.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Cel-Sci, Emmaus, Gilead, Scisparc.
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