Iceni Diagnostics Ltd. is accelerating efforts to commercialize a diagnostic for detecting COVID-19 using sugars rather than antibodies. Lateral flow diagnostics (LFDs) have been widely used during the COVID-19 pandemic to diagnose people with an active infection. The tests use antibodies, which attach to the SARS-COV-2 virus but Iceni’s Host-Pathogen Glycan Recognition technology has been touted as a potential alternative due to its polymer approach.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baxter, Biomérieux, Genentech, Naviswiss, Xtrava Health.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 23andme, Cardiogram, Ilumivu, Labcon, Karkinos, Lemonaid Health, Qiagen, Rakuten.
Pfizer Inc. said that, in children aged 5 through 11, the COVID-19 vaccine it co-developed with Biontech SE showed 90.7% efficacy against all variants of concern following two doses. The data were included in briefing documents filed ahead of a full discussion at the FDA’s Vaccines and Related Biological Products advisory committee meeting set for Oct. 26.
Despite some concerns from a few members, the Advisory Committee on Immunization Practices unanimously approved recommendations to the CDC that boosters be made available to those wanting them. The advisory committee recommended that a single COVID-19 vaccine booster dose be given six months or more after completing an mRNA primary series in the same risk group for whom the CDC recommended a booster dose of Pfizer Inc-Biontech SA’s vaccine. The CDC presented data to the committee that the single mRNA COVID-19 vaccine dose be given to those age 65 and older, for those at least 18 years old and reside in long-term-care settings, and also for those ages 50 to 60 with certain underlying medical conditions.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Algernon, Antengene, Aqilion, Atreca, Big Cypress, Cedilla, China Resources, Inovio, Legochem, Ligand, Logicbio, SAB.