Vir Biotechnology Inc. said it won’t be discussing further the phase II data from the influenza A prevention study called Peninsula until the company’s second-quarter earnings update Aug. 3, and a closer look at the results has yet to decide the fate of monoclonal antibody VIR-2482, which missed its primary and secondary endpoints.
T2 Biosystems Inc. received a third FDA breakthrough device designation with its direct-from-blood molecular diagnostic test for Candida auris. The test joins its T2resistance panel and T2Lyme panel in gaining the breakthrough recognition and the increased access to the FDA that comes with it as the company seeks final approval or clearance. The C. auris test enables identification of the challenging pathogen in three to five hours instead of the several days often required to grow a culture traditionally.
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.
Researchers from Assembly Biosciences Inc. reported on the preclinical characterization of ABI-5366, a potent helicase-primase inhibitor against both HSV-1 and HSV-2.
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option.
Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement.
RSS
