Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, AB Science, Accord, Advantage, Direct, Edesa, Inflarx, Mirum, Perfuse, Soligenix, Verismo.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Karveer, Merck & Co., Nanoviricides, Respirerx, Seelos, Simcha, Transcode.
Although COVID-19 may be more severe in people with HIV (PWH), the underlying biological mechanisms among PWH treated with antiretroviral therapy (ART) remain largely unknown.
A live-attenuated vaccine targeting SARS-CoV-2 infection, which can be administered through the nose, has shown promise in preclinical animal studies carried out by researchers in Berlin. In an article published April 3, 2023, in Nature Microbiology, the authors reported that the COVID-19 vaccine candidate – sCPD9 – triggered the most robust immune response in a hamster model when compared with Biontech/Pfizer’s mRNA vaccine BNT162b2 and Ad2-Spike.
Despite an early stumble, the U.S. FDA granted emergency use authorization (EUA) to the C5a inhibitor Gohibic (vilobelimab) from Inflarx NV for treating COVID-19 in hospitalized adults. A year ago, an initial phase III analysis had failed to show a statistically significant effect on the primary endpoint of 28-day all-cause mortality though there was a relative reduction in mortality in the active arm vs. placebo.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Aim, Amarin, Astellas, Caribou, Gennova, Hutchmed, Pfizer, Phathom, Scisparc, Seagen, Shionogi.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Almirall, Anavex Life Sciences, Curasen, Cytokinetics, Eisai, Eledon, Eli Lilly, Hansa, Immutep, Insmed, Invivyd.
With the public health emergency for the COVID-19 pandemic rapidly winding down, the U.S. FDA has published guidance for the transition of COVID-specific diagnostic tests and other articles to conventional premarket review mechanisms.
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