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Home » Topics » Infection » Coronavirus

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Regulatory actions for Nov. 12, 2024

Nov. 12, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Autolus, Neurizon, Novavax, Rapt, Recce, Resq, Zai Lab.
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Infection

Westlake Pharmaceutical discloses new Mpro inhibitors

Nov. 8, 2024
Westlake Pharmaceutical (Hangzhou) Co. Ltd. has prepared and tested new 3C-like proteinase (3CLpro; Mpro; nsp5) inhibitors reported to be useful for the treatment of coronavirus acute respiratory syndrome.
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Shionogi finds positive data on ensitrelvir for COVID-19

Nov. 5, 2024
By Marian (YoonJee) Chu
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members.
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Shionogi finds positive data on ensitrelvir for COVID-19

Oct. 30, 2024
By Marian (YoonJee) Chu
Phase III Scorpio-PEP study results showed Shionogi & Co. Ltd.’s oral antiviral ensitrelvir fumaric acid (Xocova) reduced risk of symptomatic COVID-19 infection in subjects who were exposed to the virus by infected household members.
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In the clinic for Oct. 30, 2024

Oct. 30, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cantargia, Clover, Coya, Eledon, Gemvax, Glycomimetics, Innovent, Invivyd, Kind, Nektar, Nkgen, Purdue, Regeneration, Zai Lab.
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Blood test for Coccidioidomycosis infection
Infection

Fungal, SARS-CoV-2 coinfection studied in new mouse model

Oct. 30, 2024
One of the challenges associated with COVID-19 has been an increase of secondary infections, including fungal infections. These coinfections can hinder treatment efficacy and increase illness severity.
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In the clinic for Oct. 22, 2024

Oct. 22, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Cerevance, Foresee, Galderma, Genentech, Gilead, Karolinska, Merck, Mitsubishi Tanabe, Novo Nordisk, Nurix, Regeneron, Regenxbio, Roche.
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Regulatory actions for Oct. 17, 2024

Oct. 17, 2024
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Astria, GSK, ipsen, Novavax, Theriva, Tonix, Urogen.
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FDA pauses Novavax’s flu and COVID-19 combo vaccines

Oct. 16, 2024
By Jennifer Boggs
Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
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In the clinic for Oct. 10, 2024

Oct. 10, 2024
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aurigene, Clearside, Dyne, Entrada, Innocare, Insmed, Panavance, Tevogen, Vanqua, Viatris, Viking.
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