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BioWorld - Sunday, April 12, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Sept. 12, 2023

Sep. 12, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Bicycle, Biolinerx, Biosyngen, Day One, Tango, Verona.
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In the clinic for Sept. 12, 2023

Sep. 12, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atyr, Autobahn, Black Diamond, BMS, Cingulate, Crinetics, Eyepoint, Ideaya, Inflarx, Invivyd, Lassen, MBX, Merck & Co., Neurocrine, Oxford Vaccine, Pepromene, Sinovac, Stealth, Takeda, Urovant, Veru.
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Rx pricing clause: One-off or HHS policy?

Sep. 11, 2023
By Mari Serebrov
If the modification to Regeneron Pharmaceuticals Inc.’s $326 million contract with the U.S. Biomedical Advanced Research and Development Authority is anything to go by, pricing clauses could once again become a common feature in biopharma contracts involving government R&D funding.
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South Korean flag on building

GPKOL 2023: Amid global downturn, experts mull pharma’s growth post-pandemic

Sep. 7, 2023
By Marian (YoonJee) Chu
South Korean biopharmaceutical firms are facing a harsher climate and an uphill battle both domestically and abroad, amid the larger economic downturn that has slowed everything from new drug approval to dealmaking. At the Global Pharma Key Opinion Leaders (GPKOL) 2023 Symposium held at the El Tower on Sept. 7 in Seocho-gu, Seoul, officials from the industry, government and academia gathered to discuss strategies on bouncing back from the lasting effects of the COVID-19 pandemic.
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In the clinic for Sept. 7, 2023

Sep. 7, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amo, Cytokinetics, Endeavor, Eom, Glycomimetics, Hoth, Imvax, Janssen, Lisata, Moderna, Orbus, Splisense, Teikoku, Trevena, VBI, Verismo, Viking.
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Infection

Arbutus Biopharma presents new RNA polymerase inhibitors for coronavirus infection

Sep. 7, 2023
Arbutus Biopharma Corp. has divulged RNA polymerase inhibitors reported to be useful for the treatment of coronavirus infection.
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Regulatory actions for Sept. 6, 2023

Sep. 6, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Aspargo, Astrazeneca, CSL, Inmune, Italfarmaco, Krystal, Nykode, Uniqure, Viatris, Wave, X4.
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In the clinic for Sept. 6, 2023

Sep. 6, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: ABM, ACM, Addex, Biohaven, Cantargia, Eledon, Escocap, Genmab, Iliad, Insmed, Invlos, Mindbio, Nuvalent, Oncopeptides, Oncorena, Plus, Rallybio, Sareum, Seagen, Stoke, Tonix, Tris.
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In the clinic for Sept. 5, 2023

Sep. 5, 2023
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acticor, AI, Bavarian Nordic, Carisma, Nuvox, Roche, Tvardi.
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Regulatory actions for Sept. 1, 2023

Sep. 1, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alcresta, Astrazeneca, Biontech, Daiichi Sankyo, Mallinckrodt, Pfizer.
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