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BioWorld - Tuesday, February 10, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Sept. 10, 2021

Sep. 10, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diacarta.
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In the clinic for Sept. 10, 2021

Sep. 10, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Strata Oncology, T2 Biosystems.
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In the clinic for Sept. 10, 2021

Sep. 10, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alvotech, Apellis, Astrazeneca, Azurx, Cartargia, Cassiopea, Cytodyn, Mersana, Rezolute, Scpharmaceuticals, Senhwa, Sunovion.
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Judge's gavel with US flag

Novel theories of prosecution emerging among US enforcement agencies

Sep. 9, 2021
By Mark McCarty
The COVID-19 pandemic has exerted a significant effect on enforcement in the U.S., but Ethan Davis of King & Spalding (K&S) said federal prosecutors have made use of several novel approaches to prosecution in the past year.
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Financial chart

COVID-19 efforts carry infectious disease stocks amid UTI and HBV defeats

Sep. 9, 2021
By Karen Carey
If there is one thing that potently illustrates the hope and despair of the COVID-19 pandemic, it is the zigzag of BioWorld’s Infectious Disease Index. Up by nearly 64%, it is towering over both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are up 12.4% and 15.5%, respectively, but it has experienced several downward swings this year as well.
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Humanigen's lenzilumab meets FDA refusal on emergency use for COVID-19

Sep. 9, 2021
By Michael Fitzhugh
Initial efforts at Humanigen Inc. to win an FDA emergency use authorization (EUA) for treating hospitalized COVID-19 patients with its monoclonal antibody, lenzilumab, have failed to gain the regulator's buy-in, sending company shares (NASDAQ:HGEN) down 47.3% to $7.97 on Sept. 9 after touching a 52-week low during the session, a reaction part of a volatile arc that has seen shares climb as high as $29.20 during the same time span.
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Regulatory actions for Sept. 9, 2021

Sep. 9, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aim Immunotech, Albireo, Ascendis, Azurrx, Benitec, Biocryst, Boehringer, Clover, Decibel, Eli Lilly, Eloxx, Freeline, GNT, Hibercell, Humanigen, Inflarx, Myovant, Nabriva, Pfizer, Phathom, Sigilon, Sinovac, Sinovant, Soin, Soligenix, Tearclear, Viewpoint, Vor.
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Other news to note for Sept. 9, 2021

Sep. 9, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Affinia, Agentix, Arctic Vision, Benitec, Biocentriq, BMS, Boehringer, Calcimedica, CG Oncology, Clearside, Flamingo, Herantis, Iecure, Ionis, Mindset, Moderna, Nabriva, Nanoform, Neumentum, Precision, Prevail Infoworks, Rhythm, Sen Jam, Telix, Tevogen, Twist, Venturis.
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In the clinic for Sept. 9, 2021

Sep. 9, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Adlai Nortye, Amgen, Applied Therapeutics, Astrazeneca, Avillion, Azurrx, Biohaven, Calypso, Cardiff, Centessa, Clene, Connect, Cortexyme, Cstone, Denali, Dermavant, Edigene, Ensysce, Erasca, Excalibur, Eyegate, Galera, Gannex, Gensight, Hoth, IGC, Innovent, Inventiva, Isa, Ixaka, Jasper, Kintor, Longboard, Longeveron, Macrogenics, Meiragtx, Metacrine, Novavax, PDS, Resverlogix, Seven and Eight, Sio Gene, Soleno, Stuart, Syros, Telix, Terns, Teva, Wave Life, Xwpharma, Zambon, Zynerba.
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Coronavac product packaging

Chinese vaccines show promise as booster shots as more study results shared

Sep. 8, 2021
By Doris Yu
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge.
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