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BioWorld - Wednesday, March 25, 2026
Home » Topics » Infection » Coronavirus

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Regulatory actions for Dec. 17, 2021

Dec. 17, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, BMS, Braeburn, Calliditas, Camurus, Daiichi, Innoskel, Mesoblast, Mitotech, Neuvivo, Nkarta, Novavax, Pfizer, Rakuten, Sobi, Verrica, Zai Lab.
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Other news to note for Dec. 17, 2021

Dec. 17, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Advaxis, Amplyx, Biomarin, Cadila, Cassiopea, Cava, Cosmo, Hyloris, Iktos, Kineta, Lipidor, Mynd, Pfizer, Providence, Purdue, Skyline, Vaneltix, Vera.
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In the clinic for Dec. 17, 2021

Dec. 17, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Albireo, Alligator, Apnimed, Applied, Aptinyx, Arcturus, Attralus, Axcella, Celyad, Cullinan, Debiopharm, Denovo, Diffusion, Douglas, Emergent, Ensysce, Fortress, In8bio, Innate, Kodiak, Kura, Kymera, Mallinckrodt, Matinas, Navidea, Nicox, Novaliq, Proqr, Seres, Uniqure, Valneva, Zealand.
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Regulatory actions for Dec. 17, 2021

Dec. 17, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Firstkind, Implicity, Roche, Sky Medical Technology.
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Regulatory actions for Dec. 16, 2021

Dec. 16, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Biocode, Fist Assist, Mdoloris, Mindray.
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Vial and syringe

ACIP prefers mRNA COVID-19 vaccines to Janssen’s as Valneva posts strong data

Dec. 16, 2021
By Lee Landenberger
In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
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In the clinic for Dec. 16, 2021

Dec. 16, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 60 Degrees, Aerovate, Amgen, Arthrosi, Artax, Bioxcel, City of Hope, Eiger, Eli Lilly, Enbiotix, Exelixis, Geovax, GSK, Idera, Jazz, Nektar, NFL, Pharma Two, Polyphor, Recce, Sanofi, Sumitomo, Travere, Ultimovacs, Varmx.
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Regulatory actions for Dec. 16, 2021

Dec. 16, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Boehringer, CSL, Everest, Fate, I-Mab, Incyte, J&J, Laurent, Merck, Nuvation, Sapience, Sobi.
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Other news to note for Dec. 16, 2021

Dec. 16, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acurastem, Alpine Immune, Amgen, Anabio, Antares, Antengene, Aperion, Aqemia, Argobio, Assertio, Astrazeneca, BCI, Cerevel, Evofem, Evotec, Genecode, Herophilus, Horizon, ICER, Inceptor, Metrion, Mithra, Orion, Poolbeg, SAB, Servier, Sosei, Twist, Vaxart, Verona, Xtalpi.
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Sanofi-GSK vaccine works as booster, but faces more delays as trials drag on

Dec. 15, 2021
By Richard Staines
Vaccine specialists Sanofi SA and Glaxosmithkline plc have been behind the curve throughout the pandemic, with upstarts such as Moderna Inc. and Biontech SE stealing the show with their ground-breaking mRNA technology. While their rivals were beginning to launch the first wave of vaccines early last year, Sanofi and GSK had to reformulate theirs after it failed to produce a strong enough immune response in older people. New results show that the shot, SP-0253, could play a role as a booster but there will be another delay after the companies struggled to recruit enough participants in a crucial phase III trial.
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