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BioWorld - Saturday, July 4, 2026
Home » Topics » Infection » Coronavirus

Coronavirus
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U.S. vaccine illustration

U.S. turning point in sight, but innovation still needed in COVID-19 fight

May 11, 2021
By Mari Serebrov
A cautious optimism pervaded the March 11 Senate Health, Education, Labor and Pensions (HELP) Committee update on COVID-19, with witnesses and lawmakers alike welcoming the continuing decline of infections, hospitalizations and deaths in the U.S.
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SARS-CoV-2 illustration turns from blue to red

New SARS-CoV-2 ‘variant of concern’ designated as labs seek more data

May 11, 2021
By Nuala Moran
LONDON – The SARS-CoV-2 variant first detected in India last year has joined those from the U.K., South Africa and Brazil as a “variant of global concern,” the World Health Organization said on May 10.
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Pfizer-Biontech COVID-19 vaccine vial

FDA expands EUA for Pfizer-Biontech COVID-19 vaccine to adolescents

May 11, 2021
By Michael Fitzhugh
As expected, the FDA has expanded emergency use authorization (EUA) for Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, marking what Acting FDA Commissioner Janet Woodcock called "a significant step in the fight against the COVID-19 pandemic."
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Regulatory actions for May 11, 2021

May 11, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Bold, Cerecor, Foghorn, Organicell Regenerative Medicine, Pfizer, Rocket, Samus.
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Other news to note for May 11, 2021

May 11, 2021
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alexion, Anticancer, Astellas, Astrazeneca, Aum, Autobahn, Bostongene, CMG, Facio, Handok, Hifibio, Iktos, Immatics, Kadimastem, Monrol, Navidea, Prothena, Roche, Siteone, Telix, Tevogen.
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In the clinic for May 11, 2021

May 11, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Algernon, Alnylam, Arcturus, Arthrosi, Ascendis, Axcella, Biosight, Bioxcel, Brooklyn Immunotherapeutics, Day One, Harbour, Larimar, MAPS, Noxopharm, Noxxon, Oculis, Orchard, Tetra.
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Teen receiving vaccine

SARS-CoV-2 vaccines make progress in the young, the old, the in-between

May 11, 2021
By Anette Breindl
With Monday's announcement that the U.S. FDA has expanded emergency use authorization for Pfizer and BioNtech's COVID-19 vaccine, Comirnaty (tozinameran), to include adolescents 12 through 15 years of age, and the EMA expected to follow suit in short order, the COVID vaccination campaign is expanding its age range.
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Regulatory actions for May 10, 2021

May 10, 2021
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bigfoot Biomedical, Conformis, Edge Surgical, Inova Diagnostics, Ortho Development, Orthofix, Think Surgical.
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Novavax logo, coronavirus vaccine vials

Novavax now pushes anticipated EUA filing from June to the third quarter

May 10, 2021
By Lee Landenberger
Novavax Inc. backed off its guidance of submitting an EUA for its COVID-19 vaccine in June, pushing the anticipated date to this fall. “We expect to complete regulatory filings in the third quarter,” Stan Erck, Novavax’s president and CEO, told investors on a May 10 conference call. “We hope to have market authorizations in multiple countries in the third quarter, as early in the quarter as possible.”
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Regulatory actions for May 10, 2021

May 10, 2021
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Ampio, Astrazeneca, Biocorrx, Eagle, Kyowa Kirin, Liquidia, Merck, Mustang, Pfizer, Smart.
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