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BioWorld - Tuesday, July 5, 2022
Home » Topics » Infection » Coronavirus

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Regulatory actions for June 16, 2022

June 16, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Biontech, Covis, Horizon, Jazz, Kintara, Moderna, Omega, Pfizer, Phanes, Redx.
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In the clinic for June 16, 2022

June 16, 2022
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aceragen, Astrocyte, Attralus, Biogen, Clovis, Fusion, Halia, Immunic, Kymera, Pfizer, Recordati, Renibus, Scancell.
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Infant receiving vaccine

Adcom says yes to two vaccines, two approaches for US tots

June 15, 2022
By Mari Serebrov
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After a two-day session of the FDA’s Vaccines and Related Biologic Products Advisory Committee, the U.S. is within days of a long-awaited milestone of having not just one but at least two vaccines available for nearly every American. The VRBPAC voted unanimously, 21-0, June 15 to support amending the emergency use authorizations for both the Moderna Inc. and Pfizer Inc.-Biontech SE COVID-19 mRNA vaccines to allow their use in children 6 months and older.
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Despite some non-significant data, Pfizer plunges ahead with Paxlovid NDA

June 15, 2022
By Lee Landenberger
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A day after announcing it would pump $120 million into a Michigan manufacturing facility for Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. produced new data it plans to use in an U.S. NDA submission for treating COVID-19. While some data for the oral antiviral fell short of statistical significance, other companies are not far behind Pfizer in their drive for FDA acceptance using similar approaches.
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Regulatory actions for June 15, 2022

June 15, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Attgeno, Cellenkos, Eli Lilly, Incyte, Innovent, Moderna, Nammi, Outlook, Stealth, Tremeau.
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Other news to note for June 15, 2022

June 15, 2022
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blue Earth, Boehringer, Contrafect, Evotec, Hemostemix, Heron, Hibio, Incyte, J&J, Jupiter, Maia, Morphosys, Oragenics, Pfizer, Pike, Precerv, Telix, Trutino, Vyluma.
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In the clinic for June 15, 2022

June 15, 2022
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinogen, Biomarin, Clover, Codagenix, Exscientia, Freeline, Genexine, Huyabio, Puretech, Soleno, Treadwell, Zhimeng.
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Time to share the US pediatric COVID-19 vaccine market?

June 14, 2022
By Mari Serebrov
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Up to now, the Pfizer Inc.-Biontech SE COVID-19 vaccine has had a lock on the U.S. pediatric market, for ages 5 to 17, but that could change as early as next week.
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Regulatory actions for June 14, 2022

June 14, 2022
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Amivas, Amylyx, Beigene, Bluebird, Guerbet, Homology, Ionis, Mallinckrodt, Merck & Co., Novavax, Nrx, Relief, Veralox.
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Other news to note for June 14, 2022

June 14, 2022
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Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Atyr, AVM, Bavarian, Orion, Sarepta, Sirona, Umoja, Valneva.
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