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.
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.
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.
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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinogen, Biomarin, Clover, Codagenix, Exscientia, Freeline, Genexine, Huyabio, Puretech, Soleno, Treadwell, Zhimeng.
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.
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.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Atyr, AVM, Bavarian, Orion, Sarepta, Sirona, Umoja, Valneva.
A lot of eyes are on the World Trade Organization (WTO) Ministerial Conference taking place in Geneva June 12-15, as member countries try to reach a consensus on a proposal that would allow certain members to waive intellectual property (IP) rights on COVID-19 vaccines for at least three to five years.
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