As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
As talk increases of third doses of COVID-19 vaccine, a game-changing option is delivering them intranasally instead of intramuscularly. “It’s all about nasal carriage. It’s a better way to not carry the virus and not make others sick,” Bluewillow Biologics Inc. CEO Chad Costley told BioWorld. “The most important thing is that it’s safe.”
Biopharma company deals with nonprofit entities, as well as grants, are not keeping the same pace as last year, but the proportion of money flowing into COVID-19 efforts continues to account for the majority of those recorded overall.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Axsome, Beigene, BMS, GSK, Jupiter, Kalvista, Pfizer, RDIF, Ultragenyx, Valneva, Vir, Xeris, Zydus.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bavarian Nordic, Foghorn, Hepagene, Kezar, Lexicon, Orphazyme Plus, Puretech, Sen-Jam.
The quiet cancellation of an Aug. 24 meeting in which the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) was supposed to discuss COVID-19 vaccine boosters is raising more questions about whether the Biden administration got ahead of the data with its Aug. 18 announcement that it planned to roll out mRNA booster shots to adults beginning next month.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beeline, Cynergi Health Partners, Lightpoint Medical, Neupath Health, Opum, Provista Diagnostics, Thuasne Group, Todos Medical, Veon.
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Biontech, Covis, Fibrogen, Gilead, Hebabiz, Ortho, Pfizer, Regeneron.
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