Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Alnylam, Alterity, Beigene, Chinook, Hemogenyx, J&J, Kenox, Merck, Moderna, Pfizer, Rockwell, Sparro, TG, Tonix.
Rnaimmune Inc., which in April raised a $10 million seed round to support its discovery and development of RNAi therapies, said it is now studying the neutralizing effects of its mRNA-based COVID-19 vaccine candidate on the Omicron variant.
Little more than a year since FDA approval of its COVID-19 vaccine, Pfizer Inc. has published final phase II/III data on its oral antiviral candidate, Paxlovid (nirmatrelvir + ritonavir), confirming that, for non-hospitalized, high-risk adults with COVID-19, taking the drug within three days of symptom onset reduced all-cause risk of hospitalization or death by 89% vs. placebo.
While biopharma companies across the world pulled out all the stops in 2021 to develop and manufacture COVID-19 vaccines and therapies, the pandemic highlighted supply chain weaknesses, spurring demands in many countries for more domestic manufacturing and less reliance on production in other countries.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biohaven, Cellular Biomedicine, Egetis, Enlivex, Genmab, Janssen, Novavax, Nurix, Nuvation, Pfizer, Therapeuticsmd, Veru.