Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Boehringer, CSL, Everest, Fate, I-Mab, Incyte, J&J, Laurent, Merck, Nuvation, Sapience, Sobi.
Vaccine specialists Sanofi SA and Glaxosmithkline plc have been behind the curve throughout the pandemic, with upstarts such as Moderna Inc. and Biontech SE stealing the show with their ground-breaking mRNA technology. While their rivals were beginning to launch the first wave of vaccines early last year, Sanofi and GSK had to reformulate theirs after it failed to produce a strong enough immune response in older people. New results show that the shot, SP-0253, could play a role as a booster but there will be another delay after the companies struggled to recruit enough participants in a crucial phase III trial.
Xandar Kardian Inc. closed a $10 million series A funding round to support the rollout of the company’s contactless health monitoring solution. Phoenix Venture Partners led the round with participation from Portfolia Active Aging & Longevity Fund, Taronga Ventures and others. “With the new financing round, Xandar Kardian looks forward to expanding its core team in Toronto and in the United States, in addition to placing increased emphasis on R&D and mass production for its technologies,” Xandar Kardian co-founder and CEO Sam Yang told BioWorld.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Audere, Biognosys, Bostongene, Gretel, Illumina, IQ Group, Life Science Biosensor, Lumiradx, NEC, Thermo Fisher.
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.
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