In the face of rare, sometimes fatal, side effects associated with Janssen’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend that the agency say it prefers mRNA COVID-19 vaccines over the Janssen vaccine for preventing COVID-19 in those ages 18 years and older.
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.