FDA accepts for priority review a Biologics License Application for V114, Merck's investigational 15-valent pneumococcal conjugate vaccine; bluebird bio will be split into 2 publicly traded drug companies; a new variant of coronavirus is reported in Japan.
Today, Merck announced that the FDA accepted for priority review a Biologics License Application (BLA) for V114, an investigational 15-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease in adults 18 years and older. The BLA and priority review designation of Merck’s vaccine comes amid results presented in phase 2 and phase 3 clinical studies in several adult cohorts, including healthy adults and at-risk populations such as those with chronic medical conditions and HIV. The FDA set a target action date for July 18, 2021, with the European Medicines Agency also reviewing an application for V114 in adults.
According to the Boston Globe, bluebird bio, a pioneer in gene therapy, will be split into 2 publicly traded drug companies, with one focused on the treatment of severe genetic diseases and the other on treating forms of cancer. The move comes as values of shares of bluebird had fallen by more than 46% in the past year among difficulties winning commercial approvals in the United States and manufacturing concerns. The announcement came on the first day of the virtual JP Morgan 39th Annual Healthcare Conference.
Yesterday, the World Health Organization (WHO) said that a new variant of the novel coronavirus was reported in Japan and found in 4 people arriving from Brazil, although details of whether the variant is more infectious, like that found in the United Kingdom and South Africa, remains to be determined. As reported by The Hill, WHO Director-General Tedros Adhanom Ghebreyesus noted that as the virus continues to spread worldwide, the chance of new changes in the virus increases. Experts say they have not seen evidence that the new variants cause more severe disease or are resistant to vaccines.