logo
Plus   Neg
Share
Email

Merck : FDA Accepts For Priority Review BLA For Adult Invasive Pneumococcal Vaccine

Merck & Co Inc. (MRK) said Tuesday that the U.S. Food and Drug Administration accepted for priority review a Biologics License Application or BLA for V114 for the prevention of invasive pneumococcal disease in adults 18 years of age and older.

The FDA set a Prescription Drug User Fee Act (PDUFA), or target action date, of July 18, 2021. The European Medicines Agency is also reviewing an application for licensure of V114 in adults.

V114 is Merck's investigational 15-valent pneumococcal conjugate vaccine candidate for the prevention of invasive pneumococcal disease in adults. Merck is also developing V114 for use in children.

V114 previously received Breakthrough Therapy Designation from the FDA for the prevention of invasive pneumococcal disease in pediatric patients 6 weeks to 18 years of age and adults 18 years of age and older.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The Inter-American Development Bank and Citi Innovation Labs have successfully completed a proof-of-concept to make cross-border payments from the U.S. to countries in Latin America and the Caribbean, using blockchain and tokenized money. The platform provided full traceability of the transactions, exchange rates, and fees on blockchain. Australian competition regulator said the country's Federal Court found that Google and its Australian arm misled users about the collection and use of personal location data. The data was collected through Android mobile devices between January 2017 and December 2018. This is said to be the world-first enforcement action brought by the Australian Competition and Consumer Commission or ACCC. Morgan Stanley (MS) reported a first-quarter profit that more than doubled from last year, reflecting strong performance across all of its business segment. Net revenues for the quarter grew 61 percent from the previous year. Quarterly adjusted earnings per share beat analysts' estimates.
Follow RTT