New US formulations will contain only one B virus antigen after shedding the B/Yamagata component, a strain that has not been detected in circulation since March 2020. However, some US manufacturers will continue to produce quadrivalent vaccine for use in other countries, which have been slower to transition to trivalent.
Wheels are in motion for a global change to trivalent seasonal flu vaccine, with the US leading the way. • Source: Shutterstock
Only trivalent versions of seasonal influenza vaccine will be available in the US for the 2024-2025 season following the recommended removal of one of the B virus strains from formulations for domestic use.
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.
Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
