Pfizer Receives Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate
Pfizer intends to submit a biologics license application for its investigational Meningococcal B vaccine candidate, Bivalent rlp2086, to FDA by mid-2014.
FDA granted breakthrough therapy designation to Pfizer’s vaccine candidate, bivalent rLP2086, which is currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in persons 10–25 years of age. Disease caused by Neisseria meningitidis serogroup B has been estimated at between 20,000 and 80,000 cases per year globally and can result in death or significant long-term disabilities, including brain damage and hearing loss, Pfizer noted in the press release.
Pfizer is conducting a global clinical development program for rLP2086, which includes both Phase 2 and Phase 3 trials evaluating more than 20,000 participants, about 14,000 of whom will receive the investigational vaccine, according to the press release. Pfizer intends to submit a Biologics License Application (BLA) to FDA for bivalent rLP2086 by mid-2014.
Source: Pfizer
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
