Pfizer Announces Submission of Biologics License Application to the FDA for Investigational Meningococcal B Vaccine

June 17, 2014 Pfizer Inc. announced today that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for bivalent recombinant LP2086 (rLP2086), the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 to 25 year olds. Each year, approximately 500,000 cases of meningococcal disease occur worldwide …

Novartis Receives Australian Approval for Bexsero

Novartis Bexsero® meningitis B vaccine receives clinical recommendation for use in infants and adolescents in Australia March 13, 2014 Novartis has announced that Australia has joined the growing number of countries where following licensure, Bexsero® (Meningococcal Group B Vaccine [rDNA, component, adsorbed]) has received a clinical recommendation for the vaccine’s routine use to help protect against meningitis B. These recommendations follow recent access milestones for Bexsero in multiple …

Novartis provides second US university with Bexsero

February 24, 2014 Novartis announced today that its meningococcal serogroup B (MenB) vaccine, Bexsero (Meningococcal Group B Vaccine [rDNA, component, adsorbed]), will be used as part of a vaccination program at the University of California Santa Barbara (UCSB) that began today and will end on March 7. In the last three months, the Food and Drug Administration (FDA) has approved …

If it’s Good Enough for the EU is it Good Enough for US? Bexsero in the USA

In the aftermath of the Meningitis B outbreaks at Princeton University and  the University of California, Santa Barbara, a debate has sparked over whether medicines with marketing approval on one side of the Atlantic should be automatically granted approval across the pond? When MenB broke out in Pinceton University late 2013 there was no vaccine available in the US which …

An interview with Dr Rappuoli on the vaccine industry

As part of a series of interviews conducted with leading speakers of the World Vaccine Congress in Washington D.C., Terrapinn were delighted to sit down with Dr Rino Rappuoli, Global Head of Vaccines Research at Novartis Vaccines and Diagnostics. The conversation delved into the future role of big pharma in vaccines, how to deal with anti-vaccine rhetoric and what big …