16:12 , Mar 16, 2017 |  BC Week In Review  |  Clinical News

Fluarix Quadrivalent regulatory update

GlaxoSmithKline submitted an sBLA to FDA for Fluarix Quadrivalent influenza vaccine for use in children ages ≥6 months. The intramuscular vaccine is approved in patients ages ≥3 to prevent disease caused by the 2 influenza...
07:00 , Oct 3, 2016 |  BC Week In Review  |  Clinical News

Afluria Quadrivalent: Phase III data

CSL’s Seqirus unit reported data from a double-blind, U.S. Phase III trial in 2,278 children ages 5-17 showing that intramuscular Afluria Quadrivalent met the primary endpoint of non-inferior immunogenicity to Fluarix Quadrivalent as assessed by...
07:00 , Aug 24, 2015 |  BC Week In Review  |  Company News

GlaxoSmithKline sales and marketing update

GlaxoSmithKline began shipping doses of Fluarix Quadrivalent for the 2015-16 flu season to U.S. pharmacies and healthcare providers. Fluarix is an intramuscular vaccine against influenza A and B strains. GSK will also begin shipping Flulaval...
07:00 , Aug 12, 2013 |  BC Week In Review  |  Clinical News

Influsplit Tetra regulatory update

GlaxoSmithKline said it received FDA approval to begin shipping Fluarix Quadrivalent seasonal flu vaccine to U.S. Centers for Disease Control and Prevention (CDC) distribution centers and U.S. healthcare providers for the 2013-2014 flu season. GSK...
07:00 , Jul 1, 2013 |  BC Week In Review  |  Company News

AstraZeneca, GlaxoSmithKline, Sanofi infectious news

President Obama signed into law H.R. 475 to update the existing excise tax to include coverage of any vaccine against seasonal flu. The update now allows the excise tax to apply to quadrivalent seasonal influenza...
07:00 , Apr 8, 2013 |  BC Week In Review  |  Clinical News

Influsplit Tetra regulatory update

GlaxoSmithKline said Germany and the U.K. approved its quadrivalent seasonal flu vaccine under the EU's decentralized procedure to prevent influenza subtypes A and B infection in people >=3 years of age. According to GSK, the...
23:32 , Apr 3, 2013 |  BC Extra  |  Company News

U.K., Germany approve GSK's quadrivalent flu vaccine

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said Germany and the U.K. approved its quadrivalent seasonal flu vaccine under the EU's decentralized procedure to prevent influenza subtypes A and B infection in people three years of age and...
08:00 , Dec 24, 2012 |  BC Week In Review  |  Clinical News

Fluarix Quadrivalent regulatory update

FDA approved GlaxoSmithKline's seasonal flu vaccine Fluarix Quadrivalent to prevent influenza subtypes A and type B infection in people >=3 years. According to GSK, the vaccine helps protect against the 2 most common A virus...
08:00 , Dec 3, 2012 |  BC Week In Review  |  Clinical News

D-QIV: Phase III data

A double-blind, international Phase III trial in 2,738 children aged 3-17 showed that D-QIV was non-inferior and superior to both control trivalent vaccines containing either a type B strain of Yamagata or Victoria lineage in...
08:00 , Dec 3, 2012 |  BC Week In Review  |  Clinical News

D-QIV: Phase III data

A double-blind, international Phase III trial in 4,656 adults showed that D-QIV was non-inferior and superior to both control trivalent vaccines containing either a type B strain of Yamagata or Victoria lineage in humoral immune...