Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

EC Approves Additional Pneumonia Indication for Synflorix

By Drug Discovery Trends Editor | December 6, 2013

GlaxoSmithKline (GSK) announced that the European Commission (EC) has granted marketing authorization for an additional indication for Synflorix for the immunization against pneumonia caused by Streptococcus pneumonia in children from six weeks up to five years of age.
 
This approval was based on results from a Phase 3 double-blind, randomized, controlled trial named COMPAS. This efficacy study for a latest-generation pneumococcal conjugate vaccine (PCV) was conducted in 63 centers in South America, involving 24,000 children.
 
The EU Summary of Product Characteristics for Synflorix is available online. (https://ec.europa.eu/health/documents/community-register/html/h508.htm)
 
“GSK welcomes this approval for an additional Synflorix indication in Europe,” said Thomas Breuer, senior vice president and lead physician, GSK Vaccines. “Pneumonia continues to kill more children under five than AIDs, malaria and measles combined and affects both the developed and the developing world. There are three million cases of pneumonia in children under five in Europe each year. With this new indication, we are confident that Synflorix will contribute to a significant reduction in cases of pneumonia caused by Streptococcus pneumonia.”
 
Date: December 5, 2013
Source: GlaxoSmithKline
 

Filed Under: Drug Discovery

 

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50