CLDF Title
Home | Contact Us | Bookmark
HBV HE HCC HCV
About CLDF Centers of Educational Expertise  
Live CME Meetings Telewebs Webcasts Slide Library Abstract Library Conference Highlights
 
Back  
 
Reuters Health Information (2014-02-18): Dynavax withdraws EU marketing application for Hep B vaccine

Drug & Device Development

Dynavax withdraws EU marketing application for Hep B vaccine

Last Updated: 2014-02-18 13:15:13 -0500 (Reuters Health)

(Reuters) - Dynavax Technologies Corp said it had withdrawn a European marketing application for its experimental hepatitis B vaccine due to safety concerns raised by the European Medicines Agency.

The EMA had said current safety data on the vaccine, Heplisav, was too limited to rule out a risk of less common serious adverse events.

Heplisav is the company's most advanced produced under development.

The drug developer said it withdrew the application because it would not be able to gather sufficient data to respond to the regulator in the time required.

An additional 8,000-subject trial intended to provide the data is expected to begin soon, the company said.

Berkeley, California-based Dynavax suffered a similar setback in February last year when the U.S. Food and Drug Administration rejected the Heplisav vaccine.

 
 
 
 
                 
 
HBV
Webcasts
Slide Library
Abstract Library
 
HE
Live CME Meetings
Webcasts
Slide Library
Abstract Library
 
HCC
Slide Library
Abstract Library
 
 
HCV
Live CME Meetings
Webcasts
Slide Library
Abstract Library
 
CLDF Follow Us
   
 
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Supporters
 
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
 
Centers of
Educational Expertise
Regional Map
     
   
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2014 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.