Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Heplisav Vaccine Postmarketing Study Might Overcome FDA Safety Worries At Panel

Executive Summary

Dynavax has already received two complete response letters for its hepatitis B vaccine; more patients who received Heplisav died or experienced cardiovascular events compared with the competitor arm.

You may also be interested in...



Second Time Lucky For Dynavax’s Hep B Vaccine In EU?

The European Medicines Agency is set to decide whether Dynavax’s “fewer dose” Heplisav-B vaccine should be authorized for use across the EU – years after the company experienced a setback with its first attempt to get the vaccine approved.

VBI Is Ready To Take On HBV Vaccine Market

VBI’s Sci-B-Vac CONSTANT data firmly establishes the hepatitis B vaccine’s advantages over GSK’s longstanding Engerix-B, but it faces a tougher challenge with Heplisav-B from Dynavax. 

Keeping Track: A Massive Week Of Agency Approvals

The latest drug approval and development news from our US FDA Performance Tracker.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS121193

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel