Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Dynavax Will Not Pursue Narrow Indication For Heplisav After Meeting With FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

The company will be collecting additional safety data for approval of its hepatitis B vaccine in adults 18 to 70 years old; the size, duration and cost of the study are yet to be determined.

You may also be interested in...



Dynavax Hep B Vaccine Gets Second Panel Review; Scrutiny On Safety, Superiority

After clinical hold, lost partnership and rejection by an advisory committee four years ago, Dynavax will again make its case for approval of Heplisav-B.

Will Dynavax’ HBV Vaccine Resubmission Make The Safety Grade?

Company says it now has enough safety data to support a new FDA filing in the first quarter of 2016, and that it expects a superiority claim for diabetics.

Encore? FDA Could Come Close To Record 2012 NME Count This Year

With 19 novel agents approved so far in 2013 and a full slate of candidates under review, the recovery in novel agent approvals after the doldrums of the 2000s is likely to continue even if the agency falls short of last year’s 45 approvals. Watch for action on the first “breakthrough” therapies submitted and advances in hepatitis C treatment.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS075802

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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