Heplisav Phase III Data Good, But Timing Of Complete Response Still Unclear
This article was originally published in The Pink Sheet Daily
Executive Summary
Dynavax, Merck assembling package on HBV drug for FDA.
You may also be interested in...
Merck Returns Heplisav To Dynavax After FDA Rules Vaccine Too Risky For Healthy Adults
Regulators offer option to proceed with the hepatitis B vaccine in kidney disease patients, but can the company bear the risk/cost burden of going it alone until it can repartner?
Merck Returns Heplisav To Dynavax After FDA Rules Vaccine Too Risky For Healthy Adults
Regulators offer option to proceed with the hepatitis B vaccine in kidney disease patients, but can the company bear the risk/cost burden of going it alone until it can repartner?
Dynavax’s Vasculitis Case With Heplisav Could Be Random
Response to FDA on hepatitis B vaccine clinical hold points to a case in the control as well as the drug arm.