Dynavax's hepatitis B vaccine could end up as preferred choice for certain groups once safety and cost-effectiveness studies are completed.
Dynavax Technologies Corp.'s Heplisav-B got a vote of support from the US Centers for Disease Control and Prevention's advisory committee. But more significantly, the panel left the door open to a future recommendation endorsing Heplisav-B over other hepatitis B vaccines.
At its Feb. 21 meeting, the Advisory Committee on Immunization Practices (ACIP) voted 14-0 that "Heplisav-B is a hepatitis B vaccine that may be used to vaccinate persons aged 18...
The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.
In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
