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.
Dynavax Technologies Corp. is hoping that new safety and efficacy data for its hepatitis B vaccine Heplisav-B will win over FDA's Vaccines and Related Biological Products Advisory Committee, which voted against the product's approval in 2012.
The committee will review the vaccine candidate for immunization against hepatitis B virus infection in adults ages 18 years and...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
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