CSL's Fluad Seems Headed For Post-Marketing Safety Study
This article was originally published in The Pink Sheet Daily
Executive Summary
Adjuvanted seasonal influenza vaccine should get accelerated approval but needs confirmatory trial to address imbalance in deaths following revaccination, FDA advisory committee says.
You may also be interested in...
Fluzone Maker Sanofi Wants Language On Failed Confirmatory Study Added To Seqirus’ Fluad Label
In new twist on debate over ‘dangling’ accelerated approvals, Sanofi wants Fluad label to reflect failure of confirmatory trial to meet primary efficacy endpoint; Seqirus says Sanofi is trying to interfere with ACIP’s possible preferential recommendation of enhanced seasonal flu vaccines in elderly.
Fluad Adjuvant Could Come Under Fire At Advisory Committee
CSL’s (formerly Novartis’) flu vaccine was shown to be non-inferior, but not superior, on immunogenicity endpoints compared to an unadjuvanted vaccine in individuals ages 65 years and older.
Puberty Blockers: FDA's Califf Asked If REMS, Boxed Warning Against Off-Label Use In The Works
FDA Commissioner Robert Califf tells House appropriations subcommittee chair the agency will 'consider any information that may be available' on off-label use of puberty blockers for gender dysphoria before making a regulatory decision.