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FDA Advisory Committees

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Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Novo’s Victoza CV Benefit Claim Could Be Narrowed With FDA Panel Vote

US advisory committee strongly endorses cardiovascular risk reduction claim for the GLP-1 agonist but some panelists say new indication should be limited to diabetics with established CV disease, not the broad primary prevention claim Novo Nordisk is seeking.

Advisory Committees Drug Review

Victoza’s Non-Cardio Safety May Dominate At FDA Panel Review

US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.

Advisory Committees Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered

Advisory Committees Drug Review

Taking Biosimilars Down A PEG: Why Copying Neulasta Isn’t So Easy

Biosimilar sponsors are 0-3 so far in attempts to win US FDA approval for copies of Amgen’s pegfilgrastim (Neulasta). FDA’s recent review of a novel clotting factor formulation offers a clue why it is turning out to be harder than it seems to copy a pegylated protein.

Advisory Committees Biosimilars

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Regulation Advisory Committees
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