Stallergenes SA’s Oralair Beats Merck’s Grastek To Market, But With Limited Label
This article was originally published in The Pink Sheet Daily
Oral grass allergy immunotherapy becomes the first alternative to allergy shots; modified indication, boxed warning reflects advisory panel recommendations.
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Proposal, which could be formally endorsed by MedPac this spring, would lower the payment rates for vaccines while simultaneously moving all preventative vaccine coverage to Medicare Part B. Commission signals further cuts to payment rate, through an average sales priced-based methodology that might eventually be recommended.
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
Agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give Biden team cushion to confirm a permanent leader of whom a top contender is former senior FDA staffer Joshua Sharfstein, a proponent of drug reforms that may irk manufacturers.