The figures continue a recent trend of decreases in fee-paying full application equivalents but were not as low as had been estimated.
FDA did not see the drop in fee-paying applications it predicted in FY 2011, but the figure continues to decrease, which could point to a large increase in application fees in coming years.
The charge for an application requiring clinical data will be about $1.959 million in FY 2013, an increase of about...
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The new 60-day deadline for striking a deal with the drug industry underscores the challenges the Administration may be having in developing non-voluntary policies to achieve MFN pricing in the US.
Pilot is harbinger of greater transparency in the 340B program. But rebates may only be denied by manufacturers for overlap with Medicare negotiated prices, not for issues like diversion that have driven recent lawsuits.
If approved, Sanofi’s acoziborole could become the first single-dose oral treatment for sleeping sickness.
