Get Your Priority Review Voucher, While They Last
This article was originally published in RPM Report
Executive Summary
The approval of Retrophin/Asklepion’s Cholbam triggers the third pediatric rare disease priority review voucher – and the sunset provision in the statute authorizing the program.
You may also be interested in...
United Therapeutics Wins Unituxin Approval, Pediatric Priority Review Voucher – With NIH Support
The National Cancer Institute conducted the clinical trials of Unituxin for treatment of pediatric high-risk neuroblastoma and teamed with United for manufacturing and commercialization.
Gilead Puts High Premium On Priority Review Voucher; Deal May Help Protect Lead In HCV
Gilead pays $125 million for the right to a faster review of a future product, doubling the price paid in the first priority review voucher sale just months before. The value of the voucher may go up if pending legislation is signed into law – but the high price tag speaks volumes about the importance of maintaining the lead in Hep C formulation development.
How Much Is A Priority Review Worth? $67.5 Million, Sanofi/Regeneron Say
Companies’ decision to purchase and redeem BioMarin’s priority review voucher for their PCSK9 inhibitor alirocumab sets the first public benchmark for a voucher’s value and shows the potential advantages to be gained for sponsors in a race to market.