Priority Review Voucher Extension Scaled Back In New Cures Bill
This article was originally published in The Pink Sheet Daily
Executive Summary
Pediatric rare disease program would have been renewed for seven years under previous draft, but now would only have a three-year on life as full committee mark-up begins.
You may also be interested in...
Goodbye ‘340B,’ Hello ‘Outpatient Drug Discount Program’ In House Reform Bill
House Commerce Committee members are drafting legislation to make numerous significant changes to the 340B drug discount program, including the definition of eligible patients, new reporting and auditing requirements for providers and drug manufacturers, rules for contract pharmacies – and a new user-fee program for participating health care providers.
Priority Review Weirdness: Tropical Voucher Sells For More; Owner Says It’s Worth Less
Knight Therapeutics says a rare pediatric disease voucher is more valuable than its tropical disease voucher despite the sale price.
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.