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Priority Review Voucher Sales Prices Level Off In 2017

 
• By Sue Sutter

BioMarin's sale of voucher earned with approval of rare pediatric disease drug Brineura the fourth publicly disclosed voucher sale this year with a price tag between $125m and $150m.

Priority Review Voucher

BioMarin Pharmaceutical Inc.'s latest priority review voucher sale is further evidence that the price for the coupons, which entitle the holder to a speedier US FDA review, is leveling off.

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Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
• By Eliza Slawther

Industry feedback on a European Medicines Agency pilot that introduced a “stepwise” approach to pediatric investigation plans was positive, but the future of the new model will depend on the outcome of the pharmaceutical legislation negotiations, the agency says.

US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says

 
• By Sue Sutter

The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.

AI Could Be Used ‘In The Deliberation’ Of HTA Reviews In England, Says NICE

 
• By Eliza Slawther

England’s health technology assessment institute, NICE, is looking to “reimagine” its evaluation process with the help of AI, rather than just using this technology to speed up its existing processes.

EU HTA Regulation: Companies Can Talk To National Authorities As ‘Substitute’ For EU-Level Advice

 
• By Eliza Slawther

Not all companies will be able to access joint scientific consultations under the EU Health Technology Assessment Regulation, but success is still possible for those that engage with national agencies early on, says EUCOPE’s Alexander Natz.

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EU HTA Regulation: Don’t Forget About Vaccines, Industry Warns

 
• By Eliza Slawther

Europe’s vaccines industry wants to make sure immunizations “are not forgotten” by policymakers who are overseeing the EU Health Technology Assessment Regulation. It has highlighted several nuances of vaccines that should be addressed over the coming years.

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

Beyond Tariffs: The Silver Lining Of The US Pharma Security Investigation

 
• By Jessica Merrill

An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.