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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.

On Nov. 27, BioMarin announced plans to sell a rare pediatric disease priority review voucher to an undisclosed purchaser for...

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EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 
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EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
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Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

Woodcock: Do Not Do The Wrong Study, Even If Against US FDA Advice

 
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The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
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Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

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Repurposed Drugs: EU Pharma Reform Offers Boost, But Payers ‘Must Recognize Health Gains’

 
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Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.

Post-BIO Podcast: Thoughts From The Frontlines

 
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New CDC Vaccine Panel Chair Vows To ‘Rebuild Public Trust’ With Evidence-Based Medicine

 
• By Sue Sutter

The newly reconstituted Advisory Committee on Immunization Practices will create new work groups to examine the cumulative impact of vaccine schedules and reexamine some older vaccines.