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Overview of articles posted on the first Pediatric Priority Review Voucher sale (KvC Newsletter)

December 2, 2014

WSJ – Drug Firms Buy $67.5 Million Voucher to Speed FDA Review

BusinessWeek – Sanofi and Regeneron Pay $67.5 Million to Fast-Track a Cholesterol Drug

Pharmaceutical Online – Sanofi And Regeneron To Use Priority Review Voucher For Alirocumab

MarketWatch – Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission

FierceBiotech – Sanofi, Regeneron pay $67M for a shortcut in the blockbuster PCSK9 race with Amgen

Nasdaq – BioMarin Sells Priority Review Voucher To Regeneron

SFGate Tech Chronicles – BioMarin sells special FDA voucher for $67.5 million

Medical Marketing and Media – Sanofi tightens PCSK9 race, exceeds Q2 expectations

StreetInsider.com – Regeneron (REGN) and Sanofi (SNY) Report Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission

Cantech Letter – What does BioMarin’s voucher sale mean to Knight Therapeutics?

thepharmaletter – Sanofi and Regeneron purchase FDA priority voucher for alirocumab

Seeking Alpha – Biotechs to use priority review voucher for cholesterol-lowering drug candidate

Regulatory Affairs Professionals Society – FDA Voucher for Accelerated Drug Review up for Saletory-Focus/News/2014/08/13/20029/FDA-Voucher-for-Accelerated-Drug-Review-up-for-Sale

PMLive – Sanofi and Regeneron pay $67.5m to speed alirocumab review

FierceBiotech – How much would you pay for FDA special treatment?

Regulatory Affairs Professionals Society – First Pediatric Priority Review Voucher Goes up for Sale, Fetching $67M

insurancenewsnet – Use of Priority Review Voucher and Financial Result Releases of Healthcare Companies – Research Reports on Regeneron, WellPoint, Edwards, Humana and Celgene

Seattlepi – BioMarin sells special FDA voucher for $67.5 million

StreetInsider.com – BioMarin (BMRN) Tops Q2 EPS by 18c, Sells riority Review Voucher for $67.5 Million

pharmiweb.com – Sanofi and Regeneron Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission

Pharmaceutical Processing – Regeneron and Sanofi to Use Priority Review Voucher For Alirocumab Submission

Pharmacy Times – Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab US FDA Submission

BioMarin – BioMarin Sells Priority Review Voucher for $67.5 Million

MarketWatch – BioMarin Sells Priority Review Voucher for $67.5 Million

BioTechSF – FDA punches BioMarin’s ‘golden ticket’ for speedy drug review

Nature Reviews – BioMarin nabs first paediatric priority review voucher

Vanrtage – Putting a value on US priority review vouchers

Zacks – BioMarin Q2 Loss Narrower than Expected, Revenue Guidance Up

SmartBrief – Sanofi, Regeneron buy BioMarin’s priority-review voucher for $67.5M

BioCentury – BioMarin sells Priority Review voucher

Evaluate – BioMarin Sells Priority Review Voucher for $67.5 Million

FirstWord Pharma – ViewPoints: But what is an FDA priority review voucher actually worth? BioMarin finally puts a price tag on it

OrphanDrugNaut – Rare Diseases: BioMarin Sells FDA Priority Review Voucher for $67.5 Million

Scrip Intelligence – Knight follows BioMarin’s lead; seeks voucher buyer 

Total Orphan Drugs – BioMarin Sells FDA Priority Review Worth $67.5 Million

Geek Talk Clinical – Rare Disease Patient Advocate Applauds FDA’s Rare Pediatric Disease Voucher Program

Regeneron – Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission

BioWorld – ‘Vouching’ for Regeneron in PCSK9 market race: Amgen catch-up via coupon buy from Biomarin?

Sanofi – Sanofi and Regeneron Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission

Coconutoil.com – New Cholesterol Drug Approval to be Fast-tracked by FDA to Highest Bidder

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