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Acthar Gel Medicaid Rebates: Mallinckrodt Loses 'Gamble' Over FDA's NDA Numbering System

 
• By Brenda Sandburg

Mallinckrodt must pay $650m in retroactive Medicaid rebate payments; case shows how application filings can impact CMS reporting requirements and price-based reimbursements.

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Mallinckrodt owes $650m in retroactive Medicaid rebates under court ruliing

Mallinckrodt PLC lost its bet to pay lower Medicaid rebates for Acthar Gel (repository corticotropin injection) by claiming the US Food and Drug Administration's approval of a new indication made it a new drug product.

In a 13 March ruling, a district court agreed with the US Centers for Medicare and Medicaid Services that Mallinckrodt and its subsidiary Questcor Pharmaceuticals Inc. have been miscalculating Acthar's Medicaid rebates since 2013

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.