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Vytorin/Zetia Affirmation Continues To Elude Merck With Denied CKD Indication

 
• By Shirley Haley

FDA shot down Merck’s bid to add an indication for cardiovascular risk reduction in renally impaired patients to Vytorin (ezetimibe/simvastatin) labeling, arguing the contribution of the two components to positive results wasn’t measured in the pivotal SHARP trial. Trial data can be added to the Vytorin label but not to labeling for Zetia (ezetimibe).

Despite an advisory committee meeting that left observers confident Merck & Co. Inc.’s Vytorin (ezetimibe/simvastatin) and Zetia (ezetimibe) used in combination with simvastatin would be approved to reduce the risk of major cardiovascular events in at least patients with pre-dialysis chronic kidney disease, FDA denied the application altogether, saying it has questions about the relative contribution of Vytorin’s component drugs to efficacy results.

Merck made the announcement Jan

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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.