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FDA's Pazdur Jumps Over To New 'Moonshot' Role

 
• By Donna Young

Creation of agency's new Oncology Center of Excellence means the Office of Hematology and Oncology Products, often seen as FDA's model product review shop, needs new leadership – at least temporarily.

When the White House earlier this year said it wanted to create a new Oncology Center of Excellence at FDA as part of the National Cancer Moonshot initiative, a $1bn effort being run by Vice President Joe Biden, it was widely speculated Richard Pazdur would be tapped for the job – that is, if he wanted it.

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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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Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry

 
• By Leela Barham

Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.

Non-Submissions To England’s NICE Surge Across All Disease Areas

 
• By Leela Barham

Blood cancer therapies were most proportionately impacted by the failure of pharmaceutical companies to submit evidence on their cancer therapies to England’s health technology appraisal body, shows analysis by the Pink Sheet.

PBMs No Longer Profit From Rebates But Plans Benefit; Should Sponsors Push More For Reform?

 
• By Cathy Kelly

Employers and other health plan sponsors may need to push for better targeted reforms that lower cost sharing for patients.