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Help Wanted: FDA Recruiting New CBER Director Ahead Of Gene, Cell Therapy Wave

 
• By Laura Helbling

CBER Director Midthun is stepping down at the end of the year, just as the center is moving into an era of more hands-on work in reviewing new therapeutics.

FDA’s Center for Biologics Evaluation & Research is recruiting a new director as a wave of cellular and gene therapies approaches the BLA filing stage.

Director Karen Midthun is retiring at the end of the year, and FDA has begun the process of searching for...

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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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Gene Therapy Elevidys Among Six Orphan Drugs Awaiting EU Marketing Verdict

 
• By Vibha Sharma

The European Medicines Agency is expected to decide whether to recommend EU-wide marketing authorization for six orphan-designated medicines that are all already approved in the US.

Business Background Of New CDER Director George Tidmarsh

 
• By Bridget Silverman

George Tidmarsh has extensive experience in the biopharmaceutical industry and led several drugs to FDA approval.

‘Prescription Drugs Are Not Golf Balls’: FTC/DoJ Solicit Clashing Opinions On Patents

 
• By Urtė Fultinavičiūtė

Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?