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When To End A REMS? Soliris Review Stirs Debate On How To Scale Back

 
• By Sue Sutter

Risk management program for Alexion’s orphan drug eculizumab appears to be succeeding, but what does FDA need to see to make it less burdensome?

More than seven years after FDA was empowered to require Risk Evaluation and Mitigation Strategies to ensure that drugs’ benefits outweigh their risks, the agency is still struggling to figure out how much evidence is needed to scale back a REMS.

The apparent success of the REMS for Alexion Pharmaceuticals Inc.’s Soliris (eculizumab) shows the challenges FDA faces in determining...

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More from United States

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• By Dean Rudge

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LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

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Novo, Lilly Ad Challenges Cause Discontinued Claims For Compounded GLP-1s

 
• By Sue Sutter

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Prasad Says Involvement In US FDA Product Approvals Will Mirror Prior CBER Directors

 
• By Sarah Karlin-Smith

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More from North America

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos For Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

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Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.