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Can Iclusig Return To Market? Ariad Sees Path Through Restricted Distribution REMS

 
• By Sue Sutter

Company reluctantly agrees to FDA’s request to suspend sales of ponatinib due to serious thrombotic risks while a narrower label and Risk Evaluation and Mitigation Strategy are negotiated. FDA cites serious adverse vascular event rates of 48% and 24% in Phase I and II ponatinib trials, respectively.

Ariad Pharmaceuticals Inc.’s hopes for restarting sales of Iclusig (ponatinib) hinge on the company’s ability to identify, to FDA’s satisfaction, a patient population for whom the leukemia drug’s benefits outweigh its thrombotic risks and to create an appropriate Risk Evaluation and Mitigation Strategy with a restricted distribution program.

Ariad announced Oct. 31 that it has temporarily suspended marketing and commercial distribution of Iclusig while it negotiates with FDA over labeling changes that would further narrow the kinase inhibitor’s...

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More from United States

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• By Francesca Bruce

Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.

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• By Laura Helbling

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Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
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Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

More from North America

US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
• By Sarah Karlin-Smith

The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

Webpages, a healthcare professional pamphlet and a medical conference exhibit booth panel make unsupported comparative superiority claims about generic torsemide products and misrepresent risks, the Office of Prescription Drug Promotion says in its first warning letter of 2025.

MAHA Commission Outlines Enhanced Research On Drug Safety In Children

 
• By Cathy Kelly

Research would include initiatives on reproducing industry-sponsored studies, postmarket surveillance, and studies of long-term neurodevelopmental and metabolic outcomes for commonly prescribed pediatric drugs.