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Ariad Took Dismissive View Of CV Events In Iclusig Labeling Proposals

 
• By Sue Sutter

FDA rejected two of the sponsor’s labeling proposals because they failed to adequately address safety issues seen in the PACE trial. Ariad apparently preferred to quantify in labeling only treatment-emergent adverse events that investigators attributed to ponatinib – an approach FDA disdains for single-arm studies.

FDA placed far greater weight on arterial thromboembolic and other cardiovascular events seen in the Iclusig (ponatinib) pivotal trial than did sponsor Ariad Pharmaceuticals Inc. when it came to labeling negotiations leading up to the leukemia drug’s December 2012 approval.

The agency outright rejected two of Ariad’s labeling proposals because they failed to adequately address safety

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US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

More from North America

Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
• By Bridget Silverman

The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.