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Savaysa A-Fib Data Led To Conflicting FDA Views On Dose, Population

 
• By Sue Sutter

Reviewers debated whether to approve Daiichi’s oral anticoagulant only for atrial fibrillation patients with renal impairment or a higher-than-tested dose for those with normal renal function. Disagreements over how to handle renal subgroup efficacy findings also led to differences of opinion on the need for a REMS.

Before FDA could approve Daiichi Sankyo Inc.’s Factor Xa inhibitor Savaysa (edoxaban) for stroke risk reduction in atrial fibrillation patients, the agency had to overcome numerous differences of opinion – both internally and among its external advisors – on some unexpected efficacy findings in the pivotal trial.

Agency staff within and across review disciplines were divided on what to do about a significant interaction between edoxaban efficacy...

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Initial Medicare Price Offer For Ozempic, Wegovy Almost Half Off Net, Analysis Suggests

 
• By Cathy Kelly

Only Bausch Health’s Xifaxan may have had a lower initial offer among the 15 drugs in the current Medicare price negotiation round, researchers at the University of Washington and the University of California, San Diego, projected.

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• By Sue Sutter

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Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
• By Derrick Gingery

The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.

More from North America

Will US FDA’s Missed Hiring Goals Impact Upcoming User Fee Negotiations?

 
• By Derrick Gingery

The FDA only added 39% of the promised new user fee-related hires in FY 2025 and also missed hiring goals for the previous two fiscal years.

Legal ‘Squishiness,’ DoJ Reorganization Could Shape Ad/Promo Enforcement Strategy

 
• By Sue Sutter

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First Cohort Shows Many Routes To US FDA’s Commissioner’s National Priority Voucher

 
• By Sarah Karlin-Smith

Experts raised concerns about the pilot program's larger than expected size and the lack of transparency about the reasons the cohort deserved vouchers over a pool that the FDA said included hundreds of candidates.