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Eliquis Delay Fuels Speculation About Advisory Committee Meeting

 
• By Emily Hayes

Three-month user fee extension for Bristol-Myers Squibb and Pfizer’s novel oral anticoagulant apixaban raises questions about whether an advisory committee panel will be convened after all, though the companies say none has been scheduled at this time.

A three-month delay for the review of Bristol-Myers Squibb Co./Pfizer Inc.’s novel oral anticoagulant Eliquis (apixaban) is fueling speculation about the potential for an FDA advisory committee meeting, even though the companies are stating that there are no plans for a panel “at this stage.”

One of a new breed of novel oral anticoagulants competing with warfarin, Eliquis is under review for prevention of stroke and systemic embolism in patients with atrial fibrillation. Upon announcing acceptance of the filing for Eliquis on Nov

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Recent and Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 
• By Michael McCaughan

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US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 
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Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.