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Keeping Track: Xermelo, Odactra, Noctiva Approved; Second Submissions For Avelumab And Deutetrabenazine

 
• By Bridget Silverman and Emily Hayes

The latest drug development news and highlights from our US FDA Performance Tracker.

FDA issued approval letters for two novel agents in the last week: Lexicon Pharmaceuticals Inc.'s Xermelo and ALK-Abello AS's Odactra.

Odactra, a sublingual house dust mite allergen extract, is the first novel biologic to come out of the Center for Biologics Evaluation and Research (CBER) in 2017

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Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

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

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

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

 
• By Sue Sutter and Derrick Gingery

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.