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Pink Sheet Podcast: Pfizer Pulls Sickle Cell Drug, ODAC Calls Back Approved Products, New AAM CEO

 
• By Pink Sheet Team

Pink Sheet reporters and editors discuss Pfizer’s abrupt decision to withdraw Oxbryta, the US FDA’s Oncologic Drugs Advisory Committee bringing sponsors of approved products back to discuss labeling changes while competitors are pending, and the new CEO of a generic industry trade association.

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Will more sponsors see advisory committees consider labeling changes for approved products along with their pending competitors? • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Reporter Alaric DeArment, and Interim Editor-in-Chief Nielsen Hobbs discuss the issues that lead Pfizer Inc. to pull the sickle cell disease treatment Oxbryta (voxelitor) from global markets (:32), the impact of the US Food and Drug Administration’s Oncologic Drugs Advisory Committee meeting about labeling changes for approved drugs along with pending competitors (10:46), as well as the decision by the Association for Accessible Medicines to name John Murphy, a former brand trade association executive, as its new president and CEO (27:34).

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More from US FDA Performance Tracker

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• By Bridget Silverman

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

Rapidly Rising RMAT Designations Crack CBER’s Communication Freeze

 
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More from US Advisory Committees

CDC Advisory Committee Postponement Upends Complex Regulatory Choreography

 
• By Bridget Silverman

The February meeting of US CDC’s Advisory Committee on Immunization Practices was indefinitely delayed to accommodate public comment, which did not open as scheduled on 3 February.

Pink Sheet Podcast: RFK’s First Actions, Pitch To Extend Current US FDA User Fee Agreement, More Trump Impacts

 
• By Derrick Gingery, Nielsen Hobbs, and Michael McCaughan

Pink Sheet editors and special guest Michael McCaughan of Prevision Policy discuss Robert F. Kennedy Jr.’s first act as HHS Secretary, former FDA Commissioner Scott Gottlieb’s suggestion that industry extend the existing user fee agreement rather than negotiate a new one, and President Trump’s policies impacting FDA advisory committee schedules and staffing.

US FDA Advisory Committee Freeze Raises Concerns Of Delayed, More Controversial Approvals

 
• By Sarah Karlin-Smith and Sue Sutter

HHS communications restrictions are keeping the FDA from publicly scheduling expected advisory committee meetings. The lack of upcoming meetings is raising concern about missed user fee dates or lower-quality agency decision-making.