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Novo Nordisk’s Liraglutide Gets Panel Nod For Weight Management

 
• By Sue Sutter

Advisory committee members are generally comfortable with use of the GLP-1 receptor agonist in the first-line setting, suggesting that a second-line treatment restriction in diabetes could be lifted.

An FDA advisory committee’s endorsement of Novo Nordisk AS’ liraglutide for chronic weight management also could mean a broader label for the glucagon-like peptide-1 receptor agonist’s current use in type 2 diabetes.

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More from United States

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
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Makary’s Reorganization Decision A Turning Point For US FDA?

 
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US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

More from North America

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
• By Sue Sutter

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