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PROs In Diabetes: FDA Panel Wanted Data Proving Insulin Icodec’s ‘Theoretical’ Benefits In Type 1

 
• By Sue Sutter

Patient-reported diabetes treatment satisfaction questionnaire used in Novo Nordisk’s ONWARDS 6 study had methodological shortcomings, US FDA said. Without reliable PRO data, benefits from a once-weekly injection remained theoretical, while hypoglycemia risks were real, panelists said.

Once a week
Novo failed to prove the benefits of once-weekly basal insulin dosing. • Source: Shutterstock

US Food and Drug Administration advisory committee members have a message for biopharma sponsors: If you’re going to claim that a reduction in doses improves adherence, you’d better show proof.

Panelists at the recent Endocrinologic and Metabolic Drugs Advisory Committee meeting on Novo Nordisk A/S’s once-weekly insulin icodec found...

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Complete Response Letter Trio Raises Prospect Of Tidal Shift In Regenerative Medicine Regulation

 
• By Bridget Silverman

Replimune's RP1 oncolytic immunotherapy became the third regenerative medicine to receive an FDA complete response letter this month as the agency appears to re-visit previous agreements about accelerated approval.

US FDA’s Second Half 2025 User Fee Goals Swing Toward Respiratory Disease

 
• By Bridget Silverman

The 43 novel agents with user fee goal dates in the remainder of 2025 have fewer oncologics and infectious disease drugs than the first half of the year.

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

More from Regulatory Trackers

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.