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2013 Diabetes NMEs Span Classes, But Safety Is A Review Issue For All

 
• By Bridget Silverman

The repercussions of FDA’s 2008 guidance on cardiovascular risk evaluation in diabetes trials are still being felt in reviews of new agents. Pending applications include two GLP-1 agonists, the third review of a DPP-IV inhibitor, a possible first-in-class SGLT-2 inhibitor and a long-acting basal insulin, and safety is a major review issue for all of them.

Four years after FDA promulgated its guidance on assessment of cardiovascular risk in type 2 diabetes therapy trials, cardiovascular safety remains a major hurdle in reviews of new anti-diabetic agents.

FDA reviewers will address new agents in four major categories of recent diabetes advances – glucagon-like peptide 1 agonists, dipeptidyl peptidase IV inhibitors, long-acting basal insulin and the yet-to-be-approved sodium...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

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.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.