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Riding High, Victoza Hopes To Gain Ground Over Popular DPP-4s With Label Change

 
• By Emily Hayes

FDA label now notes superior efficacy and greater weight loss for Novo Nordisk’s injectable GLP-1 receptor agonist Victoza vs. Mercks’ DPP-4 inhibitor Januvia. Superiority would be expected for a GLP-1, but label still has potential to encourage earlier use of the class.

Novo Nordisk AS’s popular injectable GLP-1 receptor agonist Victoza (liraglutide) for type 2 diabetes should get a bit of a boost from a label change that adds a claim of superior blood sugar control and greater weight loss compared to Merck & Co. Inc.’s oral DPP-4 inhibitor Januvia (sitagliptin).

Based on results from two randomized controlled studies, Victoza’s label was revised April 6 to note superior efficacy compared to...

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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.

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• 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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US FDA To Advisory Committee Industry Reps: Don’t Talk Too Much

 
• By Sue Sutter

Nonvoting industry representative’s presence at Pediatric Advisory Committee meeting was required by statute, the agency said, a de facto acknowledgement that an April directive precluding industry reps from sitting on advisory committees has had little practical effect.

New US FDA Biologics License Pathway Could Be Missing Link To Reduce Animal Testing

 
• By Bridget Silverman

Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.

Capricor Gets Complete Response For DMD Cell Therapy: Unconvincing Data Or New Attitude At FDA?

 
• By Joseph Haas

Seven weeks before its action date and a month after an advisory committee was hastily cancelled, Capricor gets a CRL for its cell therapy deramiocel in DMD-related cardiomyopathy citing efficacy and manufacturing concerns. It has a Phase III study nearing readout, though.