1. Scrip

Semaglutide's CHMP Backing Stipulates Post-Approval Safety Studies

 
• By Sten Stovall

Novo Nordisk's once-weekly diabetes treatment semaglutide wins backing from EMA's top advisory panel one week after the GLP-1 agonist was approved in the US, the first country to do so. Safety studies have been required.

Recommended
Novo Nordisk's Ozempic (semaglutide) Gets Recommended For Approval By EMA's CHMP • Source: Shutterstock

Novo Nordisk AS has committed to conducting post-approval safety studies on semaglutide - including a long-term diabetic retinopathy outcome study - in return for regulatory backing for the GLP-1 therapy in Europe.

Ozempic, semaglutide's proposed brand name, is a glucagon-like peptide 1 (GLP-1) receptor agonist designed to improve glycemic control in adults,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

More from Scrip

Syncona Looks To Go Private As Market Decline Deepens

 
• By Andrew McConaghie

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

ASCO: Pushing The Frontiers Of ADCs

 
• By Mary Jo Laffler

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.