1. Scrip
  2. >>New Products

Novo Nordisk Using Priority Review Voucher To Propel Oral Semaglutide To Market

 
• By Sten Stovall

Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time for expected approval to six months.

Track
Novo Nordisk Aims to cut FDA review time to six months for its oral GLP-1. • Source: Shutterstock

Prospects of a 2020 market arrival for Novo Nordisk AS’s ground-breaking oral GLP-1 diabetes therapy remain on track, propelled by solid clinical trial data and a priority review voucher purchased by the Denmark-based group to speed the process.

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

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Leqembi Launch Set For Germany And Austria As EU Approval Finally Comes

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Stock Watch: Dollar Weakness, Tariffs, Biosimilars In J&J’s Q1 Mix

 
• By Andy Smith

Announcing increased full-year earnings guidance and another dividend increase, Johnson & Johnson’s stock price weakened, outweighed by concerns about the replacement of Stelara revenues and possible drug import tariffs.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Roche US Exports To Exceed Imports After New $50bn Investment

 
• By Andrew McConaghie

A brand new R&D center in Massachusetts and a giant manufacturing site for its future obesity drugs are among the key investments in the US.