1. Pink Sheet
  2. >>Geography
  3. >>Europe

EMA And Commission Correct Altuvoct, Celldemic, Lytenava Active Substance Status Discrepancies

 
• By Ian Schofield

Lytenava, Outlook Therapeutics’ ophthalmic version of bevacizumab for wet AMD, has been given the INN bevacizumab gamma, but it is not a new active substance, the EU authorities have confirmed.

The question of what's new surrounded by wooden blocks
Determining what is a new active substance can be tricky. • Source: Shutterstock

The European Medicines Agency and the European Commission have clarified the “new active substance” (NAS) status of a number of newly authorized products after conflicting information was published on their respective websites.

The discrepancies were picked up by the Pink Sheet during the compilation of data on first-half EU approvals of NAS-containing products

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Europe

More from Geography

Inclusive By Design: UK Pilots Diversity Plans For Drug & Device Trials

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

FDA Use Of Artificial Intelligence Will Help US Retain Biotech Leadership

 
• By Sue Sutter and Derrick Gingery

At a House subcommittee hearing, HHS Secretary Robert F. Kennedy Jr. rebutted lawmaker concerns that NIH cuts will drive research and scientists to other countries and said he does not want to advise parents on vaccinating children for measles, chickenpox or polio.