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

Sanofi ‘Strongly Disagrees’ With EMA Rejection Of NAS Status For Nexviadyme

 
• By Neena Brizmohun

Sanofi argues that the European Medicines Agency applies a narrow interpretation of its new active substance principles which is not appropriate for biological therapies, and that the regulator fails to consider the challenges of conducting clinical research in rare diseases.

Doctors and medical researchers on conference meeting, discussing possible solutions for resolving a world health crisis.
Sanofi says the CHMP's rejection of NAS status fails to recognize and reward innovation • Source: Alamy

Sanofi Genzyme is urging the European Medicines Agency to redefine the methodology it uses to assess the new active substance (NAS) status of biological products, especially those for rare diseases, after the regulator concluded that the company’s Pompe disease drug, Nexviadyme (avalglucosidase alfa), did not qualify as a NAS.

“Avalglucosidase alfa could not be considered to be a new active substance because there was not enough difference between avalglucosidase...

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

Room For Improvement? EU Industry Prepares Feedback For SPC Manufacturing Waiver Review

 
• By Dave Wallace

As the European Commission prepares a formal evaluation of the SPC manufacturing waiver, the generics and biosimilars industry is getting ready to provide detailed feedback on what works – and what doesn’t. At Medicines for Europe’s legal affairs conference, delegates heard the latest updates.

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 
• By Francesca Bruce

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

UK HRA Sets Targets For Digital Overhaul, Trial Transparency And Trust

 
• By Vibha Sharma

The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.

More from Geography

Report Shows Extent Of AI Use In EU Medicines Regulation During 2024

 
• By Eliza Slawther

The AI observatory, created by the European medicines regulatory network to track the evolving use of artificial intelligence in medicines development and regulation, has issued its first annual report.

Prasad Cites Unproven Theory Defending His COVID-19 Vaccine Decisions

 
• By Sarah Karlin-Smith

In defending his decision to overrule agency staff on three recent COVID-19 vaccine applications, the CBER director questioned the original timing of Pfizer’s COVID-19 vaccine authorization, reviving a long-held, but unproven grievance of President Trump.

33 States Agree To Standardized Access Policies In Medicaid Sickle Cell Payment Demo

 
• By Alaric DeArment and Cathy Kelly

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.