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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...

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England Prioritizes SGLT-2s & GLP-1s In Diabetes Market Access ‘Shake Up’

 
• By Neena Brizmohun

Recommendations from the health technology assessment institute, NICE, reflect a strategic shift from treating type 2 diabetes to proactively preventing future complications of the condition.

UK Tests Risk-Proportionate Review Of Substantial Clinical Trial Amendments

 
• By Vibha Sharma

Sponsors running clinical trials in the UK can get a decision on their applications to make substantial but low-risk amendments to their studies within 14 days under a pilot that is testing a streamlined pathway ahead of new clinical trial regulations coming into force in April 2026.

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

More from Geography

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Boosting EU Clinical Trials: EMA Opens Dialogue With Global CRO Group

 
• By Vibha Sharma

The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.

Zimbabwe Tackles Medicines Falsification With New Requirements For Pharma

 
• By Neena Brizmohun

The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.