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Why Novartis Rejected Access Consortium In Favor Of Direct UK Radioligand Filing

 
• By Francesca Bruce

A direct marketing authorization application to the UK medicines regulator offered a quicker route to approval for Novartis’ prostate cancer treatment Pluvicto than following the international Access Consortium process, because of the novel nature of the therapy, according to the company.

Prostate Cancer Cell
MHRA is first European regulator to authorize Novartis' prostate cancer radioligand therapy • Source: Shutterstock

Novartis AG decided against using the international Access Consortium work-sharing procedure to obtain a marketing authorization for its radioligand therapy Pluvicto in Great Britain because it felt that a direct application to the UK regulator, the MHRA, would be faster.

The Access Consortium had not yet assessed a radioligand therapy (RLT), which is an emerging treatment approach, so it was felt that the consortium process would have been slower to deliver an

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More from Europe

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

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EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
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The European Health Data Space Regulation is deliberately “vague” when it comes to defining trade secrets because the EU wants the pharma industry to make recommendations on safeguarding intellectual property, a policy officer for the European Commission says.

Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 
• By Neena Brizmohun

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

More from Geography

Recent and Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
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