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EMA: Marinus Filing Up For An Opinion; Amylyx, GSK & Curium Due For Oral Explanations

 
• By Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, is meeting this week to discuss the EU marketing applications for a number of products that have reached the late stages of the regulatory review cycle.

European Flags in front of the European Commission Headquarters building in Brussels, Belgium
New drugs could be approved for use in the EU soon • Source: Shutterstock

Marinus Pharmaceuticals could learn this week whether the European Medicines Agency will recommend that its drug ganaxolone be authorized for marketing across the EU for treating epileptic seizures associated with cyclin dependent kinase-like 5 (CDKL5) deficiency disorder (CDD).

Key Takeaways
  • The latest monthly meeting of the European Medicines Agency's human medicines committee, the CHMP, is taking place on 22-25 May
  • Initial EU marketing applications for ganaxolone and enalapril maleate are up for a CHMP opinion

Ganaxolone, which is approved for use in the US as Ztalmy, is one of just two products that are listed as being up for an opinion on the

More from Europe

International Group Aims To Shape The Inevitable Future Of AI In Pharmacovigilance

 
• By Urtė Fultinavičiūtė

Pharmacovigilance is a perfect rule-based and manual work-intensive playground for experimenting with AI. While some off-patent drug firms are already exploring new automation tools, regulation is lagging behind, leaving a gap for uncertainty.

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

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

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

 
• By Eliza Slawther

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.

More from Geography

Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

US FDA Restoring Some Library Resources

 
• By Sue Sutter and Derrick Gingery

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

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.