First Lassa Fever Vaccine Wins EMA PRIME Designation; Advanced Therapies Dominate 2024 Entries

Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.

Lassa fever viruses, 3D illustration
There are no approved vaccines for Lassa fever (Shutterstock)

IAVI’s rVSVdeltaG-LASV-GPC, which is the first Lassa fever vaccine candidate to be evaluated in a Phase II trial, is among the first two products in 2025 to secure a place on PRIME, the European Medicines Agency’s priority medicines scheme for drugs for unmet medical needs.

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First Lassa Fever Vaccine Wins EMA PRIME Designation; Advanced Therapies Dominate 2024 Entries

 

Two investigational products have made it onto the European Medicines Agency’s priority medicines scheme so far this year. Meanwhile, of the 14 products that entered the scheme last year, six were advanced therapies.

EU Approvals

Products containing new active substances that have been approved for marketing in the EU under the EU’s centralized authorization procedure. Updated monthly.

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EMA Recommends EU Approval For Averoa’s Xoanacyl And Four Other Drugs

 

The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.

European Regulator Deals Blow For Lilly’s Alzheimer’s Drug Kisunla

 

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Recent And Upcoming FDA Advisory Committee Meetings

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