COVID-19 Vaccine Skycovion Among Raft Of New EU Filings

EU marketing authorization applications for 12 products, including Skycovion, trastuzumab duocarmazine, alpelisib and sparsenta, are now being evaluated by the European Medicines Agency.

The EMA is reviewing new drugs for potential use in the EU • Source: Alamy

The European Medicines Agency has begun reviewing EU marketing authorization applications (MAAs) for a raft of new products, including SK bioscience’s COVID-19 vaccine, Skycovion, and Byondis’s trastuzumab duocarmazine, for treating HER2-positive metastatic breast cancer.

Skycovion (GBP510), which was approved in South Korea in June, is a recombinant protein-based COVID-19 vaccine candidate adjuvanted with GSK’s pandemic adjuvant. The MAA for the product is being reviewed under the EMA’s conditional marketing authorization (CMA) pathway

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

More from Product Reviews

More from Pink Sheet

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

 

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.

Global Pharma Guidance Tracker - April 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Medicare Negotiation Does Not Violate Due Process, Appeals Court Rules, Other Suits At Risk

 
• By 

Decision in AstraZeneca’s lawsuit against the Health and Human Services Department is a precedent-setting victory for the government and a blow to manufacturer efforts to block the price negotiation program.