Cell Therapy Plots European Conditional Approval For Heart Regeneration Product

 
• By Sukaina Virji
  
Generate a summary of this article
Listen to this article
Beta

Cell Therapy Ltd says that following a pre-submission meeting with the European Medicines Agency (EMA) in September, it now plans to begin applying for a conditional marketing authorization (CMA) for Heartcel, its lead allogeneic stem cell therapy, which has been designed to regenerate the heart. Filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017.

Cell Therapy Ltd says that following a pre-submission meeting with the European Medicines Agency (EMA) in September, it now plans to begin applying for a conditional marketing authorization (CMA) for Heartcel, its lead allogeneic stem cell therapy, which has been designed to regenerate the heart. Filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017.

Cell Therapy's CEO Ajan Reginald (previously Roche's global head of emerging technologies) spoke to Scrip earlier this year in...

Scrip Podcast

Keep up with the top pharma business news of the week. On the go.

Scrip brings you a weekly bulletin of top picks.

SpotifyApple PodcastsWebsite

More from Cardiovascular

Aerovate Tanks On Trial Catastrophe

 
• By Elizabeth Cairns

A disastrous Phase II miss for the pulmonary arterial hypertension candidate AV-101 leaves Aerovate drifting. Could Gossamer stand to benefit?    

Cagrisema Leads The Charge For 2025

 
• By Elizabeth Cairns

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

Evidence Growing For GLP-1s To Treat Alzheimer’s And Parkinson’s

 
• By Andrew McConaghie

GLP-1 receptor agonists could play a big role in tackling neurodegeneration and a new academic study has raised expectations of Novo Nordisk’s latest semaglutide Phase III results

Kerendia Could Be Next Jewel In Bayer's Pharma Crown

 
• By Kevin Grogan

CEO Bill Anderson would not be drawn on whether the drug, currently approved for chronic kidney disease associated with type 2 diabetes, will hit a previous forecast of €3bn peak sales, but expansion into heart failure may make that figure look conservative.

More from Therapeutic Category

Scrip Data Article Without An Author

"Neque porro quisquam est qui dolorem ipsum quia dolor sit amet, consectetur, adipisci velit..."

Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]

Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.

Fosun ALK/ROS1 Inhibitor Shows 1L Promise In Advanced NSCLC

Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.