by Stacey Johnson | Jan 31, 2025
In a new location, with highways replacing waterways, it’s comforting to have an agenda with some consistent touchpoints for familiarity, and Advanced Therapies Week 2025 (ATW25), January 20-23 in Dallas, Texas, began with two of my favourites: the Super plenary,...
by Anis Fahandej-Sadi | Dec 5, 2024
If you’re reading this, you’re probably aware of the massive strides the cell and gene therapy (CGT) industry has made in the last few years. Between 2017 and 2022, six CGT products were approved by the U.S. Food and Drug Administration, but we saw eight approvals in...
by Kevin Robb | Aug 22, 2024
Last month, the U.S. Food and Drug Administration (FDA) agreed to formally review a revised Biologics License Application (BLA) from Mesoblast for their mesenchymal stromal cell (MSC) product, remestemcel-L. The submission represents the third attempt by the company...
by Laya Kiani | Jul 18, 2024
In last week’s post, “The role and impact of IP rights on innovation and investment in RM,” I discussed the importance of intellectual property (IP) rights in regenerative medicine (RM), highlighting how they drive innovation and secure competitive advantages....
by Laya Kiani | Jul 11, 2024
Intellectual property (IP) rights in regenerative medicine (RM) are crucial for sparking innovation and staying ahead in a competitive market. Protecting inventions through patents and other IP rights encourages investment by giving inventors exclusive market rights....
by Laine Bodnar | Jun 12, 2024
Have you wondered how many cell and gene therapies (CGTs) have been approved in Canada? So did I. To track the number down, I first turned to my trusty internet search engine with hopes that a list of Health Canada-approved CGTs would already exist online. Notably, it...
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