MaaT’s FDA Woes Highlight Rocky Regulatory Path For Microbiome-Based Therapies
Clinical Hold Remains On Graft-Versus Host Disease Drug
Executive Summary
The French firm's lead microbiome therapy has been on clinical hold in the US for a year and continuing concerns about MaaT's 'pooling' approach (mixing donations from multiple donors) suggests the wait to restart trials will not be a short one.
You may also be interested in...
Ferring Chief Muses On Moment Of Truth For Microbiome Therapy
When the Swiss company files RBX2660 in the US later this year to reduce recurrences of Clostridioides difficile infection, it will be the first time any firm has tried to get a non-antibiotic product approved to address an infectious disease. Ferring president Per Falk tells Scrip about the 35-year journey to get to this stage and why standardization is key when it comes to microbiome-based therapy.
Fresh Data Pushes Microbiome Pioneer Ferring Closer To Approval Line
The promise of microbiome-based therapeutics to treat a variety of diseases has become a hot topic and the first to get to market will be targeting Clostridioides difficile infection. Ferring and its subsidiary Rebiotix are in pole position.
Scrip M&A Podcast: Which Companies Could Be Acquired Next?
The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.