FDA proposes new clinical trial pathway to accelerate development timelines
Under new proposals led by FDA Commissioner Marty Makary, the agency is exploring a new clinical trial initiation pathway as a faster, less burdensome alternative to the traditional IND process. This approach would allow certain therapies to enter clinic with reduced regulatory friction, in part to ensure the US remains competitive with faster moving markets such as China.
Read more via Fiercepharma →
Mesoblast advances Duchenne cell therapy with FDA IND clearance
Mesoblast has received IND clearance from the FDA to process with a registrational trial for its cell therapy, Ryoncil in Duchenne muscular dystrophy. The therapy, which targets inflammation-driven disease progressions, is now positioned to move into a late-stage study supporting potential approval. Proceeding directly to a registrational trial reflects the strength of Ryoncil’s existing safety record in children and underscores the FDA’s willingness to leverage real-world data from approved products to accelerate development in new indications.
Read more via First World Pharma → https://firstwordpharma.com/story/7174711
RoosterBio and MineBio partner to expand MSC and exosome manufacturing capabilities in China
RooserBio and MineBio Life Sciences have announced a strategic partnership to expand access to scalable MSC and exosome bioprocessing solutions in China. The collaboration aims to support local developers with high-quality, standardised manufacturing inputs for cell and exosome-based therapies. This partnership highlights growing efforts to industrialise exosome production and expand access to enabling technologies in key global markets. For the industry, it reinforces the importance of manufacturing infrastructure and standardisation in supporting the next wave of CGT innovation
Read more via PR Newswire → https://www.prnewswire.com/news-releases/roosterbio-and-minebio-life-sciences-partner-to-expand-access-to-scalable-high-quality-msc-and-exosome-bioprocessing-solutions-in-china-302736060.html
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