The trial clearance for Shanghai-based Unixell is another step forward for the rapidly advancing Chinese biotech ecosystem, which has invested heavily in cell and gene therapy technology.
Ugur Sahin and Özlem Türeci, who directed the COVID vaccine maker’s rise to prominence, will helm an as-yet-unnamed company ...
Evotec will cut 800 employees in its second layoff round since 2024. Elsewhere, Ultragenyx got a needed win and a twice-rejected cell therapy is getting an audience at the FDA.
More early-stage data show the drug, called salanersen, appeared to have positive effects on neurodegeneration and motor function in patients previously treated with Novartis' Zolgensma.
Xenon shares skyrocketed nearly 50% on results that handily beat Wall Street expectations. Elsewhere, Capricor got a decision date for a spurned cell therapy and AbbVie and Regeneron showcased obesity ...
The detection of certain cardiac issues in a study of healthy volunteers led Aardvark to pause a Phase 3 trial only months before an expected data readout.
The proposed acquisition would hand Servier a couple experimental drugs in human testing as well as Ojemda, an approved ...
Cell therapy manufacturing is uniquely vulnerable to contamination, variability, and operational burden because the product - ...
Combining the disparate databases used to detect potential issues with drugs, vaccines and other products into a single dashboard will enhance their utility and cut costs, the agency said.
Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo.
The approval represents a win in what’s been a difficult regulatory environment of late for vaccine makers, and could boost uptake of a shot that’s posted flattening sales after an initially strong ...
The agency acted after reviewing mouse data submitted in 2024, making the timing of the new pause “confusing,” one analyst wrote.
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