The Skyrizi approval pairs an interleukin-23 antibody with an on-body injector for 720 mg subcutaneous induction in adults, per phase 3 AFFIRM data.
|Articles|June 1, 2022
Meeting Regulatory Needs in the Characterization of Lipid Nanoparticles (LNPs) for RNA Delivery via FFF-MALS
Author(s)Wyatt
The white paper discusses a validated FFF-MALS method in line with technical specification ISO/TS 21362 for the analysis of lipid-based nanoparticles (LNPs).
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Roche gains exclusive global rights to ZW209, a DLL3×CD3×CD28 trispecific T-cell engager designed for CD28 co-stimulation. A phase 1 study in small cell lung cancer and other neuroendocrine tumors is underway.
A Treasury proposed rule would restrict certain US investments in biotechnology in China and other countries of concern, raising questions about how cross-border licensing and joint venture deals will be treated.
Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
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