This app note demonstrates automation of the OligoWorks SPE Microplate Kit and protocol using the Andrew + pipetting robot and presents quantitative LC-MS data across a diverse set of oligonucleotide therapeutics spiked into plasma. Quantitative LC-MS results from the automated detergent-free workflow are compared to results from manual processing demonstrating equivalent performance as well as excellent reproducibility, underscoring the benefits of automating the OligoWorks SPE Microplate Kit: a streamlined sample extraction workflow, reduced errors, reproducible analytical method performance and enhanced lab productivity.
Accelerated approval for dostarlimab-gxly (Jemperli) pairs a single-arm phase 2 dataset with an FDA-authorized biomarker test and confirmatory requirements.
In the phase 3 SHINE-2 trial, half of pediatric patients who responded to mirikizumab induction were in clinical remission at week 52. Lilly plans to file for a pediatric UC label expansion.
Roche will take ex-China development of Hansoh’s two preclinical ADCs and multiple programs against Roche-proposed targets once Hansoh completes global phase 1a trials. The deal includes $400 million upfront and more than $15 billion in potential milestones.
Opus Genetics reports sustained vision gains with gene therapy, the FDA approves Roche’s Enspryng for at-home treatment of thyroid eye disease, and Estuary Biotherapeutics launches with $103 million to develop gene therapies for polycystic kidney disease.
When large pharmaceutical companies deprioritize drug candidates, smaller developers may license or acquire them, but due diligence, deal structure, and trial planning determine whether a program can move forward.