Protometrix's microarray technology enables it to produce, purify, and assay thousands of proteins at once on a solid surface. With this skill set, the company believes it can become the first firm able to offer drug developers the ability to scan the entire human proteome in a high-throughput setting.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Recent moves in the industry include C-suite changes at Mitsubishi Tanabe Pharma and Oculis Holding, plus clock.bio gets a new chief business officer from BioNTech.
Approval in alpha- and beta-thalassemia by a Sept. 7 action date seemed assured, but an FDA review of proposed REMS regarding potential liver injury pushed it back to Dec. 7.
Amgen and Zai Lab said the final analysis of the FORTITUDE-101 trial showed a decreased magnitude of OS benefit in first-line gastric cancer.
