Spectral Genomics Inc., aims to become one of the first, if not the first, to bring a diagnostic microarray through to FDA approval. Spectral belives its BAC clone arrays offer major advantages in detecting large scale chromosomal amplifications, deletions and rearrangements characteristic of cancers and many congenital defects. The speed and universality of the arrays make them potentially practical for low-cost, high-speed, and targeted diagnostic purposes.
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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
The FDA go-ahead makes it the first for a BTK inhibitor in immune thrombocytopenia. Sanofi hopes it will mark the start of a number of indications for rilzabrutinib.
Alnylam and Roche refine zilebesiran’s Phase III trial design after a Phase II miss, focusing on patients on diuretics.
In this week's episode: Lilly’s orforglipron strong in diabetic obesity; Ascletis confident in oral GLP-1 challenger; myostatin drugs progress for obesity; an interview with OneSource’s CEO; and an analysis of Dupixent’s pipeline-in-a-product success.
