Histogen is developing an extracellular matrix aimed at the aesthetics market as well as wound healing and research applications. Its technology derives from fibroblasts isolated from newborns, which are then seeded onto a bead-like structure and provided with growth media, where they secrete extracellular matrix proteins and growth factors. Because the fibroblasts come from newborns, they proliferate more rapidly and can last longer than fibroblasts from adults.
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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 information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.
The company highlighted the KLK2-targeting agent’s safety at ASCO but it may have to rely on combinations to make pasritamig competitive.
The drugmaker presented oral abstracts at the meeting for Libtayo in adjuvant cutaneous squamous-cell carcinoma and linvoseltamab in multiple myeloma.
