Optivia Biotechnology Inc. is positioned to help drug developers address clinically significant transporter-related drug-drug interactions. In addition to its polarized mammalian cell assay, it is developing a platform for studying transporter biology and optimizing drug discovery and development.
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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
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Following US approval of its first-in-class drug for IgAN sibeprelimab, Otsuka is planning an sNDA for an autoinjector in 2026 and is in talks with regulatory authorities in Japan and Europe.
The growth of China’s biopharma sector has been perhaps the most significant sector trend this year – Scrip outlines five themes that have emerged during 2025 and in discussions at the recent Jefferies conference in London.
