A U.S. FDA warning letter coming on top of an import alert suggests the agency doesn't trust India-based Aurobindo Pharma's quality control
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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 quarter saw strong growth overall, but the company now expects sales of Yescarta and Tecartus to fall for the full year 2025 versus 2024 thanks to competition.
Royalty deals are on track for another blowout year, but it’s not only because of a depressed biotech market. Large investment firms such as KKR are taking note.
The accelerated approval came three months after Jazz completed the acquisition of Modeyso’s developer, Chimerix.
