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The U.S. Pharmacopeia is taking a forward-looking, risk-based approach to protecting the supply chain for biological drug products from intentional and unintentional adulteration, even as it adds testing requirements aimed at preventing a new heparin crisis
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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
Rivals Mineralys could be first to file but AstraZeneca is banking on its cardiovascular market know-how to lead the emerging class.
Paying €90m upfront for rights to generalized pustular psoriasis drug.
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.