Cephalon is making a significant bet on an Australian biotech's adult stem cell technology, taking it forward in multiple indications, including some fields where it isn't currently active, but which its executives say it can get up to speed on quickly. The deal is the specialty pharma company's fourth in biologics since it announced nearly two years ago that expanding into biologics would be a priority
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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
In this week's episode: J&J delivers in Q2 despite Stelara drop; Sarepta cuts jobs as Elevidys slumps; AI is inevitable but needs to be applied appropriately; China’s mid-cap companies thrive; and a look behind Glenmark’s landmark trispecific deal.
A deal last year with Sanofi relieved Novavax of commercial costs for the COVID-19 vaccine Nuvaxovid, allowing the company to focus on R&D and finding partners for its other vaccines.
Drug manufacturers may find comfort in the appointment of former biotech CEO and entrepreneur George Tidmarsh to lead the FDA’s Center for Drug Evaluation and Research.
