Gene therapy has yet to become a popular treatment for any disease, but vectors originally developed for that purpose may soon give rise to treatments for chronic infections including hepatitis C and malaria. Okairos SRL is working to commercialize therapies based on viral vectors it acquired when Merck & Co. Inc. agreed in 2007 to spin out the technology from IRBM, a small subsidiary in Rome, Italy.
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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.
Senior Indegene executive William Lobb talks about complexities of the direct-to-patient distribution model in the US and underlines that it isn’t a comprehensive healthcare fix. Feasibility of MFN pricing and why it may be “catastrophic” to the industry were some of the other topics discussed.
In this week's episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion.
