4Tech Inc.
Hardip
Start-Up Execs On The Move, April 2016
Recent executive-level hires and director appointments at venture capital firms and biopharma and medtech start-ups.
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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.
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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
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Vertex is in need of diversification, but in addition to its lower-than-expected Q1 revenue, sales of the company’s newest CF drug Alyftrek and pain medicine Journavx disappointed.
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The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.
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The biotech said it will have a type A meeting with the agency to resubmit for the cell therapy’s approval in EBV+ PTLD.