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Pharma Now Editorial Team
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Roche Gains FDA Priority Review Acceptance for Giredestrant NDA in Early-Stage ER-Positive Breast Cancer
FDA accepts Roche's giredestrant NDA under Priority Review; PDUFA date set for 30 November 2026 for early-stage ER-positive breast cancer.
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CellCarta and Leica Biosystems Expand Collaboration to Accelerate End-to-End Companion Diagnostic Development
CellCarta and Leica Biosystems expand their CDx collaboration, offering pharma sponsors an integrated framework spanning assay development to GMP manufacturing.
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Moderna Secures Up to $50M from CEPI to Advance mRNA Ebola Vaccine into Phase 1
CEPI commits up to $50M to fund Moderna's mRNA Ebola vaccine through preclinical and Phase 1 trials.
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Moderna and Merck Achieve Five-Year Survival Signal in mRNA Melanoma Vaccine Program
Moderna and Merck's mRNA-4157/V940 plus pembrolizumab combination shows five-year survival signal in melanoma, raising manufacturing and regulatory planning questions.
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