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Moderna

Moderna Reports the EC Approval of mNEXSPIKE to Protect Against COVID-19 

Shots:  The EC has approved mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (aged≥12 yrs)   Approval was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (aged ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination   mNEXSPIKE showed 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in a descriptive sub-group analysis mNEXSPIKE showed 13.5%…

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Hansoh Pharmaceutical Reports the EC Approval of Aumseqa for Non-small Cell Lung Cancer (NSCLC) 

Shots:  The EC has approved Hansoh Pharmaceutical’s Aumseqa (aumolertinib mesylate tablets), marketed as Ameile in China, for use as monotx. in adult pts with advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations in the 1L therapy, and for advanced EGFR T790M mutation-positive NSCLC  Aumseqa is an oral, third-generation EGFR tyrosine kinase inhibitor (TKI) that selectively targets mutated EGFR to inhibit tumor cell growth and reduce the spread of EGFR-mutated lung cancer, while…

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