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  1. Nicox’s NCX 470 new drug application submitted in the United States by Kowa The submission is based on positive results from two Phase III clinical trials (Mont Blanc and Denali)
  2. Thermo Fisher's Patheon becomes exclusive third-party CDMO for KinetiSol technology The agreement will install KinetiSol Formulator equipment across Patheon's Bend and Cincinnati OSD sites, offering pharma customers an integrated development-to-commercial pathway for poorly soluble drug candidates
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    Annex 1 at the transfer point: how to meet the evolving evidence challenge As Annex 1 raises expectations for contamination control, transfer-point evidence must become more dynamic, connected and defensible throughout the entire product lifecycle
  4. Sanofi offers EU commitments for flu vaccine disparagement claims Sanofi has proposed remedies to EU antitrust regulators after allegations it disparaged rival CSL Seqirus's Fluad vaccine in Germany and France since 2024
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    Back to basics: a simple guide to checkweighing in pharmaceutical production Mettler-Toledo’s Miriam Krechlok tells Dr Kevin Robinson how checkweighing helps pharmaceutical manufacturers to verify product completeness, control fill levels and maintain compliance, safety and efficiency

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