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Pharma Now Editorial Team
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Pharma Now Editorial Team
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Pharma Now Editorial Team
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ENSPRYNG Phase III Data Sets Stage for MOGAD Label Push
Roche's ENSPRYNG cuts MOGAD relapse risk by 68% in Phase III, signaling potential BLA/MAA filings and CMC obligations for biologics teams.
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Ultomiris Phase III Interim Data Signals Capacity Reckoning for Biologics Makers
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Pharma Now Editorial Team
EU's First Combined mRNA Flu/COVID Approval Resets Combination Vaccine CMC Expectations
Moderna's EU approval for the first combined flu/COVID mRNA vaccine resets CMC, cold chain, and batch release expectations for combination vaccine manufacturers.
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Deramiocel Phase 3 Data Raise Stakes for Allogeneic Cell Therapy Manufacturing
Capricor's HOPE-3 Phase 3 DMD data, presented at AAN 2026, intensify focus on allogeneic cell therapy manufacturing ahead of an August 22 PDUFA date.
Pharma Now Editorial Team
