由于FDA的制造问题,ImuCell停止了Re-Tain乳腺炎药物的开发,将重点转移到其第一防御小牛产品. ImmuCell halts Re-Tain mastitis drug development due to FDA manufacturing concerns, shifting focus to its First Defense calf product.

ImmuCell已停止进一步发展其Re-Tain胸膜炎药物,因为林业发展局签发了一份不完整的核准书,其中列举了合同设施中尚未解决的制造问题。 ImmuCell has halted further development of its Re-Tain mastitis drug after the FDA issued an incomplete approval letter citing unresolved manufacturing issues at its contract facility. 该公司将把资源转用于第一家国防小牛保健产品,将销售力量扩大50%,并增加产量,以解决440万美元的积压问题。 The company will redirect resources to its First Defense calf-health product, expanding its sales force by 50% and boosting production to address a $4.4 million backlog. 预计2025年第4季度将收取230万美元的非现金费用。 A $2.3 million non-cash charge is expected in Q4 2025. 虽然Re-Tain的发展暂停, ImmuCell计划探讨药品的许可或合伙关系。 While Re-Tain’s development is paused, ImmuCell plans to explore licensing or partnerships for the drug. 该决定反映了小型生物技术在依赖第三方制造商时在林业发展局遵守规定方面遇到的挑战。 The decision reflects challenges small biotechs face with FDA compliance when relying on third-party manufacturers.