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Latest From Kite Pharma

EU Approval Decision Imminent For First CD20xCD3 Bispecific Antibody

If Roche gets the nod from the European Medicines Agency for mosunetuzumab this week, it could become the first company to market a CD20xCD3 bispecific antibody for follicular lymphoma.

Europe Approvals

Proactive US FDA Propelled Review Of Genentech’s Actemra In Systemic Sclerosis Amid Evolving Regulatory Landscape

Pink Sheet’s Drug Review Profile series looks at the unusual history of a systemic sclerosis interstitial lung disease indication for Genentech’s Actemra that was revived at the FDA’s behest and vetted by CDER’s high-level CDER policy council.

Drug Review Profile Approvals

CAR-T Manufacturing: Guidance Anticipates Platform Challenges And Opportunities

Draft from US FDA advises sponsors on how to draw from platform knowledge, while anticipating issues associated with emerging centralized and distributed manufacturing approaches for autologous and allogeneic products and their viral vectors.

Manufacturing Gene Therapy

CAR-T Cell Product Development Guidance Covers Previous Recipients, ‘Bridging Therapy’

Testing of autologous therapy in clinical trial patients who previously received CAR-T cells requires special consideration in initial material testing and study design, US FDA says in a draft guidance that also addresses potential need for bridging therapy in the event of a manufacturing delay or failure.

Gene Therapy Guidance Documents
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