Astellas Pharma, Inc.
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Latest From Astellas Pharma, Inc.
Gene And Cell Therapy Clinical Holds Decline While Those For Drugs Hit 12-Year High
FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.
Products Targeting Alzheimer's, Duchenne & COVID-19 Among New EU Filings
EU marketing authorization applications have been submitted for a number of new drugs, including Eli Lilly’s donanemab, Italfarmaco's givinostat and Arcturus Therapeutics/CSL’s ARCT-154.
Finding The Sweet Spot For Real-World Evidence: Aetion Stresses Early Feasibility Assessment
Robust natural history data sets with well-chosen outcomes are fundamental in Aetion’s regulatory feasibility tool for real-world evidence, built through analysis of US FDA case studies and guidance.
Seagen, Astellas Data Support Broader Indication For Padcev/Keytruda Combo
With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval.
Company Information
- Industry
- Pharmaceuticals
- Other Names / Subsidiaries
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- Advanced Cell Technology, Inc.
- Agensys, Inc.
- Audentes Therapeutics, Inc.
- Fujisawa GmbH
- Ganymed Pharmaceuticals AG GmbH
- iota Biosciences
- Mytogen, Inc.
- Nanna Therapeutics Limited
- Perseid Therapeutics LLC
- Potenza Therapeutics Inc.
- Ocata Therapeutics, Inc.
- OSI Pharmaceuticals, LLC (Cell Pathways
- Prosidion)
- Yamanouchi Pharmaceutical Co., Ltd.
- Ogeda S.A.
- Mitobridge, Inc.
- Mitokyne, Inc.
- Quethera Limited
- Universal Cells, Inc.
- Xyphos Biosciences, Inc.
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