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Policy & Medicine 12/05/2019 05:05
Last week, the US Food and Drug Administration (“FDA”) released a draft guidance which provides recommendations regarding the need for comparative clinical immunogenicity studies to support biosimilar insulin applications. The draft, entitled Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products, is intended to “facilitate the development of, and improve patient access to, life-saving insulin […]
PR Newswire 12/02/2019 20:00
TOKYO, Dec. 2, 2019 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the presentation of new data in acute myeloid leukemia (AML) at the 61st American Society of Hematology (ASH) Annual Meeting, taking place Dec. 7-10...

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