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Top Stories
The $8-billion acquisition will broaden Lilly's oncology portfolio in precision medicines and treatments that target cancers caused by specific gene abnormalities.
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The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.
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Industry News
The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.
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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) revealed 22 new projects and funding aimed to advance US biopharmaceutical manufacturing.
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Biopharma News
The companies entered a license agreement for the Trianni Mouse, a transgenic mouse R&D platform for the discovery of fully-human monoclonal antibodies (mAbs), to support MacroGenics' discovery programs for mAb-based therapeutics.
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The companies will collaborate to improve the manufacturability for two of Sanofi's biotherapeutics.
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Supplier News
Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.
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Agenus will leverage Selexis' SUREtechnology Platform to progress Agenus' portfolio of next-generation antibody programs.
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Regulatory News
The plan details five goals to guide the development of Sentinel, a national electronic system for medical product safety surveillance established as part of the FDA Amendments Act of 2007, over the next five years.
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Biosimilars and biobetters have their own unique manufacturing strategies and challenges.
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