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Top Stories
FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.
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Vertex will use the acquisition to develop cell-based treatments for type 1 diabetes.
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Industry News
The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.
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The company is voluntarily recalling BACTERIOSTATIC WATER for Injection, USP, 30 mL, multi-dose vial, lot W20308, to the hospital/retail level because of a lack of confirmation of sterilization for some vials from this lot.
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Supplier News
The organization will utilize the cancer center’s Research for Biologics and Immunotherapy Translation platform for the development of therapeutic monoclonal antibodies against a novel immune checkpoint target.
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The new antibody, Citryll’s CIT-013, could offer new treatment options for various human diseases including lupus, vasculitis, pulmonary fibrosis, and organ damage due to sepsis.
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Bio/Pharma News
Passage Bio has licensed a sixth gene therapy development program under its partnership with the University of Pennsylvania for the clinical development of a potential treatment for a nerve disorder.
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The agency has approved Boehringer Ingelheim's Ofev (nintedanib), its lung disease drug, for the treatment of patients with systemic sclerosis associated with lung disease
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Regulatory News
Xeris Pharmaceuticals has received FDA approval for GVOKE (glucagon), a liquid glucagon for treating hypoglycemia.
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A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.
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QUALITY
The authors provide an introduction to aluminum adsorbed vaccines, review studies of antigen stability, and propose test methods for the analysis of aluminum vaccine release and stability analysis.
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ANALYTICS
As regulatory guidance has evolved, changes in CCIT testing have also become apparent. In this article, possible CCIT strategy approaches are outlined.
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MANUFACTURING
Digital tools, such as building information modeling (BIM) software, improves efficiency for optimizing pharmaceutical facility design.
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