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U.S. Food and Drug Administration (FDA) - Articles and news items

Whitepaper: Possible Mechanism of Low Endotoxin Recovery

Whitepapers / 26 October 2016 / Charles River Laboratories

Since the risks of LER relate to the reversible biological activity change of endotoxin, it is worth reviewing previous papers on the aggregation of purified lipopolysaccharide (LPS) and its biological activity. The purpose of this article is to discuss the potency change of endotoxin in the LER by reviewing previous studies…

US FDA Purchases Transmission Raman for Quantitative Analysis of Tablets and Capsules

Supplier news / 26 October 2016 / Cobalt Light Systems

The United States Food and Drug Administration (FDA) has purchased Cobalt’s TRS100 transmission Raman instrument for use by the Division of Pharmaceutical Analysis (DPA)…

FDA approves Merck’s head and neck cancer drug

Industry news / 8 August 2016 / Merck

Under the FDA’s accelerated approval regulations, Keytruda, a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells, is approved based on tumour response rate and durability of response. However, continued approval for the drug may be contingent upon verification and description of clinical benefit in the confirmatory trials…

EU approval in sight as Bellicum’s BPX-501 granted orphan drug designation

Industry news / 5 August 2016 / Bellicum Pharmaceuticals

Bellicum Pharmaceuticals, a clinical stage biopharmaceutical company, has been granted orphan drug designations for both its T-cell therapy product candidate BPX-501 for treatment in hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid…


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