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American Pharmaceutical News In Review
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June 11, 2021
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  Not all Cyclodextrins are created equally

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including uding Gilead’s VEKLURY®, Amgen’s KYPROLIS®, Baxter International’s NEXTERONE®, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA®, Melinta Therapeutics’ BAXDELA™.

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» Industry News
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  Eurofins Launches a New Multiplex PCR Assay for Rapid Detection of the B.1.617 “India” SARS-CoV-2 Variant
Eurofins Technologies announces the launch of its GSD NovaType III SARS-CoV-2 RT-PCR assay, ... read more »
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  Organon Launches as New Global Women’s Health Company
Organon celebrates its launch as a global women’s health company with employees and women from ... read more »
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  FDA Grants Accelerated Approval to Infigratinib for Metastatic Cholangiocarcinoma
The FDA granted accelerated approval to infigratinib, a kinase inhibitor for adults with previously ... read more »
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  FDA Accepts NDA for First Potential Treatment for Fibrodysplasia Ossificans Progressiva
Ipsen announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, ... read more »

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» Infographic
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  Top 5 Things to Know About the USP <643> Changes
The United States Pharmacopeia (USP) specifies regulations for pharmaceutical manufacturing to ensure safe and effective drug products. USP <643> Total ... read more »
» Featured Articles
Validation of Bacterial Endotoxins Testing Platforms
Validation. This one word can invoke a series of feelings in any lab. It might invoke a feeling of fear or uneasiness because the process can be time-... read more »
Base Editing: A New Player in the Cell and Gene Therapy Space
Last December, Vertex Pharmaceuticals and CRISPR Therapeutics shared initial clinical trial data from studies on CTX001, a cell-based therapy for ... read more »
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» Featured Video
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  On-Demand Webinar: High-Purity Albumin Improves Biopharmaceutical Formulations and Performance
In this webinar you’ll learn: optimizing final formulation of drug products with albumin; how to avoid the variable nature of albumin’s structure, how... watch »
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  On-Demand Webinar: TOC and Conductivity Analysis: Back to Basics
In this webinar, you'll learn about regulations for USP <643> Total Organic Carbon, USP <645> Conductivity and regulatory expectations for cleaning validation, ... watch »

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» Featured Whitepaper
Microbiology and More - Unleashing the Power of the MODA-EM Solution
Challenge: Capturing QC data electronically in a single system When setting up their facility in Tokyo, Japan, NCLi wanted to maximize the efficiency of their quality control (QC) laboratories by ... read more »

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| Events
EVENT
  Excipient World 2021
National Harbor, MD –  09/27/2021
Excipient World is the leading education, networking and sourcing resource for the $6+ billion and growing global excipient market. It’s the ONLY U.S....
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EVENT
  9th Annual Immuno-Oncology Summit
Westin Copley Place, Boston, MA & Online –  10/04/2021
Over the past 9 years, CHI's Immuno-Oncology Summit has become the leading annual meeting focusing on the latest applied research, providing ...
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