American Pharmaceutical News In Review

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August 14, 2020

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The Ultimate Workflow for Small Molecule Discovery

This application-based eBook provides an overview of the experimental requirements and goals for a diverse subset of small molecule applications, including how the Thermo Scientific Orbitrap ID-X workflow is designed to adapt for maximum performance and efficiency, regardless of the sample type.

	Industry News

Helix Receives EUA for the Helix COVID-19 NGS Test
Helix has received EUA from the FDA for the Helix COVID-19 NGS Test. read more »

Seelos Receives FDA May Proceed Notice to Initiate a Trial of SLS-005 in ALS
Seelos received notice from the FDA that the company may proceed with initiating a trial studying ... read more »

Clearside Biomedical Announces FDA Acceptance of CLS-AX IND
Clearside Biomedical announced the FDA has accepted its IND application for CLS-AX, for CLS-AX in ... read more »

FDA Approves New Opioid for Intravenous Use in Hospitals, Other Clinical Settings
The FDA approved Olinvyk, an opioid agonist for moderate to severe acute pain in adults, where the ... read more »

Amydis Receives Grant to Accelerate Development of Alpha-Synuclein Retinal Tracer
Amydis has received a new grant from MJFF for the Company’s pioneering retinal tracer program for ... read more »

Protalix BioTherapeutics, Chiesi Global Announce BLA Acceptance of Pegunigalsidase Alfa
Protalix BioTherapeutics together with Chiesi Global Rare Diseases announced the FDA has accepted ... read more »

	Featured Articles

What Does Digitalization Really Mean to Drug Substance Manufacturing? A Case Study Advanced data analytics tools are used throughout the biopharmaceutical industry, from leveraging ... read more »

Unlocking the Use of Lipid-Based Formulations with Lipophilic Salts to Address Bioavailability Challenges in Small Molecule Drug Development Drug developers have traditionally benefited from the ionizability of acidic or basic drugs to form ... read more »

	Infographic

Total Organic Carbon (TOC) Monitoring Efficiency Quiz
Take our 10-question quiz with your team to find out if you have the most efficient TOC monitoring ... read more »

	Featured Video

Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and ... watch »

On-Demand Webinar: Validation Guidance for Residual Host Cell DNA Testing of Biologics
In this webinar, you'll learn the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) ... watch »

	Featured Products

BARETab TM PH
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Eshmuno® CMX Chromatography Resin
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	Featured Whitepaper

eBook: TOC and Microbial Detection Monitoring
Proper and thorough monitoring of pharmaceutical water systems is imperative to deliver the highest quality products to patients. read more »

New Data to Support Activation Test for pyrogen detection Detect both endotoxin and non-endotoxin pyrogens in a single in vitro assay
Wondering how suitable a cell line-based Monocyte Activation Test is for detecting pyrogens? read more »

	Events

A Novel At-Line Pharmaceutical-Grade Mycoplasma Testing Solution: Sample to Results in Less than One-Hour
Online – 08/27/2020
With a small footprint, two minutes hands on-time, and less than one-hour time-to-result, BIOFIRE® Mycoplasma makes it easy to quickly test diverse ... event details »

Webinar: Vision for FDA’s Inactive Ingredient Database in 2020 and Beyond
Online – 09/16/2020
Excipients, the inactive ingredients in pharmaceutical products, are essential drug product components that facilitate drug delivery, promote ... event details »

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