American Pharmaceutical News In Review

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March 12, 2021

Newsletter Sponsor

Automation of endotoxin testing is simplified with a compact benchtop platform
Sponsored by SUEZ
Microfluidic automation simplifies endotoxin assays and enables streamlined setup, validation, and training using a compact benchtop system. The Sievers Eclipse BET Platform is an easy-to-use, fully compliant kinetic chromogenic method that can be set up in less than 10 minutes and validated in days. This enables manufacturers to improve system implementation and increase speed.

	Industry News

FDA Authorizes Cue Health's COVID-19 Test for At-Home, OTC Use
Cue Health has received EUA from the FDA for OTC sale of its fast, accurate, COVID-19 test. read more »

Pneumagen Announces Neumifil is Efficacious in Established Model of COVID-19 Infection
Pneumagen announced a further milestone in the development of Neumifil for the treatment of COVID-19... read more »

TissueTech Receives FDA Clearance for TTAX03 Study to Treat Facet Joint Osteoarthritis Pain
TissueTech had received clearance from the FDA to proceed with a dosing study using its IND TTAX03 ... read more »

Roche Receives FDA approval for VENTANA ALK CDx Assay with LORBRENA
Roche announced FDA approval of the VENTANA ALK CDx Assay as a companion diagnostic to identify ALK-... read more »

Breckenridge Receives ANDA Approval for Asenapine Sublingual Tablets
Breckenridge announced the FDA has granted final approval of its ANDA for Asenapine Sublingual ... read more »

Pathios Receives Innovate UK Smart Grant
Pathios has been awarded £350K in the form a Smart Grant from Innovate UK, the UK Government’s ... read more »

	QC Corner

On Demand Webinar: Unlock Your QC Lab’s Full Potential Using the Digital Key
In this webinar, Dr. Haydn Boehm will address how to unlock your QC lab’s full potential. read more »

The Effect of Surge Vessels on the Residence Time Distribution of Drug Substance Continuous Processes
While most of the published work on the impact of residence time distribution (RTD) to ... read more »

	Featured Articles

An Interview With... Vaibhav Kshirsagar, Technical Product Manager, IMA Life North America Operating through six production sites, IMA Life (Aseptic Processing & Freeze Drying Solutions) is one of the three pharmaceutical divisions of the ... read more »

Poor Solubility – Where Do We Stand 25 Years after the ‘Rule of Five’? The ‘Rule of Five’ (Ro5) is clearly aimed at medicinal chemists. However, in the past 25 years we have seen an increase in the number of poorly water-... read more »

	Featured Video

On-Demand Webinar: Formulation and Development Strategies for Amorphous Solid Dispersion Drug Products
In this webinar you’ll learn formulation screening strategies for amorphous solid dispersions, details on an integrated approach for developing ASDs ... watch »

On-Demand Webinar: A Novel At-Line Pharmaceutical-Grade Mycoplasma Testing Solution: Sample to Results in Less than One-Hour
In this webinar you’ll learn about how this “lab in a pouch” technology works, primary validation data, and biopharmaceutical company evaluation data. watch »

	Featured Products

InPro6860i/12/120/mA/HD DO Sensor
read more »

Precirol® ATO 5
read more »

	Featured Whitepaper

White Paper: Optimizing the Bio-Rad NGC Chromatography System for Cryo-EM Applications for High-Resolution and Low-Volume SEC
Structural biology is the three-dimensional study of complex biological molecules, like proteins, to determine their structures at atomic resolution. read more »

eBook: Lipid Technologies: Helping to Develop the Next Generation of Pharmaceuticals
The FDA recently issued guidance intended to curtail the use of medically important antibiotics in agricultural applications. read more »

	Events

Use of the Andrew+ Robot and OneLab Automated Liquid Handling Platform for Bacterial Endotoxin Testing
Online – 03/25/2021
A bacterial endotoxin test (BET) is a requirement for any injectable drug or medical device to ensure safety. event details »

CPhI North America
Philadelphia, PA – 04/20/2021
Over the last three years, CPhI North America has brought together more than 15,000 industry professionals across the entire pharmaceutical supply ... event details »

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