American Pharmaceutical News In Review

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February 24, 2021

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	Industry News

Pfizer, BioNTech Submit COVID-19 Vaccine Stability Data at Standard Freezer Temperature
Pfizer and BioNTech announced the submission of new data to the FDA demonstrating the stability of ... read more »

FDA Authorizes Everlywell's COVID-19 Test Home Collection Kit
Everlywell announced the Everlywell COVID-19 Test Home Collection Kit DTC is now available for broad... read more »

R-ketamine Demonstrates Tolerability in Phase 1 Single Ascending Dose Study
Perception Neuroscience announced positive data from its first Phase 1 clinical study demonstrating ... read more »

EC Grants Orphan Designation to Sparsentan for IgA Nephropathy
Travere announced the European Commission has granted orphan designation to sparsentan for the ... read more »

Data Safety Monitoring Committee Green Lights Ovarian Cancer Study
VBL announced the results of the independent DSMC pre-planned review of the ongoing OVAL Phase 3 ... read more »

Astellas, Seagen Submit sBLAs for PADCEV for Urothelial Cancer
Astellas and Seagen announced completion of submissions for two sBLAs to the FDA for PADCEV. read more »

	QC Corner

QC Corner: Quality Control in Pharmaceutical Development
Bikash Chatterjee, Chief Operating and Science Officer at Pharmatech Associates discusses quality ... read more »

The Human Microbiome: What It Is, Why It Is Important and Opportunities for Microbiome-Based Therapeutics
The human body is home to a huge and diverse community of microorganisms, consisting of bacteria, ... read more »

	Featured Articles

Recent Advances to Help Cope with the Complexity of MS-Based Glycan Analysis In a post-translational modification reaction called glycosylation, living organisms attach carbohydrate residues known as glycans to their proteins. ... read more »

Advanced Weigh Cell Technology for Healthcare Packaging Applications For healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable. read more »

	Featured Video

On-Demand Webinar: Microbial Identification for All: Exploring the MicroSEQ ID Microbial Identification System
In this webinar you’ll learn how the MicroSEQ ID Microbial Identification System fits into your bioproduction workflow, how the MicroSEQ ID Microbial ... watch »

On-Demand Webinar: Developing Inhaled Generic Medicines – Navigating Complexity and Overcoming Challenges
This webinar explores the key considerations and strategies for demonstrating equivalence, accelerating development and reducing late-stage product ... watch »

	Featured Products

BacT/ALERT 3D Microbial Detection System
read more »

Xcelolab Powder Dispenser
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	Featured Whitepaper

Reformulation into Long-Acting Injectables and Implants
Long-acting, drug delivery products based on PLG-parenteral functional excipients have been used to reformulate and repurpose more than 60 drugs. This white paper reviews the conversion of oral and ... read more »

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 »

	Events

Integrated Production Process of mRNA from E. coli to Highly Purified mRNA
Online – 03/10/2021
In vitro transcription (IVT), the enzymatic process used for mRNA vaccines' production, is different from from biological fermentation processes as it... event details »

Development Strategies for Expediting Time-to-Market of Spray Dried Amorphous Solid Dispersions
Online – 03/10/2021
Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. event details »

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