American Pharmaceutical News In Review

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December 02, 2020

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	Industry News

Pfizer, BioNTech Submit CMA for COVID-19 Vaccine
Pfizer and BioNTech have submitted a formal Application for CMA to the EMA for their mRNA vaccine ... read more »

Ampion Study Advances to 3rd Group of COVID-19 Patients with Respiratory Distress
Ampio announced the third group in the Phase I inhaled Ampion clinical study is being treated ... read more »

Crestor to be Divested to Grünenthal in Europe
AstraZeneca has agreed to sell the rights to Crestor and associated medicines in over 30 countries ... read more »

ELITechGroup MDx Announces EUA Submission for SARS-CoV-2 Plus ELITe MGB Assay
ELITechGroup MDx has submitted the SARS-CoV-2 Plus ELITe MGB Assay to the FDA's for EUA. read more »

AIVITA Biomedical's Glioblastoma Trial Shows Improved Progression Free Survival
AIVITA Biomedical announced data from its multi-center Phase 2 clinical trial of its personalized ... read more »

Camfil to Build New Manufacturing Facility in Arkansas
Camfil has announced the construction of a new manufacturing facility in Jonesboro to replace its ... read more »

	QC Corner

Horseshoe Crab Sustainability Project
In this poster video, Brett Hoffmeister, the LAL Production Manager from the Associates of Cape Cod ... read more »

The Role of Chemical Development and Drug Substance Manufacturing in Early Integrated CMC Development at Emerging and Virtual Pharma
Integrated chemistry, manufacturing and controls (CMC) development views the entire effort to ... read more »

	Featured Announcements

Microbial Identification for All: Exploring the MicroSEQ ID Microbial Identification System
Webinar
Join us for a webinar on December 3rd regarding the MicroSEQ ID System. This ID system is based on sequence analysis of ribosomal genes in bacteria and fungi. The MicroSEQ ID method is a well-established genotypic system that has been adopted by 23 ... read more »

	Infographic

5 Quick Tips to Optimize Water Monitoring
Pure water is essential to all pharmaceutical development, scale-up, and manufacturing functions. read more »

	Featured Articles

Analytical Method Validation for Quality Assurance and Process Validation Professionals Method validation is a critical activity in the pharmaceutical industry. Validation data are used to confirm that the analytical procedure employed ... read more »

The Process of Pharmaceutical Elastomer Selection for Injectable Biologics Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable... 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: 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 »

	Featured Products

PyroGene rFC Endpoint Fluorescent Assays
read more »

Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
read more »

	Featured Whitepaper

Recognizing the Potential Impact of Agitation Directionality On Oxygen Mass Transfer Through a kLa Evaluation Within the BIOne Single-Use Bioreactor
Defining a suitable agitation strategy is essential for the successful development of upstream mammalian bioprocesses. 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

Six Steps to a Successful Windows® 10 Upgrade
Online – 12/03/2020
Microsoft has ended support for Windows 7 and older versions on Jan 14, 2022, pushing all users to move to Windows 10. event details »

Solid Form Analysis: In-depth Understanding of API’s Behavior
Online – 12/16/2020
Solid form analysis plays a vital role in material’s characterization throughout the whole pharmaceutical development cycle. event details »

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