American Pharmaceutical News In Review

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June 30, 2021

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[On-Demand] Rapid Pandemic Response: Building Cleanrooms at Warp Speed

A look into how AES rapidly responded to the nations need for new manufacturing space for COVID 19 vaccine production. Learn the details on the challenges faced and how the AES organization mobilized to help the United States government and pharmaceutical companies rapidly build the necessary infrastructure to manufacture COVID19 vaccines.

	Industry News

FDA Authorizes Stem Cell Trials for Parkinson’s
Hope Biosciences Stem Cell Research Foundation (HBSCRF) has received FDA authorization for a Phase ... read more »

Roche SARS-CoV-2 Molecular Test Gets FDA Emergency Use Authorization for PCR Testing of both Symptomatic and Asymptomatic Individuals
The cobas SARS-CoV-2 test is the first RT-PCR test that screens within 20 minutes both asymptomatic ... read more »

Koselugo Approved in EU for Children with Neurofibromatosis Type 1 and Plexiform Neurofibromas
AstraZeneca and MSD's Koselugo (selumetinib) has been granted conditional approval in the European ... read more »

FDA Approves First Oral Blood Thinner for Children
The U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less... read more »

	Infographic

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

An Interview With Jim Huang, PhD - CEO - Ascendia Pharmaceuticals Ascendia Pharmaceuticals is a specialty pharmaceutical CDMO that provides custom sterile- and non-sterile-enabling formulations, along with analytical... read more »

Key Considerations for Stabilizing Oxidation-Prone Lipid-Based Drug Delivery Systems Lipid-based excipients are present in a wide range of drug delivery systems for different routes of administration, including oral, topical, ... read more »

	Featured Video

On-Demand Webinar: "A Little Too Quiet” – Case Study on Asset Utilization
Live Webinar: "A Little Too Quiet” – Case Study on Asset Utilization watch »

On-Demand Webinar: Building Cleanrooms At Warp Speed
In this webinar, you’ll learn about the additional challenges COVID presented to already compressed timelines and the strategies AES utilized to ... watch »

	Featured Products

Lasair Pro
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	Featured Whitepaper

eBook: Implementing Microbial Analysis Technologies for World-Class Production
This eBook covers microbial testing, analysis, and monitoring technologies and strategies to ensure world-class pharmaceutical production. Article cover topics such as data integrity issues, ... read more »

	Events

Microscopy & Microanalysis 2021
Virtual – 08/01/2021
Brought to you by the Microscopy Society of America (MSA) and the Microanalysis Society (MAS), the M&M conference is the largest scientific meeting ... event details »

Virtual DCAT Week 2021
Online – 07/12/2021
DCAT Week is the premier business event for the Bio/Pharmaceutical development and manufacturing industry. The DCAT Board of Directors has decided to ... event details »

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