American Pharmaceutical News In Review

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August 16, 2021

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Container Closure Integrity and Stability Testing for Rigid Containers

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	Industry News

Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Re-submit Following Additional Data Analyses
Ipsen announced, following very recent discussions with the US FDA, the withdrawal of the New Drug ... read more »

Bruce Frank Joins Altasciences as VP, CDMO Operations
Altasciences announced the appointment of Dr. Bruce Frank, PhD, as Vice President, CDMO Operations. ... read more »

Sesen Bio Receives Complete Response Letter from FDA for Vicineum™
Sesen Bio, a late-stage clinical company developing targeted fusion protein therapeutics for the ... read more »

Mustang Bio Collaborates with Mayo Clinic on Novel CAR T Technology
Mustang Bio Inc., a clinical-stage biopharmaceutical company focused on translating medical ... read more »

	Infographic

6 Reasons to Switch to Automated Titration
If you still perform titrations the old-fashioned way (by hand), you are not alone. Learn how automation can improve not just sample throughput, but... read more »

	Featured Articles

Vaccines and Therapeutics for COVID-19 – How Can Understanding SARS-CoV-2 Glycosylation Lead to Pharmaceutical Advances? The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has infected more than 160 million people worldwide. ... read more »

A Model for Aseptic Operations Governance (Structure, Competencies, Governance and Attitude) Manufacturing sterile parenteral products with aseptic technique has become more complex because of multiple technical, scientific and compliance ... read more »

	Featured Video

On-Demand Webinar: A Straightforward Path Toward Regulatory Compliance and Data Integrity with Your Microbial Testing Systems
On-Demand Webinar: A Straightforward Path Toward Regulatory Compliance and Data Integrity with Your Microbial Testing Systems watch »

On-Demand Webinar: Development and Validation of a Platform Assay Method Using Variable Pathlength Technology for Oligonucleotide Drug Products
This webinar will share Ionis’ experience with developing and validating a platform SoloVPE® in-process assay method for GMP manufacturing of ... watch »

	Featured Whitepaper

eBook: BET Automation Simplified: How to achieve simple, automated endotoxin testing
To succeed and thrive in today’s pharmaceutical QC environment, it is critical to increase efficiency while maintaining compliance. The need to quickly and accurately test samples, review data, and ... read more »

	Events

SMi's 2nd Annual Next Generation Pharmaceutical Cleanroom
London, UK – 10/05/2021
SMi Group are pleased to announce the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference. An event that focuses on cleanroom technology in... event details »

Medical Wearables for Biosensors USA Conference 2021
Boston, MA – 10/25/2021
Exploring therapeutic applications of connected on-body devices The global wearable biosensors market is a rapidly expanding industry with ... event details »

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