American Pharmaceutical News In Review

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May 24, 2021

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Hunt for N-nitrosamines in medicinal products

In the EMA newsletter published in September 2019, the pharma industry was given a wake-up call regarding the request to evaluate the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients. This presentation will look at case studies of analytical testing in the three-step request to review the risk for presence of nitrosamines in medicinal products process issued by EMA/FDA.

	Industry News

Pfizer and BioNTech to Supply the European Union With up to 1.8 Billion Additional Doses of COMIRNATY®
Pfizer Inc. and BioNTech announced a new agreement with the European Commission (EC) to supply 900 ... read more »

AstraZeneca COVID-19 Vaccine Vaxzevria Authorized for Emergency Use in Japan
AstraZeneca’s COVID-19 vaccine, Vaxzevria, has been granted special approval for emergency use in ... read more »

U.S. Food & Drug Administration Grants Priority Review of Maribavir
Takeda Pharmaceutical Company Limited announced that the U.S. Food & Drug Administration (FDA) has ... read more »

	Infographic

Reasons to Upgrade to Windows® 10 for Your Lab
With the end of support for Windows® 7 more than a year ago, it's definitely time to upgrade to Window® 10. Many labs are still running various ... read more »

	Featured Articles

Were My Parents Dumb? Let’s talk vaccines for a minute. Everyone else is these days – right? So, let’s take a quick walk-through recent vaccine history – looking at the ... read more »

Pharmaceutical P.I.N. Points Patent Innovation News The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Offi ce in January-... read more »

	Featured Video

On-Demand Webinar: Validation of BET Platforms and Product Samples: What is Required and What are Some of the Common Challenges?
What has your experience with endotoxin systems and product validation been like? In this webinar, we will look at what steps are needed for a new ... watch »

On-Demand Webinar: Risk Assessment for Potential Elemental Impurities on Drug Products/Medical Devices
This webinar will address how to deal with “Risk Assessment for Potential Elemental Impurities” on Drug Products and Medical Devices. The USP, in ... watch »

On-Demand Webinar: Development and Validation of a Robust Commercial Solution for Measuring Residual Kanamycin-Resistant Plasmid DNA
In this webinar you’ll learn: overview of current regulatory requirements for residual DNA clearance for biological products including residual ... watch »

	Featured Whitepaper

eBook: Optimizing Your Biopharmaceutical Processes
eBook offers a complete guide to ensure your biopharmaceutical process produces the highest quality product as efficiently as possible. read more »

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