American Pharmaceutical News In Review

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July 22, 2021

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Watch Webinar: Regulatory Compliance and Data Integrity for Microbial Testing Systems

Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical manufacturing. Regulatory agencies require that the many components of the system implemented, from assays to data integrity, be qualified and validated to meet regulatory guidance in a CGMP environment. Therefore, when choosing a microbial testing solution, it’s important to have a clear path toward regulatory compliance from the start in order to avoid any costly complications down the road.

	Industry News

Pfizer and BioNTech to Collaborate with Biovac to Manufacture and Distribute COVID-19 Vaccine Doses within Africa
Pfizer Inc. and BioNTech SE announced the signing of a letter of intent with The Biovac Institute (... read more »

AstraZeneca Completes Acquisition of Alexion
AstraZeneca completed the acquisition of Alexion Pharmaceuticals, Inc. (Alexion). The closing of the... read more »

FDA Approves Drug for Severe Itching in Patients Liver Disease
FDA has approved Bylvay (odevixibat), the first treatment for pruritus (moderate to severe itching) ... read more »

Pfizer Expands its Voluntary Recall of Chantix
Pfizer expanded its voluntary recall of varenicline (Chantix) to 12 consumer level lots. Pfizer is ... read more »

	Infographic

5 Key Steps to a Successful Laboratory Relocation
20 instruments or 2,000? Across the hall or across the world? Moving a laboratory anywhere can be an extensive process. Worried you'll overlook an ... 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 »

How to Investigate Temperature and Humidity Excursions of Stability Chambers The purpose of a Stability Program is to support the expiration dating of pharmaceutical products, medical devices, and biologics and recommend ... 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 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 Products

Process Monitoring Systems
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	Featured Whitepaper

Hybrid Pharmaceutical Vials for Lyophilized Biological Drugs and Vaccines
Most parenteral therapeutic drugs are formulated liquids that are ready to be injected or infused directly into a patient’s tissue. Typical formulations contain the active pharmaceutical drug ... read more »

	Events

Oligonucleotide Therapeutics and Delivery Conference 2021
London, UK – 09/22/2021
Oligonucleotide therapeutics - the emerging medicine class - are harnessing the therapeutic benefit of targeting genetic material via antisense, mRNA,... event details »

Medical Devices and IVD Conference 2021
London, UK – 11/15/2021
The MDR and IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were ... event details »

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