American Pharmaceutical News In Review

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September 28, 2021

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	Industry News

Federal Court Prohibits Florida Compounder from Manufacturing and Distributing Drugs Due to Unsanitary Conditions
The U.S. District Court for the Middle District of Florida has entered a consent decree of permanent... read more »

AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients with Crohn's Disease
AbbVie announced that it has submitted an application to the FDA seeking approval for risankizumab-... read more »

Alvotech Provides Update on FDA Action Regarding AVT02, Proposed High-Concentration Biosimilar to Humira
Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of ... read more »

Lilly Announces Procurement Agreement with European Commission to Supply Bamlanivimab and Etesevimab Together for the Treatment of COVID-19
Eli Lilly and Company announced a Joint Procurement Agreement with the European Commission (EC) to ... read more »

	Infographic

Top 5 Tips for Easier Bacterial Endotoxin Testing (BET)
BET is an essential step of pharmaceutical manufacturing for injectable drugs and implantable medical devices. Testing for endotoxins prevents fever ... read more »

	Featured Articles

QC Corner: Recent Updates to Guidances Help Standardize Extractables and Leachables Testing Risk assessment for extractables and leachables (E&L) contained in polymeric manufacturing components is an important step to evaluate patient safety.... read more »

New Expectations for Training – Tied to Implementation of Contamination Control Strategies With the upcoming implementation of the revised Annex 1 of the European Union GMPs, many companies are developing contamination control strategies. ... read more »

	Featured Video

On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

On-Demand Webinar: Unified Particle Analysis by Raman and Infrared Microscopy
In this webinar you’ll learn: Identification of unknown particles in a wide variety of manufacturing processes. Reverse engineering and failure ... watch »

	Featured Products

Sterile CyQuanol Disinfectant Solution
read more »

	Featured Whitepaper

eBook: Microbial Identification - Trends and Technologies for Aseptic Manufacturing Facilities
eBook content includes a wide variety of topics for microbial identification in pharmaceutical facilities. Strategies, tools, and technologies are featured. Articles feature an analysis of FDA ... read more »

	Events

Ophthalmic Drugs Conference
London, UK – 11/22/2021
The global ophthalmic drug market is forecast to surpass $60 billion USD by 2025 with increasing focus from the industry on alternative delivery ... 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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