American Pharmaceutical News In Review

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December 22, 2020

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	Industry News

FDA Issues Emergency Use Authorization for Moderna COVID-19 Vaccine
The FDA has issued an EUA for the second vaccine for the prevention of COVID-19 caused by severe ... read more »

Novartis Announces FDA Approval of Xolair for Nasal Polyps
Novartis announced the FDA has approved the company's sBLA for Xolair for the add-on maintenance ... read more »

SARS-CoV-2 Antigen Test Kit Receives CE Certification
Beroni has received notification from its European Authorized Representative its newly developed ... read more »

BioEclipse Initiates Enrollment in Phase 1 Dose-Escalation Trial for Solid Tumors
BioEclipse Therapeutics announced the initiation of patient enrollment in a Phase 1 dose-escalation ... read more »

Aeglea Receives FDA Rare Pediatric Disease Designation for Homocystinuria Treatment
Aeglea announced the FDA has granted Rare Pediatric Disease Designation to ACN00177 for ... read more »

FDA Approves HETLIOZ for Nighttime Sleep Disturbances in Smith-Magenis Syndrome
Vanda announced the FDA has approved HETLIOZ capsule and liquid formulations for nighttime sleep ... read more »

	QC Corner

Rely on Data, Not Lore to Meet Rising Demand
The COVID-19 pandemic has forced countless difficult decisions to be made in the face of ... read more »

QC Corner: Practical Tips for Monomer/Aggregate and Fragment Content Monitoring of mAbs and ADCs
Product characterization is the essential foundation for successful biological drug development. read more »

	Infographic

How to Maximize Viral Clearance in a Membrane-Based Process
Product safety is a big concern in biopharmaceutical manufacturing. Specifically, virus contamination in biopharmaceutical products is critical to ... read more »

	Featured Articles

Transition to Modern Microbiological Methods in the Pharmaceutical Industry Microbiologists have the continuing challenge of evaluating, validating, and implementing emerging testing technologies to enhance the performance of ... read more »

A New Hybrid Material for Packaging COVID-19 Vaccines and Other Biologics: Combining the Best of Glass and Plastic A Leader for COVID-19 Vaccines by Operation Warp Speed The global hunt for a COVID-19 vaccine has been underway at breakneck speed by the best ... read more »

	Featured Video

Watch Video: G-Con Manufacturing, Inc. Facility Tour
Since 2009, G-CON has lead the cleanroom industry, fulfilling pharmaceutical and biopharmaceutical needs and embracing new trends. G-CON designs, ... watch »

On-Demand Webinar: Platform Purification Approaches for the Production of Complex Biologics
In this webinar we will discuss the attributes of Thermo Scientific POROS Ion Exchange and Hydrophobic Interaction chromatography resins, addressing ... watch »

	Featured Products

Pegasus 4D GCxGC-TOFMS
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PYROGENT Gel Clot LAL Assays
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	Featured Whitepaper

Tips for Choosing a Reliable Temperature Control System in the Pharmaceutical Industry
When considering a temperature control system for medical processing, precision and accuracy are key. Mokon’s advanced solutions are relied on by critical medical, pharmaceutical and biotechnology ... read more »

The Process of Pharmaceutical Elastomer Selection for Injectable Biologics
Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable drugs was bright thanks to the accelerating ... read more »

	Events

IFPAC - 2021
Virtual – 02/28/2021
IFPAC - 2021 will be held February 28 - March 5, 2021 LIVE, REAL-TIME event. The goal of IFPAC remains to support, connect, and unite our Community. ... event details »

Parallel Trade 2021
Virtual – 03/22/2021
SMi present’s its 15th annual Parallel Trade virtual conference, taking place virtually on the 22nd and the 23rd March 2021. As the only parallel ... event details »

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