American Pharmaceutical News In Review

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February 16, 2021

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Upcoming Webinar: Integrated Production Process of mRNA from E. coli to Highly Purified mRNA

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	Industry News

Sagent Begins NIAID-Sponsored Study Investigating Outpatient COVID-19 Treatments
Sagent announced Camostat mesilate, is one of four therapies being added to the existing ACTIV-2 ... read more »

FDA Delays StrataGraft Application
The FDA has informed Mallinckrodt it is deferring action on the Stratatech BLA for StrataGraft. read more »

Canada Purchases Additional 4 Million Doses of Moderna’s COVID-19 Vaccine
Moderna announced the Canadian Government has increased its confirmed order commitment by 4 million ... read more »

Xeris Receives European Commission Approval of Ogluo for Hypoglycemia
Xeris announced the EC has approved Ogluo injection severe hypoglycemia in adults, adolescents, and ... read more »

Novavax Announces Rolling Review of COVID-19 Vaccine by Regulatory Authorities
Novavax announced the start of the rolling review process for authorization of NVX-CoV2373, its ... read more »

FDA Approves Drug to Reduce Bone Marrow Suppression Caused by Chemotherapy
The FDA approved Cosela as the first therapy in its class to reduce the frequency of chemotherapy-... read more »

	QC Corner

Watch Webinar: Bio-fluorescent Particle Counters: Enhancing Your Understanding of Process Water
Watch Webinar: Bio-fluorescent Particle Counters: Enhancing Your Understanding of Process Water read more »

QC Corner: Particle Detection & Identification in Parenteral Products
Robin Sweeney, Product Manager at Unchained Labs joins Editor-in-Chief Mike Auerbach to discuss ... read more »

	Featured Articles

An Interview With... Anne Connors, Senior Field Marketing Manager BioMonitoring, MilliporeSigma and Lamin Jallow, Microbiology Applications Scientist, MilliporeSigma Pyrogens are substances that induce a rise in the body temperature of a human being or an animal, to the point of becoming a health concern. The ... read more »

Nonlinear Optical Spectroscopy Techniques for Pharmaceutical Analysis Ensuring the quality of pharmaceutical products is paramount for bringing them to market. This calls for analytical methods with high accuracy, ... read more »

	Featured Video

On-Demand Webinar: Advancements in the Characterization of Pharmaceuticals by DSC
In this webinar, we will explore the use of new technologies and some advanced DSC techniques of the analysis of pharmaceutical materials to better ... watch »

On-Demand Webinar: Validation Guidance for Residual Host Cell DNA Testing of Biologics
In this webinar, you'll learn the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) ... watch »

	Featured Products

MB3000-PH FT-IR Analyzer
read more »

APAF-BP AdvantaFlex™ Biopharmaceutical Grade TPE Tubing
read more »

	Featured Whitepaper

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 »

Reformulation into Long-Acting Injectables and Implants
Long-acting, drug delivery products based on PLG-parenteral functional excipients have been used to reformulate and repurpose more than 60 drugs. This white paper reviews the conversion of oral and ... read more »

	Events

Performance Enhancement Strategies for Low Solubility APIs
Online – 03/18/2021
Close to 90% of drugs coming out of the drug discovery pipeline, have solubility limitations translating into poor bioavailability, which may ... event details »

Use of the Andrew+ Robot and OneLab Automated Liquid Handling Platform for Bacterial Endotoxin Testing
Online – 03/25/2021
A bacterial endotoxin test (BET) is a requirement for any injectable drug or medical device to ensure safety. event details »

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