American Pharmaceutical News In Review

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April 15, 2022

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Webinar: Solid Form Screening and Rapid Formulation Selection to Meet Demands of Accelerated Timelines

This webinar highlights how a combination of experience, targeted testing, and basic scientific principles can quickly lead to the selection of effective and commercially viable formulations at an early stage of a drug’s development cycle.

	Industry News

FDA Extends Review of Biologics License Application for REGEN-COV® for Treatment and Prophylaxis of COVID-19
Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has ... read more »

FDA Publishes MAPP 5240.10, Classifying Approved New Drug Products and Drug-Device Combination Products as Complex Products for Generic Drug Development Purposes
The FDA has published Manual of Policies and Procedures (MAPP) 5240.10, “Classifying Approved New ... read more »

FDA Grants Direct Biologics Regenerative Medicine Advanced Therapy Designation for ExoFlo in COVID-19 Related ARDS
Direct Biologics announced that the U.S. Food and Drug Administration (FDA) has awarded their EV ... read more »

Longeveron Announces Agreement with the US Department of Veterans Affairs for Phase 2 Alzheimer’s Trial
Longeveron Inc. announced a Cooperative Research and Development Agreement (CRADA) with the United ... read more »

	Infographic

Transition to Recombinant rFC for Endotoxin Testing: The Sustainable Choice
Transition to Recombinant rFC for Endotoxin Testing: The Sustainable Choice
Recombinant Horseshoe Crab Factor C (rFC) provides a sustainable, highly effective, and environmentally friendly sustainable means of endotoxin ... read more »

	Featured Articles

Inspectional Readiness for Aseptic Cleanroom Operations When the FDA conducts inspections of aseptic drug manufacturers, they cover systems and areas within systems that present the greatest risk of product... read more »

Current Updates on In-vitro Drug Release Testing of Long-Acting Injectables Long acting injectables (LAIs) are drug products, intended for administration through the parenteral route and designed to release Active ... read more »

	Featured Video

On-Demand Webinar: Sophisticated Formulation Approaches for Insoluble Drug Candidates
The webinar will explain the role nano-formulations play to accelerate the drug discovery/development process. It will also outline a formulation ... watch »

On-Demand Webinar: Mitigating Risk in Manufacturing with Rapid Microbial Monitoring in Pharmaceutical Water
In this webinar we discuss examples of real-world conversations as pharmaceutical customers grapple with true microbial contaminations within their ... watch »

	Featured Products

alpha300 R Confocal Raman Imaging System
read more »

	Featured Whitepaper

Whitepaper: Comprehensive Pure Water Guide for Pharmaceutical Engineers
In today’s pharmaceutical facilities the availability of purified water is essential. While the domestic consumer considers tap water to be “pure”, the pharmaceutical end-user regards it as grossly ... read more »

Analyses of Antibody Drugs Using Inert Ultra High Performance Liquid Chromatography
This article introduces analyses of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) for quality control using an inert UHPLC system that is extremely resistant to mobile phases ... read more »

	Events

IFPAC 2022
North Bethesda, MD – 06/12/2022
IFPAC brings together experienced professionals and the next generation of leaders to share in discussions, give input and get ideas for the future ... event details »

SMi’s 22nd Annual Pain Therapeutics Conference
London, UK – 05/04/2022
SMi’s 22nd Pain Therapeutics Conference will cover the leading advances in pain therapeutics, exploring late development clinical trials, novel ... event details »

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