American Pharmaceutical News In Review

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April 25, 2024

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	Industry News

Freedom Biosciences Announces FDA Approval of IND Application for FREE001 in Patients with Treatment-Resistant Depression
Freedom Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has notified ... read more »

Compass Therapeutics Receives FDA Fast Track Designation for CTX-009 in Combination with Paclitaxel for the Treatment of Metastatic or Locally Advanced Biliary Tract Tumors
Compass Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted ... read more »

XOMA Earns $9M Milestone as FDA Grants Accelerated Approval to Day One’s OJEMDATM for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG)
XOMA Corporation announced it has earned a $9 million milestone related to the U.S. Food and Drug ... read more »

Asahi Kasei Bioprocess and Axolabs Announce Strategic Partnership to Accelerate Oligonucleotide Therapeutics Development
Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and Axolabs have announced a strategic ... read more »

	QC Corner

Increasing Pharmaceutical Quality Control with Automation
How can automation improve your QC? This white paper explores the future of QC and automation. ... read more »

	Infographic

Pharmaceutical Solid-State Characterization and Crystallization within the Product Lifecycle
This infographic covers five essential considerations for solid-state characterization. read more »

	Featured Articles

		Your Nails and You Over time, humans’ fingernails and toenails have evolved from claws to what they are now. It is believed that human ancestors utilized claws to grab ... read more »

		Critical Behavioral Attributes and the Application of COM-B Framework in Aseptic Processing The pivotal role of human behavior in aseptic operations cannot be overstated, as it significantly influences the safety and efficacy of sterile drug ... read more »

	Featured Video

Live Webinar: Achieving EU GMP Annex 1 Compliance: Monitoring Compressed Gases for Microbial and Particle Contamination
In this Webinar you will learn the requirements for monitoring of particles and microorganisms in controlled cleanroom environments. watch »

Live Webinar: Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
In this webinar, hear from Shiri Hechter from Nelson Labs as she will cover the testing of high-risk drug components for Diethylene Glycol and ... watch »

	Featured Products

Demonstrating Value Throughout the Bio/Pharma Product Development Lifecycle: An e-Book of CMC Testing Case Studies
SGS The journey to deliver high-quality, safe and effective medicines to market has never been more ... learn more »

Whitepaper: Changing Regulatory Environment for Nitrosamine Impurities
SGS Regulatory agencies worldwide, including the European Medicines Agency (EMA) and US Federal Drug ... learn more »

Whitepaper: Are Nitrosamines a Concern for Biologic Manufacturers?
SGS The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-... learn more »

	Featured Whitepaper

BioReliance® contract testing services - Let's shape the future together
When asked what matters most when it comes to testing today, many developers say it’s all about speed and turnaround time. This is where innovation is a key differentiator. But speed is nothing ... read more »

Article: How to Meet Regulatory Demands for Therapeutic Quality
Discover how METTLER TOLEDO's UV7 Excellence Spectrophotometer and LabX™ software are enabling pharmaceutical companies to meet and exceed regulatory standards for quality control. Learn how secure ... read more »

	More Products

Alconox Powdered Precision Cleaner Learn More
Barnstead GenPure Ultrapure Water Purificaion System Learn More
Captisol® Modified Cyclodextrin Learn More

	Directory Categories

Pharmaceutical Bioreactors and Fermentors Search More

Pharmaceutical Drug Delivery Technologies Search More

Pharmaceutical Excipients Search More

	Events

CPHI North America
Pennsylvania Convention Center – 05/07/2024
The growing US pharma event is back in Philadelphia for May 2024 Don’t miss out on turning connections into endless opportunity. Learn, innovate, and... event details »

Excipient World Conference & Expo
Florida, USA – 05/13/2024
Excipient World is the only U.S. event focused exclusively on excipients. Join professionals from pharmaceutical, biologics, veterinary medicine, ... event details »

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