American Pharmaceutical News In Review

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April 30, 2024

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	Industry News

FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests
The FDA has taken action aimed at helping to ensure the safety and effectiveness of laboratory ... read more »

Abbott's Dissolving Stent Receives FDA Approval for Arteries Below the Knee
Abbott announced that the FDA approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System... read more »

FDA Grants Full Approval for TIVDAK® to Treat Recurrent or Metastatic Cervical Cancer
Pfizer Inc. and Genmab A/S announced that the FDA approved the supplemental Biologics License ... read more »

Truqap Plus Faslodex Recommended for Approval in the EU by CHMP for Advanced ER-Positive Breast Cancer
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended ... read more »

	QC Corner

QC Corner: Environmental Monitoring: Expert Discussion on the Benefits of a Single Incubation Temperature
The Environmental Monitoring program is an important quality control for the pharmaceutical ... 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

		Using Rapid Microbiological Methods Flexibly to Ensure Safe Cell and Gene Therapeutics Testing short-life cell and gene therapeutics for microbiological contamination is a challenge because they usually need to be administered before the... read more »

		Viral Vector Process Development and Manufacturing The field of clinical gene therapy has advanced rapidly and now accounts for over 2,200 clinical trials initiated since 1989, of which ~65% are being ... read more »

	Featured Video

On-Demand 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 »

On-Demand 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

Modified Beta Cyclodextrin
Ligand Pharmaceuticals Captisol® is a patent protected, uniquely modified cyclodextrin, whose chemical structure was ... 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 »

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 »

	Featured Whitepaper

Demonstrating Value Throughout the Bio/Pharma Product Development Lifecycle: An e-Book of CMC Testing Case Studies
The journey to deliver high-quality, safe and effective medicines to market has never been more challenging than it is today. Shorter product lifecycles, pricing concerns, and added pressure from ... read more »

Whitepaper: Unlocking the Potential of Biosimilars
A keystone to the biosimilar approval process, comparative analytical assessments are critical to providing substantive evidence of similarity during non-clinical and clinical studies. With the ... read more »

	More Products

AccuSizer SIS Liquid Particle Counter System Learn More
Allegro 200 L Single-Use Mixer Learn More
Ventipharm Steam-Air Mixture Sterilizers Learn More

	Directory Categories

Pharmaceutical Excipients Search More

Cell Culture Media Search More

Pharmaceutical Air Quality Monitoring Equipment 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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