American Pharmaceutical News In Review

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March 26, 2024

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Data Integrity in Pharmaceutical Quality Control

A large amount of data is generated through pharmaceutical research and development, clinical trial, and production processes. It is vital that pharmaceutical companies take steps to ensure the integrity of data through every stage of the drug development process. This infographic gives an overview on important terms and definitions, points of compliance, and ways to achieve quality control and data integrity.

	Industry News

FDA Authorizes New Long-Acting Monoclonal Antibody for Pre-Exposure Prevention of COVID-19 in Certain Immunocompromised Individuals
The FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure ... read more »

FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use
Esperion announced that the FDA approved broad new label expansions for NEXLETOL® (bempedoic acid) ... read more »

FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy
The U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the ... read more »

Lisata Therapeutics’ Osteosarcoma Treatment Receives FDA Rare Pediatric Disease Designation
Lisata Therapeutics, Inc. announced that the U.S. FDA granted Rare Pediatric Disease Designation (“... read more »

	QC Corner

QC Corner: Automated Data Integrity in Sterility Testing
Pharma 4.0 transformation processes are reaching microbiological QC labs, using automation, robotics... read more »

	Featured Announcements

Reducing Candidate Risk and Achieving Development Success with a Robust Developability Assessment Tool
On-Demand Webinar
Explore: high-throughput developability assessment to enable efficient drug development read more »

	Infographic

Eight Benefits of Switching to Digital Pharmaceutical Production
This infographic covers the reasons and benefits of transitioning from paper-based processes to a digital manufacturing production process. read more »

	Featured Articles

		Lipid Nanoparticles – The Enablers for Nucleic Acids Delivery Nucleic acid therapeutics have emerged as new class of potential drugs for targeting and treatment of various diseases. In recent years, there has ... read more »

		Unveiling Americans’ Attitudes Towards Over-The-Counter Drugs With an estimated revenue of $40.72 billion in 2024, the OTC pharmaceuticals market in the US is projected to experience a compounded annual growth ... read more »

	Featured Video

On-Demand Webinar: Transforming Nanoparticles by Continuous Manufacturing
In this Live Webinar: hear from Diant Pharma's CEO Antonio Costa, PhD as he discusses Transforming Nanoparticles by Continuous Manufacturing. watch »

Video: How to Customize Biosafety Cabinets to Enclose Large Lab Automation Equipment
When research laboratories use automated devices that will not fit into a standard biosafety cabinet, they need a customized design. Collaborating ... watch »

	Featured Products

SentroPAT FO Compact NIR Process Spectrometer
Sentronic GmbH SentroPAT FO NIR is a flexible, robust, and reliable system that can be used to monitor a variety of... learn more »

SentroPAT DA PAT System
Sentronic GmbH The SentroPAT DA is a dedicated NIR analyzer for non-invasive online monitoring of pharmaceutical ... learn more »

Metrohm 913 pH Meter
Metrohm USA pH/mV and temperature measurement for routine use in the laboratory and on the road.pH or mV and ... learn more »

	Featured Whitepaper

Whitepaper: Learn How Resilience Utilizes a Stage-Gate Approach to Technology Transfer and Biomanufacturing to Mitigate Risk While Shortening Cycle Times Throughout the Project Lifecycle
To ensure lab processes and analytical methods transfer to the plant floor in a cost- and time-effective manner, many CDMOs have established cross-functional teams and systematic processes to guide ... read more »

Article: Making Automation the Standard: An Annex 1 Overview
The final version of the European Union (EU) good manufacturing practice (GMP) Annex 1 took effect in August 2023, advocating automated quality control (QC) technologies as a means of minimizing risk ... read more »

	More Products

Adept 4 Binary Gradient High Pressure LC System Learn More
PROSOLV® SMCC HD 90 - Silicified Microcrystalline Cellulose Learn More
Adept 1 Analytical Isocratic High Pressure LC System Learn More

	Directory Categories

Cell Culture Growth Factors Search More

Limulus Amebocyte Lysate (LAL) Endotoxin Detection Assays Search More

Pharmaceutical Excipients Search More

	Events

INTERPHEX 2024
Javits Center, NYC – 04/16/2024
INTERPHEX returns to New York City on April 16-18, 2024. Register today and see for yourself why INTERPHEX is THE leading global event that takes you ... 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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