American Pharmaceutical News In Review

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September 29, 2023

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	Industry News

Akebia Therapeutics Resubmits NDA to FDA to Treat Patients on Dialysis
Akebia Therapeutics, a biopharmaceutical company with the purpose of bettering the lives of people ... read more »

Pfizer and BioNTech Receive Health Canada Authorization for XBB.1.5-Adapted Monovalent COVID-19 Vaccine
Pfizer Canada ULC and BioNTech SE announced that Health Canada has authorized the companies' Omicron... read more »

Peptone Expands Leadership Team with Key Executive Hires
Peptone, a leader in translational biophysics and the design of novel therapeutics against ... read more »

SGC and HitGen Announce Research Collaboration Focused on DNA-Encoded Library Based Drug Discovery
HitGen announced a partnership with The Structural Genomics Consortium ("SGC"), a public-private ... 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 »

	Infographic

Data Integrity in Pharmaceutical Quality Control
This infographic gives an overview on important terms and definitions, points of compliance, and ways to achieve quality control and data integrity. read more »

	Featured Articles

		Regulatory Submissions for Rapid Microbiological Methods (RMMs) More than twenty years ago, companies started introducing rapid microbiological methods (RMMs) to the industry. Some call these methods alternative ... read more »

		Design And Evaluation of a Disinfectant/Sporicide Combination Triple Sanitization And In-Situ Disinfectant Validation There remains debate on both how to conduct a triple clean evaluation as well as what data generation is optimal during the process in order to ... read more »

	Featured Video

On-Demand Webinar: Detecting Contaminants, Ensuring Safety: A Closer Look at Our New High-Performance Mycoplasma Testing Solution
In this webinar, hear from Sharon Rouw, Senior Product Manager at Thermo, as she discusses discuss the benefits and performance characteristics of ... watch »

Watch Video: Testing-Ready Microbial Controls Made with Your Environmental Isolates
Microbiologics Custom Environmental Isolate Controls are made with isolates recovered from a facility’s environment, utility systems or microbial ... watch »

On-Demand Webinar: The Ultimate Guide to Fluid Transfer Systems: From Selection to Maintenance
Fluid transfer is vital across industries, but it comes with challenges like material selection, kinking, and contamination. Join us to master these, ... watch »

	Featured Products

Pearlitol 200SD
Barentz PEARLITOL® 200 SD / Mannitol is a direct compression excipient. Rotary press tablet simulator ... learn more »

IND-Enabling Testing
WuXi AppTec One of the most common challenges for drug developers pursuing global IND submissions is ... learn more »

Thermo Scientific™ Pharma 11 Twin-screw Extruder
Thermo Fisher Scientific Perform material- and labor-effective extrusion and granulation processes with the Pharma 11 Twin-... learn more »

	Featured Whitepaper

eBook: Guide to High Barrier Packaging Films for Sensitive OSD Formulations
Selecting the right packaging material early on leads to quicker stability testing, faster product launches, and lower chances of needing reformulation. Download this detailed guide to learn about ... read more »

Datasheet: CHO Media and Feed Portfolio from Sartorius
Sartorius’ CHO media portfolio was developed for the cultivation of Chinese Hamster Ovary (CHO) and other mammalian cell lines. CHO Cells can be used for both stable and transient expression of ... read more »

	More Products

Pyrotell-T Turbidimetric Formulation Learn More
Elix 100 Water Purification System Learn More
Model 2500 Select Bathless Dissolution Instrument Learn More

	Directory Categories

Dissolution Instruments Search More

Pharmaceutical Capsule Filling Machine Search More

Pharmaceutical Time of Flight Mass Spectrometry Search More

	Events

ISPE Annual Meeting & Expo
Las Vegas, Nevada – 10/15/2023
The 2023 ISPE Annual Meeting & Expo is focused on excellence, modernization, and harmonization in pharmaceutical science and manufacturing across the ... event details »

AAPS PharmSci 360
Orlando, FL – 10/22/2023
PharmSci 360 delivers research from across the pharmaceutical continuum, from discovery to delivery, and all stages in between. Thousands of ... event details »

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