American Pharmaceutical News In Review

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October 18, 2024

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	Industry News

Novartis Receives Positive CHMP Opinion for Kisqali® to Reduce Risk of Breast Cancer Recurrence
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European ... read more »

FDA Releases Final Guidance on Drug Master Files in Advance of Certain ANDAs
The U.S. Food and Drug Administration is announcing the final guidance for industry, “Review of Drug... read more »

CHMP Maintains Negative Opinion on Translarna™ Reexamination
PTC Therapeutics, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of ... read more »

OmniaBio Opens Cell and Gene Therapies Manufacturing Facility in Canada
OmniaBio Inc. announced the opening of a new North American cell and gene therapy (CGT) ... read more »

	QC Corner

Enhanced Cleanroom Control: Modern Methods for Accurate Mold Detection
In this webinar, hear from Dr. Doug Botkin from Charles River Laboratories as he discusses Enhanced ... read more »

	Infographic

Revolutionizing Bioburden Testing
Download this infographic to learn ten benefits of the Sievers Soleil Rapid Bioburden Analyzer, including comprehensive monitoring, rapid time to ... read more »

	Featured Articles

		Pre-Emptively Satisfying Agency Queries and Other Concrete Use Cases for Regulatory AI Today, everyone has something to say about the potential for artificial intelligence – including Generative AI - in transforming Life Sciences ... read more »

		Cleanroom Disinfection: Maintaining Sterility by Design The use of disinfectants in a cleanroom requires a robust supplier quality approval program for each product, knowledge of the efficacy of the chosen ... read more »

	Featured Video

On-Demand Webinar: How to Achieve Growth Based Microbial Contamination Detection in Less than 24 Hours
In this webinar, we will look together into real-world data that was generated during numerous validations of Growth Direct® Systems at various sites ... watch »

On-Demand Webinar: Analytical Considerations for the Development of Protein Therapies
This webinar will cover key aspects to consider for CMC Testing for Protein-Based Therapeutics watch »

	Featured Products

BASF Virtual Pharma Assistants
BASF North America Save time and avoid costly missteps with the BASF Virtual Pharma Assistants, your interactive ... learn more »

JCF-100 Fully Automatic Auger Capsule Filling Machine
Qualicaps As a pioneer in capsule manufacturing, Qualicaps has accumulated a wealth of know-how and ... learn more »

OMNIS NIR Analyzer
Metrohm USA The OMNIS NIR Analyzer series consists of modern, Swiss-made laboratory instruments for quality ... learn more »

	Featured Whitepaper

How BASF is Using Digitalization to Improve its Customer Experience
Thanks to constant industry analysis and co-creation with customers, BASF is developing digital tools and features that ensure data is as accessible as it is empowering. read more »

eBook: Mastering Pharmaceutical Technology Transfer: From Strategy to Success
This eBook details planning for successful oral solid dosage technology transfers, ways to ensure a reliable technology transfer, best practices to mitigate risks and ensure reliability in drug ... read more »

	More Products

Allegro 200 L Single-Use Mixer Learn More
BioFlo 120 Single-Use Bioreactor Learn More
EMPROVE® exp Low Endotoxin Sucrose Learn More

	Directory Categories

Excipient Search Search More

Pharmaceutical Bioreactors and Fermentors Search More

Pharmaceutical Manufacturing and Testing Services Search More

	Events

SciX 2024
Raleigh Convention Center -Raleigh, NC – 10/20/2024
Come and be a part of SciX 2024, taking place from October 20 to 25 at the Raleigh Convention Center in Raleigh, NC. We have planned special sessions ... event details »

PDA Universe of Pre-Filled Syringes and Injection Devices Conference 2024
Phoenix, AZ – 10/22/2024
Learn about groundbreaking innovation in injectable drug delivery at the 21st edition of this popular conference! The largest event on pre-filled ... event details »

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