American Pharmaceutical News In Review

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July 27, 2023

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Initiating Confidence in Your Organizations Data Governance
Initiating Confidence in Your Organizations Data Governance
This webinar explores the benefits of transitioning from manual to automated technologies in quality control microbiology processes within the industry. By implementing integrated digital automation, organizations can improve data integrity, operational efficiencies, and quality control test data, ultimately leading to increased confidence in product quality and patient safety. The use of automated technologies ensures accurate, auditable, and trustworthy data, enabling organizations to comply with stringent data integrity standards and regulatory requirements effectively.

	Industry News

Warfarin Reversal Drug Balfaxar® Receives FDA Approval For Urgent Procedures
Octapharma announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe... read more »

Astellas and PeptiDream to Discover Novel Targeted Protein Degraders
Astellas Pharma and PeptiDream announced a collaboration and license agreement to discover novel ... read more »

United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation
United Therapeutics Corporation announced that the United States Court of Appeals for the Federal ... read more »

FDA Accepts sNDA for OFEV® for Children and Adolescents 6-17 Years Old with Fibrosing Interstitial Lung Disease
Boehringer Ingelheim announced that the FDA accepted its supplemental New Drug Application (sNDA) ... 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

Pharma Tech Compare: MMS vs Traditional IR
Download this infographic to read about four key benefits that distinguish MMS from traditional IR methods. read more »

	Featured Articles

		Application of Rules-Based QRM Approach for Selection of Number of PPQ Batches In January 2023, ICH Q9 Quality Risk Management was updated. Managing and minimizing subjectivity within quality risk management (QRM) was a major ... read more »

		Improving the Sterility Assurance Section of an Application to Allow for More Efficient Assessment of ANDA and NDA Submissions to the FDA A goal within the FDA Division of Microbiology Assessment is to improve the quality of the sterility assurance submission for Abbreviated New Drug ... read more »

	Featured Video

On-Demand Webinar: Initiating Confidence in Your Organizations Data Governance
Live Webinar: Rapid Micro watch »

The Pharma Flash – Regulatory News and More in this Week’s Pharma Flash
Watch Video: FDA approves OTC oral contraceptive and Fast-Track STD treatment plus more news in this week’s Pharma Flash. watch »

	Featured Products

Klucel™ xtend Hydroxypropylcellulose (HPC) Controlled Release Matrix Former
Ashland Inc. Klucel™ xtend hydroxypropyl cellulose (HPC) is a controlled release matrix former, designed to ... learn more »

Aquarius™ Genesis Film Coating System
Ashland Inc. Aquarius™ Genesis film coating systems are designed for application at up to 35% solids, which can ... learn more »

BRAND® HandyStep® Touch Electronic Repeating Pipette
BRANDTECH® Scientific The BRAND® HandyStep® Touch and Touch S are the first electronic repeating pipettes with touchscreen... learn more »

	Featured Whitepaper

The Value and Benefits of Rapid Mold Detection in the Pharmaceutical Industry
Download this white paper to learn more about the advantages and value of rapid mold detection, the crucial role of accurate microbial identifications, and the significance of implementing stringent ... read more »

Article: Overcoming Obstacles in Gene Therapy Manufacturing
The gene therapy and viral vector space has yet to achieve the level of standardization that typifies established modalities, such as monoclonal antibodies. Consequently, there exists a tremendous ... read more »

	More Products

Ambr® 250 Modular Benchtop Bioreactor System Learn More
CE 4201 Variable Wavelength UV-Vis Detector Learn More
2.5S Nerve Growth Factor (NGF), Mouse Natural Learn More

	Directory Categories

Pharmaceutical Excipients Search More

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Pharmaceutical Manufacturing Search More

	Events

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 »

Pharmacovigilance World 2023
London, United Kingdom – 11/01/2023
The Pharmacovigilance World 2023 will provide a platform for the participants to discuss, share and stay updated with present state of affairs in ... event details »

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