American Pharmaceutical News In Review

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May 25, 2023

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	Industry News

Sandoz Marketing Authorization Applications for Proposed Biosimilar Denosumab Accepted by EMA
Sandoz has received news that the European Medicines Agency (EMA) has accepted the marketing ... read more »

HI-Bio™ Receives FDA Orphan Drug Designation for Felzartamab in Treatment of Rare Kidney Disease
Human Immunology Biosciences (HI-Bio™), a clinical-stage biotech company focusing on severe immune-... read more »

Ginkgo Bioworks and Centrient Pharmaceuticals Expand Partnership for Sustainable Innovation in Generic APIs
Centrient Pharmaceuticals and Ginkgo Bioworks are expanding their partnership. Together, they aim to... read more »

Alvotech and Advanz Pharma Extend Partnership to Commercialize Five Proposed Biosimilars
Alvotech and Advanz Pharma have entered into an exclusive partnership agreement regarding the supply... 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

Working with Lipid Nanoparticle-Based Drugs (LNPs) and Other Complex Formulations
If you are considering an LNP-based formulation or another complex drug, here are several points to consider to make the process more efficient. read more »

	Featured Articles

		Moving Towards Genome Integrity Evaluation of Gene Therapy Viral Vectors Gene therapy is a rapidly developing field that holds promise for the treatment of a variety of genetic disorders. One of the most important ... read more »

		Data Governance: Tackling Complexity with Baby Steps Everything in life sciences – from the latest measures around safety and regulatory rigor to renewed focus on agility, efficiency, and streamlined ... read more »

	Featured Video

On-Demand Webinar: Implementing a Recombinant Cascade Reagent for BET
In this live webinar, hear from Veronika Wills as she discusses Implementing a Recombinant Cascade Reagent for BET. watch »

The Pharma Flash - FDA Approves 2 New Drugs, Issues Draft Guidance - May 26, 2023
Check out the top pharma news of the week from our Editor-In-Chief, Mike Auerbach. watch »

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Acconon Mixtures for Bioavailability and Emulsion
ABITEC Acconon excipients are well-characterized mixtures of polyoxyethylene mono- and diglycerides, fatty ... learn more »

	Featured Whitepaper

Whitepaper: Are Nitrosamines a Concern for Biologic Manufacturers?
The discovery of nitrosamine genotoxins in several pharmaceuticals has led to monitoring and re-evaluation of manufacturing practices for those products considered at risk. This article provides an ... read more »

Whitepaper: The Relevance of Polymorph Screening in the Pharmaceutical Industry
Solid form screening, the activity of discovering and characterizing different solid forms of an active pharmaceutical ingredient (API), is an essential part of drug development. This screening ... read more »

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Abbemat 300/350 Refractometer Learn More
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	Directory Categories

Analytical Instrumentation Search More

Pharmaceutical Excipients Search More

Biopharmaceutical Fluid Storage Search More

	Events

CRS 2023 Annual Meeting
Las Vegas, Nevada, USA – 07/24/2023
The 2023 Annual Meeting & Expo reflects our focus on cutting-edge research and innovation across our strong discipline that will keep you up-to-date ... event details »

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 »

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