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American Pharmaceutical News In Review
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April 29, 2024
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  Take the Faster Path to Biosimilar Licensing
Sponsored by SGS
A keystone to the biosimilar approval process, comparative analytical assessments are critical to providing substantive evidence of similarity during non-clinical and clinical studies. With the right partner and expertise, comprehensive analytical testing can allow you to shorten the clinical development plan and enable a faster path to licensing. Read our whitepaper to learn how the experts at SGS can help you mitigate the risks associated with biosimilar product development and help you expedite approval.

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» Industry News
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  Lonza Launches AI-Enabled Route Scouting Service to Accelerate Small Molecule Development
Lonza announced the launch of its AI-enabled Route Scouting Service offering. The offering aims to ... read more »
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  Amgen to Submit Teprotumumab Marketing Authorization Application to the EMA
Amgen announced the imminent submission of a Marketing Authorization Application (MAA) to the ... read more »
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  FDA Approves RAG-01, a First-in-Class saRNA Therapy for BCG-Unresponsive NMIBC
Ractigen Therapeutics, announced that the FDA approved the company's Investigational New Drug (IND) ... read more »
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  Truqap Plus Faslodex Recommended for Approval in the EU by CHMP for Advanced ER-Positive Breast Cancer
AstraZeneca’s Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been recommended ... read more »

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» QC Corner
QC Corner
  Critical Considerations in Validating Alternative Mycoplasma Detection Methods
This video introduces critical considerations in validating an alternative method, and demonstrates ... read more »

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» Infographic
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  Pharmaceutical Solid-State Characterization and Crystallization within the Product Lifecycle
This infographic covers five essential considerations for solid-state characterization. read more »
» Featured Articles
EVENT   Applying Rigor to Regulatory Information Management Procurement
As data standards compliance becomes increasingly stringent and as digital transformation ambitions expand beyond the Regulatory remit to encompass ... read more »
EVENT   Material World: Selecting Representative Surfaces for Disinfectant Compatibility and Efficacy Studies
Disinfection of pharmaceutical facilities represents a critical element of contamination control. With disinfectant efficacy testing, the surface or ... read more »
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» Featured Video
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  On-Demand Webinar: Achieving EU GMP Annex 1 Compliance: Monitoring Compressed Gases for Microbial and Particle Contamination
In this Webinar you will learn the requirements for monitoring of particles and microorganisms in controlled cleanroom environments. watch »
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  On-Demand Webinar: Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol
In this webinar, hear from Shiri Hechter from Nelson Labs as she will cover the testing of high-risk drug components for Diethylene Glycol and ... watch »

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» Featured Products
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  S-125 Fully-Automatic Capsule Sealing Machine
Qualicaps As a pioneer in capsule manufacturing, Qualicaps has accumulated a wealth of know-how and ... learn more »
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  DynaPro™ ZetaStar™: Wyatt Technology™
Wyatt Technology Corporation The DynaPro ZetaStar instrument from Wyatt Technology™ a portfolio of Waters Corporation, was ... learn more »
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  EZ-Accu Shot™ Growth Promotion Test
Microbiologics Growth Promotion Testing of culture media can be a resource-consuming and tedious task. ... learn more »

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» Featured Whitepaper
EVENT   Whitepaper: Unlocking the Potential of Biosimilars
A keystone to the biosimilar approval process, comparative analytical assessments are critical to providing substantive evidence of similarity during non-clinical and clinical studies. With the ... read more »
EVENT   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 »

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» More Products
EMPROVE Parteck ODT Directly Compressible Disintegrant Learn More
i-Series Integrated HPLC/ UHPLC Systems Learn More
Xevo G2-S QTof Quadrupole Time-of-flight Mass Spectrometer Learn More
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» Directory Categories
Pharmaceutical Excipients Search More
Pharmaceutical Bioreactors and Fermentors Search More
Pharmaceutical Capsule Filling Machine Search More
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| Events
EVENT
  CPHI North America
Pennsylvania Convention Center –  05/07/2024
The growing US pharma event is back in Philadelphia for May 2024 Don’t miss out on turning connections into endless opportunity. Learn, innovate, and...
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EVENT
  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, ...
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