American Pharmaceutical News In Review

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January 30, 2023

Newsletter Sponsor

Sterility Testing of Parenteral & Ophthalmic Drug Products
Sponsored by Nelson Labs
Offering tests through traditional cleanroom and also isolators, Nelson Labs can provide customers with the most appropriate product-sterility testing. To help ensure that we can accommodate our customers’ requirements, we have added a new isolator line to better support the sterility assurance programs of our customers. Testing in our isolators is performed by highly skilled analysts, further increasing the likelihood of positive outcomes.

	Industry News

FDA Says Evusheld is Not Currently Authorized for Emergency Use in the US
The FDA revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with ... read more »

FDA Approves KEYTRUDA as Adjuvant Treatment for Patients with Non-Small Cell Lung Cancer
Merck announced that the FDA approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a single agent, for ... read more »

AstraZeneca and Daiichi Sankyo’s Enhertu Approved in EU for Breast Cancer
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European ... read more »

FDA Approves House Dust Mite Allergen Extract Tablet for Allergic Rhinitis
ALK announced that the FDA approved ODACTRA (House Dust Mite Allergen Extract) Tablet for Sublingual... read more »

	QC Corner

Effective Contamination Control Strategy and Microbial ID Workshop
What is an effective contamination control strategy, microbial ID methodology? This video goes in-... read more »

	Infographic

5 Ways to Optimize Water Monitoring
Download this Infographic Now!
This collection of articles covers a number of key topics in pharmaceutical water analysis. read more »

	Featured Articles

		Facility Tour: Eurofins BioPharma Product Testing -ATMP and Cell and Gene Therapy Testing Services for the Global Market The global biopharmaceutical industry is continually innovating and looking forward to discover the next class of therapies to treat and cure patients... read more »

		What’s Keeping Your Enterprise from Fully Leveraging Its Data? Research & development (R&D) processes are increasingly being redefined within the framework of digital transformation. With these initiatives, pharma... read more »

	Featured Video

On-Demand Webinar: Lower Bioprocessing Costs and Time with Raman Spectroscopy
In this live webinar, hear from Dean Stuart as he talks about Lower Bioprocessing Costs and Time with Raman Spectroscopy watch »

Watch Video: Catalent Cell and Gene Therapy
Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. watch »

	Featured Products

Pyros Kinetix® Flex Incubating Kinetic Tube Reader
ACC The Pyros Kinetix® Flex and Pyros® EQS 21 CFR Part 11 compliant Software combine to provide a ... learn more »

Pyrotell Gel-clot Formulation
ACC Pyrotell® lysate was the first LAL gel-clot reagent licensed by the US FDA. It is easy to use ... learn more »

Pyrosate Kit Rapid Endotoxin Detection
ACC The Pyrosate kit offers some unique advantages over standard LAL gel-glot testing methods. The assay... learn more »

	Featured Whitepaper

Whitepaper: Stay on Target: Improving Process Control through Strategic Cascade Feedback Loop Tuning
Well-developed control strategies are essential for reliable and consistent upstream bioprocess manufacturing. Feedback control loops must be properly engineered to ensure critical process parameters ... read more »

Poster: Adoption of ATP Bioluminescence Technology
SQZ Biotechnologies has successfully adopted the established Milliflex® Rapid ATP Bioluminescence based RMM (Rapid Microbiological Method) technology platform from MilliporeSigma to support 3 ... read more »

	More Products

Abbemat MW Multiwavelengths Refractometer Learn More
Atmospheric Air Dryers Learn More
BENCHTOP Manifold Freeze Dryer Learn More

	Directory Categories

Pharmaceutical Excipients Search More

Automated Sample Dilution Equipment Search More

Pharmaceutical Formulation Development Search More

	Events

DCAT Week
New York, NY – 03/20/2023
The Premiere Event for the Global Bio/Pharmaceutical Manufacturing Value Chain event details »

CPHI North America
Pennsylvania Convention Center, Philadelphia – 04/25/2023
CPHI North America is the only end-to-end pharma event in the Americas. event details »

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