American Pharmaceutical News In Review

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October 14, 2021

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	Industry News

GE Healthcare Receives FDA Approval for Change in Prescribing Information for Optison
GE Healthcare announced that it has received approval from the U.S. Food and Drug Administration (... read more »

FDA Announces Availability of Draft Guidance on Microbiological Quality Considerations in Non-sterile Drug Manufacturing
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for ... read more »

Enhertu Receives Breakthrough Therapy Designation in Breast Cancer
The Food and Drug Administration (FDA) has granted Enhertu (trastuzumab deruxtecan), Breakthrough ... read more »

Sandoz Resolves Legacy Federal Government Civil Investigation in the U.S. Regarding Generic Drugs
Sandoz has entered a settlement agreement with the Civil Division of the U.S. Department of Justice ... read more »

	Infographic

The Top 4 Considerations in Lyophilized Product Development
To eliminate the concern of parenteral pharmaceuticals becoming unstable over time, lyophilization, or freeze-drying, is used to remove the water from... read more »

	Featured Articles

Countering Misinformation Spread About the COVID-19 Pandemic Today it’s a free-for-all on social media, which has become the main source of information for people on the COVID-19 pandemic, and sometimes a major ... read more »

Advancing to Recombinant Heparin Heparin is a potent anticoagulant that has been used clinically to manage blood clotting since 1935. Hundreds of thousands of doses are administered ... read more »

	Featured Video

On-Demand Webinar: Validation of a Mycoplasma NAT Platform for Product Release in Cell Therapy
This webinar will provide a review of validation strategies and implementation for a rapid at-line mycoplasma test for cell therapy companies. watch »

On-Demand Webinar: Clarifying Pharmacopeial Requirements for Pharma Waters and Process Analytics
In this webinar you’ll learn answers to common questions to distinguish actual pharmacopeial requirements for pharmaceutical waters vs what has become... watch »

	Featured Products

Nano DSC Complete Autosampler System v2
read more »

	Featured Whitepaper

eBook: Microbial Identification - Trends and Technologies for Aseptic Manufacturing Facilities
eBook content includes a wide variety of topics for microbial identification in pharmaceutical facilities. Strategies, tools, and technologies are featured. Articles feature an analysis of FDA ... read more »

	Events

Ophthalmic Drugs Conference
London, UK – 11/22/2021
The global ophthalmic drug market is forecast to surpass $60 billion USD by 2025 with increasing focus from the industry on alternative delivery ... event details »

Wearable Injectors and Connected Devices Conference 2021
London, UK – 10/18/2021
SMi’s 2nd annual Wearable Injectors and Connected Devices Conference will explore real world case studies of on-body device design and development for... event details »

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