American Pharmaceutical News In Review

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January 19, 2021

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Webinar: Advancing Vaccine Development with Novel Chromatography Solutions and State of the Art Quality Testing

The rise of new diseases and infections has led to the need for accelerated development of safe and effective vaccines. Join this webinar on January 26th to learn more on novel chromatography solutions which can help in improving the downstream processes of different vaccine types such as mRNA, recombinant proteins and Virus Like Particles (VLPs).

	Industry News

Gritstone Advances Second Generation COVID-19 Vaccine
Gritstone Oncology is advancing development of a second-generation vaccine against SARS-CoV-2 with ... read more »

Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets
Nostrum Laboratories is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP... read more »

FDA Releases Update on OTC Monograph Drug User Fee Program Implementation
The CARES Act, enacted in March 2020, amended the Federal Food, Drug, and Cosmetic Act to provide ... read more »

Novartis Expands Oncology Pipeline with In-Licensing of Tislelizumab from BeiGene
Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene in ... read more »

Clearside Biomedical Begins Enrollment for CLS-AX Trial for Wet AMD
Clearside Biomedical announced the first patients have been enrolled in its Phase 1/2a clinical ... read more »

Lower-Profile Web Intrasaccular Aneurysm Treatment Device Receives FDA Approval
MicroVention announced the FDA Approval of the PMA Supplement for the WEB 17 System. read more »

	QC Corner

Perfusion Medium Development for Continuous Bioprocessing of Animal Cell Cultures
Traditional bioprocesses of mammalian cell cultures are operated in batch- or fed-batch mode. To ... read more »

On-Demand Webinar: Millipore Making sense of Analytical Standards in Pharma QC
On-Demand Webinar: Millipore Making sense of Analytical Standards in Pharma QC read more »

	Featured Articles

Transition to Modern Microbiological Methods in the Pharmaceutical Industry Microbiologists have the continuing challenge of evaluating, validating, and implementing emerging testing technologies to enhance the performance of ... read more »

2020 in Review: Remote Regulatory Information Management and Other Real-Life RA Process Challenges Highlighted by the Unforeseen Events of This Year Amplexor’s David Gwyn reflects on what the last year has exposed in terms of RIM-related shortcomings, and how the Regulatory Affairs agenda should ... read more »

	Featured Video

On-Demand Webinar: Microbial Identification for All: Exploring the MicroSEQ ID Microbial Identification System
In this webinar you’ll learn how the MicroSEQ ID Microbial Identification System fits into your bioproduction workflow, how the MicroSEQ ID Microbial ... watch »

On-Demand Webinar: Developing Inhaled Generic Medicines – Navigating Complexity and Overcoming Challenges
This webinar explores the key considerations and strategies for demonstrating equivalence, accelerating development and reducing late-stage product ... watch »

	Featured Products

CEOLUS UF Grade Microcrystalline Cellulose
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BacT/ALERT 3D Microbial Detection System
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	Featured Whitepaper

The Process of Pharmaceutical Elastomer Selection for Injectable Biologics
Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable drugs was bright thanks to the accelerating ... read more »

Reformulation into Long-Acting Injectables and Implants
Long-acting, drug delivery products based on PLG-parenteral functional excipients have been used to reformulate and repurpose more than 60 drugs. This white paper reviews the conversion of oral and ... read more »

	Events

Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection
Online – 01/26/2021
For the last several years, Bionique Testing Laboratories has been in a unique position to facilitate the adoption of rapid mycoplasma testing ... event details »

Pittcon 2021
Virtual – 03/08/2021
Pittcon is a dynamic, transnational exposition and comprehensive technical conference, a venue for presenting the latest advances in research and ... event details »

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