American Pharmaceutical News In Review

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October 22, 2020

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Nitrosamine Risk Assessment Whitepaper

In this paper, we review the nitrosamine impurities limits accepted by the regulatory agencies, look at risk assessment and the regulatory perspective and then explain a three step approach to evaluate risk, confirmatory testing and the corrective actions to take to comply with FDA, EMA and Health Canada.

	Industry News

DOJ Announces Deal with Purdue Pharma, Civil Settlement with Sackler Family
The DOJ has announced a global resolution of its criminal and civil investigations into Purdue ... read more »

First Patient Dosed in Trial to Treat Complications in COVID-19
Arch Biopartners has dosed the first patient in the Phase II trial of its lead drug LSALT peptide. read more »

First Patient Dosed in RGLS4326 Trial for Autosomal Dominant Polycystic Kidney Disease
Regulus Therapeutics announced initiation of dosing in its Phase 1b clinical study of RGLS4326 in ... read more »

VENCLEXTA Receives FDA Approval for AML
AbbVie announced the FDA has provided full approval to VENCLEXTA in combination with azacitidine, or... read more »

Genalyte Obtains EUA for Rapid COVID-19 Antibody Test
Genalyte announced its SARS-CoV-2 Multi-Antigen Serology Panel has received EUA from the FDA. read more »

entrinsic bioscience Secures U.S. Patent Grant for Breakthrough Respiratory Disease Program
EBS has been granted USPN 10,758,507 for novel therapeutic formulations in the treatment of a range ... read more »

	Featured Articles

QC Corner: Upholding Biosafety Standards Despite the Acute Need for a SARS-CoV-2 Vaccine Viral vaccines were the first pharmaceuticals manufactured using living cells, revolutionizing the industry at a time when regulatory compliance was ... read more »

Harnessing Synthetic Lipids for Drug Development: Strategies for Success Lipids are gaining enhanced momentum due to their vital role in the field of ribonucleic acid (RNA) therapeutics and vaccine development for diseases ... read more »

	Infographic

Choosing a CDMO for your Reformulation Needs
Here are some points to consider when choosing a CDMO for your drug product reformulation project. read more »

	Featured Video

On-Demand Webinar: Quality Control in the Next Normal
On-Demand Webinar: Quality Control in the Next Normal watch »

Watch Webinar: Bio-fluorescent Particle Counters: Enhancing Your Understanding of Process Water
Watch Webinar: Bio-fluorescent Particle Counters: Enhancing Your Understanding of Process Water watch »

	Featured Products

FTPA2000-260PH Multi-point FT-NIR Analyzer
read more »

APAF-BP AdvantaFlex™ Biopharmaceutical Grade TPE Tubing
read more »

	Featured Whitepaper

Recognizing the Potential Impact of Agitation Directionality On Oxygen Mass Transfer Through a kLa Evaluation Within the BIOne Single-Use Bioreactor
Defining a suitable agitation strategy is essential for the successful development of upstream mammalian bioprocesses. read more »

White Paper: Optimizing the Bio-Rad NGC Chromatography System for Cryo-EM Applications for High-Resolution and Low-Volume SEC
Structural biology is the three-dimensional study of complex biological molecules, like proteins, to determine their structures at atomic resolution. read more »

	Events

7th Microbiome and Probiotics R&D and Business Collaboration Forum
Rotterdam, The Netherlands – 12/02/2020
Microbiome and Probiotics R&D and Business Collaboration Forum brings together 400+ industry, academic, and investment leaders to discuss the latest ... event details »

Excipient World 2021
National Harbor, MD – 09/27/2021
Excipient World is the leading education, networking and sourcing resource for the $6+ billion and growing global excipient market. It’s the ONLY U.S.... event details »

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