American Pharmaceutical News In Review

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January 25, 2021

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Webinar: Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection

In this webinar you’ll learn the importance of demonstrating product specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.

	Industry News

ConserV Bioscience, LLNL to Collaborate on Development of Broad-spectrum Coronavirus Vaccine
ConserV Bioscience Limited and LLNL have agreed to collaborate on the development of a broad-... read more »

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV
The FDA approved Cabenuva as a complete regimen for the treatment of HIV-1. read more »

Impel NeuroPharma Announces NDA Acceptance of INP104 for Acute Migraine
Impel NeuroPharma announced the FDA has accepted for review the company's 5O5(b)(2) NDA for INP104 ... read more »

FDA Publishes New Guidance on Protecting Participants in Bioequivalence Studies During COVID-19
The FDA has published a new guidance for industry, Protecting Participants in Bioequivalence Studies... read more »

Jubilant, Wistar Institute to Evaluate Novel PAD4 Inhibitors to Reduce Severity of COVID-19
Jubilant Therapeutics announced a collaboration with The Wistar Institute to evaluate PAD4 ... read more »

BioPharma Companies Announce Formation of Accumulus Synergy
Ten biopharmaceutical companies announced the formation of a new non-profit corporation, Accumulus ... read more »

	QC Corner

The Human Microbiome: What It Is, Why It Is Important and Opportunities for Microbiome-Based Therapeutics
The human body is home to a huge and diverse community of microorganisms, consisting of bacteria, ... read more »

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

	Featured Articles

Three Ways to Simplify Endotoxin Testing The race to develop and manufacture COVID-19 vaccines and treatments has put a spotlight on Bacterial Endotoxins Testing (BET) and the criticality of... read more »

Test Your Readiness for New ICH M10 Reporting Requirements As 2020 comes to a close, drug development companies await the finalization and implementation of the ICH M10 guidance. The M10 guidance from the ... read more »

	Featured Video

On-Demand Webinar: Formulation and Development Strategies for Amorphous Solid Dispersion Drug Products
In this webinar you’ll learn formulation screening strategies for amorphous solid dispersions, details on an integrated approach for developing ASDs ... watch »

On-Demand Webinar: A Novel At-Line Pharmaceutical-Grade Mycoplasma Testing Solution: Sample to Results in Less than One-Hour
In this webinar you’ll learn about how this “lab in a pouch” technology works, primary validation data, and biopharmaceutical company evaluation data. watch »

	Featured Products

PYROGENT Gel Clot LAL Assays
read more »

DO Sensor InPro6860i/12/220/mA/HD
read more »

	Featured Whitepaper

eBook: TOC and Microbial Detection Monitoring
Proper and thorough monitoring of pharmaceutical water systems is imperative to deliver the highest quality products to patients. read more »

New Data to Support Activation Test for pyrogen detection Detect both endotoxin and non-endotoxin pyrogens in a single in vitro assay
Wondering how suitable a cell line-based Monocyte Activation Test is for detecting pyrogens? read more »

	Events

3D Cell Culture Conference
Virtual – 02/10/2021
3D Cell Culture is gaining momentum in the pharmaceutical industry, with the global 3D Cell Culture market predicted to surpass a value of $3.2 ... event details »

RNA Therapeutics 2021
London, UK – 02/10/2021
RNA therapeutics is a rapidly expanding industry with increasingly growing potential for immunotherapy personalised medicines, and treatment of ... event details »

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