American Pharmaceutical News In Review

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December 24, 2019

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The Clean Facility of the Future Discussion: bioMérieux

Félix Alejandro Montero-Julian, Ph.D., bioMérieux Scientific Director Healthcare, discusses how pharmaceutical companies must adapt to meet new microbial monitoring requirements.

	Industry News

Nabriva Therapeutics Resubmits NDA for Intravenous CONTEPO
Nabriva Therapeutics has resubmitted its NDA to the FDA for CONTEPO for injection for the treatment ... read more »

FDA Releases New Drug Safety Communication on Gabapentin, Pregabalin
The FDA is warning that serious breathing difficulties may occur in patients using gabapentin or ... read more »

GB Sciences Announces Results from Parkinson's Disease Study
GB Sciences announced preclinical results for their Parkinson's disease formulations from the ... read more »

Elamipretide Study Does Not Meet Primary Endpoint
Stealth BioTherapeutics announced top-line data from the Phase 3 MMPOWER-3 trial evaluating ... read more »

Quantum Genomics Initiates its Trial in Difficult-to-Treat and Resistant Hypertension
Quantum Genomics announced the initiation of its pivotal Phase III FRESH study in difficult-to-... read more »

Boston Pharmaceuticals Announces COO Appointment
Boston Pharmaceuticals announced the appointment of Joanne Beck, Ph.D., as Chief Operating Officer. read more »

	Featured Articles

Bacterial Endotoxins Testing in Lipid-Based Drug Formulations Using Liquid-Liquid Extraction Lipid-based drug products present complications for bacterial endotoxins testing because the Limulus... read more »

An Interview with... Kali Sorum, RM(NRCM), Technical Support Supervisor, Microbiologics, Inc. Pharmaceutical laboratories ultimately want to make sure their products are safe. They need to ... read more »

	Featured Video

On-Demand Webinar: Dissolved CO2: A Critical Process Parameter in Upstream Bioprocessing
In this webinar, you’ll learn the importance of CO2 and how to produce consistent product quality and optimize cell culture performance. How to ... read more »

On-Demand Webinar: Microbial Identification via DNA-Sequencing Method to Support Risk Mitigation Strategies
In this webinar, you'll learn about current methods of microbial monitoring, discuss when it's appropriate to identify organisms to help with risk ... read more »

	Featured Products

TruCLEAN Pro Cleaning & Disinfecting System
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i-Series Integrated HPLC Systems
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	Featured Whitepaper

The Need for Standards in Microbiome Research
The human body harbors a series of diverse, dynamic microbial communities comprising bacteria, archaea, viruses, and eukaryotes. These communities, collectively termed the human microbiome, play a ... read more »

Simultaneous extraction of mycoplasma, mouse minute virus (MMV), and vesivirus nucleic acids from a single sample
Early detection of cell culture contamination is critical to prevent further contamination of facilities and requires fast, reliable assay methods. Here we describe an integrated nucleic acid ... read more »

	Events

PepTalk: The Protein Science Week
San Diego, CA – 01/20/2020
More than 1,300 researchers from around the world convene at PepTalk to hear inspiring presentations from industry experts and for valuable networking... event details »

SMi’s 9th Annual Pharmaceutical Microbiology Conference
London, UK – 01/20/2020
Pharmaceutical Microbiology as an industry is projected to see significant advancements in the next five years. This forecast is largely attributed to... event details »

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