American Pharmaceutical News In Review

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March 04, 2021

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Register Now: Scalable In-line Concentration Measurement for Biologic Process Development and GMP Manufacturing

In this webinar we will demonstrate how the FlowVPE Slope Spectroscopy System, when directly integrated in one or more locations of a process stream, has helped reveal process characteristics that until now have been hidden due to the limitations of the most commonly used online fixed pathlength UV-Vis solutions.

	Industry News

FDA Authorizes Quidel QuickVue At-Home COVID-19 Test
The FDA has issued an EUA for the Quidel QuickVue At-Home COVID-19 Test. read more »

FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine
The FDA announced it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to ... read more »

Agios Submits sNDA for TIBSOVO for IDH1-Mutant Cholangiocarcinoma
Agios has submitted a sNDA to the FDA for TIBSOVO as a potential treatment for patients with ... read more »

PLx Pharma Receives FDA Approval of SNDAs for Two VAZALORE Dosages
PLx Pharma announced the FDA approved sNDAs for its lead products, VAZALORE 325 mg and VAZALORE 81 ... read more »

VBL Announces Patient Dosing of Recurrent Glioblastoma Multiforme Trial
VBL announced patient dosing has been initiated in a Phase 2 clinical trial investigating ... read more »

GW Receives Positive CHMP Opinion for EPIDYOLEX for TSC Seizures
GW announced the CHMP has adopted a positive opinion on the Company’s Type II variation application ... 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 »

QC Corner: Large Molecule Manufacturing Technologies
Trends and advances in manufacturing of large molecules are discussed in this chat with HDR Company'... read more »

	Featured Articles

Characterization of DNA Impurities in Cell Therapies T cells play important roles in adaptive immunity by serving as sentinels against foreign pathogens. T cells that have been engineered to recognize ... read more »

Overcoming Challenges Along the Path to Routine Endotoxins Testing One of the most meticulous assays in a quality control laboratory is the bacterial endotoxins test. With patient lives at risk, the criticality of the... read more »

	Featured Video

On-Demand 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 ... watch »

On-Demand Webinar: Revolutionary approach to UV-Vis measurements using the SoloVPE® Slope Spectroscopy
In this webinar, we will review VPT and how it can be used in various applications from protein therapeutics to gene therapy. We will share real-world... watch »

	Featured Products

Pegasus 4D GCxGC-TOFMS
read more »

PYROGENT Gel Clot LAL Assays
read more »

	Featured Whitepaper

eBook: Slope Spectroscopy Method
The SoloVPE System is an innovative instrument for the UV-VIS-NIR spectroscopy. read more »

Tips for Choosing a Reliable Temperature Control System in the Pharmaceutical Industry
When considering a temperature control system for medical processing, precision and accuracy are key. Mokon’s advanced solutions are relied on by critical medical, pharmaceutical and biotechnology ... read more »

	Events

Development Strategies for Expediting Time-to-Market of Spray Dried Amorphous Solid Dispersions
Online – 03/10/2021
Spray drying is a continuous and scalable manufacturing process commonly used in the pharmaceutical industry. 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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