American Pharmaceutical News In Review

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December 16, 2020

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The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

Understand the need to perform extractable and leachable evaluations for lyophilized drug products from a scientific perspective. Lyophilized drug product containers and administration devices consist of the primary packaging (typically a glass vial and a rubber stopper), the reconstitution solution container (typically a vial or a prefilled syringe system), and the drug administration set (such as a disposable syringe, an intravenous bag, or a pump system with administration tubing).

	Industry News

RedHill's COVID-19 Candidate Reduces ARDS-Related Blood Clotting in Preclinical Study
RedHill Biopharma announced promising preliminary results from a preclinical study within which ... read more »

Forxiga Approved in Japan for Chronic Heart Failure
AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with ... read more »

MapLight Therapeutics Receives Grant for Parkinson's Disease Research
MapLight Therapeutics announced a $8.1 million grant from The Michael J. Fox Foundation for ... read more »

Iterum Therapeutics Submits NDA for Oral Sulopenem
Iterum has submitted its NDA to the FDA for sulopenem etzadroxil/probenecid for uUTIs in patients ... read more »

binx health receives EUA Authorizing at-Home COVID-19 Sample Collection by Universities, Employers
binx health has received an amendment to its COVID-19 EUA from the FDA, this time for centralized ... read more »

REGENXBIO Doses First Patient in RGX-111 Trial for Mucopolysaccharidosis Type I Treatment
REGENXBIO announced the first patient has been dosed in the Phase I/II trial of RGX-111 for the ... read more »

	QC Corner

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

Maintain Operational Efficiencies in Micro Lab During a Pandemic
COVID-19 has caused many micro labs to re-evaluate current processes. As such, this brief 15-minute ... read more »

	Infographic

5 Quick Tips to Optimize Water Monitoring
Pure water is essential to all pharmaceutical development, scale-up, and manufacturing functions. read more »

	Featured Articles

Polysorbate, the Good, the Bad and the Ugly Polysorbate (PS) refers to a family of amphipathic, nonionic surfactants that is derived from ethoxylated sorbitan or isosorbide (a derivative of ... read more »

Endotoxin Detection: The Four Pillars of rFC Adoption in Lieu of LAL Endotoxin from Gram Negative Bacteria (GNB) interacts with cellular receptors to trigger strong systemic inflammatory responses including fever, ... read more »

	Featured Video

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 »

On-Demand Webinar: Sievers Eclipse BET Platform: A Closer Look at Efficiency Gains, Comparability, and Analytical Results
This webinar will also focus on how to evaluate this revolutionary technology. From comparability of analytical results across platforms to data ... watch »

	Featured Products

CEOLUS UF Grade Microcrystalline Cellulose
read more »

NanoRam Handheld Raman Spectrometer
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	Featured Whitepaper

From LAL to rFC Assays: A more sustainable future for endotoxin testing
Bacterial endotoxins are pyrogenic lipopolysaccharides found in the outer cell membrane of Gram-negative bacteria. Ubiquitous in the environment, endotoxins can easily enter the patient’s bloodstream ... read more »

Tabletability: Compactibility and Compressibility: What’s the difference?
The science behind compressing a block of particles or granules into a single tablet can be complicated. But compression studies can tell you everything you need to know about compressing a ... read more »

	Events

IFPAC - 2021
Virtual – 02/28/2021
IFPAC - 2021 will be held February 28 - March 5, 2021 LIVE, REAL-TIME event. The goal of IFPAC remains to support, connect, and unite our Community. ... event details »

Wearable Injectors and Connected Devices Conference 2021
London, United Kingdom & Online – 10/18/2021
Innovations in on-body devices and connectivity to aid drug delivery and patient experience The global wearable devices market size is expected to... event details »

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