American Pharmaceutical News In Review

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January 14, 2021

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Why is the sterility of your drug product much more than just a test of sterility?

A lack of sterility and sterility assurance continue to be a significant reason for drug recalls and regulatory citations and can pose a very real risk to patient safety and public health. Sterilization is a pivotal step in the pharmaceutical drug development process to help ensure overall safety is maintained.

	Industry News

BlueRock, Sloan Kettering Receive IND Clearance for DA01 for Parkinson’s Disease
BlueRock in collaboration with MSK, announced the FDA has cleared their IND application to proceed ... read more »

Adamas Completes Acquisition of OSMOLEX ER
Adamas announced the closing of the settlement of patent litigation with Osmotica and completes the ... read more »

FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer
Ambrx announced the FDA granted ARX788 Fast Track Designation as monotherapy for the treatment of ... read more »

Radius Health Announces Acquisition of Orphan Disease Program
Radius Health announced an agreement to acquire the global development and commercialization rights ... read more »

Farxiga Granted Priority Review in US for Chronic Kidney Disease
AstraZeneca’s Farxiga has been granted Priority Review in the US for the treatment of new or ... read more »

RedHill Biopharma's RHB-204 Granted FDA Fast Track Designation for NTM Disease
RedHill announced that RHB-204 has been granted Fast Track designation by the FDA for its ... read more »

	QC Corner

QC Corner: Particle Detection & Identification in Parenteral Products
Robin Sweeney, Product Manager at Unchained Labs joins Editor-in-Chief Mike Auerbach to discuss ... 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 »

	Featured Articles

Advanced Weigh Cell Technology for Healthcare Packaging Applications For healthcare packaging, recent technology advancements have made in-motion weighing operations more precise and profitable. read more »

As Injectables Become More Complex, Filling Lines Must Become More Modular Injectables last year accounted for 49% of the global pharmaceutical clinical pipeline, an increase of 6% since 2015. Much of this growth towards ... read more »

	Featured Video

Watch Poster Video: Validation of design features and method reducing risk of false positives during bioburden filtration testing
Zahira Perez Lopez elaborates on the methods and outcomes of a study aiming to mimic a month of use of the Milliflex Oasis™ under the worst case ... watch »

Watch Video: Unchained Labs - Hound Demo
Unchained Labs - Hound Demo watch »

	Featured Products

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

Diffucaps Customized Release Technology
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	Featured Whitepaper

ebook: Aseptic Processing Trends and Technologies
eBook offers a variety of strategies to optimize you aseptic fill finish small batch manufacturing to take advantage of the growing market for small-batch biopharmaceuticals. read more »

A Green Solution for the Dissolution Laboratory
Going “Green” in today’s business climate where maximizing shareholder equity and conserving capital is a top priority can be difficult, especially if the project increases the overall cost of doing ... read more »

	Events

Revolutionary Approach to UV-Vis Measurements: SoloVPE® Slope Spectroscopy®
Online – 01/19/2021
Traditional UV/Vis spectroscopy uses fixed pathlengths to measure different analytes, such as nucleic acids, proteins, and cells from biological ... event details »

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 »

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