American Pharmaceutical News In Review

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November 23, 2020

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ICON Government and Public Health Solutions

Over the past 30 years we have continuously worked in partnership with US Federal agencies, leading global non-government organizations and multi-national public health organizations to fight infectious diseases. We have conducted more than 200 infectious disease and vaccine studies globally, including over 40 studies in respiratory viruses, within the past five years alone. We are currently working on over 20 COVID-19 trials today, including 9 vaccine, 7 treatment, 4 diagnostic and 1 preventative.

	Industry News

ADVAITE CLIA Lab Receives Authorization to Offer COVID-19 SalivaDirect Test
ADVAITE announced the company's high complexity CLIA laboratory operating out of Chicago, IL has ... read more »

Inhaled Ampion Advances to Second Group of COVID-19 Patients with Respiratory Distress
Ampio announced the second group in the Phase I inhaled Ampion clinical study is being treated ... read more »

Rafael Pharmaceuticals Receives Fast Track Designation for CPI-613
Rafael announced the FDA has granted Fast Track designation for the Company’s lead compound CPI-613 ... read more »

Thermo Fisher Scientific, Northeastern University Announces Collaboration
Thermo Fisher Scientific and the BATL at Northeastern University have entered into a collaborative ... read more »

Agenus Announces Milestone Payment from Merck
Agenus announced that a milestone payment of $10M from Merck has been triggered with the advancement... read more »

University of Cambridge Announces Agreement with AstraZeneca, GSK
The University of Cambridge announced a five-year agreement with AstraZeneca and GSK to fund the ... read more »

	QC Corner

Analysis of FDA Enforcement Reports (2012-2019) to Determine the Microbial Diversity in Contaminated Non-Sterile and Sterile Drugs
An analysis of FDA enforcement reports from 2012 to 2019 showed that Gram-negative bacteria were the... read more »

Linking Drug Shortages, Quality Metrics and Aging Facilities
There are three topics in today’s pharmaceutical landscape com-manding the attention of both the ... read more »

	Infographic

Top 5 Secrets to a Successful Cleaning Validation Program
Here are five ways to ensure a successful and compliant cleaning validation program. read more »

	Featured Articles

Launch and Scale-Up of Multiproduct/Multiplatform Cell Therapy Manufacturing Facilities Cell therapies are living drug products that continue to provide hope and promise to patients around the world. They are transformative biological ... read more »

Why analyte binding to syringe filters must be studied during filter validation for QC testing Many pharmaceutical QC tests such as dissolution testing, content uniformity, assay, and blend uniformity require sample filtration prior to HPLC or ... read more »

	Featured Video

On-Demand Webinar: Amorphous Solid Dispersions by Spray Drying from Bench to Market
In this webinar, you’ll learn how to accelerate development of SDD formulations, importance of integrated formulation/process development, and ... watch »

On-Demand Webinar: Validation Guidance for Residual Host Cell DNA Testing of Biologics
In this webinar, you'll learn the components of a method validation per ICH Q2(R1) in the context of a quantitative polymerase chain reaction (PCR) ... watch »

	Featured Products

Facility Monitoring System
read more »

Impact of Container Closure on Drug Safety
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	Featured Whitepaper

Steritest NEO Sterility Testing Devices
Our Steritest™ NEO devices simplify every aspect of testing, from handling to traceability, all within a closed concept system. The ease and convenience of this closed assembly enable you to increase ... read more »

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 »

	Events

Developing Inhaled Generic Medicines – Navigating Complexity and Overcoming Challenges
Online – 12/01/2020
This webinar explores the key considerations and strategies for demonstrating equivalence, accelerating development and reducing late-stage product ... event details »

Injectable Drug Delivery 2021
Kensington, London – 05/12/2021
Innovations in formulation and device design for enhanced subcutaneous delivery SMi Group is pleased to announce the third annual Injectable Drug ... event details »

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