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American Pharmaceutical News In Review
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March 11, 2021
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  Large Volume Parenteral Packaging Virtual Symposium

Large Volume Parenteral (LVP) dosage forms, including saline solutions, nutrition solutions, emulsions, blood products and derivatives, contrast agents, antibiotics, oncological drug products, etc., are a clinically important class of parenteral pharmaceutical therapeutics. While LVP dosage forms have been clinically and commercially relevant for decades, the evolving regulatory landscape has substantially increased the level of rigor and detail with which LVPs dosage forms and their associated packaging systems are qualified as being suited for their intended use, including patient safety.

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» Industry News
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  Abbott Receives EUA for PCR Assay That Detects, Differentiates SARS-CoV-2, Flu, RSV in One Test
Abbott announced EUA for Alinity m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-... read more »
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  Quantum Leap Healthcare Discontinues Razuprotafib I-SPY COVID Trial
Quantum Leap, the sponsor of the I-SPY COVID Trial, will not proceed with further testing of the ... read more »
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  Viatris, Kindeva Announce FDA Tentative Approval of ANDA Generic Version of Symbicort Inhalation Aerosol
Viatris and Kindeva Drug Delivery announced the FDA granted tentative approval of budesonide/... read more »
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  Longeveron Expands Enrollment Criteria for Trial Evaluating Lomecel-B Infusion ARDS due to COVID-19
Longeveron announced enrollment criteria for its Phase 1 ARDS RECOVER trial has been expanded to ... read more »
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  BioMarin Announces RMAT Designation Granted to Valoctocogene Roxaparvovec for Hemophilia A
BioMarin announced the FDA granted RMAT designation to valoctocogene roxaparvovec, an ... read more »
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  Emerald Health Starts Activities for Initiation of Phase 2 Clinical Study in Multiple Sclerosis
Emerald Health has initiated activities for a Phase 2 international clinical study for the treatment... read more »

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» QC Corner
QC Corner
  Rely on Data, Not Lore to Meet Rising Demand
The COVID-19 pandemic has forced countless difficult decisions to be made in the face of ... read more »
QC Corner
  On-Demand Webinar: Millipore Making sense of Analytical Standards in Pharma QC
On-Demand Webinar: Millipore Making sense of Analytical Standards in Pharma QC read more »

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» 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 »
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» Featured Video
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  On-Demand Webinar: Extended Release Injectables: Essential Polymer Design for Successful Microsphere-Based Drug Delivery
This webinar will provide scientists and technical stakeholders working in drug delivery with a detailed explanation of theory and application of an ... watch »
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  On-Demand Webinar: Development and Validation of a Duplex qPCR assay for the Detection of Residual Sf9 Host Cell DNA and Baculovirus DNA
In this webinar, you will learn more about current regulatory requirements for residual host DNA clearance for biological products and what that means... watch »

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» Featured Products
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  APAF-BP AdvantaFlex™ Biopharmaceutical Grade TPE Tubing
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  Universal Mycoplasma Detection Kit
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» Featured Whitepaper
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 »
The Process of Pharmaceutical Elastomer Selection for Injectable Biologics
Even before the current pandemic laser-focused the pharmaceutical industry’s attention on achieving a coronavirus vaccine, the spotlight on injectable drugs was bright thanks to the accelerating ... read more »

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| Events
EVENT
  Reactive-to-Proactive Process Monitoring in Pharmaceutical Waters
Online –  03/17/2021
In pharmaceutical water process monitoring, there is a need to change operating philosophy from reactive to proactive.
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EVENT
  Performance Enhancement Strategies for Low Solubility APIs
Online –  03/18/2021
Close to 90% of drugs coming out of the drug discovery pipeline, have solubility limitations translating into poor bioavailability, which may ...
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