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American Pharmaceutical News In Review
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December 23, 2020
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  Disaster Prevention and Recovery

Natural disasters, man-made disasters, and cybercrimes occur with little or no warning, and can have catastrophic effects on laboratories, never the more evident with the current COVID-19 pandemic. These events bring operations to a halt, creating significant delays in production, increasing time to market, creating drug shortages, impacting quality and contributing to potentially devastating financial losses. OneSource provides solutions for maintaining operations following disaster events, as well as minimizing risk related to lab instruments, data and adherence to regulatory compliance.

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» Industry News
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  Pfizer, BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine
Pfizer and BioNTech announced the CHMP of the EMA issued a positive opinion to recommend the CMA of ... read more »
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  FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer
The FDA approved Tagrisso as the first adjuvant treatment for patients with non-small cell lung ... read more »
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  COVID-19 Study of Opaganib Passes Second DSMB
RedHill announced the study with opaganib in patients hospitalized with severe COVID-19 pneumonia ... read more »
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  Hepcidin Mimetic Candidate Receives Fast Track Designation for Polycythemia Vera
Protagonist announced the FDA has granted Fast Track designation to PTG-300 in the treatment of ... read more »
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  Astellas Reports XOSPATA, Azacitidine Combination Did Not Meet Endpoint
Astellas announced that a Phase 3 trial of XOSPATA plus azacitidine versus azacitidine alone in ... read more »
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  Neurotrope, Metuchen Announce Merger Completion Forming Petros
Neurotrope and Metuchen Pharmaceuticals have announced the completion of their previously announced ... read more »

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» QC Corner
QC Corner
  QC Corner: The Intersection of Development and Manufacturing
QC Corner: The Intersection of Development and Manufacturing read more »
QC Corner
  PyroSmart NextGen™ : Sustainable LAL Recombinant Cascade Reagent (rCR)
PyroSmart NextGen™ is the first and only recombinant reagent for kinetic chromogenic assays. Shown ... read more »

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» Infographic
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  Reach your Drug Discovery Goals with these 3 Essential Sample Quality Checks
Performing sample quality checks on assay components, such as reagents, proteins or compounds, is an essential but often overlooked step. Taking the ... read more »
» Featured Articles
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 »
An Interview with... Chris Weikart, Chief Scientist, SiO2 Material Science
Early packaging of pharmaceuticals was based on the availability of mass-produced containers of the day. Glass was the best choice at that time for ... read more »
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» Featured Video
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  On-Demand Webinar: Solid Form Analysis – In-depth Understanding of API’s Behavior
In this webinar you’ll learn how to evaluate stability of a formulation early in the drug product development process, what impact can distribution of... watch »
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  On-Demand Webinar: Sustainability In Bacterial Endotoxin Testing – A Holistic Approach to Conservation and Recombinant Technology
In this webinar you’ll learn about the current conservation/sustainability status of the horseshoe crab population in the US, new developments in ... watch »

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» Featured Products
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  CHIRALPAK ZWIX - Immobilized Zwitterionic CSPs
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  Crodasol HS HP
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» Featured Whitepaper
Reformulation into Long-Acting Injectables and Implants
Long-acting, drug delivery products based on PLG-parenteral functional excipients have been used to reformulate and repurpose more than 60 drugs. This white paper reviews the conversion of oral and ... read more »
Recognizing the Potential Impact of Agitation Directionality On Oxygen Mass Transfer Through a kLa Evaluation Within the BIOne Single-Use Bioreactor
Defining a suitable agitation strategy is essential for the successful development of upstream mammalian bioprocesses. read more »

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| Events
EVENT
  Pre-Filled Syringes and Injectable Drug Devices 2021
London, UK –  01/13/2021
Device design, regulatory and strategic pathways for parenteral drug delivery   SMi is proud to present the 13th Annual Pre-Filled Syringes ...
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EVENT
  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....
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