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American Pharmaceutical News In Review
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August 21, 2020
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» Industry News
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  FDA Warns of Risk of Inaccurate Results with TaqPath COVID-19 Combo Kit
The FDA is alerting clinical laboratory staff and health care providers of a risk of false results ... read more »
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  BioMarin Receives CRL for Valoctocogene Roxaparvovec Gene Therapy for Severe Hemophilia A
BioMarin announced the FDA issued a CRL to the Company's BLA for valoctocogene roxaparvovec gene ... read more »
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  Cannformatics Receives Pilot Study Approval Identifying Cannabis-Responsive Biomarkers in Autism
Cannformatics has received IRB approval to conduct a pilot study to identify cannabisresponsive ... read more »
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  FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord
The FDA has approved Enspryng for neuromyelitis optica spectrum disorder in patients who are anti-... read more »
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  FDA Accepts sNDA for Tyvaso from United Therapeutics
United Therapeutics announced the FDA accepted for review the sNDA for Tyvaso Inhalation Solution ... read more »
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  Imfinzi Granted FDA Priority Review for Less-Frequent, Fixed-Dose Use
AstraZeneca's Imfinzi has received acceptance for its sBLA and has also been granted Priority Review... read more »

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» Featured Articles
Elvis and Stranger Things
If you haven’t seen the series Stranger Things on Netflix – I urge you to give it a try. read more »
The Importance of Amorphous Stability: Mesoporous Silica for Poor Glass Formers
Poor drug solubility has become an increasingly important consideration in the development of orally delivered drugs. For example, although it is ... read more »
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» Featured Announcements
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  Advancements in the Characterization of Pharmaceuticals by DSC
Webinar
This webinar will provide an in-depth review of the upgrades to the Milliflex Oasis Pump and ... read more »
» Infographic
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  Quality Control and Assurance Across Industries
Spectroscopy and Microscopy are used across industries in QC and QA applications. read more »
» Featured Video
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  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 »
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  On-Demand Webinar: Identifying & Mitigating Errors in Organic Extractables & Leachables Screening
In this webinar, you'll learn the risks of omission, inexact identification, and inaccurate and imprecise quantitation in chromatographic screening ... watch »

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» Featured Products
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  APAF-BP AdvantaFlex™ Biopharmaceutical Grade TPE Tubing
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  Crodasol HS HP
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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 accidentally via contaminated parenteral drugs or implantable medical tools such as intravenous infusion devices. 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 formulation into a tablet. Learn how development of profiles for each of the terms tabletability, compactability, and compressibility can benefit the development of a tablet and how each of their respective meanings offer different ways to characterize material under compress. read more »

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| Events
EVENT
  A Novel At-Line Pharmaceutical-Grade Mycoplasma Testing Solution: Sample to Results in Less than One-Hour
Online –  08/27/2020
With a small footprint, two minutes hands on-time, and less than one-hour time-to-result, BIOFIRE® Mycoplasma makes it easy to quickly test diverse ...
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EVENT
  Pre-filled Syringes San Francisco
Virtual –  09/14/2020
SMi is proud to announce the inaugural Prefilled Syringes San Francisco event taking place in September 2020. The global pre-filled syringes market...
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