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American Pharmaceutical News In Review
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June 25, 2019
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  Monocyte Activation Test (MAT): The in vitro test for pyrogen detection

Drugs that are purported to be sterile must also be free from pyrogens to prevent patients from febrile reactions. A sterile product does not mean “pyrogen-free” product. The control of pyrogens is mandatory in pharmaceutical products and regulated by several standards from organizations such as Food and Drug Administration (FDA), United States Pharmacopeia (USP) or European Pharmacopeia (EP). Our highly sensitive and easy to perform in vitro pyrogen test based on human cells offers a valuable alternative to the rabbit pyrogen test. Learn more in the featured articles.

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» Industry News
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  Infusion Options Issues Recall of All Lots of All Sterile Products Due to Lack of Sterility Assurance
Infusion Options is voluntarily recalling all lots of all sterile products within expiry to the ... read more »
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  FDA Expands Approval of Cystic Fibrosis Treatment
The FDA expanded the indication for Symdeko tablets for treatment of pediatric patients ages 6 years... read more »
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  Emmaus Life Sciences Announces Study Protocol for Pharmaceutical-grade L-glutamine
Emmaus Life Sciences has announced the use of its pharmaceutical-grade L-glutamine (PGLG) in a ... read more »
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  FDA Lifts Partial Clinical Hold on Phase 3 Study of Venetoclax
AbbVie announced the FDA has lifted the partial clinical hold placed on CANOVA, a Phase 3 trial ... read more »
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  Epygenix Submits IND Application for EPX-100 for Dravet Syndrome
Epygenix Therapeutics announced the Company has submitted IND and Fast Track Designation Request for... read more »
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  Shionogi Concludes Licensing Agreements with Eddingpharm for Lusutrombopag
Shionogi announces the Company has concluded an agreement with Eddingpharm to license-out ... read more »

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» Featured Articles
Aggregates Quantification of Biopharmaceuticals in a Wide Range of Sizes Using Orthogonal Methods
While the relation of protein aggregates in biopharmaceutical products to the immunogenicity after ... read more »
Realizing the Full Value of Clinician Engagement in Pharmaceutical Development and Manufacturing
Adoption of ICH Q8-11 has provided a more structured way to define product Critical Quality ... read more »
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» Featured Video
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  Watch Video: Sievers Complete Pharma Solution
Watch Video: Sievers Complete Pharma Solution read more »
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  B&W Tek- Celebrating 20 Years of Excellence!
B&W Tek is excited to celebrate 20 years of providing innovative solutions to a variety of different industries worldwide, including the ... read more »

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» Featured Products
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  PYROGENT Gel Clot LAL Assays
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  Sterility Test Isolator
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» Featured Whitepaper
Cleaning Botanical Residue in Manufacturing
Fundamentally when processing marijuana for making regulated drug products, the same guidance that applies to cGMP for pharmaceuticals applies to medical cannabis products. read more »
Cleaning and disinfecting in controlled environments: Mop Selection Guide
Effective cleaning and overall contamination control is key to a functional and efficient cleanroom. Selecting the appropriate mop and mopping system for your conditions can determine whether a ... read more »

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| Events
EVENT
  Clinical Operations in Oncology Trials East Coast 2019
Cambridge, MA –  07/10/2019
The Clinical Operations in Oncology Trials (CTO) meeting returned to Boston for its 6th year with over 150 attendees from biopharmaceutical, medical ...
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EVENT
  Highly Potent Active Pharmaceuticals Ingredients
Boston, MA –  10/21/2019
The HPAPI global market is growing at an ever-increasing rate of CAGR at 8.6% that is projected to reach USD $31.56 Billion by 2025, with a ...
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