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American Pharmaceutical News In Review
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August 28, 2019
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  Stability Testing Comes to San Diego, CA October 21 - 22!

KENX is pleased to announce the launch of two new interactive one-day seminars addressing the complexities of stability testing. This live and interactive course delivers a comprehensive look at ICH and global regulations and operational issues surrounding the stability program. This training program delivers advanced technical issues to design the most effective stability program; and covers forced degradation studies to establish stability-indicating methods, monitoring organic impurities, handling deviations, data investigations, and different control strategies to improve stability program and manage regulatory inspections.

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» Industry News
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  Johnson & Johnson Ordered to pay $572M in OK Opioid Case
An Oklahoma judge found Johnson & Johnson and Janssen Pharmaceutical liable for fueling the opioid ... read more »
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  Viela Bio Announces Review of Inebilizumab BLA
Viela Bio announced the FDA accepted for review its BLA for inebilizumab for the treatment of ... read more »
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  FDA Grants Fast Track Designation for FARXIGA in Chronic Kidney Disease
AstraZeneca announced the FDA has granted Fast Track designation for the development of FARXIGA to ... read more »
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  Sigilon Receives Orphan Drug Designation for SIG-001 for Hemophilia A
Sigilon Therapeutics has received Orphan Drug Designation for SIG-001, an investigational therapy ... read more »
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  European Commission Approves SOLIRIS for NMOSD
Alexion announced the EC has approved the extension of the current marketing authorization of ... read more »
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  BiomX Announces In-house Phage Manufacturing Facility
BiomX announced completion a new manufacturing facility. read more »

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» Featured Articles
Environmental Monitoring Performance Qualification (EMPQ) Risk Assessment
Producing non-terminally sterilized parenteral products requires strict microbiological controls to ... read more »
Pharmaceutical P.I.N. Points Patent Innovation News
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical ... read more »
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» Featured Video
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  Watch Webinar: New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis
Watch Webinar: New USP Monographs – Solving Analytical Challenges in Pharmaceutical Analysis read more »
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  Watch Webinar: Global Regulators’ FAQs on CMC in IND/BLA: Filing A Retrospective Look At Past Mycoplasma Validation Queries and Responses
Watch Webinar: Global Regulators’ FAQs on CMC in IND/BLA: Filing A Retrospective Look At Past Mycoplasma Validation Queries and Responses read more »

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» Featured Products
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  AeroTrak+ Remote Airborne Particle Counters
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  TruCLEAN II Compact Flat Mopping System
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» Featured Whitepaper
Hound blasts through your problems: ID inorganic and metal particles with LIBS
Hound can identify a wide range of contaminants including organic, inorganic, protein, and elemental particles using a combination of automated microscopy, Raman and LIBS. Learn how LIBS was used to ... read more »
The NEXT GENERATION in Protein Characterization
The ability to measure and characterize changes in the secondary structure of proteins is critical to many research applications, especially the formulation and development of biotherapeutics. read more »

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| Events
EVENT
  SMi’s 9th Annual Orphan Drugs & Rare Diseases Conference
London, UK –  10/15/2019
Addressing the Microbiological Aspects in Cleanroom Design and Engineering SMi Group are pleased to announce the Inaugural Pharmaceutical Cleanroom ...
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EVENT
  FierceBiotech’s 4th Drug Development Forum
Boston, MA –  10/28/2019
FierceBiotech’s 4th Drug Development Forum provides a unique networking opportunity, featuring insights from C-suite and executive leadership at ...
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