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January 18, 2019

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	Industry News

Aquinnah Pharmaceuticals Receives Grant from Alzheimer's Association, Tau Consortium
Aquinnah has been awarded $750,000 from the T-PEP to advance its drug development programs in ... read more »

AMAG Completes Acquisition of Perosphere Pharmaceuticals
AMAG Pharmaceuticals has completed the previously announced acquisition of Perosphere ... read more »

Omeros Finalizes with FDA Clinical Plan for OMS721 Approval in IgA Nephropathy
Omeros has finalized its clinical plan for OMS721 submission and approval in immunoglobulin A ... read more »

Actelion Receives Complete Response Letter from FDA for OPSUMIT
Actelion has received a complete response letter from the FDA for its sNDA for OPSUMIT (macitentan) ... read more »

Amgen, UCB Receive Positive Vote from FDA in Favor of EVENITY Approval
Amgen and UCB announced strong support from the FDA BRUDAC for the approval of EVENITY for the ... read more »

FDA Issues Revised Draft Guidance: Rare Diseases: Common Issues in Drug Development Guidance for Industry
The FDA is making available a revised draft guidance titled Rare Diseases: Common Issues in Drug ... read more »

	Featured Articles

Clean Facilities Roundtable Standard equipment found in a typical microbiology lab includes active air samplers, incubators, pH ... read more »

Biopharmaceuticals/Biosimilars Roundtable The biopharmaceutical market has risen exponentially on the back of innovation, and science will ... read more »

	Featured Video

Watch Poster Video: Validation of an Automated Alternative Microbiology Method in the Age of Diverging Guidance
Validation of an Automated Alternative Microbiology Method in the Age of Diverging Guidance read more »

Watch Video: The TacticID-1064 from B&W Tek
The TacticID-1064 is the newest addition to B&W Tek’s family of handheld Raman analyzers, designed for safety personnel and first responders facing ... read more »

	Featured Products

TruCLEAN II Compact Flat Mopping System
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Crodasol HS HP
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	Featured Whitepaper

Validation of the Performance of the PerkinElmer FL 6500 and FL 8500 Fluorescence Spectrometers
For certain analyses, fluorescence is the method of choice due to its superior sensitivity compared to UV/Visible absorption spectrophotometry. read more »

Analysis of Extractable and Leachable Metals In Plastic Materials of Construction as per USP Acid Extraction Procedure Using the Agilent 5110 VDV ICP-OES
This document highlights an end to end solution for the quantitation of trace and toxic extractable and leachable metals in plastic materials of construction, as per the United States Pharmacopeia (... read more »

	Events

Clinical Trials West Coast
Burlingame, CA – 02/12/2019
Clinical Trials West Coast conference returns to the Bay Area for its 11th year in February 2019. With 6 tracks spanning across 2 days, the 2019 ... event details »

BIO Asia International Conference
Tokyo, Japan – 03/05/2019
The 16th annual BIO Asia International Conference is an exclusive partnering forum that brings together the global biotechnology and pharmaceutical ... event details »

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