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October 12, 2016

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	Industry News

FDA Accepts Supplemental New Drug Application (sNDA) for AVYCAZ®

FDA Approves Alexza’s ADASUVE® sNDA

Aetna and Merck Sign a Unique Value-Based Contract for Januvia® and Janumet

Charles River Extends Integrated Discovery Program with Genentech

Dr. Reddy's Launches Lamotrigine Orally Disintegrating Tablets in the U.S.

Paratek, U.S. Department of Defense to Study Omadacycline Against Biodefense Pathogens

	Featured Articles

Naturally Occurring Endotoxin: A New Reference Material Proposed By the US Pharmacopeia Naturally Occurring Endotoxin: A New Reference Material Proposed By the US Pharmacopeia In response to stakeholder requests, USP (US Pharmacopeial Convention; www.usp.org) is proposing a ... read more »

Rapid Bacterial Endotoxin Testing (BET) Rapid Bacterial Endotoxin Testing (BET) One of the most frequently asked questions by the end user of endotoxin testing systems is “How can... read more »

	Featured Video

Introducing New Product and Process Impurities Analysis from Thermo Fisher Scientific
Introducing New Product and Process Impurities Analysis from Thermo Fisher Scientific
The removal of host cell impurity is a critical step in the production of biopharmaceuticals. Introducing a new single, efficient platform from Thermo... read more »

GlycanAssure Glycan Analysis Technology from Thermo Fisher Scientific
GlycanAssure Glycan Analysis Technology from Thermo Fisher Scientific
The Applied Biosystems GlycanAssure Glycan Analysis and Quantitation System is the first glycan analysis platform that combines both throughput and ... read more »

	Featured Whitepaper

Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients
The International Conference on Harmonization (ICH) finalized the ICH Q3D Guideline for Elemental Impurities in December 2014. Regulators are now implementing the requirements worldwide. The U.S. ... read more »

Innovative Membrane Filtration Technologies for Upstream and Downstream Bioprocessing
Innovative Membrane Filtration Technologies for Upstream and Downstream Bioprocessing
In bioprocessing, process development scientists and engineers regularly seek improvements in filter performance to facilitate safe, cost-effective manufacture of drug and vaccine products. The latest... read more »

	Events

Lyophilization Week
Bethesda, MD – 12/05/2016
Available Courses Fundamentals of Lyophilization (December 5-6) This course is designed for participants to develop an understanding of the basic ... event details »

Pharmaceutical Microbiology
London, UK – 01/18/2017
SMi proudly presents the return of the 6th annual Pharmaceutical Microbiology conference to London in 2017! ?The microbiology market has ... event details »

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