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October 03, 2019

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	Industry News

FDA Provides Update on Testing of Ranitidine for NDMA Impurities
The FDA is continuing to test ranitidine products from multiple manufacturers and is assessing the ... read more »

FDA Rejects AstraZeneca COPD Treatment
AstraZeneca announced the FDA has issued a CRL rejecting the NDA for PT010, an inhaled triple-... read more »

Heron Therapeutics Resubmits NDA for HTX-011 for Postoperative Pain
Heron Therapeutics has resubmitted its NDA to the FDA for HTX-011, an investigational agent for the ... read more »

Biomica Announces Advancement in IBD Program
Biomica announced the initiation of pre-clinical studies for BMC321 & BMC322, two rationally-... read more »

Upsher-Smith Launches Tosymra Nasal Spray for Migraine
Upsher-Smith announced the launch of Tosymra™ (sumatriptan) Nasal Spray, 10 mg for the acute ... read more »

Fast Track Designation Granted to Imetelstat for Relapsed/Refractory Myelofibrosis
Geron announced the FDA has granted Fast Track designation to imetelstat for the treatment of adult ... read more »

	Featured Articles

Structural Information to Aid in silico Therapeutic Antibody Design from Next-Generation Sequencing Repertoires Approvals of antibody and nanobody therapeutics are increasing rapidly.1 The Antibody Society has ... read more »

Microbiology Roundtable In general, what are some of the current critical issues/trends facing pharmaceutical manufacturers ... read more »

	Featured Announcements

[Webinar] The Life Cycle of Big Data in a Contamination Control Strategy
PMS
Overview Data collection and analysis is a critical component of a robust contamination control ... read more »

	Featured Video

Watch Video: Vi-CELL BLU Viability Analyzer from Beckman Coulter
Watch Video: Vi-CELL BLU Viability Analyzer from Beckman Coulter read more »

Watch Video: SKAN INTERPHEX Overview 2019
SKAN INTERPHEX Overview 2019 read more »

	Featured Products

Pegasus GC-HRT High Resolution TOFMS
read more »

HyClone CCM5 Cell Culture Media
read more »

	Featured Whitepaper

Benefits of 2D-LC/MS/MS in Pharmaceutical Bioanalytics
This application demonstrates the 2D-LC/MS/MS analysis of cell supernatants from an in vitro cell suspension-based assay. Superior separation by 2D-LC allowed the analysis of 16 target metabolites ... read more »

A Guide to Developing an Effective Cleaning and Disinfection Program in Aseptic Environments
Regulatory agencies require pharmaceutical manufacturers to control the environments in which they produce finished products to ensure they are free of contamination. read more »

	Events

Supporting CAR-T Process Performance through Advanced Analytics
Online – 10/03/2019
Learn how Sartorius' Umetrics Suite of Data Analytics Solutions support and improve CAR-T process performance. event details »

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 ... event details »

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