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April 27, 2020

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	Industry News

CNS Announces Filing of Orphan Drug Designation for Brain Cancer Drug
CNS has filed an application with the FDA to receive Orphan Drug Designation for its lead product ... read more »

Kymriah Receives FDA Regenerative Medicine Advanced Therapy Designation
Novartis announced the FDA granted RMAT designation to Kymriah for an investigational new indication... read more »

FDA Cautions Use of Hydroxychloroquine, Chloroquine for COVID-19 Outside Hospital Due
The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with ... read more »

Janssen Submits sBLA for SIMPONI ARIA for Juvenile Arthritis
Janssen announced the submission of two sBLAs to the FDA seeking approval of SIMPONI ARIA for the ... read more »

HVP Launches Global Initiative to Accelerate the Development of COVID-19 Vaccines
The HVP is launching the COVID Vaccine Initiative to develop safe, effective, accessible vaccines ... read more »

Lynparza Demonstrated Overall Survival Benefit for Prostate Cancer in Trial
AstraZeneca and Merck announced further positive results from the Phase III PROfound trial of ... read more »

	Featured Articles

QC Corner: Sterility Testing of Difficult-to-Filter and Growth-Inhibiting Samples An important question for many companies in the pharmaceutical industry is whether to use membrane ... read more »

Microbiological Data Integrity: Points to Consider Regarding Second Analyst Verification Data integrity is a topic of great importance in our industry. Robust data integrity is critical to ... read more »

	Featured Announcements

An Optimized Workflow for Single-Cell Transcriptomics and Repertoire Profiling of Purified Lymphocytes from Clinical Samples
Webinar
This webinar explores various sample preparation techniques on previously cryopreserved clinical ... read more »

	Featured Video

On-Demand Webinar: Making the Switch: The Evaluation, Implementation and Validation of Bringing Rapid Mycoplasma Testing In-House to Expedite Lot Release of Recombinant Protein Product
In this webinar, you'll learn about Octapharma’s evaluation of the PCR method, as an alternative to the traditional growth-based mycoplasma testing ... watch »

On-Demand Webinar: A 360 Overview of Data Integrity in Life Sciences
In this webinar, you’ll learn the most common pitfalls and challenges Life Sciences companies are facing when improving their data integrity, how to ... watch »

	Featured Products

Universal Mycoplasma Detection Kit
read more »

HyClone CCM5 Cell Culture Media
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	Featured Whitepaper

MicroED and Drug Discovery
Recent blogs highlighting the technique of micro-electron diffraction (microED) and its utility in the structural determination of small molecules have significantly increased its visibility in the ... read more »

Simultaneous extraction of mycoplasma, mouse minute virus (MMV), and vesivirus nucleic acids from a single sample
Early detection of cell culture contamination is critical to prevent further contamination of facilities and requires fast, reliable assay methods. Here we describe an integrated nucleic acid ... read more »

	Events

Identifying & Mitigating Errors in Organic Extractables & Leachables Screening
Online – 06/17/2020
The discipline of Organic Chromatographic “Screening” to discover, identify and (semi-)quantify organic compounds in an extract (from a pharmaceutical... event details »

6th Annual QC Micro Summit
Francis Marion Hotel – 09/14/2020
It’s an event that’s aimed to let you step away from the bench, learn about the big trends impacting our industry, share great ideas, and develop new ... event details »

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