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January 29, 2020

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[Webinar] Microbiological Control in a Pharmaceutical Manufacturing Environment

This webinar will address the evaluation of microbiological, environmental monitoring data. The analysis of this trended data allows us to establish alert and action levels as well as methods for determining these levels. Evaluate and define a robust program to protect your products, personnel, and equipment. Learn more now!

	Industry News

FDA Warns Purell to Stop Making Unverified Health Claims
A warning letter sent by the FDA has warned GoJo, the maker of Purell products, to stop making ... read more »

Researchers Find Injecting Influenza Vaccines into Tumors Triggers Immune System Response
Physicians and scientists at Rush University Medical Center found injecting tumors with influenza ... read more »

Alkermes Announces FDA Acceptance of NDA for Schizophrenia, Bipolar Treatment
Alkermes announced the FDA has accepted for review the company's NDA seeking approval of ALKS 3831 ... read more »

HTG Receives European Patent Grant for Subtyping Diffuse Large B-cell Lymphoma
HTG has received notification of validation of European patent number EP 3356554 for its methods for... read more »

Abbott Receives Expanded Indication for Directional DBS to Treat Parkinson's
Abbott has received approval from the FDA for a new, expanded indication for the company's Infinity™... read more »

FDA Approves Only Triple-Combination Tablet with Jardiance for Type 2 Diabetes
The FDA has approved Trijardy™ XR to lower blood sugar in adults with type 2 diabetes, along with ... read more »

	Featured Articles

Oral Solid Dosage Trends American Pharmaceutical asked our readers several questions regarding the technologies and processes... read more »

Outsourcing & Insourcing: How Eurofins solves the bio/pharma industry’s challenges associated with meeting drug development timelines and budgets with restricted headcounts Pharmaceutical and biopharmaceutical companies face a significant challenge to get their drug ... read more »

	Featured Video

On-Demand Webinar: Best Practices for Aseptic Sampling from Stainless Process Equipment
In this webinar we’ll review the pros and cons of common sampling methodologies and best practices for choosing the most appropriate sample collection... read more »

Watch Video: Sartorius Seminar - Driving Value Through Intensified Single-Use Bioprocessing & Advanced Data Analytics from PD to Commercial Manufacturing
Watch Video: Sartorius Stedim Biotech Seminar - Driving Value Through Intensified Single-Use Bioprocessing & Advanced Data Analytics from PD to ... read more »

	Featured Products

Soluplus
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PYROGENT Gel Clot LAL Assays
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	Featured Whitepaper

Secure the quality of your gene delivery and liposomal-based drug delivery platforms
Quality-critical attributes particular to liposome drug products include physicochemical properties such as particle size distribution and morphology, e.g. their overall shape. Such properties will ... read more »

Impact of Data Integrity Audits on Pharma Microbial QC Labs
Most people are aware of the requirements of the code of federal regulations 21 CFR Part 11 for computer software security, which have been a major pharmaceutical IT focus for approximately 10 years. read more »

	Events

Burkholderia cepacia Contamination of Pharmaceutical Products
Online – 02/13/2020
Join Dr. Luis Jimenez as he discusses current research and FDA recall information of Burkholderia cepacia complex (Bcc) contamination in the ... event details »

3rd Cold Chain Global Forum West Coast
San Diego, California – 02/25/2020
The 3rd Cold Chain Global Forum West Coast has Cyber Week specials next week only! • 50% Off Standard Package Rates on Cyber Monday, December 2nd. •... event details »

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