American Pharmaceutical News In Review

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May 03, 2019

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Clean Facility Roundtable Part 3: Applications for Strict Microbial Monitoring

In our round table series, we ask thought leaders to expand on topics presented in the The Clean Facility of the Future documentary. In part 3 we asked, "Do you foresee pharmaceutical companies implementing the strict microbial monitoring strategies used for sterile product production on other types of products – such as solid dosage?"

	Industry News

New Drug Safety Communication from FDA on Certain Prescription Insomnia Medicines
The FDA is advising that rare but serious injuries have happened with certain common prescription ... read more »

Sagent Issues Recall of Ketorolac Tromethamine Injection
Sagent Pharmaceuticals announced the voluntary nationwide recall of one lot of Ketorolac ... read more »

Presage Announces Collaboration with Celgene
Presage Biosciences has entered into a research collaboration with Celgene Corporation to evaluate ... read more »

Eisai Buys Out Purdue Rights to End Lemborexant Collaboration
Eisai and Purdue announced that Eisai will buy out Purdue's rights to the worldwide collaboration ... read more »

3-V Biosciences Commences Dosing in TVB-2640 Study
3-V Biosciences and Ascletis Pharma announced 3-V Biosciences has recently dosed its first patient ... read more »

Sartorius Stedim Biotech Launches ambr® 15 Cell Culture Microbioreactor System
Sartorius Stedim Biotech is introducing its new generation of ambr® 15 cell culture automated ... read more »

	Featured Articles

Raw Materials and Functional Excipients Roundtable The contribution of functional excipients has greatly increased over the last decade. The key ... read more »

Contamination Control Roundtable The usual suspects are aging facilities, the incomplete implementation of barrier technologies, ... read more »

	Featured Video

On-Demand Webinar: Novel ADC Conjugates: Characterization Tools and Formulation/Process Development
In this webinar, you'll learn ADC analytical characterization techniques and current regulatory expectations, alternative approaches to quantitate ADC... read more »

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 »

	Featured Products

MicraSpray MS 2500
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Parteck LUB STA 50 Vegetable Grade Stearic Acid 50
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	Featured Whitepaper

Incremental Economic Value of the Agilent 1260 Infinity II Prime LC
The Agilent 1260 Infinity II Prime LC is the most capable and convenient LC for routine analysis. Instrument features include a pressure range up to 800 bar, built-in automation solutions, and best ... read more »

Mission: Freeze-Drying Control
Biologic drugs have shown great promise in curing many life changing diseases, even some that were once thought incurable. read more »

	Events

Excipient World
National Harbor, MD – 05/07/2019
Excipient World is the leading education, networking and sourcing resource for the $6+ billion and growing global excipient market. Excipient World is... event details »

Lonza’s 5th Global Endotoxin Testing Summit
Annapolis, MD – 06/03/2019
Lonza’s 5th Global Endotoxin Testing Summit will bring together the community to explore the most pertinent topics in the industry. event details »

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