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December 2, 2014

 
Featured Content
Developing Representative Sampling Plans for Development, Problem Solving, and Validation
The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.

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New single-use bag family Flexsafe
Sartorius Stedim Biotech is introducing a brand-new, scalable range of single-use bags. Its completely new developed product family Flexsafe enables the implementation of single-use bioprocessing throughout all steps of drug manufacture, from process development to production, in upstream and downstream – all using just the one innovative polyethylene film. Learn more
New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

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Top Stories
Janssen Partners with Transposagen Biopharmaceuticals for CAR-T Therapies
The announcement calls attention to another partnership in the growing T-cell receptor engineering space.

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Merck Enters into Licensing Agreement with NewLink for Investigational Ebola Vaccine
Merck announced an agreement with NewLink Genetics to acquire exclusive rights to its experimental Ebola vaccine, rVSV-EBOV, for $50 million.

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Developing a Comprehensive Tool Kit for Microbial Identification
November 18, 2014
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Bristol-Myers Squibb and Five Prime Therapeutics Collaborate on Development of Immunomodulator
Opdivo and investigational agent FPA008 will be tested in combination for their efficacy in boosting antitumor immune response.

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Industry News
AstraZeneca Expands Biologics Manufacturing in Maryland
The more than $200 million project will increase production capacity at the facility to support AstraZeneca's maturing pipeline.

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FDA Extends Review of Novartis' Investigational Compound for Multiple Myeloma
FDA will delay its decision regarding the new drug application for panobinostat.

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The Future of Continuous Downstream Processing
December 3, 2014
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Lundbeck CEO Resigns Due to Code of Conduct Breach
Ulf Wiinberg has resigned as Lundbeck's CEO over unapproved acceptance of shares in a biotech company.

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IMS: Global Spending on Medicines to Rise 30% by 2018
Approximately 40% of total global growth will come from specialty medications, according to a new report from the IMS Institute for Healthcare Informatics.

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The 7th Annual Biomanufacturing Summit (18-20 February)
Make sure you join companies like UCB, GSK, MEDIMMUNE and GENENTECH to learn how to deliver excellence and efficiency gains through manufacturing, quality and supply chain strategies in Biotechnology. Book using code BIOPP and save 20%
GSK Announces Shareholders Meeting to Discuss Novartis Deal
GSK and Novartis announced a meeting on Dec. 18, 2014 to discuss the $20 billion asset swap between the two companies.

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Tufts’ New Figures on Drug-Development Costs Spark Debate
Tufts research suggests costs to launch a new drug have doubled since 2003, but some question conclusions.

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Ireland: The Gateway to Biopharma's Future
Despite recent changes in corporate tax law, Ireland remains a valuable and attractive partner in the development and manufacture of biopharmaceuticals.

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e-Book
Secure Single-Use Systems
In this digital e-Book, the editors discuss trends in single-use bioreactors, disposable chromatography, and best practices for reducing particulates in single-use systems.

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Webcasts
The Future of Continuous Downstream Processing
Wednesday, December 3, 2014, at 3 times - 3PM CST (Beijing); 11AM CET (Stockholm); 1PM EST (New York)
Sponsored by GE Healthcare
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Events
PepTalk: The Protein Science Week
Date: January 19-23, 2015
San Diego, CA

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The Society for Laboratory Automation and Screening (SLAS) 2015
Date: February 7-11, 2015

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7th Annual Global Biomanufacturing Summit
Date: February 18-19, 2015

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Reference Library
BioPharm International Releases New eBook: Single-Use Technology
The industry sees great promise in the continued adoption of disposable devices. Entirely disposable upstream processes that can support large, commercial-scale production are becoming a reality, and now companies are focusing on cost-effective downstream single-use innovations.
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