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Podcasts

Webcast:Improving Cell Culture Productivity: Best Practices for Automation and Control
Sponsored by Parker Hannifan

Webcast:Application of QWBA and Short-Lived Isotopes in the Drug Development Paradigm
Sponsored by MPI Research

Webcast: API Development: Risk and Control of Genotoxic Impurities
Sponsored by Neuland

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Events

BIO-Europe Spring 2013
March 11–13, 2013
Barcelona, Spain

Informex
February 19–22, 2013
California, USA

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News

FDA Approves Influenza Vaccine Manufactured with Novel Technology
FDA has approved Protein Sciences’s FluBlok, a seasonal influenza vaccine made with a novel technology that uses recombinant DNA and a modified baculovirus.
Click Here to Read More

FTC Reports Increase in Anticompetitive Activities Among Drug Makers
In a new report issued by the Federal Trade Commission (FTC), FTC analysts reported that the number of potentially anticompetitive patent dispute settlements between branded and generic drug companies increased from 28 in 2011 to 40 in 2012.
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Rutgers University Research Center and Janssen Develop Continuous Manufacturing Process
Researchers in the Engineering Research Center for Structured Organic Particulate Systems at Rutgers University have collaborated with Janssen to develop a direct-compaction line using continuous manufacturing principles.
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FDA's Position on Abuse-Deterrent Opioid Formulations Becomes Clearer
With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class.
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Root Causes of R&D Inefficiency Must be Identified, Says Report
Drug developers need to fully identify and address root causes of R&D inefficiency if they want to replenish their sparse R&D pipelines, according to the Tufts Center for the Study of Drug Development.
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IndustryBriefs
  • Amgen has announced plans to build a new manufacturing facility in the Tuas Biomedical Park area of Singapore. Over the next several years, Amgen anticipates investing approximately $200 million to build the facility.
  • Accelrys, a provider of scientific innovation lifecycle-management software, has agreed to acquire Vialis, a systems integrator serving the pharmaceutical, biotechnology, chemicals, and agroscience industries.
  • Almac has completed its Knowledge Transfer Partnership (KTP) with Queens University Belfast intended to develop, improve, and embed bioprocesses to facilitate the delivery of novel products for its biocatalysis business.
  • Daiichi Sankyo and Ranbaxy Laboratories have agreed to integrate their business operations in Thailand, to leverage and maximize the synergies of the hybrid business model, which is expected to commence business on Apr. 1, 2013.
  • Read More Industry Briefs.
 
Survey
What area do you think will see increased regulatory attention and enforcement in 2013?
 
Foreign APIs 32%
 
 
GMP inspections 19%
     
 
Manufacturing processes 13%
     
 
Counterfeit medicines 28%
     
 
Social media and digital marketing 8%

This week we would like to know...

Which of the following has had the most significant advances in PAT over the last 5 years?

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