Outsourcing
European CDMOs Venture Into US Market
By Jim Miller
European CDMOs want into the US market, but limited options leave them on the outside, looking in.
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Regulatory Developments
Generic Drugs Face New Regulatory Future
By Jill Wechsler
Regulatory overhaul looms as brand and generic debates escalate over biosimilars and labeling changes.
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API Synthesis & Manufacturing
Practical Approaches to Large-Scale Heterocyclic Synthesis
By Cynthia Challener, PhD
Recent efforts have led to improved, practical methods for the synthesis of complex heterocyclic compounds.
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Moving from Corrective to Preventive Actions
By KR Karu
For global supply chains, enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.
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Business
Tufts’ New Figures on Drug-Development Costs Spark Debate
By Agnes Shanley
Tufts research suggests costs to launch a new drug have doubled since 2003, but some question conclusions.
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Drug Benefit Assessment Challenges Market Access in Germany
By Jill E. Sackman and Michael Kuchenreuther
Significant attention must be given to regulatory and pricing changes in established markets, such as Germany.
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Viewpoint — Ireland: The Gateway to Biopharma's Future
By: Rory Mullen, senior vice-president and West Coast director, IDA Ireland
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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