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In this issue: News, interviews, and articles on global activity in drug development and contract outsourcing providers, generic drug regulations, advances in heterocyclic synthesis, CAPA, and business news.

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.
>> Read More

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.
>> Read More

Supply Chain
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.
>> Read More

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.
>> Read More

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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Recipharm Acquires Flamel Technologies Facility in Strategic Partnership Deal

Vetter Opens New Office in Singapore to Support Growing Asian Market

Grand River Aseptic Manufacturing Secures Two Contracts

Catalent Acquires Micron Technologies, Adds Particle Engineering Capabilities to Portfolio

Consort Medical Completes Acquisition of Aesica

Capsugel Expands User Program for Enteric Capsule Technology

SGS Lab in Italy Earns cGMP Accreditation

Catalent Expands Highly Potent Drug Packaging Capabilities

Bosch Joins Forces with Indian Cleanroom and Pharmaceutical Machinery Supplier to Extend Global Reach

Webcasts
Maximizing Roller Compaction Benefits with Proper Excipient Selection
Tuesday, December 9, 2014 at 10AM ET
Sponsored by BASF