President of Cuban Chemical Society to Lead Opening Keynote at InformEx 2016

President of Cuban Chemical Society, Luis Alberto Montero-Cabrera, will lead the opening keynote address at InformEx 2016.
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Collaboration Seeks to Reduce Animal Testing

BASF and Sumitomo Chemical explore in vitro system for chemical safety evaluation.
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Outsourcing Update

CMO Consolidation Pace May Slow Down

As CMOs consolidate to gain a competitive edge, fewer acquisition targets may slow buying pace.
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Regulatory

Final Rule on Labeling Changes Pushed Back to July 2016

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.
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Litigation and Manufacturing Hurdles Block US Biosimilars Market Success

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.
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Sun Pharmaceutical Issued Warning Letter for Microbial Violations

Inadequate response to violations cited in a 2014 inspection leads to an FDA warning letter for Sun Pharmaceutical Industries.
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Contract Services Update

Capsugel to Acquire Xcelience and Powdersize

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.
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Ropack Expands Capabilities and Establishes US Presence

Ropack Inc. adds R&D, formulation, lab analysis, and manufacturing capabilities in Long Island, NY.
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Catalent Secures Manufacturing Contract for Pfizer’s OTC Heartburn Treatment

Catalent has entered into an exclusive long-term supply agreement to produce Pfizer's OTC proton-pump inhibitor for heartburn treatment, Nexium 24HR (esomeprazole), which is also marketed as Nexium Control outside the US.
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Paragon Bioservices to Develop HIV Vaccine Candidate

Paragon Bioservices entered into a contract with the International Aids Vaccine Initiative for the process and analytical development and cGMP manufacturing of an HIV vaccine candidate.
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Recipharm Signs Agreement to Manufacture Liproca Depot

Recipharm has signed an agreement with Swedish pharmaceutical company LIDDS for the production scale up and manufacture of LIDDS' Liproca depot for the treatment of prostate cancer.
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AMRI Acquires Whitehouse Laboratories

AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.
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GENEWIZ Acquires Beckman Coulter Gene Services

GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.
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Quotient Clinical Acquires Co-Formulate Limited

Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.
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Althea Expands Biological Drug Product Manufacturing Operations

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.
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TxCell Signs Strategic Agreement with MaSTherCell

TxCell signs strategic agreement with MaSTherCell for European manufacturing of its cell therapy products.
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