PTSM: Pharmaceutical Technology Sourcing and Management-01-06-2016

PTSM: Pharmaceutical Technology Sourcing and Management

CMO Consolidation Pace May Slow Down

January 06, 2016

Outsourcing

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

Sun Pharmaceutical Issued Warning Letter for Microbial Violations

December 30, 2015

Regulatory

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

Collaboration Seeks to Reduce Animal Testing

December 30, 2015

API Synthesis and Manufacturing

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1

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

GENEWIZ Acquires Beckman Coulter Gene Services

December 21, 2015

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1

GENEWIZ signs definitive agreement to acquire Beckman Coulter's gene services business.

Recipharm Signs Agreement to Manufacture Liproca Depot

December 17, 2015

Contract Services Update

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Recipharm has signed an agreement with Sweddish pharmaceutical company LIDDS for the production scale up and manufacture of LIDDS’ Liproca depot for the treatment of prostate cancer.

AMRI Acquires Whitehouse Laboratories

December 16, 2015

Contract Services Update

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1

AMRI adds analytical capabilities to its outsourcing services offerings with the acquisition of Whitehouse Labs.

Quotient Clinical Acquires Co-Formulate Limited

December 16, 2015

Contract Services Update

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1

Quotient Clinical announced on Dec. 16, 2015 that is has acquired Co-Formulate Limited.

Capsugel to Acquire Xcelience and Powdersize

December 14, 2015

Contract Services Update

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1

Capsugel adds clinical trial and commercial manufacturing, as well as particle engineering services with two acquisitions.

FDA Warns of Potential Baclofen API Contamination

December 10, 2015

API Synthesis and Manufacturing

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1

FDA warns the industry of possible contamination in the API baclofen from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited.

Althea Expands Biological Drug Product Manufacturing Operations

December 10, 2015

Contract Services Update

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1

Ajinomoto Althea expands biological drug product manufacturing operations to include ADCs.

Ropack Expands Capabilities and Establishes US Presence

December 08, 2015

Contract Services Update

12

1

Ropack Inc. adds R&D, formulation, lab analysis, and manufacturing capabilities in Long Island, NY.

Catalent Secures Manufacturing Contract for Pfizer’s OTC Heartburn Treatment

December 07, 2015

Contract Services Update

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1

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.

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

December 07, 2015

API Synthesis and Manufacturing

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President of Cuban Chemical Society, Luis Alberto Montero-Cabrera, will lead the opening keynote address at InformEx 2016.

TxCell Signs Strategic Agreement with MaSTherCell

December 05, 2015

Contract Services Update

12

1

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

Final Rule on Labeling Changes Pushed Back to July 2016

December 04, 2015

Regulatory

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1

FDA sets a July 2016 deadline for the final version of the rule on labeling changes for approved drugs and biologics.

Paragon Bioservices to Develop HIV Vaccine Candidate

December 04, 2015

Contract Services Update

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1

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.