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Manufacturing is the production of products across all industries, on a large-scale, using machinery.

Five best practices for medical device industry

In early 2010, regulations in the medical device industry are already coming under increased scrutiny as product recalls and new research raise concerns about consumer safety. Regulatory authorities are responding on multiple levels, from the FDA's public meeting on pre-market medical device notification to new investments in medical product safety.

19 Feb 2010

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

Depomed, Inc. today announced that it has received final meeting minutes from the FDA for a pre-NDA meeting related to DM-1796 for postherpetic neuralgia (PHN) held in December 2009. Depomed also commented on recent public disclosures related to the Complete Response letter from the U.S. Food and Drug Administration regarding the New Drug Application (NDA) for Horizant™ (gabapentin enacarbil) Extended-Release Tablets.

19 Feb 2010

Parker Waichman Alonso applauds GSK for deciding to stop manufacturing denture adhesive products made with zinc

The attorneys of Parker Waichman Alonso LLP applaud GlaxoSmithKline for its decision to voluntarily stop the manufacture, distribution and advertising of all Super PoliGrip denture adhesive products made with zinc.

19 Feb 2010

DSM Pharmaceutical Products wins Profiles in Sustainability award

DSM Pharmaceutical Products, based in Parsippany, NJ, today announced that it has received a Profiles in Sustainability award from United Business Media and ICIS Chemical Business. United Business Media Limited is a leading global business media company and parent of InformexUSA, where the award was announced today in San Francisco.

19 Feb 2010

Echo Therapeutics makes significant advance in designing Symphony tCGM device

Echo Therapeutics, Inc., a company developing the needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, announced today that the Company has made a significant advance in the product design of its Symphony tCGM device and that it has developed its next generation electronic component package.

19 Feb 2010

Epeius Biotechnologies completes construction of VPU to manufacture targeted genetic medicines

Epeius Biotechnologies (www.epeiusbiotech.com) announces the completion of the design engineering and construction phase of a state-of-the-art Vector Production Unit (VPU) for the commercial manufacturing of its advanced targeted genetic medicines. In accordance with an FDA Critical Path initiative, which encourages innovation and the implementation of new technological advances in GMP, CMC, aseptic processing, and quality control, the Epeius VPU is poised to launch the large-scale production of targeted genetic medicine into the 21st century.

18 Feb 2010

OPKO Health acquires Pharmacos Exakta

OPKO Health, Inc. today announced that it has completed the acquisition of Pharmacos Exakta, S.A. de C.V. (“Pharmacos Exakta”), a privately-owned Mexican pharmaceutical company engaged in the manufacture, marketing and distribution of ophthalmic and other pharmaceutical products for government and private markets since 1957. OPKO acquired Pharmacos Exakta, including a manufacturing facility owned by an affiliate, for cash and shares of OPKO Common Stock.

18 Feb 2010

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Incyte Corporation today reported fourth quarter and full year 2009 financial results, provided an update on key fourth quarter accomplishments and 2010 objectives, and announced its 2010 financial guidance.

18 Feb 2010

Taro Pharmaceutical Industries to discontinue manufacturing operations in Roscrea, Ireland

Taro Pharmaceutical Industries Ltd. today announced that it will discontinue manufacturing operations at the sterile manufacturing facility of its Irish subsidiary, Taro Pharmaceuticals Ireland Limited, in Roscrea, Ireland (“Taro Ireland”).

18 Feb 2010

West Pharmaceutical Services reports 19.9% growth in consolidated fourth-quarter sales

West Pharmaceutical Services, Inc. today announced its results for the fourth quarter and full year of 2009.

18 Feb 2010

ScienceWorksForUS reveals how Recovery Act science funding benefits their campuses and communities

On the first anniversary of the American Recovery and Reinvestment Act (ARRA) - the economic stimulus - the nation's research universities today provided nearly 100 examples of how a relatively small element of the measure is paying outsize short- and long-term dividends for the nation. Of the $787 billion contained in the ARRA, $21.5 billion is allocated for research and science infrastructure.

18 Feb 2010

AutoGenomics awarded ISO 13485 certification for quality management system

AutoGenomics, a leader in providing automated, molecular testing solutions announced today that the organization has been awarded the ISO 13485 certification in recognition of its outstanding quality management system throughout the organization. TUV SUD America Inc. was the Certification Body.

18 Feb 2010

AMRI announces Excelsyn acquisition

AMRI today announced the acquisition of Excelsyn Ltd., a well recognized leader in providing chemical development and manufacturing services to the pharmaceutical industry in Europe. Located in Holywell, North Wales, UK, Excelsyn has 60 employees and generated revenue of $15 million in 2009.

18 Feb 2010

Rondaxe and TD2 announce cancer drug development alliance

TGen Drug Development (TD2) and Rondaxe Enterprises today announced a strategic alliance that will help emerging companies speed new high-quality treatments to cancer patients.

18 Feb 2010

Sorin Group's newest generation C5 HLM system receives FDA clearance

Sorin Group, a global company and a leader in the treatment of cardiovascular diseases, announced today the U.S. Food and Drug Administration (FDA) clearance of its newest generation C5 Heart-Lung Machine (HLM).

18 Feb 2010

Biogen Idec, Swedish Orphan Biovitrum restructure collaboration agreement for rFVIIIFc and rFIXFc programs

Biogen Idec and Swedish Orphan Biovitrum today announced that they have restructured the collaboration agreement for the companies’ long-acting, recombinant Factor VIII Fc fusion protein (rFVIIIFc) in hemophilia A patients and the recombinant Factor IX Fc fusion protein (rFIXFc) in hemophilia B patients.

18 Feb 2010

Asuragen announces agreement to develop and manufacture RNA Control Kits for Affymetrix

Asuragen Inc., a leading molecular biology diagnostic company and service provider, today announced an agreement to develop and manufacture RNA Control Kits for Affymetrix. The RNA Control Kit is intended for use with in vitro transcription (IVT) reagent kits for clinical molecular diagnostic applications that Asuragen has licensed and supplied to Affymetrix.

18 Feb 2010

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

BioMimetic Therapeutics, Inc. today announced it has submitted the third and final module of its Premarket Approval (PMA) application for marketing of Augment™ Bone Graft in the U.S. This final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA. The Company previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June of 2009.

18 Feb 2010

Genzyme announces fourth-quarter and full-year 2009 financial results

Genzyme Corp., a diversified, global biotechnology company, today announced fourth-quarter and full year 2009 financial results and provided 2010 guidance that reflects growth across its businesses and a focus on strengthening core areas of the company.

18 Feb 2010

Codexis announces two separate collaborations in pharmaceutical manufacturing

Codexis, Inc. today announced two separate collaborations in pharmaceutical manufacturing with Dishman Pharmaceuticals and Chemicals and AMPAC Fine Chemicals LLC, a subsidiary of American Pacific Corporation. These agreements expand the application of Codexis technology to a broadened pipeline of branded innovator pharmaceutical products.

17 Feb 2010

Manufacturing News and Research

Further Reading

Five best practices for medical device industry

Depomed receives final meeting minutes from FDA for pre-NDA meeting on DM-1796 for PHN

Parker Waichman Alonso applauds GSK for deciding to stop manufacturing denture adhesive products made with zinc

DSM Pharmaceutical Products wins Profiles in Sustainability award

Echo Therapeutics makes significant advance in designing Symphony tCGM device

Epeius Biotechnologies completes construction of VPU to manufacture targeted genetic medicines

OPKO Health acquires Pharmacos Exakta

Incyte announces 2009 financial results and key fourth-quarter accomplishments

Taro Pharmaceutical Industries to discontinue manufacturing operations in Roscrea, Ireland

West Pharmaceutical Services reports 19.9% growth in consolidated fourth-quarter sales

ScienceWorksForUS reveals how Recovery Act science funding benefits their campuses and communities

AutoGenomics awarded ISO 13485 certification for quality management system

AMRI announces Excelsyn acquisition

Rondaxe and TD2 announce cancer drug development alliance

Sorin Group's newest generation C5 HLM system receives FDA clearance

Biogen Idec, Swedish Orphan Biovitrum restructure collaboration agreement for rFVIIIFc and rFIXFc programs

Asuragen announces agreement to develop and manufacture RNA Control Kits for Affymetrix

BioMimetic Therapeutics annouces completion of Augment Bone Graft PMA submission

Genzyme announces fourth-quarter and full-year 2009 financial results

Codexis announces two separate collaborations in pharmaceutical manufacturing

Achieving and maintaining ISO 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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