Manufacturing News and Research

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

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

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Talecris Biotherapeutics announced today that it has received approval from Health Canada for PROLASTIN®-C (Alpha1-Proteinase Inhibitor [Human]), a more purified and concentrated version of PROLASTIN® produced using advances in manufacturing technology. A similar approval for PROLASTIN-C was granted by the U.S. Food and Drug Administration on October 17, 2009.

17 Feb 2010

Pharmatek Laboratories meets DEA requirements for developing and manufacturing controlled substances

Pharmatek Laboratories, Inc., a premier contract development and manufacturing organization supporting the pharmaceutical industry, announced that it has successfully met Drug Enforcement Agency (DEA) requirements to be registered for the development and manufacture of Schedule IV and V controlled substances.

17 Feb 2010

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

Dyax Corp. today announced financial results for the fourth quarter and year ended December 31, 2009. Dyax will host a webcast and conference call at 10 a.m. (ET) this morning to review the financial results and corporate progress for the quarter.

17 Feb 2010

Scotland's $13 billion chemicals sector to showcase new initiatives at Informex

Scotland's $13 billion chemicals sector will showcase innovative new initiatives at Informex this week, highlighting the country's research and manufacturing expertise, and offering integrated, world-class solutions to the global chemicals industry.

17 Feb 2010

International Stem Cell's human cornea technology: Clinical-commercial opportunities in Asia and Europe

International Stem Cell Corporation, announced today that multiple international meetings taking place between ISCO’s executive management and researchers and clinicians from commercial entities in both Asia and Europe revealed significant clinical-commercial opportunities for the company’s stem cell-derived human cornea technology in those regions.

17 Feb 2010

FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

CombinatoRx, Incorporated today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for review of the Exalgo™ (hydromorphone HCl) extended-release tablets New Drug Application (NDA) from Monday, February 22, 2010 to Monday, March 1, 2010 due to federal government closings.

16 Feb 2010

AB SCIEX acquires liquid chromatography business of Eksigent Technologies

AB SCIEX, a global leader in life science analytical technologies, today announced that it has acquired the liquid chromatography business of Eksigent Technologies. This acquisition significantly strengthens AB SCIEX’s position in liquid chromatography, which is a key technology used frequently in a broad range of life science applications such as protein biomarker research, drug discovery and basic research.

16 Feb 2010

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

Vanda Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of clinical-stage products for central nervous system disorders, today announced financial and operational results for the fourth quarter and full year ended December 31, 2009.

16 Feb 2010

AGA Medical Holdings announces fourth-quarter and full-year 2009 financial results

AGA Medical Holdings, a leading developer of interventional medical devices for the minimally invasive treatment of structural heart defects and vascular abnormalities, today reported financial results for the fourth quarter and full year ended Dec. 31, 2009.

16 Feb 2010

Merck announces global sales of $27.4 billion for full-year 2009

Merck & Co., Inc. today announced financial results for the fourth quarter and the full year of 2009 which include the results of legacy Schering-Plough operations from the close of the merger on Nov. 3, 2009 through Dec. 31, 2009.

16 Feb 2010

BUSACC hosts breakfast panel over reconstruction opportunities in Iraq, covering healthcare and pharma

The reconstruction of Iraq is under way and opportunities for Texas businesses abound. The Bilateral U.S. – Arab Chamber of Commerce (BUSACC) is hosting a business breakfast and panel discussion featuring Iraq’s Ambassador to the United States, the Senior Commercial Counsel and a high level Ministry of Energy official and delegation, along with American risk and security mitigation experts.

16 Feb 2010

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

AstraZeneca and Rigel Pharmaceuticals today announced an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications.

16 Feb 2010

BioOhio awarded $5M grant to implement Ohio Bioscience Industry Workforce Preparedness project

BioOhio and partners have been awarded a $5 million grant from the U.S. Department of Labor Employment and Training Administration to implement the Ohio Bioscience Industry Workforce Preparedness project.

16 Feb 2010

Albemarle, Pharmacore partner to provide manufacturing capabilities for high volume capacity projects

Albemarle Corporation, a leading global provider of custom manufacturing services, announced today it will partner with PharmaCore to provide manufacturing capabilities for customers with projects that require high volume capacity.

16 Feb 2010

Manufacturing News and Research

Further Reading

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

Health Canada approves Talecris Biotherapeutics' PROLASTIN-C for AAT deficiency

Pharmatek Laboratories meets DEA requirements for developing and manufacturing controlled substances

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

Scotland's $13 billion chemicals sector to showcase new initiatives at Informex

International Stem Cell's human cornea technology: Clinical-commercial opportunities in Asia and Europe

FDA extends CombinatoRx' Exalgo tablets NDA PDUFA review date

AB SCIEX acquires liquid chromatography business of Eksigent Technologies

Fourth-quarter and full-year 2009 results announced by Vanda Pharmaceuticals

AGA Medical Holdings announces fourth-quarter and full-year 2009 financial results

Merck announces global sales of $27.4 billion for full-year 2009

BUSACC hosts breakfast panel over reconstruction opportunities in Iraq, covering healthcare and pharma

AstraZeneca, Rigel Pharmaceuticals announce exclusive worldwide license agreement for R788

BioOhio awarded $5M grant to implement Ohio Bioscience Industry Workforce Preparedness project

Albemarle, Pharmacore partner to provide manufacturing capabilities for high volume capacity projects

Achieving and maintaining ISO/IEC 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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