Manufacturing News and Research

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

Avecia Biotechnology reaches agreement with Pfizer to market Macugen

Avecia Biotechnology, Inc., a leading provider of drug development and manufacturing services for oligonucleotide therapeutics, has reached agreement with Pfizer Inc. regarding the commercial supply of a key component of Macugen (pegaptanib sodium injection), marketed in the E.U. by Pfizer for the treatment of wet Age-Related Macular Degeneration.

26 Apr 2010

Bruker to supply customized N8 TITANOS large sample AFM to US Commerce Department's NIST

Bruker today announced that it has been awarded a $1.1 million contract to supply a customized N8 TITANOS™ large sample Atomic Force Microscope (AFM) to the United States Commerce Department's National Institute of Standards and Technology (NIST). The instrument will be used by NIST's Precision Engineering Division (PED) at its Manufacturing Engineering Laboratory, with a main focus on metrology applications which require traceable AFM (T-AFM).

26 Apr 2010

BioSante signs Option Agreement to obtain non-exclusive worldwide license for 2A/Furin technology

BioSante Pharmaceuticals, Inc. today announced that it has entered into an Option Agreement with an undisclosed large multi-national pharmaceutical company to obtain a non-exclusive worldwide license for the use of BioSante's 2A/Furin technology in the expression of antibodies.

26 Apr 2010

Ness Technologies announces implementation of Oracle E-Business Suite at Teva Czech Industries

Ness Technologies, Inc., a global provider of information technology solutions and services, announced today the start of an Oracle E-Business Suite implementation at Teva Czech Industries s.r.o., a provider of pharmaceutical products. The new system will handle financial and logistics issues, replacing a current QAD MFG/Pro system.

26 Apr 2010

Symphogen's Sympress II technology demonstrates cost-effective single batch production of rpAb

Symphogen A/S today announced the publication of data in the March 20, 2010 online edition of Molecular Biotechnology by Nielsen LS et al. [epub ahead of print] demonstrating the ability of its Sympress II technology to enable cost-effective production of recombinant polyclonal antibodies (rpAb) and antibody mixtures with batch-to-batch consistency that the Company believes could supply drug product for large indications such as cancer and infectious disease.

26 Apr 2010

Golub Capital provides $12.0M of senior subordinated debt to support recapitalization of IDT

Golub Capital today announced that it has provided $12.0 million of senior subordinated debt to support the recapitalization and ongoing growth of Integrated DNA Technologies, Inc. This transaction marks the first investment made by GC 2009 Mezzanine Partners, L.P., which is Golub Capital's sixth fund dedicated to middle market mezzanine debt financings.

From Integrated DNA Technologies 24 Apr 2010

IDEXX Laboratories' first-quarter 2010 revenues increase 14% to $268.5M

IDEXX Laboratories, Inc., today reported that revenues for the first quarter of 2010 increased 14% to $268.5 million, from $236.5 million for the first quarter of 2009. Organic revenue growth, as defined below, was 9%. Earnings per diluted share for the quarter ended March 31, 2010 increased 28% to $0.55, compared to $0.43 for the same period in the prior year.

23 Apr 2010

Plant-based vaccine factory to produce vaccines and therapeutics within weeks of outbreaks

The Fraunhofer Center for Molecular Biotechnology in Newark, Delaware, the Fraunhofer Center for Manufacturing Innovation in Boston, Massachusetts, the Boston University College of Engineering, and the biopharmaceutical company iBio, Inc. in Newark, Delaware, announced today that they have developed a fully automated, scalable "factory" that uses natural (non-genetically-modified) green plants to efficiently produce large quantities of vaccines and therapeutics within weeks.

23 Apr 2010

pHase Pharmaceuticals launches new drug development company

pHase Pharmaceuticals, LLC announces the launch of its new drug development company. pHase Pharmaceuticals is led by a cohesive team of drug development experts who have extensive experience bringing new drugs to market and garnering FDA approval.

23 Apr 2010

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration had granted tentative approval of adenosine injection, USP, the generic equivalent of Astellas Pharmaceuticals' Adenoscan®, in 60 mg per 20 mL and 90 mg per 30 mL vials. IMS data indicate that the 2009 U.S. innovator market for these adenosine presentations approximated $124 million. The Company plans to launch the product upon expiry of applicable innovator patents.

23 Apr 2010

Colorcon acquires NP Pharm

Colorcon, Inc. today announced the acquisition of the full-service pharmaceutical excipient company, NP Pharm, a Division of Ethypharm. This acquisition expands Colorcon's global excipient product offerings in the pharmaceutical and nutritional markets.

23 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Align Technology reports 28.5% increase year-over-year in first-quarter revenues

Align Technology, Inc. today reported financial results for the first quarter of fiscal 2010, ended March 31, 2010.

22 Apr 2010

Columbia Laboratories' net revenues from US progesterone sales for first-quarter up 36%

Columbia Laboratories, Inc. today announced preliminary results for the quarter ended March 31, 2010.

22 Apr 2010

Life sciences companies shifting away from traditional document management systems to emerging ECC solutions

Virtify, Inc., today announced the availability of a new IDC Health Insights study titled "Managing Paper at Its Roots: Extending Beyond Document Management to Enterprise Content Compliance." The new IDC Health Insights study, which was commissioned by Virtify, shows a growing trend in the life sciences industry away from traditional document management systems to emerging Enterprise Content Compliance (ECC) solutions.

22 Apr 2010

Syntagon contract research organisation announces strategic pricing initiative

Leading contract research organisation, Syntagon, has unveiled a strategic pricing initiative that will see substantial cost savings for biotechnology and pharmaceutical customers taking compounds into phase I and phase II clinical trials.

22 Apr 2010

Cybex International defends intellectual property rights related to patented Plate Loaded Leg Press

Cybex International, Inc., a leading manufacturer of premium exercise equipment, announced today that it has decisively responded to infringements of its intellectual property rights related to its patented Plate Loaded Leg Press and the company's pending patent applications for the Bravo Functional Trainer.

22 Apr 2010

ImmunoCellular Therapeutics, UPENN sign research agreement

ImmunoCellular Therapeutics, Ltd., a biotechnology company that is developing immune based therapies for the treatment of various forms of cancer, announced today that the Company has entered into a sponsored research agreement and an option agreement with The University of Pennsylvania to support process development and manufacturing in a planned Phase II clinical trial of ICT-107, the Company's dendritic-cell based cancer vaccine product candidate for the treatment of glioblastoma multiforme.

22 Apr 2010

Genmab introduces new pre-clinical antibody program and novel bispecific antibody technology

Genmab A/S will announce today at its Annual General Meeting a new pre-clinical antibody program, HuMax-cMet,as well as a novel next generation bispecific antibody technology.

22 Apr 2010

Affymetrix reports first-quarter total revenue of $80.2M

Affymetrix, Inc., today reported its operating results for the first quarter of 2010. Total revenue for the quarter was $80.2 million, as compared to total revenue of $78.6 million in the first quarter of 2009.

22 Apr 2010

Manufacturing News and Research

Further Reading

Avecia Biotechnology reaches agreement with Pfizer to market Macugen

Bruker to supply customized N8 TITANOS large sample AFM to US Commerce Department's NIST

BioSante signs Option Agreement to obtain non-exclusive worldwide license for 2A/Furin technology

Ness Technologies announces implementation of Oracle E-Business Suite at Teva Czech Industries

Symphogen's Sympress II technology demonstrates cost-effective single batch production of rpAb

Golub Capital provides $12.0M of senior subordinated debt to support recapitalization of IDT

IDEXX Laboratories' first-quarter 2010 revenues increase 14% to $268.5M

Plant-based vaccine factory to produce vaccines and therapeutics within weeks of outbreaks

pHase Pharmaceuticals launches new drug development company

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Colorcon acquires NP Pharm

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Align Technology reports 28.5% increase year-over-year in first-quarter revenues

Columbia Laboratories' net revenues from US progesterone sales for first-quarter up 36%

Life sciences companies shifting away from traditional document management systems to emerging ECC solutions

Syntagon contract research organisation announces strategic pricing initiative

Cybex International defends intellectual property rights related to patented Plate Loaded Leg Press

ImmunoCellular Therapeutics, UPENN sign research agreement

Genmab introduces new pre-clinical antibody program and novel bispecific antibody technology

Affymetrix reports first-quarter total revenue of $80.2M

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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