Manufacturing News and Research

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

Meridian Bioscience revises fiscal 2010 guidance, expects net sales between $145M and $153M

Meridian Bioscience, Inc., Cincinnati, Ohio today announced that it is revising downward its previous sales and earnings guidance for the fiscal year ending September 30, 2010. This action is being taken as a result of weaker than expected operating results for the second quarter ending March 31, 2010, based on preliminary results to date. Separately, Meridian announced that it will file a 510(k) for FDA marketing clearance next week in connection with its illumigene™ C. difficile product.

17 Mar 2010

TSO3 reports net loss of $9.2M for fiscal 2009

TSO3 Inc. an innovator in sterilization technology for medical devices in healthcare settings using ozone, posted sales totalling $1.3 million for the fiscal year ended December 31, 2009, compared to $2.2 million one year earlier. During the year, the Company sold five of its first generation STERIZONE(R) sterilizers and accessories, whereas it sold 13 in the preceding fiscal year.

17 Mar 2010

Agilent Technologies introduces new ion exchange and size exclusion columns for analysis of bio-molecules

Agilent Technologies Inc. today announced the availability of new ion exchange and size exclusion columns specifically designed for the analysis of bio-molecules including monoclonal antibodies, recombinant proteins, peptides, vaccine products and DNA/RNA. The columns provide robust, reproducible and high-resolution solutions for biopharmaceutical manufacturers to effectively monitor the safety, efficacy and stability of their products.

17 Mar 2010

Avid Bioservices highlights data of single-use bioreactors and traditional stainless steel bioreactors

Avid Bioservices, Inc. today presented data highlighting the comparability of production run performance between the company's single-use bioreactors (Thermo Scientific HyClone S.U.B.) and its traditional stainless steel bioreactors at the Thermo Scientific BioProduction Optimization Workshop in San Francisco, California.

From Thermo Fisher Scientific Inc. 17 Mar 2010

Pew Prescription Project statement: Protect Americans from unsafe drugs made overseas

Two years after dozens of Americans lost their lives to contaminated heparin, we are still not able to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health.

17 Mar 2010

Glenmark Generics, Konec ordered to stop marketing unapproved nitroglycerin tablets

The U.S. Food and Drug Administration today ordered Glenmark Generics of Mahwah, N.J., and Konec Inc. of Tucson, Ariz., to stop marketing unapproved nitroglycerin tablets. The tablets are placed under the tongue to relieve chest pain or to stop a heart attack and are marketed in 0.3 mg, 0.4 mg, and 0.6 mg dosages.

17 Mar 2010

Human Genome Sciences to deploy Aegis Analytical's Discoverant manufacturing intelligence solution

Aegis Analytical Corp., the leading provider of Enterprise Manufacturing Intelligence software, announced today that Human Genome Sciences, Inc. will deploy Aegis’ Discoverant® as its data management, analytics and reporting solution in the scale-up and production of BENLYSTA™ (belimumab), an investigational drug for the treatment of systemic lupus that has successfully completed Phase 3 trials.

17 Mar 2010

Unapproved nitroglycerin tablets: FDA orders Glenmark Generics and Konec to stop marketing

17 Mar 2010

Optics Balzers acquires mso jena Mikroschichtoptik

Optics Balzers, a leading supplier of innovative optical thin-film components and assemblies, is continuing its growth in great strides. With its acquisition of “mso jena Mikroschichtoptik GmbH” in Jena, Germany, it is expanding its competencies and manufacturing technologies into a unique portfolio.

16 Mar 2010

Bovie Medical reports revenues totalling $6.5M for fourth-quarter 2009

Bovie Medical Corporation, a manufacturer and marketer of electrosurgical products, today announced its financial results for the fourth quarter and year ended December 31, 2009.

16 Mar 2010

Fraunhofer USA CMB receives $4.395M award from DARPA to develop H1N1 influenza vaccine

Fraunhofer USA Center for Molecular Biotechnology announced today that it has received a $4.395 million award from the Defense Advanced Research Projects Agency to develop a vaccine against H1N1 influenza virus using its plant-based production platform.

16 Mar 2010

InnerPulse selects Dassault Systemes' Abaqus FEA software

Dassault Systèmes, a world leader in 3D and Product Lifecycle Management (PLM) solutions, today announced that InnerPulse, a medical device company pioneering a novel technology for those patients with cardiac rhythm disorders, has selected Abaqus finite element analysis (FEA) software from the SIMULIA to assist in development of their technology designed in SolidWorks CAD software.

16 Mar 2010

Simcere Pharmaceutical Group report 15.5% sequential growth in fourth quarter revenues

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported unaudited financial results for the quarter and the fiscal year ended December 31, 2009.

16 Mar 2010

IMIX, Arcoma announce intended merger

IMIX, an end-user provider of superior digital radiography (DR) systems, and Arcoma, a leading supplier of medical radiology systems and sub-systems, announce a letter-of-intent to combine the two companies into a single holding company, IMIX Holding AB. The proposed combination will allow both companies to offer a comprehensive line of leading radiology systems and sub-systems to markets and customers around the world.

16 Mar 2010

Savient Pharmaceuticals resubmits KRYSTEXXA BLA

Savient Pharmaceuticals, Inc. announced that it has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for KRYSTEXXA™ (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy. Chronic gout that is refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

16 Mar 2010

Lilly receives exclusive rights to commercialize Acrux's testosterone solution

Eli Lilly and Company and Acrux announced today that they have entered into an exclusive worldwide license agreement for the potential commercialization of Acrux's experimental underarm testosterone solution (proposed tradename AXIRON™).

16 Mar 2010

Boston Scientific stops shipment and announces inventory retrieval of ICDs and CRT-Ds

Boston Scientific Corporation announced today that it has stopped shipment and is retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

15 Mar 2010

Hemispherx Biopharma reports net loss of $13,438,000 for fiscal year 2009

Hemispherx Biopharma, Inc., announced its financial results for the fiscal year ended December 31, 2009. The net loss for the year (including non-cash charges) was approximately $13,438,000 or $0.12 per share as compared to a net loss of $12,219,000 or $0.16 per share in 2008.

15 Mar 2010

Patheon's first-quarter fiscal 2010 total revenues up 5.2%

Patheon a global provider of drug development and manufacturing services to the international pharmaceutical industry today announced results for its first quarter ended January 31, 2010. All amounts are in U.S. dollars unless otherwise indicated.

15 Mar 2010

Insmed posts net profit of $2.3M for fourth-quarter 2009

Insmed Inc., a biopharmaceutical company, today reported results for the fourth quarter and full-year ended December 31, 2009.

15 Mar 2010

Manufacturing News and Research

Further Reading

Meridian Bioscience revises fiscal 2010 guidance, expects net sales between $145M and $153M

TSO3 reports net loss of $9.2M for fiscal 2009

Agilent Technologies introduces new ion exchange and size exclusion columns for analysis of bio-molecules

Avid Bioservices highlights data of single-use bioreactors and traditional stainless steel bioreactors

Pew Prescription Project statement: Protect Americans from unsafe drugs made overseas

Glenmark Generics, Konec ordered to stop marketing unapproved nitroglycerin tablets

Human Genome Sciences to deploy Aegis Analytical's Discoverant manufacturing intelligence solution

Unapproved nitroglycerin tablets: FDA orders Glenmark Generics and Konec to stop marketing

Optics Balzers acquires mso jena Mikroschichtoptik

Bovie Medical reports revenues totalling $6.5M for fourth-quarter 2009

Fraunhofer USA CMB receives $4.395M award from DARPA to develop H1N1 influenza vaccine

InnerPulse selects Dassault Systemes' Abaqus FEA software

Simcere Pharmaceutical Group report 15.5% sequential growth in fourth quarter revenues

IMIX, Arcoma announce intended merger

Savient Pharmaceuticals resubmits KRYSTEXXA BLA

Lilly receives exclusive rights to commercialize Acrux's testosterone solution

Boston Scientific stops shipment and announces inventory retrieval of ICDs and CRT-Ds

Hemispherx Biopharma reports net loss of $13,438,000 for fiscal year 2009

Patheon's first-quarter fiscal 2010 total revenues up 5.2%

Insmed posts net profit of $2.3M for fourth-quarter 2009

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