Manufacturing News and Research

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

IMIX, Sunstone Capital sign investment agreement

Sunstone Capital has signed an investment agreement with IMIX, an end-user provider of superior digital radiography (DR) systems for hospitals and specialist clinics. Simultaneously IMIX and ARCOMA AB, a leading OEM supplier of medical and radiology systems and sub-systems, have signed a Letter of Intent to combine the activities of the two companies in a single holding company, IMIX Holding AB. The combined company will become a leading global supplier of radiographic solutions.

15 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the New Drug Application for BYDUREON™ (exenatide for extended-release injectable suspension).

15 Mar 2010

AAPHP urges FDA to reclassify electronic cigarette as tobacco product

The American Association of Public Health Physicians submitted a petition to the US Food and Drug Administration on February 23rd in response to their official stance concerning electronic cigarettes.

15 Mar 2010

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc., a global provider of drug development and manufacturing services, announced today a long-term agreement for commercial manufacturing of Contrave® (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products.

15 Mar 2010

Medafor, Magle Life Sciences of Sweden sign long-term raw material supply agreement

Medafor Inc. announced today that it has signed a long-term raw material supply agreement with Magle Life Sciences of Sweden, the supplier of the key powder component for Medafor’s patented MPH(R) (Microporous Polysaccharide Hemosphere) surgical product, which is used by surgeons to control bleeding in complex surgical operations.

15 Mar 2010

Bio-Path Holdings' liposomal Grb-2 IND receives FDA clearance to proceed into clinical trials

Bio-Path Holdings, Inc., a publicly traded biotechnology company with drug development operations in Houston, Texas, announced today that the U.S. Food and Drug Administration has allowed an IND (Investigational New Drug) for the Company’s lead cancer drug candidate liposomal Grb-2 to proceed into clinical trials.

15 Mar 2010

FDA accepts proposed proprietary name Exelbine for ADVENTRX Pharmaceuticals' ANX-530

ADVENTRX Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted the proposed proprietary name "Exelbine™" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion).

12 Mar 2010

GTC Biotherapeutics reports total net loss of $1.7M for fourth-quarter 2009

GTC Biotherapeutics, Inc. today reported its financial results for the fourth quarter and fiscal year ended January 3, 2010. The total net loss for the fourth quarter was $1.7 million, or $0.09 per share, compared with $6.2 million, or $0.60 per share, for the fourth quarter of 2008. The total net loss for 2009 was $27.9 million, or $2.18 per share, compared to $22.7 million, or $2.31 per share, for 2008.

12 Mar 2010

Halozyme Therapeutics reports net loss of $12.7M for fourth-quarter of 2009

Halozyme Therapeutics, Inc., a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the fourth quarter and year ended December 31, 2009.

12 Mar 2010

Arena Pharmaceuticals reports lower net loss allocable to common stockholders in fourth-quarter 2009

Arena Pharmaceuticals, Inc. today reported financial results for the fourth quarter and full year ended December 31, 2009.

12 Mar 2010

Neoprobe meets with FDA to review Phase 3 clinical trial results of Lymphoseek drug

Neoprobe Corporation, a diversified developer of innovative oncology and surgical diagnostic and treatment products, today announced that it recently met with the United States Food and Drug Administration to review the clinical trial results of a Phase 3 investigational new drug, Lymphoseek®.

12 Mar 2010

Roche Diagnostics purchases NimbleGen microarray workflow assets from BioMicro Systems

Roche Diagnostics has purchased assets from BioMicro Systems for all products associated with the Roche NimbleGen microarray workflow. These assets consist of key instrumentation in the comprehensive Roche NimbleGen microarray workflow including the NimbleGen Hybridization Systems (both 4- and 12-bay models).

12 Mar 2010

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

Baxter International Inc., in conjunction with DynPort Vaccine Company LLC, a CSC Company, today presented Phase III study data measuring the clinical efficacy for PREFLUCEL, a trivalent seasonal influenza candidate vaccine. PREFLUCEL is made using Baxter’s Vero cell culture platform and does not contain an adjuvant or preservatives. The data were presented at the International Congress on Infectious Disease (ICID) in Miami, Florida.

From Baxter International Inc. 12 Mar 2010

Covidien to use FDA, Health Canada approved Mo 99 from Maria for manufacturing Tc 99m generators

Covidien, a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) and Health Canada have approved the use of the Maria Research Reactor (Maria) in Poland as a site to irradiate highly-enriched uranium targets for Molybdenum 99 (Mo 99) production. Covidien will use the Mo 99 obtained from Maria in the manufacture of its Technetium 99m (Tc 99m) generators. Patients should begin to benefit from Maria-produced Mo 99 in the United States and Canada later this month.

12 Mar 2010

Peregrine Pharmaceuticals' third-quarter fiscal 2010 total revenues up 45%

Peregrine Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing innovative monoclonal antibodies for the treatment of cancer and serious viral infections, today announced financial results for the third quarter of fiscal year (FY) 2010 ended January 31, 2010. The company also provided an update on its clinical programs and corporate developments.

From Thermo Fisher Scientific Inc. 11 Mar 2010

Lorom West certifies to ISO 13485: 2003 QMS for Medical Devices

Lorom West, a premier manufacturer of custom cables, wire harnesses, PCB and high quality OEM/ODM products today announced successful certification to the ISO 13485: 2003 Quality Management Standard (QMS) for Medical Devices.

11 Mar 2010

Safeguard Scientifics' aggregate partner company revenue rises 46% in 2009

Safeguard Scientifics, Inc., a holding company that builds value in growth-stage life sciences and technology companies, today announced that aggregate revenue of its partner companies for the year was $262 million, up 46% from $179 million in 2008, exceeding the company’s 2009 guidance of $223 million to $243 million, as adjusted to reflect the inclusion of two new partner companies.

11 Mar 2010

Manufacturing News and Research

Further Reading

IMIX, Sunstone Capital sign investment agreement

NDA for BYDUREON: FDA issues complete response letter

AAPHP urges FDA to reclassify electronic cigarette as tobacco product

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

Medafor, Magle Life Sciences of Sweden sign long-term raw material supply agreement

Bio-Path Holdings' liposomal Grb-2 IND receives FDA clearance to proceed into clinical trials

FDA accepts proposed proprietary name Exelbine for ADVENTRX Pharmaceuticals' ANX-530

GTC Biotherapeutics reports total net loss of $1.7M for fourth-quarter 2009

Halozyme Therapeutics reports net loss of $12.7M for fourth-quarter of 2009

Arena Pharmaceuticals reports lower net loss allocable to common stockholders in fourth-quarter 2009

Neoprobe meets with FDA to review Phase 3 clinical trial results of Lymphoseek drug

Roche Diagnostics purchases NimbleGen microarray workflow assets from BioMicro Systems

Baxter International, DVC present Phase III clinical efficacy data for PREFLUCEL

Covidien to use FDA, Health Canada approved Mo 99 from Maria for manufacturing Tc 99m generators

Peregrine Pharmaceuticals' third-quarter fiscal 2010 total revenues up 45%

Lorom West certifies to ISO 13485: 2003 QMS for Medical Devices

Safeguard Scientifics' aggregate partner company revenue rises 46% in 2009

Columbia Laboratories' fourth-quarter 2009 net revenues up 21%

BioInvent International, HGS announce collaboration to develop therapeutic monoclonal antibodies

HGS, BioInvent International AB to discover, develop and commercialize therapeutic monoclonal antibodies

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