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

Guerbet: FDA approves manufacturing plant for Lipiodol (ethiodized oil) Injection

Guerbet (GBT), the contrast agent specialist for medical imaging, today announced that it had received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing plant for Lipiodol® (ethiodized oil) Injection, in Montreal, Canada.

20 Feb 2014

PBL Assay Science, HumanZyme ink licensing agreement to expand reagent offerings

PBL Assay Science announces a licensing agreement with HumanZyme, Inc. (Chicago, USA) to expand reagent offerings. The agreement allows PBL to provide ~50 authentic human cell-expressed (HCE) cytokines and growth factors directly to scientists worldwide.

From PBL Assay Science 20 Feb 2014

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

CytoDyn Inc., a biotechnology company focused on the development of new therapies for combating infection with immune deficiency viruses, announced today that the Company has submitted a Phase 2b clinical trial protocol, for its lead product candidate, PRO 140, to the U.S. Food and Drug Administration for treatment substitution in patients with Human Immunodeficiency Virus (HIV).

19 Feb 2014

Acerde and a China-based medical imaging giant ink development contract

Acerde, an innovative company specializing in the development of rotating anodes for X-ray tubes used in the medical imaging industry, today announced (i) the signature of a development contract with a major China-based player in medical imaging, (ii) its achievement of a number of industrial development milestones and (iii) the preparation of the company's next generation of highly innovative rotating anodes (which are now composite-based rather than graphite-based).

18 Feb 2014

TPI announces financial results for second quarter fiscal year 2014

Tianyin Pharmaceutical Inc., a pharmaceutical company that specializes in the patented biopharmaceutical, modernized traditional Chinese medicine (mTCM), branded generics and active pharmaceutical ingredients (API) announced financial results for the second quarter fiscal year 2014.

14 Feb 2014

GNC Holdings reports consolidated revenue of $613.7 million in Q4 2013

GNC Holdings, Inc., a leading global specialty retailer of health and wellness products, today reported its financial results for the quarter and year-to-date period ended December 31, 2013.

13 Feb 2014

Alvogen launches Inflectra into Central and Eastern Europe

Alvogen, the multinational pharmaceuticals company, today announced the launch of Inflectra (Infliximab) into Central and Eastern Europe. Inflectra, Europe's first biosimilar monoclonal antibody (mAb) therapy that has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease (CD), ulcerative colitis (UC), psoriatic arthritis (PsA) and psoriasis.

13 Feb 2014

Researchers examine quality of needles used in acupuncture

The quality of needles used in acupuncture worldwide is high but needs to be universally improved to increase safety and avoid potential problems such as pain and allergic reactions, RMIT University researchers have found.

13 Feb 2014

Insurgical single-use orthopaedic power tools used in total knee replacement procedure

On February, 5, orthopaedic surgeon Thomas Ferro, MD, successfully performed a total knee replacement procedure using Insurgical single-use orthopaedic power tools. This operation marked the first time FDA cleared single-use, cordless, handheld power tools were used in an orthopaedic operation in the United States. Specialty surgical power tools used to cut and shape bone are required in over 1.5 million orthopaedic procedures annually in the United States.

12 Feb 2014

Cedars-Sinai receives $1M grant to study molecular changes in brain due to air pollutants

Researchers at the Maxine Dunitz Neurosurgical Institute and Department of Neurosurgery at Cedars-Sinai will conduct a study to determine if several potentially toxic compounds that exist in polluted air are capable of entering the brain from the bloodstream and causing brain cancer.

12 Feb 2014

ADM commits $25 million equity investment in Rennovia

Archer Daniels Midland Company and Rennovia, Inc. announced today that ADM has committed to a $25 million equity investment in the privately held company, which develops catalysts and processes for the cost-advantaged production of chemical products from renewable feedstocks.

11 Feb 2014

Zoetis reports revenue of $1.25 billion for Q4 2013

Zoetis Inc. today reported its financial results for the fourth quarter and full year 2013. The company reported revenue of $1.25 billion for the fourth quarter of 2013, an increase of 7% from the fourth quarter of 2012. Revenue reflected an operational increase of 9%, with foreign currency having a negative impact of 2 percentage points.

11 Feb 2014

Merck, Samsung Bioepis agree to develop, commercialize MK-1293 for treatment of diabetes

Merck, known as MSD outside the United States and Canada, and Samsung Bioepis Co., Ltd., announced today that they have expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. Phase III clinical studies in type 1 and type 2 diabetes will begin soon.

10 Feb 2014

ACell releases new MatriStem Multilayer Wound Matrix device for hard-to-heal, full-thickness wounds

ACell, Inc., a leading regenerative medicine company focused on the development, manufacturing and commercialization of tissue repair products, today announced that it has launched the new MatriStem Multilayer Wound Matrix device for deep, hard-to-heal, full-thickness wounds.

10 Feb 2014

TSRI scientists discover unusual protein that probably helps some bacteria evade immune response

A team led by scientists at The Scripps Research Institute (TSRI) has discovered an unusual bacterial protein that attaches to virtually any antibody and prevents it from binding to its target. Protein M, as it is called, probably helps some bacteria evade the immune response and establish long-term infections.

7 Feb 2014

Invacare reports net loss per share of $0.19 in fourth quarter 2013

Invacare Corporation today announced its financial results for the quarter and year ended December 31, 2013.

6 Feb 2014

Neuland Laboratories announces financial results for third quarter of fiscal year 2014

Neuland Laboratories Ltd., (NSE:NEULANDLAB; BOM:524558) a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), complex intermediates and contract manufacturing services to customers located in 85 countries, today announced financial results for the third quarter of fiscal year (FY) 2014, ended December 31, 2013.

5 Feb 2014

eInfochips launches Andromeda Reference Platform for medical imaging and telemedicine designers

The video processing system includes the system hardware and software that design teams need for fast time-to-application development

5 Feb 2014

Fraunhofer USA receives FDA clearance for IND malaria TBV that targets Pfs25 antigen

Fraunhofer USA Center for Molecular Biotechnology (FhCMB) announced today that clearance was obtained from the U.S. Food and Drug Administration (FDA) for an investigational new drug (IND), Fraunhofer's plant-derived malaria transmission-blocking vaccine (TBV), which targets the Pfs25 antigen, to proceed into the clinic in a Phase 1 safety and immunogenicity study.

5 Feb 2014

Furiex announces top-line results of Phase III clinical trials of eluxadoline in treatment of IBS-d

Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced top-line results indicating the company's two pivotal Phase III clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d) met both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) formally agreed-upon primary endpoints of composite response based on simultaneous improvements in stool consistency and abdominal pain.

4 Feb 2014

Manufacturing News and Research

Further Reading

Guerbet: FDA approves manufacturing plant for Lipiodol (ethiodized oil) Injection

PBL Assay Science, HumanZyme ink licensing agreement to expand reagent offerings

CytoDyn submits PRO 140 Phase 2b trial protocol to FDA for treatment substitution in HIV patients

Acerde and a China-based medical imaging giant ink development contract

TPI announces financial results for second quarter fiscal year 2014

GNC Holdings reports consolidated revenue of $613.7 million in Q4 2013

Alvogen launches Inflectra into Central and Eastern Europe

Researchers examine quality of needles used in acupuncture

Insurgical single-use orthopaedic power tools used in total knee replacement procedure

Cedars-Sinai receives $1M grant to study molecular changes in brain due to air pollutants

ADM commits $25 million equity investment in Rennovia

Zoetis reports revenue of $1.25 billion for Q4 2013

Merck, Samsung Bioepis agree to develop, commercialize MK-1293 for treatment of diabetes

ACell releases new MatriStem Multilayer Wound Matrix device for hard-to-heal, full-thickness wounds

TSRI scientists discover unusual protein that probably helps some bacteria evade immune response

Invacare reports net loss per share of $0.19 in fourth quarter 2013

Neuland Laboratories announces financial results for third quarter of fiscal year 2014

eInfochips launches Andromeda Reference Platform for medical imaging and telemedicine designers

Fraunhofer USA receives FDA clearance for IND malaria TBV that targets Pfs25 antigen

Furiex announces top-line results of Phase III clinical trials of eluxadoline in treatment of IBS-d

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