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Discovery Labs receives FDA guidance to gain Surfaxin approval for RDS in premature infants

Discovery Laboratories, Inc. announces today that it has received written guidance from the U.S. Food and Drug Administration (FDA) that is consistent with its ongoing, comprehensive preclinical program to resolve the sole remaining chemistry, manufacturing & control (CMC) issue necessary to potentially gain FDA marketing approval for Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

9 Jun 2010

Elekta Neuromag TRIUX system unveiled at Organization of Human Brain Mapping's Annual Meeting

At the Organization of Human Brain Mapping's 16th Annual Meeting (Barcelona, Spain, June 6-10), Elekta unveiled its next generation magnetoencephalography system, Elekta Neuromag TRIUX. A platform that addresses key requirements critical for monitoring normal and abnormal brain activity, Elekta Neuromag TRIUX was designed to operate in virtually any clinical environment – an advance welcomed by the growing number of Elekta Neuromag clinical and research facilities worldwide.

From Elekta 7 Jun 2010

New symbiotic starter culture investigated for production of original yogurt

Yogurt production is traditional branch in our food industry. Yogurt is a fermented milk product that contains the characteristic bacterial cultures Lactobacillus bulgaricus and Streptococcus thermophilus. One of them is invented and used for the first time in our country and that's why it is named after Bulgaria.

5 Jun 2010

Research focuses on art, pharmaceutical drugs and the environment

Providing solutions to any current problem is the mission of analytical chemistry, according to Ms Rosa Alonso, director of the Farmartem Research Group at the University of the Basque Country. The group's name says it all with respect to the wide range of these problems - Farmartem: the abbreviation in Spanish of pharmaceuticals, art and the environment (f-rmacos, arte, medio ambiente).

5 Jun 2010

Medicare: Both doctors and patients are looking for private options

Although people may believe that their insurance worries are over once they qualify for Medicare, both doctors and patients are looking for a private option—especially with Medicare's looming bankruptcy, and ObamaCare's promise to cut half a trillion dollars from it to help fund universal coverage.

3 Jun 2010

CCAC applauds Quebec Ministry of Health's colorectal cancer screening pilot

The Colorectal Cancer Association of Canada (CCAC) applauds the decision of the Quebec Ministry of Health and its Minister Yves Bolduc to implement a colorectal cancer screening pilot in anticipation of launching a province wide colorectal cancer screening program.

2 Jun 2010

Emerson Ecologics announces awardees of Partner status in Emerson Quality Program

Emerson Ecologics, LLC announces the debut of the first group of manufacturers to be awarded Partner status in the Emerson Quality Program(SM) (EQP). This one-of-a-kind quality assurance program for the nutritional supplements industry provides practitioners with manufacturer-specific quality and safety information to assist in confidently recommending the best products to patients.

2 Jun 2010

FDA may seek criminal penalties against J & J for faulty recall of children's Tylenol, other medicines

The Wall Street Journal: "The Food and Drug Administration said it is weighing whether to seek criminal penalties against the Johnson & Johnson unit that made children's Tylenol and other over-the-counter kids' medicines recalled last month. Joshua Sharfstein, the FDA's principal deputy commissioner, told lawmakers at a hearing Thursday that J&J's McNeil Consumer Healthcare unit had a 'pattern of noncompliance' with good manufacturing practices.

29 May 2010

Hitachi Software, OriGene announce co-marketing agreement

Hitachi Software Engineering America, Ltd. and OriGene Technologies, Inc. today announced a co-marketing agreement to jointly promote OriGene's multiplex assays built on Luminex xMAP/Bio-Plex technology and Hitachi Software's MasterPlex software suite for analysis and reporting of multiplex assay data.

29 May 2010

BTE awards Diabetes Care Recognition Program certificates to 118 Montefiore Medical Group physicians

Bridges to Excellence, a national program that recognizes and rewards physicians for delivering better quality care, today awarded its sought-after Diabetes Care Recognition Program certificate to the 118 physicians in Montefiore Medical Center's 20 outpatient care facilities, known as the Montefiore Medical Group, for substantially lowering blood sugar levels and "bad" cholesterol levels in thousands of adult patients with diabetes.

28 May 2010

European researchers define research priorities in biogerontology

The quality of the medical care for geriatric patients is a major investment for society and must imperatively be a research priority in Europe. This is why 50 European researchers, met on May 17 - 19 in Brussels, to define the research priorities in the field of biogerontology for the next 10 to 15 years.

21 May 2010

Ansell Healthcare receives "2010 European Surgical Gloves Product Quality Leadership Award"

Based on its recent research on the surgical drapes, gowns and gloves market, Frost & Sullivan presents Ansell Healthcare Europe (Ansell Healthcare) with the "2010 European Surgical Gloves Product Quality Leadership Award" for its Encore® range of surgical gloves. The range consists of multiple products that are customized to support a wide range of surgical procedures including specialty surgery such as orthopaedics and microsurgery.

21 May 2010

Eli Lilly to present results of two Phase II trials evaluating ALIMTA in combination with chemotherapy, radiation

Results of two Phase II trials evaluating ALIMTA (pemetrexed for injection) in combination with a platinum chemotherapy and radiation for patients with locally advanced non-small cell lung cancer will be presented by Eli Lilly and Company at the 46th Annual Meeting of the American Society of Clinical Oncology in Chicago, Ill., on June 6, 2010.

21 May 2010

MicroStockProfit.com releases investment report on Discovery Laboratories

MicroStockProfit.com announces an investment report featuring Discovery Laboratories Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

20 May 2010

Discovery Labs revalidates optimized BAT in program to gain FDA approval of Surfaxin for RDS

Discovery Laboratories, Inc. announces today that the revalidation of its optimized fetal rabbit Biological Activity Test (BAT, an important quality control release and stability test) has been completed, having met all pre-specified acceptance criteria.

19 May 2010

College of Physicians and Surgeons of Ontario approves premises standards to improve patient safety

At its Council meeting today, the College of Physicians and Surgeons of Ontario welcomed new regulatory oversight and approved premises standards that will improve patient safety in a wide variety of settings.

18 May 2010

ACM Global renews CAP accreditation for the third time

ACM Global Central Laboratory, the global central lab that continually defines the customer-service standard with its flexible approach, has renewed its College of American Pathologists accreditation for the third time based on the results of a recent onsite inspection.

17 May 2010

The George Washington University Board of Trustees approve formation of GW School of Nursing

Today, The George Washington University Board of Trustees voted to approve the formation of the GW School of Nursing. The nursing school will be composed of the Master of Science in Nursing programs, the Doctor of Nursing Practice program, the second degree Bachelor of Science in nursing program, and other post-masters certificate programs.

15 May 2010

BioGenes study documents insufficient sensitivity of ELISA-based generic HCP assay

BioGenes GmbH, a supplier of GMP-compliant immunoassays and antibodies, completed a study that documents the insufficient sensitivity of an ELISA-based generic host cell protein assay. The results confirm the observation of several contract manufacturers that generic HCP assays are only of limited use for detection of HCPs during manufacturing processes.

12 May 2010

Aceto third-quarter net sales up 24.5% to $99.3 million

Aceto Corporation, a global leader in the sourcing, quality assurance, regulatory support, marketing and distribution of pharmaceuticals, nutraceuticals, specialty chemicals and crop protection products, today announced results of operations for its fiscal 2010 third quarter and nine months ended March 31, 2010.

7 May 2010

Quality Control News and Research

Discovery Labs receives FDA guidance to gain Surfaxin approval for RDS in premature infants

Elekta Neuromag TRIUX system unveiled at Organization of Human Brain Mapping's Annual Meeting

New symbiotic starter culture investigated for production of original yogurt

Research focuses on art, pharmaceutical drugs and the environment

Medicare: Both doctors and patients are looking for private options

CCAC applauds Quebec Ministry of Health's colorectal cancer screening pilot

Emerson Ecologics announces awardees of Partner status in Emerson Quality Program

FDA may seek criminal penalties against J & J for faulty recall of children's Tylenol, other medicines

Hitachi Software, OriGene announce co-marketing agreement

BTE awards Diabetes Care Recognition Program certificates to 118 Montefiore Medical Group physicians

European researchers define research priorities in biogerontology

Ansell Healthcare receives "2010 European Surgical Gloves Product Quality Leadership Award"

Eli Lilly to present results of two Phase II trials evaluating ALIMTA in combination with chemotherapy, radiation

MicroStockProfit.com releases investment report on Discovery Laboratories

Discovery Labs revalidates optimized BAT in program to gain FDA approval of Surfaxin for RDS

College of Physicians and Surgeons of Ontario approves premises standards to improve patient safety

ACM Global renews CAP accreditation for the third time

The George Washington University Board of Trustees approve formation of GW School of Nursing

BioGenes study documents insufficient sensitivity of ELISA-based generic HCP assay

Aceto third-quarter net sales up 24.5% to $99.3 million

How can microdialysis benefit drug development

Global and Local Efforts to Take Action Against Hepatitis

Addressing Important Cardiac Biology Questions with Shotgun Top-Down Proteomics

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