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FDA approves Novartis' Tekamlo for treatment of high blood pressure

The US Food and Drug Administration (FDA) approved Tekamlo™ (aliskiren and amlodipine) tablets, a single-pill for the treatment of high blood pressure combining the only approved direct renin inhibitor, Tekturna® (aliskiren), with the widely used calcium channel blocker amlodipine. Tekamlo is approved as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals, and as replacement therapy for patients whose blood pressure is not adequately controlled with either aliskiren or amlodipine alone.

27 Aug 2010

Elsevier, KIT sign MoU to provide developing country researchers access to ScienceDirect and Scopus

Elsevier and the Royal Tropical Institute (KIT) in Amsterdam announced on 26th of August the signing of a Memorandum of Understanding (MoU) providing 150 researchers working in least-developed and low-income countries (for example Benin, Mozambique, Ethiopia, Togo etc.) with access to ScienceDirect and Scopus, Elsevier's online scientific research platform and flagship abstract and citation database.

27 Aug 2010

Research: Impact of seafood components on human health

Seafood has an enormous potential to promote health. At the same time the opportunities for innovation and value creation are huge. Knowledge and documentation are the keys to success.

27 Aug 2010

Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-DM1 BLA

ImmunoGen, Inc., a biotechnology company that develops antibody-based targeted anticancer products, today announced that Genentech, a member of the Roche Group, today announced its receipt of a Refuse to File (RTF) letter from the US Food and Drug Administration (FDA) for the accelerated approval of the Biologic License Application (BLA) for trastuzumab-DM1, or T-DM1, submitted in July 2010.

27 Aug 2010

Current dietary exposure to BPA through food packaging not a health risk: Health Canada

As part of its research commitment on bisphenol A (BPA), Health Canada released today the results of a new survey of BPA exposure levels in a variety of soft drink and beer products. The results from this latest government survey provide confirmation that foods and beverages packaged in BPA epoxy resin coated metal cans do not pose a health risk.

27 Aug 2010

Luminex launches FDA-cleared xTAG Cystic Fibrosis 60 Kit v2 diagnostic test

Luminex Corporation, the worldwide leader in multiplexed solutions, today announced the full commercial launch of its xTAG Cystic Fibrosis 60 Kit v2, a new diagnostic test that can simultaneously screen a single blood sample for up to 60 cystic fibrosis-causing genetic mutations in a matter of hours.

From Thermo Fisher Scientific Inc. 27 Aug 2010

New York State permits Genelex Corporation's DNA Drug Sensitivity Tests

The New York State Department of Health has licensed Genelex Corporation's DNA Drug Sensitivity Tests for use by doctors in the state. The issued Clinical Laboratory Permit is for DNA testing of three enzymes, the cytochrome P450s, that process more than 50 percent of the most commonly prescribed medicines.

27 Aug 2010

Study evaluates use of drought-tolerant maize in Africa

Reuters reports on a study (.pdf) examining the use of drought-tolerant maize in 13 African countries, which was published on Thursday by the International Maize and Wheat Improvement Centre (CIMMYT) with input from several other food research institutes (Cocks, 8/26).

27 Aug 2010

Endologix granted CE Mark approval for expanded line of stent graft products and Aortic Extensions

Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced today that it received CE Mark approval to market its expanded offering of Powerlink® stent graft products and PowerFit™ Aortic Extensions in the European Union. The Company expects to launch the products in a limited market release in Europe during the fourth quarter of 2010, followed by a full product launch in 2011.

27 Aug 2010

Drought-tolerant varieties of maize could boost harvests in 13 African countries: Study

As climate change intensifies drought conditions in Africa and sparks fears of a new cycle of crippling food shortages, a study released today finds widespread adoption of recently developed drought-tolerant varieties of maize could boost harvests in 13 African countries by 10 to 34 percent and generate up to US$1.5 billion in benefits for producers and consumers.

27 Aug 2010

Disulfiram drug effective in treating cocaine addiction: Research

Doctors have used the drug disulfiram to help patients stay sober for several decades. It interferes with the body's ability to metabolize alcohol, giving a fierce hangover to someone who consumes even a small amount of alcohol.More recently, disulfiram was shown to be effective in treating cocaine addiction as well, even though alcohol and cocaine affect the nervous system in different ways.

27 Aug 2010

At least 3.5M Pakistanis have no access to clean water, raising risk for waterborne diseases

UNICEF estimates that about 3.5 million Pakistanis only have access to contaminated water, the U.N. Office for the Coordination of Humanitarian Affairs (OCHA) said on Wednesday in a statement, Bloomberg Businessweek reports. Approximately 2.5 million flood survivors now have access clean water (Gale, 8/26).

27 Aug 2010

SYSPRO ERP solution support pharmaceutical manufacturers to new FDA regulation

SYSPRO, the leading provider of visionary, pragmatic ERP software, today announced that the company is highly confident that the SYSPRO ERP solution will enable pharmaceutical manufacturers to meet the new U.S. Food and Drug Administration (FDA) regulations being proposed by Congress.

27 Aug 2010

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

Cooper Institute receives contract from Texas Department to develop NUTRIGRAM for children

In an effort to curb the alarming rates of obesity in Texas, The Cooper Institute was recently awarded a contract from the Texas Department of Agriculture (TDA) to develop a nutrition assessment and educational service for students called NUTRIGRAM.

27 Aug 2010

Spoonful of black rice bran contains more health promoting anthocyanin antioxidants than blueberries

Health conscious consumers who hesitate at the price of fresh blueberries and blackberries, fruits renowned for high levels of healthful antioxidants, now have an economical alternative, scientists reported here today at the 240th National Meeting of the American Chemical Society. It is black rice, one variety of which got the moniker "Forbidden Rice" in ancient China because nobles commandeered every grain for themselves and forbade the common people from eating it.

27 Aug 2010

Coalition of organizations request FDA to govern antibiotic usage in food animal production

Today a broad coalition of organizations hand-delivered the U.S. Food and Drug Administration (FDA) more than 180,000 letters responding to the agency's request for comments on rules governing the use of antibiotics on industrial farms.

27 Aug 2010

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for use of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) for active immunization of infants and toddlers for the prevention of invasive meningococcal disease caused by serogroups A, C, Y, and W-135.

26 Aug 2010

DePuy Orthopaedics announces voluntary recall of ASR XL Acetabular and Hip Resurfacing systems

DePuy Orthopaedics, Inc., announced it is voluntarily recalling the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a second hip replacement procedure, called a revision surgery.

26 Aug 2010

Momenta Pharmaceuticals provides update on generic Lovenox litigation

Momenta Pharmaceuticals, Inc., a biotechnology company specializing in the characterization and engineering of complex drugs, today announced that on August 25, 2010, the United States District Court for the District of Columbia denied sanofi-aventis U.S. LLC's request for a preliminary injunction directing the FDA to suspend and withdraw its approval of the Abbreviated New Drug Application (ANDA) filed by the Company's collaboration partner, Sandoz, for enoxaparin sodium injection USP, a generic version of Lovenox®. The decision is subject to appeal.

26 Aug 2010

Food News and Research

FDA approves Novartis' Tekamlo for treatment of high blood pressure

Elsevier, KIT sign MoU to provide developing country researchers access to ScienceDirect and Scopus

Research: Impact of seafood components on human health

Genentech receives FDA Refuse to File letter for accelerated approval of trastuzumab-DM1 BLA

Current dietary exposure to BPA through food packaging not a health risk: Health Canada

Luminex launches FDA-cleared xTAG Cystic Fibrosis 60 Kit v2 diagnostic test

New York State permits Genelex Corporation's DNA Drug Sensitivity Tests

Study evaluates use of drought-tolerant maize in Africa

Endologix granted CE Mark approval for expanded line of stent graft products and Aortic Extensions

Drought-tolerant varieties of maize could boost harvests in 13 African countries: Study

Disulfiram drug effective in treating cocaine addiction: Research

At least 3.5M Pakistanis have no access to clean water, raising risk for waterborne diseases

SYSPRO ERP solution support pharmaceutical manufacturers to new FDA regulation

FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

Cooper Institute receives contract from Texas Department to develop NUTRIGRAM for children

Spoonful of black rice bran contains more health promoting anthocyanin antioxidants than blueberries

Coalition of organizations request FDA to govern antibiotic usage in food animal production

FDA accepts Sanofi Pasteur's Menactra vaccine sBLA for active immunization of infants and toddlers

DePuy Orthopaedics announces voluntary recall of ASR XL Acetabular and Hip Resurfacing systems

Momenta Pharmaceuticals provides update on generic Lovenox litigation

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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