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Protalix BioTherapeutics submits validation data for taliglucerase alfa manufacturing process to the FDA

Protalix BioTherapeutics, Inc., announced today it has submitted validation data regarding the Company's manufacturing process for taliglucerase alfa to the U.S. Food and Drug Administration (FDA). The Company made the submission in response to a request from the FDA for validation data from the Company's upgraded manufacturing facility. The FDA is currently reviewing the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease.

27 Apr 2010

New DaVita Phosphorus Challenge tool for CKD and dialysis patients

DaVita Inc., a leading provider of kidney care services for those diagnosed with chronic kidney disease, today announced the launch of the DaVita Phosphorus Challenge, an online resource designed to serve as a core learning tool for CKD and dialysis patients.

27 Apr 2010

New imaging protocol to visualize activity of brain's reward circuitry in individuals addicted to drugs

Researchers at the U.S. Department of Energy's Brookhaven National Laboratory have developed an imaging protocol that allows them to visualize the activity of the brain's reward circuitry in both normal individuals and those addicted to drugs. The technique could lead to better insight into why people take recreational drugs as well as help determine which treatment strategies might be most effective.

27 Apr 2010

Initiative to lower amount of salt in American diet

The American Heart Association and the National Salt Reduction Initiative, a national collaboration led by the City of New York, share a common goal -- to gradually lower the amount of sodium (salt) in the American diet.

27 Apr 2010

KCI applauds FDA for launching medical device home use initiative

KCI applauds the FDA for launching this important initiative to ensure that complex medical devices are used safely in the home by caregivers and patients. We have made it our priority and unwavering responsibility to help caregivers and patients understand how to use our advanced treatments safely. This includes offering a robust education and training program, employing highly trained clinical support staff and providing easy-to-read, patient-specific labeling.

27 Apr 2010

CocE exhibits potential for clinical treatment of cocaine toxicity

Cocaine toxicity due to drug overdose results in more than half a million emergency room visits annually. Despite these alarming statistics, there is no Food and Drug Administration-approved pharmacotherapy specifically designed to treat cocaine toxicity. Emergency medical personnel are limited to treating only the immediate life-threatening symptoms of patients, while toxic levels of cocaine and its metabolic break-down products persist and continue to damage the cardiovascular system, liver and brain.

27 Apr 2010

AES CHEMUNEX to distribute SDIX's RapidChek food pathogen detection systems in Europe

Strategic Diagnostics Inc., now doing business as SDIX, a leading provider of biotechnology-based products and services for a broad range of life science, biotechnology, diagnostic, and food safety applications, today announced it has signed a distribution agreement with AES CHEMUNEX.

27 Apr 2010

LCT receives grant of $500,000 for Phase II clinical trial of DIABECELL in New Zealand

Living Cell Technologies Limited, a global company pioneering the development of a cell implant to treat diabetes, has received a grant of US$500,000 for its on-going Phase II clinical trial of DIABECELL in New Zealand from the Juvenile Diabetes Research Foundation International, a world leader in setting the agenda for diabetes research and the largest charitable funder and advocate for research in type 1 diabetes.

27 Apr 2010

Opinions: G8 summit; World Malaria Day; Family planning; Global Food Security Act

As G8 development leaders gather in Halifax, Nova Scotia, this week to discuss priorities for the upcoming summit, Josette Sheeran, executive director of the WFP, calls for world leaders to focus on the nutritional needs of mothers and children in developing countries in a Toronto Star opinion piece.

27 Apr 2010

World Bank-IMF report tracks impact of global economic downturn on MDGs

Though the global economic crisis has slowed the pace of efforts to reduce poverty in developing countries, the countries remain "on track" to meet the Millennium Development Goal target to halve extreme poverty by 2015, according to a report released Friday by the World Bank and IMF, Agence France-Presse reports (4/26).

27 Apr 2010

GORE VIABIL Biliary Endoprosthesis receives European CE Mark approval for expanded indication

W. L. Gore & Associates (Gore) today announced it has received European CE Mark approval for an expanded indication of the GORE® VIABIL® Biliary Endoprosthesis that allows removal of the device up to 12 months after implantation for the treatment of benign or malignant biliary strictures. The GORE® VIABIL® Biliary Endoprosthesis first received CE Mark approval in December 1999 and U.S. Food and Drug Administration (FDA) approval in January 2002 for the treatment of biliary strictures due to malignant neoplasms.

27 Apr 2010

Phytonutrient intake may help decrease risk for certain chronic diseases: Study

Topping that bowl of cereal with raspberries instead of strawberries, or saut-ing kale instead of spinach for dinner can boost phytonutrient intake, which may help decrease risk for certain chronic diseases, including cardiovascular disease, cancer and diabetes.

27 Apr 2010

Regular exercise speeds learning, improves blood flow to the brain: Study

Regular exercise speeds learning and improves blood flow to the brain, according to a new study led by researchers from the University of Pittsburgh School of Medicine that is the first to examine these relationships in a non-human primate model. The findings are available in the journal Neuroscience.

27 Apr 2010

FDA grants NexMed clearance for HCC Phase 2 trial for PrevOnco

NexMed, Inc., a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco™, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco™ orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.

27 Apr 2010

Nitration and allergy

Food proteins are nitrated through various processes. Just how these processes affect food allergies, however, is only now coming to light. The latest findings of a research project funded by the Austrian Science Fund FWF are being presented today at an international symposium in Italy. The findings show that in the case of a particular food protein the nitrated form can trigger a stronger allergic reaction than the non-nitrated form. At the same time, however, this nitrated form of the protein is better digested and therefore rendered "harmless".

27 Apr 2010

Chocolate and depression?

The ‘chocoholics’ of the world may also be the most depressed people around. A recent study found that those who were suffering from depression ate an average of 8.4 servings of chocolate a month, compared to just 5.4 servings eaten by those who were not depressed. And the people who suffered from major depression ate 11.8 servings per month.

27 Apr 2010

Pennsylvania school districts set goals to reduce childhood obesity

Pennsylvania school districts set goals and improved snacks and a la carte offerings to meet federal legislation for reducing childhood obesity, but opportunities for physical activity did not improve in most schools, according to Pennsylvania nutritional scientists.

26 Apr 2010

Today's opinions: Health overhaul reflects history of government intervention; Importance of repairing clinical trials system; Stopping Medicare fraud

The system's opacity gives insurers the upper hand in debates over government payment rates (Austin Frakt, 4/26).

26 Apr 2010

The Frost Group agrees to make investment in ChromaDex

ChromaDex Corporation, a natural products chemistry company which provides novel and innovative ingredients to the dietary supplement, food, beverage and cosmetic markets, announced today The Frost Group, LLC, led by Miami entrepreneur and billionaire Dr. Phillip Frost, has agreed to make an investment in ChromaDex.

26 Apr 2010

Bayer Diabetes Care launches DIDGET blood glucose monitoring system in the US

Bayer Diabetes Care today announced the introduction of the DIDGET™ blood glucose monitoring system in the United States. The DIDGET meter is unique because it is the only blood glucose meter that connects directly to Nintendo DS™ and DS Lite gaming systems to help kids manage a lifelong disease by rewarding them for building consistent testing habits and meeting personalized blood glucose target ranges. Bayer's DIDGET meter is now available for purchase in the U.S. through CVS.com, Drugstore.com and Walgreens.com.

26 Apr 2010