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HHS awards $10M to support public health efforts for reducing tobacco use and obesity

The U.S. Department of Health and Human Services (HHS) today announced awards of $10 million to 10 national non-profit organizations to support public health efforts to reduce tobacco use and reduce obesity through increased physical activity and improved nutrition.

8 Jul 2010

Ethicon launches OMNEX Surgical synthetic sealant

Ethicon, Inc., a worldwide leader in surgical care, announced today the introduction of ETHICON™ OMNEX™ Surgical Sealant, ETHICON™ Biosurgery's first synthetic sealant designed to achieve adjunctive hemostasis (stoppage of bleeding) in vascular reconstructions by mechanically sealing areas of leakage. The US Food and Drug Administration (FDA) recently granted approval of the Premarket Approval Application (PMA) for ETHICON™ OMNEX™ Surgical Sealant.

8 Jul 2010

FDA invites public comments, suggestions on menu labeling

The U.S. Food and Drug Administration today announced that it is inviting the public to submit comments and information to help the agency implement a new federal law that requires the posting of calorie content and other nutrition information on menu items at certain chain restaurants and similar retail food operations and vending machines.

8 Jul 2010

Asian Development Bank, U.N. call on Asia-Pacific countries to increase agriculture funding to ensure food security

Countries in Asia and the Pacific should increase investment in agriculture by $120 billion annually through 2050 to address hunger and prevent major food price increases, U.N. and Asian Development Bank (ADB) officials said Wednesday, the Associated Press reports. According to the officials, the "onus for funding the investments would be on private sources and governments," the news service writes (7/7).

8 Jul 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, in collaboration with APR Applied Pharma Research s.a. of Switzerland and Labtec GmbH of Germany, today announced that its partner, Strativa Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for Zuplenz® oral soluble film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.

8 Jul 2010

FDA issues formal response to Nephros' 510(k) application for hemodiafiltration system

Nephros, Inc., a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification, today reported that the U.S. Food and Drug Administration has issued a formal response to the company's 510(k) application.

8 Jul 2010

Winston submits NDA for CIVANEX to U.S. FDA

Winston Laboratories, Inc., a wholly-owned subsidiary of Winston Pharmaceuticals, Inc., a pharmaceutical company focused on developing and commercializing novel pain management therapies, announced that it has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval to market its civamide (zucapsaicin) 0.075% cream, CIVANEX®, for the treatment of signs and symptoms of osteoarthritis of the knee.

7 Jul 2010

FDA grants orphan drug designation for Synageva BioPharma's SBC-102

Synageva BioPharma Corp., a privately held biopharmaceutical company, announced that the U.S. Food and Drug Administration has granted orphan drug designation for SBC-102, the Company's enzyme replacement therapy in development to treat Lysosomal Acid Lipase Deficiency, also known as Wolman Disease and Cholesteryl Ester Storage Disease, a condition for which there is currently no approved treatment.

7 Jul 2010

Rutgers researchers report genetic coding responsible for making QPM kernels sturdy

Rutgers researchers have discovered the basis for what makes corn kernels hard, a quality that allows corn to be easily harvested, stored and transported. The findings could lead to better hybrids and increase the supply for people in developing countries who rely on it as a nutritional staple.

7 Jul 2010

Researchers to discuss connection between brown fat and obesity

Researchers from all over the world will meet at Stockholm University this weekend, July 10 and 11, to discuss for the first time the connection in adult humans between brown fat and the risk of becoming obese.

7 Jul 2010

Study finds link between early nutrition and arthritis in people and moose

It's seen as a sign of getting old, but scientists have discovered that arthritis is not just a human problem as a study lasting 50 years reveals how moose suffer from an identical form of the condition. The research, published in Ecology Letters, also casts new light on how malnutrition early in life can lead to the disorder in both moose and humans.

7 Jul 2010

Codex Alimentarius Commission provides new guidance to help improve food safety

The maximum amount of melamine allowed in powdered infant formula is 1 mg/kg and the amount of the chemical allowed in other foods and animal feed is 2.5 mg/kg, according to new rulings from the United Nations' food standards body, Codex Alimentarius Commission.

7 Jul 2010

Study shows gene-environment interaction in congenital heart disease

A pregnant mother's diet may be able to interact with the genes her unborn child inherits and influence the type or severity of birth defect according to research funded by the Wellcome Trust and the British Heart Foundation. The study, published in the journal Human Molecular Genetics, suggests that mothers who eat a high fat diet before and through pregnancy could be inadvertently putting the health of their offspring at risk.

7 Jul 2010

Predictable, preventable injuries occur in children during summer months, say doctors

It is a time most families look forward to every year - summertime. For parents, the warm summer months are often filled with family vacations and cookouts. For kids, it is a chance to play outdoors and enjoy a few months without homework. However, doctors at Nationwide Children's Hospital have recently noticed a trend in injuries that occur in children during the summer months that are both predictable and preventable.

7 Jul 2010

Biotage launches AFFINILUTE Molecularly Imprinted Polymer columns for analytical sample preparation

Biotage, a leading supplier of tools and technology for analytical and medicinal chemistry, announced the introduction of high-performance, AFFINILUTE MIP (Molecularly Imprinted Polymers) columns for analytical sample preparation. Highly selective extractions with AFFINILUTE MIPs are considerably simplified resulting in faster, more robust and ultimately lower cost sample preparation.

7 Jul 2010

Experts develop HVI method for assessing hunger

World hunger is often seen as the result of overpopulation, bad geography or natural or human-made disasters. But a new book, "The Atlas of World Hunger," reveals that the contours and causes of hunger are more complex - and in some ways more easily addressed - than those old assumptions suggest.

7 Jul 2010

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

Genentech, a member of the Roche Group, today announced that the company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for trastuzumab-DM1 (T-DM1) in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies.

7 Jul 2010

Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

Apicore LLC announced today that they filed a drug master file (DMF) for Fondaparinux Sodium active pharmaceutical ingredient (API) with the U.S. Food and Drug Administration (FDA) on June 28, 2010.

7 Jul 2010

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Aastrom Biosciences, Inc., the leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today announced that the company will pursue a Phase 3 clinical program for its autologous cell therapy for the treatment of critical limb ischemia (CLI) through the U.S. Food and Drug Administration's special protocol assessment (SPA) process. Aastrom is currently completing a Phase 2b clinical trial of its cell therapy in patients with CLI and recently met with FDA officials to discuss plans for the Phase 3 program.

7 Jul 2010

Food News and Research

HHS awards $10M to support public health efforts for reducing tobacco use and obesity

Ethicon launches OMNEX Surgical synthetic sealant

FDA invites public comments, suggestions on menu labeling

Asian Development Bank, U.N. call on Asia-Pacific countries to increase agriculture funding to ensure food security

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

MonoSol partner Strativa receives FDA approval for Zuplenz OSF

FDA issues formal response to Nephros' 510(k) application for hemodiafiltration system

Winston submits NDA for CIVANEX to U.S. FDA

FDA grants orphan drug designation for Synageva BioPharma's SBC-102

Rutgers researchers report genetic coding responsible for making QPM kernels sturdy

Researchers to discuss connection between brown fat and obesity

Study finds link between early nutrition and arthritis in people and moose

Codex Alimentarius Commission provides new guidance to help improve food safety

Study shows gene-environment interaction in congenital heart disease

Predictable, preventable injuries occur in children during summer months, say doctors

Biotage launches AFFINILUTE Molecularly Imprinted Polymer columns for analytical sample preparation

Experts develop HVI method for assessing hunger

Genentech submits BLA for trastuzumab-DM1 in advanced HER2-positive breast cancer

Apicore files DMF for Fondaparinux Sodium API with U.S. FDA

Aastrom to pursue Phase 3 CLI clinical program through FDA SPA process

Understanding cultivated meat and its global potential 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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