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EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Raptor Pharmaceutical Corp., announced that the European Medicines Agency's ("EMA") Committee for Orphan Medicinal Products ("COMP") has issued a positive opinion recommending orphan medicinal product designation for DR Cysteamine for the potential treatment of cystinosis.

15 Jun 2010

Cartoon moms combat obesity

Two Latina mothers are heroes in the new comic book, Small Changes Big Results from the Frances Payne Bolton School of Nursing at Case Western Reserve University. Their quest is to create a healthier lifestyle for their children and families and combat obesity.

15 Jun 2010

AMA voted to adopt new public health policies

New policy adopted today will pair the AMA with the appropriate federal agencies to convene an expert panel to address the immediate and long-term human and environmental health impacts of the massive oil spill in the Gulf of Mexico. The AMA will also work to educate physicians, other health professionals and the public about the public health risks associated with exposure to crude oil and byproducts.

15 Jun 2010

Help Conquer Cancer Project taps World Community Grid to discover structure of cancer-related proteins

Scientists have devised a way to automate and accelerate a manual, complex process that enables researchers to more easily discover the structure of cancer-related proteins, and, eventually, formulate cancer cures. This new, automated approach may also help the exploration of other diseases and food-related research.

15 Jun 2010

New studies: Politicians could do more to tackle the spread of obesity

Politicians could do more to tackle the spread of obesity, a new series of studies suggests. Governments are being urged to encourage better eating habits by supporting financial incentives to enable production of healthier foods, such as subsidised fruit and vegetable production and levies on calorie-rich foods.

15 Jun 2010

New insight into transmission of prion diseases

Prion diseases are lethal neurodegenerative disorders that include Creutzfeldt-Jakob disease (CJD) in humans and bovine spongiform encephalopathy (BSE; commonly known as mad cow disease) in cows. A team of researchers, led by Adriano Aguzzi and Christina Sigurdson, at Universit-tsSpital Z-rich, Switzerland, has generated data in mice that provides greater understanding of the factors that determine how easy it is for prion diseases to be transmitted to a new host species.

15 Jun 2010

Female endurance sports athletes are at risk for serious health issues, say physicians

Female endurance sports athletes may be at risk for serious health issues, according to physicians at Loyola University Health System. Excessive exercise and inadequate nutrition can lead to problems such as low energy, menstrual irregularity, fertility issues, stress fractures and osteoporosis.

15 Jun 2010

NOAA, FDA take additional steps to prevent tainted seafood from reaching U.S. market

The National Oceanic and Atmospheric Administration and the U.S. Food and Drug Administration are taking additional steps to enhance inspection measures designed to ensure that seafood from the Gulf of Mexico reaching America's tables is safe to eat.

15 Jun 2010

SAS launches JMP Clinical software for drug development process

JMP Clinical software, new from SAS, can help shorten the drug development process by streamlining safety reviews during clinical trials. SAS, the leader in business analytics software and services, introduced JMP Clinical today at the annual meeting of the Drug Information Association (DIA).

15 Jun 2010

IRIN, IPS examine pending U.S. legislation to address global hunger, FGM

IRIN reports on the Global Food Security Act, a bill aimed at expanding the U.S. government's role in combatting hunger around the world. The legislation is co-sponsored by Sens. Richard Lugar (R-Ind.) and Bob Casey (D-Pa.).

15 Jun 2010

Texas prepares for health reform's changes despite opposition to new law; Other states brace for federal funding cuts

When Congress approved the sweeping federal health care overhaul in March, Texas Governor Rick Perry was one of the loudest critics. He blasted the initiative as unconstitutional, a government takeover of health care and an unfunded federal mandate on the states. … That sentiment remains widespread in Texas, which has joined with 20 other states in suing to block the law from taking effect.

15 Jun 2010

FDA grants HeartWare approval for IDE destination therapy study of Ventricular Assist System

HeartWare International, Inc., a leading innovator of less invasive, miniaturized circulatory support technologies that are revolutionizing the treatment of advanced heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted HeartWare conditional approval to begin enrollment in an Investigational Device Exemption (IDE) destination therapy clinical study for the HeartWare® Ventricular Assist System.

15 Jun 2010

Radiation scans cause increased scrutiny

The Associated Press: "Americans get the most medical radiation in the world, even more than folks in other rich countries. The U.S. accounts for half of the most advanced procedures that use radiation, and the average American's dose has grown sixfold over the last couple of decades. Too much radiation raises the risk of cancer.

15 Jun 2010

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Genzyme Corporation announced today that its alemtuzumab for multiple sclerosis development program has been granted Fast Track status by the U.S. Food and Drug Administration (FDA). This designation covers patients with relapsing-remitting forms of the disease.

15 Jun 2010

Aesculap receives FDA clearance for SterilContainer product line for use in STERIS V-PRO systems

Aesculap, Inc. is pleased to announce that the SterilContainer S product line has been cleared by the United States Food and Drug Administration (FDA), (510(k) number, K093649) for use in the STERIS Corporation's V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems.

14 Jun 2010

Fluorescent cancerous tumors for early detection

Researchers at the Ecole Polytechnique F-d-rale de Lausanne (EPFL) in Switzerland have established a procedure where cancerous tumors in the bladder become fluorescent and are more easily discoverable under blue light. The Food and Drug Administration (FDA) approved the technique- already in practice in Europe - for the American market. Under the name Cysview-, the product is commercialized by Photocure and GE Healthcare as the most efficient detection technique for early stage bladder cancer.

14 Jun 2010

FDA clears U.Va.'s SpermCheck Fertility at-home test

Couples will soon have a new tool in diagnosing male infertility - without the expense and inconvenience associated with a trip to a specialist's office.

14 Jun 2010

Human Genome Sciences receives FDA feedback for ZALBIN BLA

Human Genome Sciences, Inc. today announced that it has received preliminary written feedback from the U.S. Food and Drug Administration (FDA) regarding the Company's Biologics License Application (BLA) seeking approval in the United States to market 900-mcg ZALBIN™ (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. FDA has expressed concerns regarding the risk benefit assessment of ZALBIN dosed at 900-mcg every two weeks.

14 Jun 2010

Researchers show how tiny insect brain uses multiple brain pathways to judge motion

Insects may have tiny brains the size of a pinhead, but the latest research from the University of Adelaide shows just how clever they really are. For the first time, researchers from the University's Discipline of Physiology have worked out how insects judge the speed of moving objects.

14 Jun 2010

Intellipharmaceutics International files Protonix ANDA with FDA

Intellipharmaceutics International Inc. today announced that is has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic of Protonix® (delayed release pantoprazole sodium). Protonix inhibits gastric acid secretion and is prescribed for the short-term treatment of conditions such as stomach ulcers associated with gastroesophageal reflux disease as well as the long term treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.

14 Jun 2010

Food News and Research

EMA COMP grants orphan medicinal product designation for Raptor's DR Cysteamine for cystinosis

Cartoon moms combat obesity

AMA voted to adopt new public health policies

Help Conquer Cancer Project taps World Community Grid to discover structure of cancer-related proteins

New studies: Politicians could do more to tackle the spread of obesity

New insight into transmission of prion diseases

Female endurance sports athletes are at risk for serious health issues, say physicians

NOAA, FDA take additional steps to prevent tainted seafood from reaching U.S. market

SAS launches JMP Clinical software for drug development process

IRIN, IPS examine pending U.S. legislation to address global hunger, FGM

Texas prepares for health reform's changes despite opposition to new law; Other states brace for federal funding cuts

FDA grants HeartWare approval for IDE destination therapy study of Ventricular Assist System

Radiation scans cause increased scrutiny

FDA grants Fast Track status for Genzyme's alemtuzumab development program for MS

Aesculap receives FDA clearance for SterilContainer product line for use in STERIS V-PRO systems

Fluorescent cancerous tumors for early detection

FDA clears U.Va.'s SpermCheck Fertility at-home test

Human Genome Sciences receives FDA feedback for ZALBIN BLA

Researchers show how tiny insect brain uses multiple brain pathways to judge motion

Intellipharmaceutics International files Protonix ANDA with FDA

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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