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BioVex's Phase 3 melanoma study amended to include first line patients

BioVex Inc, a company developing new generation biologics for the treatment of cancer and prevention of infectious disease, announced today that the U.S. Food and Drug Administration (FDA) has agreed that BioVex's ongoing OPTiM clinical study in unresectable Stage IIIb-IV melanoma be amended to include untreated (i.e., first line) patients as well as previously treated patients as defined in the original protocol.

7 Jan 2010

Drug companies still under great and growing pressure to bring more products to market

Although drug developers are improving R&D efficiency, in part by terminating more unpromising drugs earlier in development, their continued success will depend on how well they partner with other firms at specific points on the development spectrum, according to the Tufts Center for the Study of Drug Development.

7 Jan 2010

Study suggests pomegranates may prevent growth of breast cancer cells

US scientists have carried out a series of laboratory tests suggesting that natural compounds in pomegranates may prevent the growth of breast cancer cells.

7 Jan 2010

ProFibrix B.V. receives loan up to $7.4 million to develop its new hemostat Fibrocaps

ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that SenterNovem, an agency of the Dutch Ministry of Economic Affairs, has granted the company a loan under its new Innovation Credit scheme of potentially up to EUR 5 million to finance the further clinical development of its unique new hemostat Fibrocaps(TM).

7 Jan 2010

Scientists use NIR to predict how quickly pills dissolve in body

Scientists at the University of Maryland, Baltimore have successfully used near-infrared spectroscopy (NIR) -- a method already used to test farm product quality -- to predict how quickly pills dissolve in the body.

7 Jan 2010

Balanced diet and exercise are the only reliable ways to lose weight

It's time to set the record straight. The only reliable way to lose weight is to eat less or exercise more. Preferably both.

7 Jan 2010

Watson Laboratories files ANDA to seek FDA's approval to market Nuvigil

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc., a Nevada Corporation, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France.

7 Jan 2010

DBA Analytical to host a 2-day training course on dietary supplements

DBA Analytical, an NSF International company, which provides a full range of compliance services for FDA regulated industries, will host a 2-day training course on 21 CFR 111, the Current Good Manufacturing Practices (cGMPs) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

6 Jan 2010

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that a recent "refuse to file" (RTF) letter issued by the Food and Drug Administration (FDA) regarding Merck Serono's oral cladribine has heightened the competition between oral cladribine and its primary competitor, Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), to be the first oral disease-modifying multiple sclerosis therapy to reach the market in the United States.

6 Jan 2010

Toxic chemicals make us susceptible to a wide range of diseases

From the Industrial Revolution and onward, the world has become an environment that is overflowing with dangerous toxins. Mass manufacturing has resulted in thousands of chemical pollutants being released in the atmosphere, water, and soil. As well, there has been a widespread increase of chemicals being added to almost every type of food and retail product.

6 Jan 2010

Federal judge upholds key provisions of new law, gives FDA the power to regulate tobacco products

In a significant victory for public health, a federal judge in Kentucky today upheld most key provisions of the new law giving the U.S. Food and Drug Administration (FDA) the power to regulate tobacco products.

6 Jan 2010

Commercially prepared foods contain more calories than indicated in nutritional labeling, say researchers

With obesity rising markedly, reliance on the accuracy of food labeling is an important weight management strategy. Since people who are trying to reduce their weight are encouraged to choose meals labeled as "lower in calories" or "reduced-energy" in restaurants and supermarkets, it is essential that the listed data are accurate.

6 Jan 2010

New survival prediction equation may impact clinical trials for treating PAH

Setting out to determine the survival of patients with pulmonary arterial hypertension (PAH), researchers at the University of Chicago Medical Center and their colleagues also discovered that an equation used for more than 20 years to predict survival is outdated.

6 Jan 2010

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD).

6 Jan 2010

Three out of four Americans fall into 'WannabeWELL' category

Most Americans make New Years' resolutions focused on wellness, and rightfully so - new research shows Americans have a long way to go toward achieving wellness based on the three pillars of health: healthy diet, responsible supplement use and regular exercise.

6 Jan 2010

British Medical Journal: Mandometer used in Swedish program helps obese children lose weight

The British Medical Journal released today a report on a study conducted in Bristol, United Kingdom, that found that a breakthrough Swedish program using a computerized device called "Mandometer"® was significantly more successful than standard treatment at helping obese children and adolescents lose weight, reduce meal size and decrease their body fat.

6 Jan 2010

NXT Nutritionals Holdings provides 2010 outlook for investors

NXT Nutritionals Holdings, Inc. (“NXT Nutritionals”) developer and marketer of SUSTA™ Natural Sweetener, the great tasting, all-natural, healthier sweetener, today released a Letter to Shareholders from Michael McCarthy, president and Chief Executive Officer, providing investors and the investment community with its outlook for 2010.

6 Jan 2010

Opinions: U.S. medical emergency response; micronutrients; rotavirus vaccine; antibiotic development

"[D]espite the tireless efforts of public health and health-care workers, America's experience with H1N1 shows that the nation is not prepared to deal with a flu pandemic," former Democratic Senator Bob Graham and former Republican Senator Jim Talent write in Washington Post opinion piece that examines U.S. preparedness for medical emergencies. The writers chaired the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism.

6 Jan 2010

ATP-sensitive potassium channel can contribute to fat deposition and obesity, new study says

A new study involving the University of Iowa, Mayo Clinic and two other institutions provides insight on weight control, suggesting that a ATP-sensitive potassium channel critical to survival and stress adaptation can contribute to fat deposition and obesity.

6 Jan 2010

Animal experiments show old antidepressant may reverse heart failure

A team of Johns Hopkins and other researchers have found in animal experiments that an antidepressant developed over 40 years ago can blunt and even reverse the muscle enlargement and weakened pumping function associated with heart failure.

6 Jan 2010

Food News and Research

BioVex's Phase 3 melanoma study amended to include first line patients

Drug companies still under great and growing pressure to bring more products to market

Study suggests pomegranates may prevent growth of breast cancer cells

ProFibrix B.V. receives loan up to $7.4 million to develop its new hemostat Fibrocaps

Scientists use NIR to predict how quickly pills dissolve in body

Balanced diet and exercise are the only reliable ways to lose weight

Watson Laboratories files ANDA to seek FDA's approval to market Nuvigil

DBA Analytical to host a 2-day training course on dietary supplements

Oral cladribine to be the first oral disease-modifying multiple sclerosis therapy despite receiving RTF letter

Toxic chemicals make us susceptible to a wide range of diseases

Federal judge upholds key provisions of new law, gives FDA the power to regulate tobacco products

Commercially prepared foods contain more calories than indicated in nutritional labeling, say researchers

New survival prediction equation may impact clinical trials for treating PAH

Keryx Biopharmaceuticals reaches SPA agreement for Phase 3 clinical program for Zerenex

Three out of four Americans fall into 'WannabeWELL' category

British Medical Journal: Mandometer used in Swedish program helps obese children lose weight

NXT Nutritionals Holdings provides 2010 outlook for investors

Opinions: U.S. medical emergency response; micronutrients; rotavirus vaccine; antibiotic development

ATP-sensitive potassium channel can contribute to fat deposition and obesity, new study says

Animal experiments show old antidepressant may reverse heart failure

Enhancing confidence in chemical ionization spectrometry data 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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