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Collaborative effort by FDA and EMEA expected to yield additional safety data when assessing new drugs

In the first use of a framework allowing submission of a single application to the two agencies, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) worked together to allow drug companies to submit the results of seven new tests that evaluate kidney damage during animal studies of new drugs. The tests measure the levels of seven key proteins or "biomarkers" found in urine that can provide additional information about drug-induced damage to kidney cells, also known as renal toxicity.

15 Jun 2008

Scientist deciphers language bacterial cells use to 'talk' to each other - also discovers how to quell their conversation

Understanding the way bacterial cells "talk" to each other could lead to more effective methods for fighting the often persistent and serious infections caused by the biofilms they form, says a Texas A&M University professor of chemical engineering who not only has deciphered their language but also discovered how to quell their conversation.

11 Jun 2008

Discovery of gene linked to adult-onset obesity

Researchers at the University of Minnesota have discovered a gene that may provide a clue as to why obesity rates increase with age. The research was published today in the Proceedings of the National Academy of Sciences.

11 Jun 2008

Vitamin D, "the heart tranquilizer"

Strong bones, a healthy immune system, protection against some types of cancer: Recent studies suggest there's yet another item for the expanding list of vitamin D benefits. Vitamin D, "the sunshine vitamin," keeps the heart, the body's long-distance runner, fit for life's demands.

11 Jun 2008

Barr confirms patent challenge of Prevacid SoluTab tablets

Barr Pharmaceuticals, Inc. has confirmed that its subsidiary, Barr Laboratories, Inc., has initiated a challenge of the patents listed by TAP Pharmaceuticals Inc. in connection with its Prevacid SoluTab Delayed-Release Orally Disintegrating Tablets (lansoprazole), 15mg and 30mg.

11 Jun 2008

Drug combo offers new approach for reversing type 1 diabetes

Promising results from a study that tested a new approach for reversing Type 1 diabetes are being presented this week at the American Diabetes Association's 68th Annual Scientific Session in San Francisco.

11 Jun 2008

Chinese red food colouring beats heart disease and cancer

According to a large study carried out in China, a red food colouring ingredient widely used in Chinese cooking protects against cancer and heart disease.

11 Jun 2008

Bush Administration requests $275 million increase for FDA in FY 2009 budget

The Bush Administration on Monday requested that Congress allocate an additional $275 million in fiscal year 2009 for FDA, the New York Times reports. The funds would be used to improve drug and food safety in the U.S. (Harris, New York Times, 6/10).

11 Jun 2008

Addicted cells provide early cancer diagnosis

Scientists at the Institute of Food Research have detected subtle changes that may make the bowel more vulnerable to the development of tumours.

10 Jun 2008

Irritable bowel syndrome linked to chilli pepper pain receptor

People with irritable bowel syndrome have a higher than usual number of chilli pepper pain receptors, according to a new study published tomorrow (Wednesday 11 June).

10 Jun 2008

ADHD an advantage for nomadic tribesmen

A propensity for attention deficit hyperactivity disorder (ADHD) might be beneficial to a group of Kenyan nomads, according to new research published in the open access journal BMC Evolutionary Biology.

10 Jun 2008

Arsenic and new rice

Amid recent reports of dangerous levels of arsenic being found in some baby rice products, scientists have found a protein in plants that could help to reduce the toxic content of crops grown in environments with high levels of this poisonous metal.

10 Jun 2008

Common cause of loss of sight may be avoided by diet rich in omega-3

New research suggests that one of the most common causes of vision loss could be avoided by eating food rich in omega-3 fatty acids.

10 Jun 2008

Administration proposes additional funding for FDA for fiscal year (FY) 2009

HHS Secretary Leavitt today announced that the Administration is amending its budget request for fiscal year (FY) 2009 to include an additional $275 million for the U.S. Food and Drug Administration (FDA). He called on Congress to act quickly on this budget amendment and pending Administration legislative proposals to strengthen FDA.

9 Jun 2008

Mylan announces final FDA approval for Zaleplon capsules, generic version of Sonata

Mylan Inc. has announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.

9 Jun 2008

Chinese red yeast rice reduces repeat heart attacks

A clinical study on patients who have suffered a heart attack found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds.

9 Jun 2008

Diabetes explosion on the cards for Brits

According to a charity in Britain, unless there is a major change in lifestyle, by 2025 there will be 3.6 million people with diabetes in England.

9 Jun 2008

Cancer warning on diabetic ulcer gel

The U.S. watchdog the Food and Drug Administration (FDA) says a warning will be added to the label of a topical gel used to treat leg and foot ulcers which refuse to heal in diabetic patients.

9 Jun 2008

Palm Beach County, Fla., commissioners approve plan to reduce HIV/AIDS services by $600,000 in 2009

The Palm Beach County, Fla., commissioners have approved a plan to reduce funding for food and medical case management services for people living with HIV/AIDS by $600,000 in 2009, Larry Leed of the Palm Beach County HIV CARE Council announced on Tuesday, the Palm Beach Post reports. According to the Post, the decision is in response to the continued decrease in Ryan White Program funding.

8 Jun 2008

Complex synapses drove brain evolution

One of the great scientific challenges is to understand the design principles and origins of the human brain. New research has shed light on the evolutionary origins of the brain and how it evolved into the remarkably complex structure found in humans.

8 Jun 2008