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Researchers identify molecular pathway by which Notch regulates cell proliferation in lung cancer

Lung cancer is one of the most aggressive types of cancer and the most common cause of death from this disease worldwide. Despite the progress in the molecular biology of lung cancer achieved in recent years, the mechanisms used by tumor cells to grow and spread throughout the body are not yet completely understood. This lack of information is responsible for the limited range of available therapeutic possibilities and their undesirable side effects.

14 Aug 2012

FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

Santarus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013.

14 Aug 2012

Six manufacturers receive FDA approval to produce 2012-2013 flu vaccines

The U.S. Food and Drug Administration announced today that it has approved the 2012-2013 influenza (flu) vaccine formulation for all six manufacturers licensed to produce and distribute the vaccines in the United States.

14 Aug 2012

FDA approves Intelliject's Auvi-Q for anaphylaxis

Intelliject, Inc. announced that the U.S. Food and Drug Administration approved Auvi-Q (epinephrine injection, USP) for the emergency treatment of life-threatening allergic reactions in people who are at risk or have a history of anaphylaxis. This is the first-and-only compact auto-injector with audio and visual cues that guide patients and caregivers step-by-step through the injection process.

13 Aug 2012

FDA accepts Teva's NDA for Quartette oral contraceptive

Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd., today announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets).

13 Aug 2012

Wound dressing containing ionic silver capable of killing multidrug-resistant organisms

ConvaTec, a world-leading developer and marketer of innovative medical technologies for community and hospital care, today announced in vitro study results showing that a wound dressing containing ionic silver is able to kill several strains of multidrug-resistant organisms (MDROs), commonly referred to as 'superbugs.' The study results were published in the August issue of the International Wound Journal.

13 Aug 2012

Latrepirdine demonstrates new potential against neurodegenerative conditions

The second of two studies on latrepirdine, recently published in Molecular Psychiatry, demonstrates new potential for the compound in the treatment of Alzheimer's disease, Parkinson's disease, sleep disorders, and other neurodegenerative conditions. An international team led by Mount Sinai School of Medicine scientists found that latrepiridine, known commercially as Dimebon, reduced the level of at least two neurodegeneration-related proteins in mice.

13 Aug 2012

Epigenetic factors involved in treatment-resistance to schizophrenia drugs

Researchers at Mount Sinai School of Medicine may have discovered why certain drugs to treat schizophrenia are ineffective in some patients. Published online in Nature Neuroscience, the research will pave the way for a new class of drugs to help treat this devastating mental illness, which impacts one percent of the world's population, 30 percent of whom do not respond to currently available treatments.

13 Aug 2012

Popular class of diabetes drugs increase risk for bladder cancer

A popular class of diabetes drugs increases patients' risk of bladder cancer, according to a new study published online this month in the Journal of the National Cancer Institute.

13 Aug 2012

New personal care product for circumcised men

Centric Research Institute today launched CIRCUMserum, the first personal care product formulated specifically for use by circumcised men. CIRCUMserum is a daily moisturizing cream made from a patent-pending blend of essential botanical oils designed to condition areas of the penis dulled by the constant exposure resulting from circumcision.

13 Aug 2012

FDA extends PDUFA action date for NPS Gattex NDA

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act action date for its New Drug Application for Gattex (teduglutide) by three months to December 30, 2012.

13 Aug 2012

Genentech receives FDA approval for Lucentis to treat diabetic macular edema

Genentech, a member of the Roche Group, today announced that Lucentis (ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness

12 Aug 2012

Medicare payments for anemia drug too high; Feds seek fix to glitch that denies some hospitalized beneficiaries coverage for follow-up nursing home care

The U.S. health-care system is vastly overspending for a single anemia drug because Medicare overestimates its use by hundreds of millions of dollars a year, according to an analysis of federal data. The overpayment to hospitals and clinics arises because Medicare reimburses them based on estimates rather than the actual use of the drug.

12 Aug 2012

Lucentis receives FDA approval for treatment of diabetic macular edema

The U.S. Food and Drug Administration today approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

10 Aug 2012

FDA approved drug to treat Ph- acute lymphoblastic leukemia

The U.S. Food and Drug Administration today approved Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL). ALL is a rapidly progressing form of blood and bone marrow cancer that is more commonly diagnosed in children than adults.

10 Aug 2012

FDA approves Perrigo's ANDA for clobetasol propionate shampoo

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for clobetasol propionate shampoo, 0.05%, the generic equivalent of Clobex Shampoo.

10 Aug 2012

FDA approves Mylan's ANDA for generic Provigil

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP,100 mg and 200 mg.

10 Aug 2012

IRIN examines administration of methadone as treatment for people who inject drugs in Bangladesh

"Methadone treatment is proving to be the most efficient way to wean people in Bangladesh from addiction to buprenorphine, a pharmaceutical drug, and health experts say it should be expanded to reach thousands more drug users to prevent the spread of HIV," IRIN reports.

10 Aug 2012

Statins: cardiovascular benefits outweigh diabetes risk

The benefits of taking statins to reduce the risk of cardiovascular disease outweigh the increased risk of developing diabetes experienced by some patients who take these cholesterol-lowering drugs, according to an Article published Online First in The Lancet.

10 Aug 2012

Link between physical fitness and iron or vitamin status in adolescents

Adolescence is an important time not only for growing but for acquiring healthy habits that will last a lifetime, such as choosing foods rich in vitamins and minerals, and adopting a regular exercise regimen. Unfortunately, several studies have shown that adolescents' intake of important nutrients, as well as their performance on standard physical fitness tests, has fallen in recent years.

9 Aug 2012