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FDA extends PDUFA goal date for Auxilium Pharmaceuticals' sBLA for XIAFLEX

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration has notified the Company that it is extending the Prescription Drug User Fee Act goal date for the Company's supplemental biologics license application for XIAFLEX (collagenase clostridium histolyticum) for the treatment of Peyronie's disease from September 6, 2013 to December 6, 2013.

28 Aug 2013

Novel machine learning-based approach used to predict hepatotoxic potential of DNA drug

New classes of therapeutic antisense oligonucleotides can have toxic effects on the liver. A novel machine learning-based approach used to predict the hepatotoxic potential of an antisense drug based on its chemical sequence is presented in Nucleic Acid Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc. publishers.

28 Aug 2013

Use of antipsychotics down among nursing home residents

A two-year effort by the federal government and the nursing-home industry has reduced the use of powerful antipsychotic drugs among elderly nursing-home residents, but the decline fell short of the program's goal, according to U.S. officials (Lagnado, 8/26).

28 Aug 2013

Study shows ABL kinases have enhanced expression and activity in CML

Chronic Myelogenous Leukemia (CML) is a cancer of the white blood cells that is most commonly found in adults and in the elderly. Its incidence has been estimated to be 1 to 2 in 100,000 people. CML was the first cancer to be associated with a genetic abnormality, known as the Philadelphia Chromosome, which 95% of all CML patients carry in their cells.

28 Aug 2013

Infant rotavirus vaccination reduced severe gastroenteritis among U.S. children

"Implementation of infant rotavirus vaccination in 2006 has substantially reduced the burden of severe gastroenteritis among U.S. children younger than 5 years," write Paul A. Gastanaduy, M.D., M.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues. "Whether indirect protection (due to reduced transmission of rotavirus) extends to adults remains unclear."

28 Aug 2013

New polymer additives enhance ability of oral drugs to reach bloodstream

All too often, when a person takes a pill full of a potent and effective drug, the drug passes straight through the body, not reaching the organ where it is needed — a waste of money and inconvenient if it is a cold medicine, but potentially dire if it is a treatment for a serious illness.

28 Aug 2013

HCV treatment with sofosbuvir and ribavirin results in sustained virologic response

Treatment of chronic hepatitis C virus genotype 1 infection with the interferon-free regimen of sofosbuvir and ribavirin resulted in a high sustained virologic response rate in a patient population with unfavorable treatment characteristics, according to a study in the August 28 issue of JAMA.

28 Aug 2013

Botox also treats facial nerve disorders that occur after Bell's palsy

Botox is best known as a cosmetic treatment for frown lines, but the drug also effectively treats the after effects of Bell's palsy and other serious facial nerve problems.

28 Aug 2013

New compound offers way to treat migraine and other disorders of central nervous system

For many migraine sufferers, bright lights are a surefire way to exacerbate their headaches. And for some night-shift workers, just a stroll through a brightly lit parking lot during the morning commute home can be enough to throw off their body's daily rhythms and make daytime sleep nearly impossible. But a new molecule that selectively blocks specialized light-sensitive receptors in the eyes could help both these groups of people, without affecting normal vision.

28 Aug 2013

Even with access to health care, racial variances in HPV vaccine initiation still exist

Even with access to health care, African-American women are less likely to receive the vaccine for human papillomavirus, which reduces the risk for cervical cancer, according to a study by researchers at the University of Pittsburgh School of Medicine.

28 Aug 2013

Haplogen, Cemm Offer Huge Collection Of Mutant Cell Lines

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27 Aug 2013

BiondVax: Priming with universal flu vaccine makes conventional bird flu vaccine effective against pandemic strains

BiondVax announced today that priming with universal flu vaccine before boosting with a conventional bird flu H5N1 vaccine (containing a single strain from Clade 1) resulted in mice exhibiting a significantly higher level of immunity to the strain contained in the conventional bird flu vaccine and in addition, broadened immunity to other H5N1 flu strains (from Clade 2).

27 Aug 2013

Companion diagnostics: an interview with Trevor Hawkins, SVP, Strategy, Innovation and Business Development for Siemens Healthcare Diagnostics

Companion diagnostics is critical in helping to pave the way for personalized medicine, in which the treatment is adapted and precisely tailored to the patient.

From Siemens Healthineers 27 Aug 2013

Vanderbilt adds genetic screening for drug tacrolimus to PREDICT program

Vanderbilt has added genetic screening for the drug tacrolimus to its personalize medicine pharmacogenomics program PREDICT. The new drug screening protocol was added following data that shows a single genetic variation largely impacts different dose requirements for patients.

27 Aug 2013

FDA grants Priority Review designation to sNDA for Nexavar tablets

Bayer HealthCare and Onyx Pharmaceuticals today announced that the U.S. Food and Drug Administration has granted Priority Review designation to the supplemental New Drug Application for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer.

27 Aug 2013

New method for checking medicines for elemental impurities

For the first time in more than 100 years, drug and dietary supplement manufacturers are updating the tests used to ensure that their products contain safe levels of metal impurities, and the stringent new requirements, instruments and costs are the topic of the cover story in the current edition of Chemical & Engineering News. C&EN is the weekly newsmagazine of the American Chemical Society, the world's largest scientific society.

27 Aug 2013

Cannabis affects addiction processes in adolescent brain

The nature of the teenage brain makes users of cannabis amongst this population particularly at risk of developing addictive behaviors and suffering other long-term negative effects, according to researchers at the University of Montreal and New York's Icahn School of Medicine at Mount Sinai.

27 Aug 2013

tDCS for 15 days improves sleep and fatigue symptoms in patients with PPS

Of the 15 million people around the world who have survived poliomyelitis, up to 80% report progressive deteriorating strength and endurance many years after infection, a condition known as post-polio syndrome (PPS).

27 Aug 2013

Unique computer technology opens up discovery of smarter drugs to treat illnesses

A unique computer technology that opens up the discovery of smarter drugs to treat major illnesses including heart disease has been invented by University of Strathclyde scientists.

27 Aug 2013

Powerful new option for treating vasculitis

In a study published in the New England Journal of Medicine, a research consortium that includes the University of Alabama at Birmingham (UAB) has shown that a new drug for vasculitis, a potentially life-threatening auto-immune disease which causes inflammation in blood vessels, is as effective as standard therapy over 18 months.

27 Aug 2013