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News From The Annals Of Internal Medicine

Trial of Two Drugs Finds One Better at Suppressing Hepatitis B VirusA 52-week, randomized trial involving 135 people with chronic hepatitis B virus (HBV) compared an older drug adefovir dipivoxil and a newer drug, telbivudine. Researchers found that telbivudine was better at suppressing blood virus levels than adefovir.

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Posted in Clinical Trials / Drug Trials on Oct 2nd, 2007, 5:00 am     

Orexo Shows Positive Results In Completed Comparative Phase III Profile Study Of The Sublinox Sleep Aid Involving Insomnia Patients

Orexo has completed a pharmocological profile study for Sublinox? (OX22) - for treatment of temporary sleeping disturbances. The study shows that Sublinox? (OX22) acts 30 percent faster than Ambien® as a sleep aid for patients suffering from sleep disturbances. The study also shows that patients remain asleep throughout the night and strengthens existing documentation that Sublinox? (OX22) represents a safe and effective treatment for temporary insomnia.

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Posted in Clinical Trials / Drug Trials on Oct 2nd, 2007, 5:00 am     

New Treatment For Stroke Works Up To A Day After Symptoms Start

People treated with the drug minocycline within six to 24 hours after a stroke had significantly fewer disabilities, according to a study published in the October 2, 2007, issue of Neurology®, the medical journal of the American Academy of Neurology. Researchers say minocycline may be an alternative treatment for stroke because current treatments only work during the first few hours after the onset of symptoms, and many people don’t get to the hospital in time to be treated.

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Posted in Clinical Trials / Drug Trials on Oct 2nd, 2007, 2:00 am     

Pharmasset Commences Dosing In Phase 3 Registration Studies Of Clevudine For HBV

Pharmasset, Inc. (Nasdaq: VRUS) has commenced dosing in Phase 3 registration clinical trials of clevudine for the treatment of chronic hepatitis B virus (HBV) infection. Clevudine is an oral, once-daily pyrimidine nucleoside analog that has previously been evaluated in 14 clinical trials in more than 800 individuals.

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Posted in Clinical Trials / Drug Trials on Oct 2nd, 2007, 2:00 am     

Ardea Biosciences’ Lead MEK Inhibitor, RDEA119, To Enter Human Clinical Trials In Advanced Cancer Patients

Ardea Biosciences, Inc. (Pink Sheets: ARDC), a company focused on the discovery and development of small-molecule therapeutics for the treatment of viral diseases, cancer and inflammatory diseases, announced that the U.S. Food and Drug Administration (FDA) granted safe-to-proceed status to the Investigational New Drug (IND) application for RDEA119, enabling initiation of a Phase 1 clinical trial in advanced cancer patients.

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Posted in Clinical Trials / Drug Trials on Oct 2nd, 2007, 2:00 am     

Nastech Pharmaceutical Company Announces Initiation Of Phase 2 Clinical Trial For PYY3 36 Nasal Spray To Treat Obesity

Nastech Pharmaceutical Company Inc. (Nasdaq: NSTK) announced the start of a Phase 2 clinical trial evaluating the Company’s PYY3-36 Nasal Spray in obese patients. The study will enroll approximately 500 obese patients for a six-month, randomized, placebo-controlled dose ranging study with weight loss as the primary endpoint.

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Posted in Clinical Trials / Drug Trials on Oct 2nd, 2007, 2:00 am     

HHS OIG Report Cites Problems With FDA Oversight Of Clinical Trials

FDA does not take adequate action to ensure the safety of millions of participants in clinical trials, according to a report from the HHS Office of Inspector General scheduled for release on Friday, the New York Times reports.

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Posted in Clinical Trials / Drug Trials on Oct 1st, 2007, 9:00 am     

HHS OIG Report Cites Problems With FDA Oversight Of Clinical Trials

FDA does not take adequate action to ensure the safety of millions of participants in clinical trials, according to a report from the HHS Office of Inspector General scheduled for release on Friday, the New York Times reports.

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Posted in Clinical Trials / Drug Trials on Oct 1st, 2007, 2:00 am     

Combined Prednisone And Mycophenolate Mofetil Treatment For Retroperitoneal Fibrosis

UroToday.com- Retroperitoneal fibrosis (RPF) is a condition characterized by inflammation and fibrosis in the retroperitoneal space. The disease process begins with the clinical symptoms of flank pain and unexplained weight loss. Radiologically fibrosis starts by surrounding the infrarenal aorta. It then progresses inferiorly and ultimately leads to ureteral obstruction and acute renal failure.

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Posted in Clinical Trials / Drug Trials on Sep 30th, 2007, 2:00 am     

Acute Lung Injury Patients One Third Less Likely To Die In “Closed” Model ICUs

Patients with acute lung injury (ALI) are nearly one third less likely to die if they are treated at ICUs that require board certified critical care physicians to oversee patient care, as compared to patients treated at ICUs that allow any attending physician to oversee admission and case management.ALI is an inflammatory disorder of the lung often seen in patients with pneumonia or sepsis. Mortality rates are high about 40 percent and worsen with age and co morbidities.

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Posted in Clinical Trials / Drug Trials on Sep 29th, 2007, 2:00 am     

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