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Investigational, orally-inhaled therapy effective in treating migraines

A new study conducted at the Jefferson Headache Center at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania shows an investigational, orally-inhaled therapy is effective in treating migraines.

12 Aug 2009

Researchers respond to concerns about international insulin drug trial

Accumulating safety data from the large, international ORIGIN trial have been reviewed by its independent data monitoring committee, who have concluded that there is no cause for concern.

12 Aug 2009

Endocyte announces results from study of EC145 in patients with advanced non-small cell lung cancer

Results were presented at the 13th World Conference on Lung Cancer in San Francisco. The single arm Phase II study evaluated the therapeutic agent EC145 and the molecular imaging agent EC20 in 42 patients with advanced adenocarcinoma of the lung. Forty percent of patients involved in the clinical trial had already failed at least four chemotherapy regimens prior to enrollment in the study.

12 Aug 2009

Britain's first swine flu vaccine trials start

Britain's first swine flu vaccine trials, led by the University of Leicester and University Hospitals of Leicester NHS Trust, are taking place at the Leicester Royal Infirmary.

11 Aug 2009

New type of anti-clotting drug called Apixaban

The dean of the University of Oklahoma College of Public Health and a team of scientists worldwide have found a better way to prevent deadly blood clots after joint replacement surgery - a major problem that results in thousands of unnecessary deaths each year. The research appears this week in the New England Journal of Medicine.

11 Aug 2009

$Denosumab reduces fracture risk in men receiving androgen-deprivation therapy for prostate cancer$

Denosumab reduces fracture risk in men receiving androgen-deprivation therapy for prostate cancer

Twice-yearly treatment with denosumab, a new targeted therapy to stop bone loss, increased bone density and prevented spinal fractures in men receiving androgen-deprivation therapy for prostate cancer.

11 Aug 2009

Knopp Neurosciences to present phase 2 results of drug candidate in amyotrophic lateral sclerosis

Knopp Neurosciences Inc. said the results of a Phase 2 safety and tolerability study of KNS-760704 in amyotrophic lateral sclerosis (ALS) will be presented at the 20th International Symposium on ALS/MND in Berlin on December 9, 2009.

11 Aug 2009

Gene Signal publishes phase I data on GS-101 for diseases of the eye

Gene Signal, a company focused on developing innovative drugs to manage angiogenesis based conditions, has announced publication of data from a phase I study demonstrating that the antisense oligonucleotide GS-101 (eye drops) is safe, with no signs of intolerability following administration to healthy volunteers.

11 Aug 2009

Depomed reports promising results in phase I trial for DM-1992 in Parkinson’s

Depomed, Inc. (NASDAQ:DEPO) today announced that in its Phase 1 pharmacokinetic study in Parkinson’s patients, DM-1992, Depomed’s investigative novel gastric retentive extended-release formulation of levodopa/carbidopa, extended coverage above levodopa’s efficacious threshold and extended the time to peak levodopa concentration relative to currently available sustained release levodopa/carbidopa formulations.

11 Aug 2009

Additional trial to be conducted for KYNAPID under FDA special protocol agreement

Cardiome Pharma Corp. (NASDAQ: CRME/TSX: COM) and its co-development partner Astellas Pharma US, Inc. ("Astellas") announced today that Astellas will undertake a single confirmatory additional Phase 3 clinical trial of KYNAPID(TM) (vernakalant hydrochloride) Injection for rapid conversion of atrial fibrillation to sinus rhythm. The trial, to be called ACT 5, is expected to begin enrolling patients by the end of 2009, with completion expected in the first half of 2011.

11 Aug 2009

Eiger Biopharmaceuticals starts CLEAN-1 HCV phase 1B trial

Eiger BioPharmaceuticals, Inc., a biotechnology company developing antiviral therapies, announced today that the first patients have been dosed in an innovative clinical trial in patients chronically infected with the hepatitis C virus (HCV). The trial, run in centers in Australia and New Zealand, will investigate the antiviral effect of clemizole monotherapy in the absence of interferon.

10 Aug 2009

Nanoviricides anti-herpes drug candidate reduces viral load by 99.99%

NanoViricides, Inc. (OTC BB: NNVC.OB) (the "Company"), has announced that the herpes simplex viral load was reduced by 99.99% or 10,000 fold in in-vitro studies by nanoviricides™ drug candidates.

10 Aug 2009

Cost-effectiveness of Cetuximab in metastatic colorectal cancer

From a health-care system perspective, it may be more efficient to use the drug cetuximab only in colorectal cancer patients whose tumors have a wild-type KRAS gene, according to a study published online August 7 in the Journal of the National Cancer Institute.

9 Aug 2009

Bellicum Pharmaceuticals starts phase I/II trial of novel advanced prostate cancer vaccine

Bellicum Pharmaceuticals, Inc. today announced dosing of the first patient in a Phase I/II clinical trial of BP-GMAX-CD1, a novel pharmacologically regulated dendritic cell vaccine for the treatment of prostate cancer. The disease-specific trial is being conducted under a Bellicum Investigational New Drug application allowed by the FDA in 2008. The company anticipates reporting initial results of the study in 2010.

6 Aug 2009

Phase 1 clinical trial starts for new antibody aimed at hepatitis C virus

Building upon a series of successful preclinical studies, researchers at MassBiologics of the University of Massachusetts Medical School (UMMS) today announced the beginning of a Phase 1 clinical trial, testing the safety and activity of a human monoclonal antibody they developed that can neutralize the Hepatitis C virus (HCV).

6 Aug 2009

Baxter completes production of batches of CELVAPAN A/H1N1 pandemic vaccine

Baxter International Inc. (NYSE: BAX) today announced that it completed production of its first commercial batches of CELVAPAN A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations. CELVAPAN, the brand name for the company’s A/H1N1 pandemic influenza vaccine, is made using Baxter’s proprietary Vero cell culture technology.

From Baxter International Inc. 5 Aug 2009

Clinical trial to test gene therapy for Alzheimer’s disease

Researchers at the Shiley-Marcos Alzheimer's Disease Research Center at the University of California San Diego are about to launch a Phase 2 clinical trial to test a gene therapy treatment for Alzheimer’s disease (AD) called CERE-110.

4 Aug 2009

Accelerating the development of new cancer drugs

A phase I clinical trial enrolled its first patient only two days after U.S. Food and Drug Administration clearance of the experimental drug for a first-in-human cancer trial, a milestone that normally takes three to six months. Investigators from The University of Texas M. D. Anderson Cancer Center and pharmaceutical company AstraZeneca have reported their work in the Journal of Clinical Oncology published online on August 3rd.

4 Aug 2009

Women and minorities under-represented in trials

Enrollment demographics published in many U.S. vascular surgery randomized control trials (RCTs) under-represent women as well as race or ethnic minorities, according to a new study published in the Society for Vascular Surgery’s August 2009 issue of the Journal of Vascular Surgery.

4 Aug 2009

Metformin associated with reduced risk of pancreatic cancer in diabetics

The antidiabetic medication metformin is associated with a reduced risk of pancreatic cancer in diabetics, according to a new study in Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute. However, other commonly used therapies, such as insulin or insulin secretagogues, may be associated with increased risk for the deadly disease.

3 Aug 2009