Clinical Trial News and Research

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AADR testifies at FDA Advisory Panel meeting on dental amalgam

On December 14-15, 2010, the U.S. Food and Drug Administration (FDA) convened an Advisory Panel to discuss several scientific issues that may affect the regulation of dental amalgam. At the conclusion of the hearing, the Panel voted to recommend that the FDA conduct further review of the material's safety.

23 Dec 2010

Medicago completes first part of H5N1 vaccine Phase II trial

Medicago, a biotechnology company focused on developing highly effective and affordable vaccines based on proprietary manufacturing technologies and Virus-Like Particles, today announced that the last dose of vaccine has been administered completing the first part of the Company's Phase II human clinical trial with its H5N1 Avian Influenza vaccine.

23 Dec 2010

Gilead stops ARTEMIS-IPF ambrisentan Phase III clinical trial in idiopathic pulmonary fibrosis

Gilead Sciences, Inc. today announced it is stopping ARTEMIS-IPF, the company's ongoing Phase III clinical trial of ambrisentan in patients with idiopathic pulmonary fibrosis (IPF), due to lack of efficacy. This decision follows an interim analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC) and review of those data by Gilead, which did not show evidence of a treatment benefit in the group of patients randomized to receive ambrisentan.

23 Dec 2010

New method predicts outcome of bleaching treatment for teeth

Researchers at the University of Granada have developed a new method for predicting the precise shade that a bleaching treatment will bring about for a patient's teeth.

23 Dec 2010

Enrollment begins in Phase 2 trial of RegeneRx’s RGN-259 in dry eye associated with graft vs. host disease

RegeneRx Biopharmaceuticals, Inc. announced today that the first patient has been screened and is being enrolled in a Phase 2 clinical trial testing the Company's drug candidate RGN-259 in patients with dry eye associated with graft vs. host disease. The double-blind, placebo-controlled, investigator-sponsored trial is expected to enroll a total of 20 patients over the next several months, with data reported later in 2011. RGN-259 is a sterile, preservative-free topical eye drop formulation of the novel therapeutic peptide Thymosin beta 4, or Tβ4.

23 Dec 2010

FDA approves Watson's novel oral contraceptive

Watson Pharmaceuticals today announced the U.S. Food and Drug Administration (FDA) approval of a novel oral contraceptive product – the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate (iron) placebo tablets. Taken orally, once daily, the product is proven effective in lowering the risk of pregnancy.

22 Dec 2010

People with high RBC folate levels more likely to have two tumor-suppressing genes

People with higher levels of folate in their red blood cells were more likely to have two tumor-suppressing genes shut down by methylation, a chemical off switch for genes, researchers report in the December issue of Cancer Prevention Research.

22 Dec 2010

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Tekmira Pharmaceuticals Corporation, a leading developer of RNA interference therapeutics, announced today it has initiated patient dosing in a Phase 1 human clinical trial for its lead oncology product, TKM-PLK1. TKM-PLK1 targets polo-like kinase 1, or PLK1, a cell cycle protein involved in tumor cell proliferation and a validated oncology target.

22 Dec 2010

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

Antares Pharma, today announced the filing of a New Drug Application with the U.S. Food and Drug Administration for Anturol Gel in patients with overactive bladder.

22 Dec 2010

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its supplemental new drug application (sNDA) for Acetadote® (acetylcysteine) Injection to treat patients with non-acetaminophen induced acute liver failure.

22 Dec 2010

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

Vertex Pharmaceuticals Incorporated today announced a modification of its Phase 2 clinical trial evaluating 12-week, response-guided regimens of its lead investigational hepatitis C virus (HCV) protease inhibitor, telaprevir, in combination with its lead investigational HCV polymerase inhibitor, VX-222.

22 Dec 2010

First implantation of Medtronic Transcatheter Aortic Valve Prosthesis in US performed at Mount Sinai

David H. Adams, MD, Marie-Jos-e and Henry R. Kravis Professor and Chairman of the Department of Cardiothoracic Surgery, Samin K. Sharma, MD, the Zena and Michael A. Weiner Professor and Director of the Cardiac Catheterization Laboratory, and Annapoorna S. Kini, MD, Associate Professor and Associate Director of the Cardiac Catheterization Laboratory at The Mount Sinai Medical Center, have performed the first implantation of the Medtronic CoreValve- Transcatheter Aortic Valve Prosthesis in the United States.

22 Dec 2010

Gold nanoparticles show great potential for tumour targeted drug delivery

The World Gold Council (WGC) is delighted with the successful phase 1 clinical trial of a unique nanomedicine that uses nanoparticles of gold as the core of a delivery system for tumour targeted drug delivery.

22 Dec 2010

U.S. pivotal clinical trial of Medtronic CoreValve begins

Medtronic, Inc. today announced the beginning of its Medtronic CoreValve® U.S. Pivotal clinical trial in the United States. The first CoreValve transcatheter aortic valve implantation (TAVI) procedure was performed by David H. Adams, M.D., and Samin K. Sharma, M.D., at The Mount Sinai Medical Center in New York City.

22 Dec 2010

Amorcyte reports AMR-001 phase I trial results in heart attack patients

The American Heart Journal today reported results of a clinical trial evaluating Amorcyte, lead product candidate, AMR-001 for the treatment of damaged heart muscle following acute myocardial infarction.

22 Dec 2010

El Camino announces first patient implant in Medtronic CoreValve clinical trial

El Camino Hospital today announced its first patient implant in the Medtronic CoreValve® U.S. Clinical Trial.

22 Dec 2010

Echinacea only offers modest benefit in common cold: study

In a large clinical trial involving more than 700 adults and children researchers showed that the popular herbal remedy Echinacea can cut only half a day from a week long common cold. Echinacea has been marketed for a long time for the common cold. Echinacea, also known as purple coneflower has been shown to have benefits in some earlier studies while some show no benefits.

21 Dec 2010

Biovest issues FAQ update on BiovaxID personalized cancer vaccine

Biovest International, Inc. today issued the following update in the form of a "Frequently Asked Questions" report in response to the high volume of inquiries received following the Company's recent presentation at the 2010 American Society of Hematology Annual Meeting (ASH 2010) in Orlando, Florida.

21 Dec 2010

Study aims to deliver safer bone marrow transplant treatment strategy in patients with multiple myeloma cancer

A national clinical trial, which opens imminently, will aim to assess the impact of a novel anti-cancer drug in the setting of donor bone marrow transplantation for myeloma.

21 Dec 2010

Emisphere, Novo Nordisk partner to develop and commercialize oral formulations of insulins

Emisphere Technologies, Inc. and Novo Nordisk A/S today announced that they have entered into an exclusive Development and License Agreement to develop and commercialize oral formulations of Novo Nordisk's insulins, which have the potential of treating diabetes, using Emisphere's Eligen® Technology. This is the second license agreement between the two companies. The first agreement, for the development of oral formulations of GLP-1 receptor agonists, was signed in June 2008, with a potential drug currently in a Phase I clinical trial.

21 Dec 2010

Clinical Trial News and Research

AADR testifies at FDA Advisory Panel meeting on dental amalgam

Medicago completes first part of H5N1 vaccine Phase II trial

Gilead stops ARTEMIS-IPF ambrisentan Phase III clinical trial in idiopathic pulmonary fibrosis

New method predicts outcome of bleaching treatment for teeth

Enrollment begins in Phase 2 trial of RegeneRx’s RGN-259 in dry eye associated with graft vs. host disease

FDA approves Watson's novel oral contraceptive

People with high RBC folate levels more likely to have two tumor-suppressing genes

Tekmira begins patient dosing in TKM-PLK1 phase 1 trail for cancer

Antares Pharma submits NDA for Anturol Gel in patients with overactive bladder

FDA issues CRL to Cumberland's Acetadote sNDA for non-acetaminophen acute liver failure

Vertex announces modification of telaprevir and VX-222 combination Phase 2 trial for treatment of HCV

First implantation of Medtronic Transcatheter Aortic Valve Prosthesis in US performed at Mount Sinai

Gold nanoparticles show great potential for tumour targeted drug delivery

U.S. pivotal clinical trial of Medtronic CoreValve begins

Amorcyte reports AMR-001 phase I trial results in heart attack patients

El Camino announces first patient implant in Medtronic CoreValve clinical trial

Echinacea only offers modest benefit in common cold: study

Biovest issues FAQ update on BiovaxID personalized cancer vaccine

Study aims to deliver safer bone marrow transplant treatment strategy in patients with multiple myeloma cancer

Emisphere, Novo Nordisk partner to develop and commercialize oral formulations of insulins

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