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Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced today that it received approval from the China State Food and Drug Administration (SFDA) to commence clinical trials for its proprietary inactivated EV71 vaccine against Hand, Foot and Mouth Disease (HFMD).

28 Dec 2010

HeartWare seeks FDA PMA approval for HeartWare Ventricular Assist System

HeartWare International, Inc. today announced that it has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the HeartWare® Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.

28 Dec 2010

Emergent initiates AV7909 Phase I trail for Anthrax vaccine

Emergent BioSolutions today announced the initiation of a Phase I clinical trial for NuThraxTM, also known as AV7909, with the dosing of the first subject.

27 Dec 2010

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Transition Therapeutics Inc. today announced that the Company and Elan Corporation, plc have mutually agreed to modify their collaboration agreement for the development and commercialization of ELND005.

27 Dec 2010

Vitamin D levels of newborns appear to predict their risk of respiratory infections

The vitamin D levels of newborn babies appear to predict their risk of respiratory infections during infancy and the occurrence of wheezing during early childhood, but not the risk of developing asthma. Results of a study in the January 2011 issue of Pediatrics support the theory that widespread vitamin D deficiency contributes to risk of infections.

27 Dec 2010

Promising initial data from STABLE clinical trial for endovascular treatment of Type B aortic dissection

Study investigators reported positive steps in Cook Medical's efforts to gain FDA approval of the treatment assessed in the STABLE clinical trial, designed to evaluate the safety and efficacy of a proximal endograft and a distal uncovered stent for the endovascular treatment of Type B aortic dissection for purposes of seeking FDA approval. The findings were presented by Dr. Joseph Lombardi at the 37th annual VEITHsymposium.

23 Dec 2010

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

Clinical Trial News and Research

Sinovac's inactivated EV71 vaccine clinical trial against HFMD receives Chinese SFDA approval

HeartWare seeks FDA PMA approval for HeartWare Ventricular Assist System

Emergent initiates AV7909 Phase I trail for Anthrax vaccine

Transition, Elan to modify collaboration agreement for development, commercialization of ELND005

Vitamin D levels of newborns appear to predict their risk of respiratory infections

Promising initial data from STABLE clinical trial for endovascular treatment of Type B aortic dissection

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

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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