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CoreValve prosthesis shows promise against severe aortic stenosis

Among individuals 65 years and older, as many as 30 percent have aortic valve sclerosis or stenosis and as a result of their deteriorating health, cannot enjoy a normal lifestyle. "The aortic valve is a gatekeeper," says Marco Costa, MD, of University Hospitals (UH) Case Medical in Cleveland.

From Medtronic 1 Oct 2011

Baxter seeks European marketing authorization for HyQ to treat PI

Baxter International Inc. announced today that it has submitted an application to the European Medicines Agency's Committee for Human Medicinal Products seeking marketing authorization for HyQ. HyQ is Baxter's investigational immunoglobulin (IG) therapy administered subcutaneously and facilitated by recombinant human hyaluronidase, a dispersion and permeation enhancer, for use in patients with primary immunodeficiencies.

From Baxter International Inc. 1 Oct 2011

JenaValve's transapical TAVI system receives CE mark approval to treat aortic valve stenosis

JenaValve Technology GmbH, a German medical device company specializing in the development of transcatheter heart valve implantation systems, announced today that the Company has received CE mark approval for its transapical TAVI system of the second-generation. This system is used to treat severe aortic valve stenosis in elderly high-risk patients, especially in patients for whom conventional open-heart surgery is not an option.

1 Oct 2011

Report on best practices in Phase IV clinical trials

Phase IV clinical research is growing rapidly, meaning expanding budgets for post-marketing research studies. And more of that work is being done by third parties and specialized vendors, according to a new study from Cutting Edge Information.

30 Sep 2011

ALK gene discovered by St. Jude scientists associated with FDA approved adult cancer drug

A drug recently approved by the U.S. Food and Drug Administration for treatment of an adult cancer targets a malfunctioning gene discovered more than a decade earlier at St. Jude Children's Research Hospital. The story highlights how scientific findings from St. Jude can be translated into therapies and tests that in addition to helping children, also help adults.

30 Sep 2011

Galectin posts new corporate video on galectin-inhibiting therapeutics to treat fibrosis and cancer

Galectin Therapeutics Inc. today announced that it posted a new corporate presentation video to its website, www.galectintherapeutics.com, that highlights the Company's leadership position in developing galectin-inhibiting therapeutics to treat fibrosis and cancer.

30 Sep 2011

Cincinnati Children's to conduct first medication clinical trial for pediatric migraine

Cincinnati Children's Hospital Medical Center has received a $12 million grant from the National Institutes of Health to conduct the first clinical trial to determine the medication of choice for preventing migraines in children and teens.

30 Sep 2011

Immunotherapeutics for treatment of metastatic melanoma

A new cancer research program at Loyola University Chicago Stritch School of Medicine will develop therapies designed to turn patients' own immune systems into potent weapons against cancer.

30 Sep 2011

Small Phase I trial shows HIV vaccine candidate is most powerful to date

Researchers at the Spanish Superior Scientific Research Council (CSIC) have successfully completed a small Phase I human clinical trial of an HIV vaccine candidate that granted 90 percent of 30 study participants an immunological response against the virus, Gizmag reports.

30 Sep 2011

Journal of Vascular Surgery publishes Atrium's COBEST Trial on aorto-iliac disease

Atrium Medical Corporation today announced the publication of the COBEST Trial by the Journal of Vascular Surgery. COBEST (Covered Versus Balloon Expandable Stent Trial) was an independent, landmark, prospective, multi center, randomized, controlled clinical trial that has demonstrated that Atrium's proprietary balloon expandable covered stent technology is superior to traditional bare metal stents for the treatment of aorto-iliac disease.

30 Sep 2011

FDA approves NeuRx Diaphragm Pacing System to treat ALS

An electronic system that stimulates the nerve of the diaphragm muscles has received approval from the Food and Drug Administration (FDA) for use in patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig's disease.

30 Sep 2011

Enrollment begins in Boston Scientific's vagal nerve stimulation trial for heart failure

Boston Scientific Corporation has enrolled the first patients in its NECTAR-HF (NEural Cardiac TherApy foR Heart Failure) clinical trial. NECTAR-HF is a prospective, randomized, international clinical feasibility study designed to assess preliminary safety and efficacy of chronic vagal nerve stimulation in heart failure patients.

30 Sep 2011

Circadian files IND with FDA for VGX-100 for the treatment of cancer patients with solid tumors

Circadian Technologies Limited (ASX: CIR, OTCQX:CKDXY) is extremely proud to announce that its 100% owned subsidiary, Vegenics Pty Ltd, has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate clinical studies of VGX-100. The first trial (Phase I) will involve the treatment of a variety of different cancer types in patients with late stage cancer.

29 Sep 2011

Powerful HIV vaccine being tested on humans

Spanish researchers have developed a prototype of a vaccine against the AIDS-causing HIV virus that is “much more powerful” than those made to date.

29 Sep 2011

Bulgaria’s decades old anti-smoking pill could be a cheap and effective answer to smoking cessation

A pill from Bulgaria during the Soviet era shows promise for helping millions of smokers cheaply and safely kick the habit, the first big clinical trial of it shows. It is unclear whether it will ever reach the market in the U.S. or Western Europe though.

29 Sep 2011

Stroke risk increases with even small rises in blood pressure

Small rises of blood pressure may greatly increase a person's risk of stroke, according to new research. The study review, published in the journal Neurology, analyzed the results of 12 studies on blood pressure and stroke incidences among a total of 518,520 adults.

29 Sep 2011

Oral tenofovir discontinued in HIV clinical trial

A large-scale clinical trial evaluating whether daily use of an oral tablet or vaginal gel containing antiretroviral drugs can prevent HIV infection in women is being modified because an interim review found that the study cannot show that one of the study products, oral tenofovir, marketed under the trade name Viread, is effective.

29 Sep 2011

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Otonomy, Inc., a clinical stage biopharmaceutical company developing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced that researchers presented positive new data from a Phase 1b study of the company's lead product candidate, OTO-104, in patients with Meniere's disease.

29 Sep 2011

Genetic variant may increase severity of coronary artery disease in patients with diabetes

Researchers at Washington University School of Medicine in St. Louis have identified the first genetic variant associated with severity of coronary artery disease in patients with type 2 diabetes.

29 Sep 2011

Cincinnati Children's to conduct first pediatric migraine medicine clinical trial

29 Sep 2011

Clinical Trial News and Research

CoreValve prosthesis shows promise against severe aortic stenosis

Baxter seeks European marketing authorization for HyQ to treat PI

JenaValve's transapical TAVI system receives CE mark approval to treat aortic valve stenosis

Report on best practices in Phase IV clinical trials

ALK gene discovered by St. Jude scientists associated with FDA approved adult cancer drug

Galectin posts new corporate video on galectin-inhibiting therapeutics to treat fibrosis and cancer

Cincinnati Children's to conduct first medication clinical trial for pediatric migraine

Immunotherapeutics for treatment of metastatic melanoma

Small Phase I trial shows HIV vaccine candidate is most powerful to date

Journal of Vascular Surgery publishes Atrium's COBEST Trial on aorto-iliac disease

FDA approves NeuRx Diaphragm Pacing System to treat ALS

Enrollment begins in Boston Scientific's vagal nerve stimulation trial for heart failure

Circadian files IND with FDA for VGX-100 for the treatment of cancer patients with solid tumors

Powerful HIV vaccine being tested on humans

Bulgaria’s decades old anti-smoking pill could be a cheap and effective answer to smoking cessation

Stroke risk increases with even small rises in blood pressure

Oral tenofovir discontinued in HIV clinical trial

Positive new data from Otonomy's OTO-104 Phase 1b study on Meniere's disease

Genetic variant may increase severity of coronary artery disease in patients with diabetes

Cincinnati Children's to conduct first pediatric migraine medicine clinical trial

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