Tag: "approval" at medical news

Texas A&M, ECOR sign deal to produce health-related proteins

...various stages of research and clinical trials for approval to one day treat ailments ranging from cancer to cystic fibrosis. ProCANE's chief operating officer, Joseph Jilka, said the company's current focus is on raising sufficient start-up funds and assembling a research and development staff to collaborat...

Testing may one day pinpoint which early-stage cancer patients are at risk for relapse

...ear. Before physicians can utilize such tests, FDA approval is required. The Agency's approval will likely require a prospective study, with data obtained from patients deemed "relapse-free" for ...

UCLA researchers release profile of proposition 36-eligible drug offenders

...eir release may also receive treatment. Upon voter approval of Proposition 36 in 2000, the governor's office designated the Department of Alcohol and Drug Programs to serve as the lead agency in implementing and evaluating SACPA. The department chose UCLA Integrated Substance Abuse Programs to conduct the ind...

OneWorld Health begins final testing of drug to cure deadly kala azar in India

...etion of the trial, the goal is to seek regulatory approval of the drug for VL, particularly in India, which h...by the disease. Paromomycin should gain regulatory approval in India by 2005, making it a valuable tool to eliminate the disease from the Indian subcontinent. A...

Studies could lead to next-generation cancer drugs

...eyers Squibb's drug Taxol received conditional FDA approval for use in the treatment of metastatic ovarian cancer. Much of that time, scientists were struggling not only to understand and maximize the therapeutic effects of paclitaxel, but also to figure out how to make it in a cost-effective manner and an e...

Experts meet to challenge approaches of testing and developing cancer treatments

...upport a single clinical trial as a basis for drug approval and use of advanced modeling and simulation techniques in drug development approval. To underscore the Centers championship of better dose finding in drug development, CDDS recently published a study that showed more than 20% of the drugs approved i...

Exanta - pivitol data from largest ever phase III stroke prevention trial announced at ACC

...ined data aim to form the basis for the FDA and EU approval application for EXANTA in this indication, which is on track for the fourth quarter of this year. "We are very pleased to see the potential for Exanta in stroke prevention among patients with atrial fibrillation demonstrated in the SPORTIF III study....

Drug reduces deaths and hospital stays in heart attack patients with heart failure

...on after a heart attack comes on top of its recent approval by the Food and Drug Administration to treat high ...anted defibrillators that are being considered for approval by the Centers for Medicare and Medicaid Services for heart failure treatment under Medicare. Epler...

Emory scientists present alternative for surgical biventricular resynchronization

...system, the Medtronic InSync device, following FDA approval at the ECLH Carlyle Fraser Heart Center in Atlanta in 2001. In all, more than 800 of these devices have been implanted in patients with CHF at Emory Hospitals - more than any other medical center in the world....

Common heart surgery potentially dangerous

...body while the heart is stopped. Since protamine's approval in the early 1960s, no drug has been approved by the Food and Drug Administration (FDA) to reverse the properties of heparin. "Without protamine to effectively reverse the properties of heparin, bypass surgery would not have reached the successful po...

California chemist wins national award for drug discoveries

...n, still holds the FDA record for the fastest drug approval ever: 42 days. "With Dr. Reider at the helm, [Merck's] process research was completed under remarkable pressure: there was a desperate need to rush drug to patients; the doses were about 100 times those for most chronic therapies; and once a patient ...

Vaccine shortage study exposes nations 'patchwork' system

...ar for children under age 2 in mid-2000, after its approval by the Food and Drug Administration that year. The Prevnar shortage began in 2001, and may continue through 2003, due to high demand and manufacturing problems. In September, 2001, the shortage led the CDC to alter its recommended vaccination schedu...

Newly approved psoriasis drug invented and tested at Univ. of Michigan

...rsity of Michigan Health System today welcomed the approval by the U.S. Food and Drug Administration of a psoriasis treatment that was first developed in a U-M Medical School laboratory. Alefacept, a specially designed molecule that blocks a specific immune-system reaction involved in the painful skin condit...

Device acts as heart's security system

...t sites could lead to Food and Drug Administration approval of the device in the next two to three years. At least 50 people are being enrolled in the Ohio State arm of the study. Almost 5 million Americans suffer from heart failure, and it is the most common cause of hospitalization for older people. Be...

New Parkinsons drug found effective

...proval. Rasagiline is now in the last stage of the approval process with a decision expected later this year. Teva Pharmaceuticals will then market the new drug. Research participants were randomized in the double-blind, placebo-controlled study. Participants were given 1 or 2 milligrams a day for one week,...

Georgia Tech researchers developing biomechanic device to grow arteries for bypass surgery patients

... by clinical trials. The team hopes to receive FDA approval and bring the product to market within five years or less. The work recently caught the attention of the Wallace H. Coulter Foundation, which will award Vito with the 2002 Coulter Award for Innovation and Entrepreneurship on Nov. 1. The award recogn...

Drug beats sleep?

...lans to submit data from this and other trials for approval for such use to the US Food and Drug Administration (FDA) this year. But critics fear that this could lead to the use of Provigil being extended from those with sleep disorders to healthy people who are simply sleep-deprived. While experts differ as...

The Lancet Oncology (TLO)

...ronic myeloid leukaemia, for which it received FDA approval last year. It has also recently been granted FDA approval for the treatment of GISTs. Other reviews: Antisense therapy -- the time of truth Radiation-induced ...

EXANTA (TM), an oral direct thrombin inhibitor, significantly reduces risk of VTE in major OS

... the first Oral DTI to be submitted for regulatory approval and works by inhibiting thrombin, a key enzyme involved in the blood clotting (coagulation) process. AstraZeneca submitted a filing for a European licence for EXANTA (ximelagatran/melagatran) in prevention of VTE following major orthopaedic surgery ...

Hope for patients with advanced bowel cancer

... that the US Food and Drug Administration gave its approval in August this year for oxaliplatin to be given to patients with advanced colorectal cancer that had progressed following first-line treatment. In Europe, however, oxaliplatin has been available since 1996. The drug is manufactured by Sanofi-Synthe...

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(Date:10/20/2014)... Pittsburgh, PA (PRWEB) October 20, 2014 ... new, minimally-invasive procedure that enables physicians to repair a ... , The MitraClip system, developed by ... regurgitation (MR), a progressive and life-threatening condition in which ... allowing blood to flow backward from the heart’s left ...
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