fail in Medical Technology

Dramatic JUPITER Findings Fail to Sway Prescribing Behavior, Poll Shows

Results reveal most respondents against expanding statin use broadly in wake of AHA-presented data LITTLE FALLS, N.J., Nov. 25 /PRNewswire/ -- JUPITER, a clinical trial suggesting rosuvastatin may lower the cardiovascular risk of healthy patients with elevated CRP, should not prompt univ...

Clinical Studies of OvaRex in Advanced Ovarian Cancer Fail to Meet Primary Endpoint

Preliminary Analysis Demonstrates Studies Failed to Reach Statistical Significance SILVER SPRING, Md. and WELLESLEY HILLS, Mass., Dec. 5 /PRNewswire- FirstCall/ -- United Therapeutics Corporation (Nasdaq: UTHR ) and its wholly- owned subsidiary, Unither Pharmaceu...

Relievant Medsystems Announces Completion of $20 Million Financing

...ion in our health care system. Every year, 12 million new patients seek treatment for back pain. Unfortunately, nearly two million of these patients fail to respond to conservative treatment. These patients have few choices - escalating use of pain medications, continued suffering or invasive surgery. ...

Mayo Clinic Proceedings Reviews Deep Brain Stimulation to Treat Psychiatric Diseases

...rsons. Medications and psychiatric therapy can effectively treat many patients with major depression; however, up to 20 percent of these patients fail to respond to these non-surgical therapeutic interventions. "DBS is not a miracle cure and should not be used to treat all depression," says Dr....

Spherix Announces Positive Phase 2 Study Results

... from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of Naturlose, the FDA may i...

Neurocrine Biosciences Presents Elagolix Data

...mpany faces with respect to the Company's GnRH program include, but are not limited to, risk that the Company's elagolix Phase II clinical trials will fail to demonstrate that elagolix is safe and effective; risk that elagolix will not proceed to later stage clinical trials; risk associated with the Compa...

Data From Clinical Study of bioTheranostics Molecular Diagnostic Test Presented at American Society of Clinical Oncology Annual Meeting

...ent) provided by the THEROS CancerTYPE ID test were accurate based on the actual clinical diagnoses. In contrast, traditional diagnostic methods often fail to properly diagnose unknown cancers even after extensive work-up that could cost up to $18,000.(2) "Cancers of unknown primary origin present un...

Keryx Biopharmaceuticals Announces Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer

...ext steps should be considered." Ron Bentsur, Chief Executive Officer of Keryx, commented, "Patients with advanced metastatic colon cancer, who fail standard first and second line treatment, are truly in need of additional therapies. We are excited about the data as the combination of perifosine a...

Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer

... next steps should be considered." Ron Bentsur, Chief Executive Officer of Keryx, commented, "Patients with advanced metastatic colon cancer, who fail standard first and second line treatment, are truly in need of additional therapies. We are excited about the data as the combination of perifosine a...

Spherix Reports First Quarter 2009 Earnings

... from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of Naturlose, the FDA may i...

Spherix Elects New Independent Director, and Elects Chairman of the Board

... from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of Naturlose, the FDA may i...

ADVENTRX Announces Results From ANX-514 Bioequivalence Study

... clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; difficulties or delays in obtaining regulatory approval for ANX-514, including validating commercial manufacturers and supplie...

Fovea Reports Positive Results with Prednisporin(TM) in Persistent Allergic Conjunctivitis

... a chronic inflammatory background (persistent allergic conjunctivitis). As current therapies do not address the underlying chronic inflammation, they fail to treat such a disease effectively. Significant opportunities exist for novel products in the ocular allergy market. Fovea is now preparing pi...

Elusys' Anthrax Anti-Toxin, Anthim(TM), Enters Second Phase I Clinical Study

...rorism emergency." Currently antibiotics represent the only therapeutic option for anthrax infection. Antibiotics target the bacteria, but can still fail to prevent death from the damaging effects of anthrax toxins. In addition, antibiotic resistant strains of anthrax could be used in a bioterror attac...

Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

...mpany faces with respect to the Company's GnRH program include, but are not limited to, risk that the Company's elagolix Phase II clinical trials will fail to demonstrate that elagolix is safe and effective; risk that elagolix will not proceed to later stage clinical trials; risk associated with the Compa...

ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance

...by ViroPharma as a trade secret. If this inactive ingredient is not present in generic versions of Vancocin, ViroPharma believes those products would fail OGD's proposed Q1Q2 standard. ViroPharma's comments to the December 2008 draft bioequivalence guidance can be found on FDA's website at http:/...

Quest Diagnostics ClariSure(TM) Postnatal Molecular Test Receives Clinical Laboratory Approval from New York State

...ical conditions, including mental retardation, birth defects, and autism spectrum and developmental disorders, which conventional laboratory tests may fail to detect. "With approval by New York State, our advanced ClariSure test has demonstrated that it fulfills test validation requirements widely r...

Healthpoint Initiates Phase II, Dose-Finding Study to Evaluate Effectiveness of a Unique Cell Based Therapy in Venous Leg Ulcers

...s can be characterized as difficult to heal and are typically caused by impaired microcirculation secondary to venous hypertension. Many venous ulcers fail to heal even after 3 months of standard treatment and develop into chronic, non-responsive wounds. Based on an estimated figure of 2.5 million venous ...

FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C

...with undetectable virus at week 12 have a better chance for success and can be motivated to continue treatment," Schiff added, "and those patients who fail to achieve an early response can have their therapy stopped with confidence, thus avoiding unnecessary treatment and potential adverse events." T...

Spherix Postpones 2009 Annual Shareholders Meeting to Share Interim Diabetes Clinical Trial Data

... from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of Naturlose, the FDA may i...

For Old or Young Dialysis Patients, AV Fistulas Remain Pure Gold

...ed access at any age," said Andrew R. Forauer, M.D., an interventional radiologist at Dartmouth-Hitchcock Medical Center in Lebanon, N.H. When kidneys fail -- called chronic kidney or end-stage renal disease -- treatment in the form of regular dialysis (or hemodialysis) is needed to replace the kidney's j...

Scientists Discover Why Teeth Form in a Single Row

... turn genes on or off. "Knocking out" (deleting) the Osr2 gene resulted in cleft palate, a birth defect where the two halves of the roof of the mouth fail to join up properly, leaving a gap. Secondly, and surprisingly, the Osr2 "knockout" mice developed teeth outside of the normal tooth row. Jiang decide...

ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study

... clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; the risk that ADVENTRX's stockholders will not approve a strategic or capital-raising transaction recommended by ADVENTRX's Bo...

St. Jude Finds More Than 100 Gene Variations Linked With Response to Leukemia Treatment

...variance has been unexplained. The newly discovered genetic variations, however, will likely give scientists a clearer understanding of why treatments fail in some patients with ALL, and how to predict early in treatment which children could be successfully treated with less aggressive treatment. "Th...

Arzerra(TM) (ofatumumab) Demonstrates High Response Rates in Patients With Fludarabine Refractory Chronic Lymphocytic Leukemia (CLL)

.... 2006 Sep 19;145(6):435-47. (3) Tam CS, O'Brien S, et al. The natural history of fludarabine-refractory chronic lymphocytic leukemia patients who fail alemtuzumab or have bulky lymphadenopathy. Leukemia and Lymphoma 2007;48(10):1931-1939 (4) Hagenbeek A, Gadeberg O, et al. First clinical use of o...

Topical Treatment for Cold Sores Achieves Efficacy of Oral Drugs; Represents Paradigm Shift in the Treatment of Skin Infections

...o oral systemic drugs, according to the NanoBio scientists. Topical treatments are widely considered inferior to oral systemic treatments because they fail to penetrate to the site of infection with adequate drug levels required to subdue infections. In the study of 482 patients, NB-001 healed lesions 1...

Mindset Media Study Reveals Which Independent Voters Favor Obama Vs. McCain

...atism 5 -- 36 percent more likely to be an Optimism 5 -- 29 percent more likely to be a Diligence 1 Highly optimistic people (Optimism 5's) never fail to look on the bright side of things, no matter how bleak the current situation. Those scoring high in Dogmatism (Dogmatism 5's) honor tradition, ac...

Thermogard XP(TM) Studies to Be Presented at American Society of Anesthesiologists Annual Meeting

...erious complications including wound infections, blood loss, cardiac arrhythmias and heart damage. Most methods of patient re-warming are imprecise, fail to warm the patient quickly enough or are not practical due to the type of surgery. The Alsius IVTM system is ideal for these circumstances since it d...

Insmed Initiates Clinical Study for Follow-on Biologic Version of Neulasta(R)

...y from those anticipated by the forward-looking statements. The risks and uncertainties include, without limitation, risks that product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the ...

Surveyed Oncologists Say That the Most Promising Targeted Therapy in Adjuvant Clinical Trials is Avastin for the Treatment of Early-Stage Colorectal Cancer

...National Cancer Institute guidelines, patients who fail Sutent could benefit from Nexavar. However, four of the MCOs that fail to cover Tykerb and six of the MCOs that fail to cover Nexavar cite the ability to negotiate a m...

Helix Receives Approval to Open Sites in Germany for its Ongoing Clinical Trial With Topical Interferon Alpha-2b in Patients With Ano-Genital Warts

... of the drug; the need for additional studies and clinical trials, the occurrence and success of which cannot be assured; the risk that many new drugs fail in later studies and clinical trials; the risk of unexpected side effects; product liability and insurance risks; research & development risks; the ri...

Cadence Pharmaceuticals Updates Omigard(TM) Clinical Timeline

... clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; clinical trial data for Omigard may demonstrate inadequate therapeutic efficacy, or the prevalence or severity of adverse side...

Most Cancer Treatment Studies Aren't Published, Study Finds

...several reasons why registered trials may not be published. Some trials may fail to meet recruitment or follow-up goals. If the trial is completed and the r...here is a need for a new venue for publishing all well-executed trials that fail to meet positive endpoints: 'negative' in a sense, but valuable nonetheless...

Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis

...mpany faces with respect to the Company's GnRH program include, but are not limited to, risk that the Company's elagolix Phase II clinical trials will fail to demonstrate that elagolix is safe and effective; risk that elagolix will not proceed to later stage clinical trials; risk associated with the Compa...

M. D. Anderson to Initiate Clinical Validation Study on Rosetta Genomics' MicroRNA-based Diagnostic Assay Identifying the Origin of Cancer Metastases

...typically diagnosed with CUP only after undergoing a wide range of tests, including various imaging tests such as x-ray, CT, MRI, and PET, which often fail to identify the origin of the cancer. Presently, the choice of treatment for metastatic cancer is largely dependent on the nature of the primary tum...

Alzheimer's Foundation of America Survey: Americans With Memory Concerns Fall Short of Talking to Doctors

... NEW YORK, July 30 /PRNewswire-USNewswire/ -- An overwhelming number of Americans with memory concerns fail to report this health issue with their doctors despite visits within the past six months, according to results released today of a survey of participa...

Insmed CEO to Present at Congressional Briefing on Follow-On Biologics

...tatements. The risks and uncertainties include, without limitation, risks that strategic alternatives may never be consummated, product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the ...

Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company

...tatements. The risks and uncertainties include, without limitation, risks that strategic alternatives may never be consummated, product candidates may fail in the clinic or may not be successfully marketed or manufactured, we may lack financial resources to complete development of product candidates, the ...

Task Force Recommends Screening for Hearing Loss in All Newborns

...commends screening using a two-step screening process that includes otoacoustic emissions followed by auditory brainstem response in those infants who fail the first test. Otoacoustic emissions check the inner ear response to sound and are measured by placing a very sensitive microphone in the ear canal t...

Neurocrine Biosciences Completes 'Petal Study' Treatment Phase for Endometriosis

...mpany faces with respect to the Company's GnRH program include, but are not limited to, risk that the Company's elagolix Phase II clinical trials will fail to demonstrate that elagolix is safe and effective; risk that elagolix will not proceed to later stage clinical trials; risk associated with the Compa...