Repeated in Medical Technology

American Academy Of Orthopaedic Surgeons 2009 Annual Meeting 'Highlights and Hot Topics'

... limited to bed rest and pain medication. repeated fractures often result, leading to stooped backs, ... in age. The presence of bone fractures from repeated stress offers insight into future bone health ... take place from bones being subjected to repeated stress, which happen in activities such as ...

Sports Legacy Institute Announces Findings of Forensic Examinations on Wrestler Chris Benoit's Brain

... has indicated there is a connection between the repeated head injuries suffered by many athletes involved ... determine if there was evidence of CTE caused by repeated trauma to the head sustained during Chris ... examinations of athletes who suffered from repeated head traumas, confirm the need for a large-scale ...

FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)

... at a dose of 15 mg/m2 via continuous IV infusion over three hours repeated every eight hours for three consecutive days per cycle. The cycle is repeated every six weeks. The alternative five-day dosing regimen of Dacogen(R) ...

Merz Pharmaceuticals Announce Three Studies of NT-201 - (Botulinum neurotoxin type A Free From Complexing Proteins)

... complexing proteins) in treatment-naive cervical dystonia patients, and repeated injections of NT-201 (Xeomin; botulinum neurotoxin type A free from ... vs 22.6%) for each group, respectively. Third Study - Title repeated injections of NT-201 (Xeomin(R); botulinum neurotoxin free from complexing ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... rank ANCOVA resulted in a P value of 0.005. A pre-specified repeated measures analysis of the primary endpoint was used to obtain a least ... course of the pirfenidone treatment effect. The results of an exploratory repeated measures analysis of ranked change from baseline, assessing treatment ...

Cardium Announces Completion of Patient Recruitment in Phase 2b Clinical Trial of Excellarate(TM) for the Potential Treatment of Diabetic Foot Ulcers

... to most diabetic wound healing agents or devices in use that require repeated administrations over a long term (weeks to months). (Logo: ... such as diabetics among others, for whom compliance with a regimen of repeated wound cleanings and product re-administrations can pose a major limitation ...

TARGETED GENE DELIVERY IN VIVO: Rexin-G Monotherapy Reveals Significant Biological Activity Without Toxicity in Chemo-Resistant Metastatic Breast Cancer (ASCO 2008)

... progressive chemo-resistant breast cancer. Once the general safety of repeated infusions of Rexin-G was documented, the FDA approved across the board ... was observed, even at the higher doses of Rexin-G, thus confirming that repeated infusions of Rexin-G are safe and well-tolerated. According to Dr. ...

Micromet Shows Feasibility of Subcutaneous Delivery of BiTE Antibody in Preclinical Primate Study

... MT103 (MEDI-538), was compared to subcutaneous administration by daily repeated bolus injection and continuous administration using mini-pumps, which are ... injection." Reference 1. Schlereth, B. et al. Feasibility of repeated Subcutaneous Delivery Establishes a New Route of Administration for ...

Trubion Pharmaceuticals Announces Presentation of Positive Data From Phase IIb and Re-treatment Studies With TRU-015 in Patients With Rheumatoid Arthritis

... to evaluate the safety, PD, PK and immunogenicity of TRU-015 for RA with repeated doses after receiving initial administration in a Phase I/IIa study. ... Ongoing patient evaluations showed maintenance of ACR responses with repeated single doses of TRU-015 at six-month intervals through at least two ...

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

... given by 30 minute intravenous infusion. This dose should be repeated once weekly for three weeks, followed by a one week rest period. This four ... given by 30 minute intravenous infusion. This dose should be repeated once weekly for up to 7 weeks, followed by a week of rest. Subsequent ...

Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

Study Shows Cancer Vaccines Led to Long-Term Survival for Patients with Metastatic Melanoma and to Long Periods of Disease Control After Completion of Therapy

... remarkable long-term, progression-free survival after completing the vaccine therapy, even though they had widely metastatic disease and/or repeated appearance of new metastases despite various therapies. The vaccine treatment was well-tolerated, with most patients experiencing mild skin ...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... potential problems that may arise in the clinical testing and approval process, including the risk that acceptable results in early trials may not be repeated in later trials, and Rigel's need for additional capital, as well as other risks detailed from time to time in Rigel's SEC reports, including its ...

R-Tech Ueno, Ltd. Completes Phase 1 Clinical Study on RK-023

... irradiation No adverse event occurred and the resulting irritation was negligible in each test. As the next step, single and 5-day repeated applications of RK-023 preparation to the scalp were conducted by a randomized, placebo-controlled, double blind method to evaluate the safety and ...

ADHD Genes Found; Known to Play Roles in Neurodevelopment

... or "snips," the alterations examined in the current study are broader changes in structure. Called copy number variations (CNVs), they are missing or repeated stretches of DNA. CNVs have recently been found to play significant roles in many diseases, including autism and schizophrenia Everyone has CNVs in ...

Pharmasset to Present at Goldman Sachs and Needham Healthcare Conferences

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

... endpoint was the change from baseline in CGI-S over the six-week study period. Efficacy data were statistically analyzed using a mixed model for repeated measures. Multiple safety assessments were done, including vital signs, weight, ECGs, movement disorder scales (SAS, BAS, AIMS), and laboratory ...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

Pharmaxis Announces Milestone in Phase III Trial for Cystic Fibrosis

... is designed to hydrate the airway surface of the lungs, and promote normal lung mucus clearance in order to improve lung function, break the cycle of repeated respiratory infections and blockages, and improve quality of life for patients with CF. Approximately 75,000 people in the major pharmaceutical ...

Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

U.S. Food and Drug Administration Clears Way for Multi-Center Clinical Trial of IDEV Technologies' SUPERA Peripheral Stent

... to the product's novel interwoven design, which adds strength without compromising flexibility. SUPERA also withstood more than 10,000,000 cycles of repeated bending - 120 degree flexion and compression loading fatigue testing, without a fracture. "We believe SUPERA may prove to be a more durable ...

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

... to flow into the vein, thus providing access for dialysis. The increased blood flow makes the vein grow larger and stronger so it can be used for repeated needle insertions. This vascular access provides an efficient way for blood to be carried from one's body to the dialyzer and back without causing ...

Studies Show Combination Laser Therapy Effective At Clearing Acne, Reducing Oil Production

... skin is suctioned to remove oil, some patients complained that their pores actually appeared larger - possibly from the skin being stretched from the repeated suctioning. The other device approved by the FDA for the treatment of acne is the 1550nm fractionated laser, which thermally burns tiny ...

Drug Development Program Started Based on CAP(R) Human Cell Line

... express glycosylated proteins. The rhuAP produced in CAP(R) cells is expected to feature improved pharmacokinetic and safety profile allowing for repeated dosing of alkaline phosphatase in chronic diseases. Based on a the anti-inflammatory mechanism of action of alkaline phosphatase towards e.g. TNFa, ...

The Children's Hospital of Philadelphia: New Gene-Searching Method Uncovers Possible New Targets for Crohn's Disease Drugs

... study team performed the initial analysis in DNA from 1,758 patients with Crohn's disease and 1,480 control subjects, all of European ancestry. They repeated the study in three additional groups, of both European and African American ancestry, and were able to replicate their results. Their study was the ...

Oramed Pharmaceuticals Completes Proof of Concept Study of Insulin Suppository

... as a treatment alternative for injectable insulin. Such an alternative may be especially useful for individuals with immunological-based reactions to repeated injections and who require a temporary recess from daily injections. Suppositories are often used in pediatrics for the treatment ...

Heavy Marijuana Use May Damage Developing Brain in Teens, Young Adults

... drug dependence, rather than drug usage causing the brain abnormalities. "Further research should be done to investigate the relation between repeated marijuana use and white matter development," said Ashtari. "However, our work reinforces the idea that the adolescent brain may be especially ...

Cymbalta(R) Significantly Reduced Osteoarthritis Knee Pain in New Study

... mg. The primary efficacy endpoint of the study was the Brief Pain Inventory (BPI) 24-hour average pain rating, which was analyzed using a mixed-model repeated measures (MMRM) approach. Secondary outcomes included the BPI-Severity and Interference items, weekly mean of the 24-hour worst pain and average pain ...

Pharmasset Reports Fiscal Year End 2008 Financial Results

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

Pharmacyclics Announces Completion of Phase 1 Clinical Trial of Factor VIIa Inhibitor PCI-27483

... error) peak INR of 2.72 (+/- 0.24) was achieved one to two hours post-dosing. The trial further established doses of PCI-27483, which upon repeated dosing are expected to maintain the INR in the range of 2.0 to 3.0, the target window for treatment and prevention of thromboembolic events (i.e., ...

Medarex Announces Initiation of Phase 1b Clinical Development Program with MDX-1106 for the Treatment of Cancer

... of certain chronic viral infections. The Phase 1b clinical trial is designed to primarily evaluate the safety and tolerability of repeated dosing of MDX-1106 in adult patients with solid tumors and will also provide a preliminary assessment of the anti-tumor activity of multiple doses of ...

Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

Richard E.T. Smith, Ph.D. Joins Pharmasset as Vice President of Investor Relations and Corporate Communications

... our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not ...

Xalieve(TM) Gains Momentum as Calabar AB Launches a Phase II Repeated Dose Study in Dry Mouth Patients

... GOTEBORG, Sweden, October 2 /PRNewswire/ -- Calabar AB announced today that their Phase II repeated dose study in xerostomia ("dry mouth") patients has been initiated. Specifically, the drug will be studied in 45 dry mouth patients between the ages ...

American Heart Association Scientific Statement: Heart Patients Should Be Screened, Treated for Depression

... of the American Heart Association. The recommendations, which are endorsed by the American Psychiatric Association, include: -- early and repeated screening for depression in heart patients; -- the use of two questions to screen patients -- if depression is suspected the remaining ...

Forest Laboratories, Inc. and Gedeon Richter Plc Announce Positive Phase II Results with the Investigational Antipsychotic Cariprazine in Patients with Acute Mania Associated with Bipolar I Disorder

... vs. -8.9 placebo, p < 0.0001) by the LOCF analysis. Statistically significant improvement in the YMRS scale was also noted in the mixed model repeated measure (MMRM) analysis (-15.5 cariprazine vs. -8.5 placebo, p < 0.0001) and the observed-cases (OC) analysis (-19.1 cariprazine vs. -13.6 placebo, p ...

Debiopharm Moves Towards a New 6-Month Formulation of Decapeptyl(R) to Further Help Prostate Cancer Patients

... below castrate level (defined as < 1.735 nmol/L or 50 ng/dL) from week 8 to 48. These efficacy results are similar to those obtained previously with repeated administrations of the 1- and 3-month formulations of triptorelin. About Decapeptyl(R) Triptorelin was licensed-in from Tulane University in ....

New Studies Highlight Benefits of Coblation(R)-Assisted Procedures in Airway Fire Prevention and Endoscopic Sinus Surgery

... surgery in oxygen-enriched environments. All experimental conditions were tested for four minutes, or until a positive result was achieved and were repeated in another model to ensure accuracy. "Intraoperative fires are a well-described and devastating complication of oropharyngeal and airway surgery, ...

Successful Results for Mymetics Corporation's Mucosal HIV/AIDS Vaccine Viral Challenge Significantly Exceeds Expectations

... of the toxicology studies on animals, the company expects to initiate Phase I Human Clinical trials process in November 2008. "Considering the repeated failures in developing a sustainable AIDS vaccine as widely reported in the press, we are very excited with the outstanding preliminary results of ...