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Lilly Advances Second Alzheimer's Disease Treatment Candidate Into Late-Stage Testing by Launching Two Global Trials

... announced it will begin enrolling patients this month in two separate but identical Phase III clinical trials of solanezumab(i), previously referred to as ... E imer's D isease I nvestiga TION s The EXPEDITION clinical trials are identical multicenter, randomized, double-blind, placebo-controlled trials. Patients ...

ISTA Pharmaceuticals Announces Phase III Results for Once-Daily Topical Xibrom(TM) 0.09%

... to evaluate Xibrom 0.09% dosed once daily to vehicle (placebo). The identical trials were performed under a common protocol and designated the East ... pain following cataract surgery. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. ...

Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market

... a biosimilar form of recombinant G-CSF known as Neukine. Neukine exhibits identical efficacy to the EU-approved reference product. Dr. Helmut Brunar, VP of ... as the reference, but the number of neutrophils also increased with identical kinetics after treatment. We are very pleased with these results." The ...

Why Do African-Americans Fare Worse With Cancer? Access and Economics Are Only Part of the Story

... first time, that African-American breast, ovarian, and prostate cancer patients tend to die earlier than patients of other races even when they get identical medical treatment and other confounding socioeconomic factors are controlled for. The finding points to biological or host genetic factors as the ...

Boston Scientific Welcomes Publication of HORIZONS AMI Trial Results in New England Journal of Medicine

... endpoint of ischemia-driven target lesion revascularization (TLR, or rate of re-intervention of the stented segment) compared to an otherwise identical bare-metal Express(R) Stent control. The primary safety measure showed no difference between the TAXUS Express Stent and the bare-metal Express ...

Bayer and Regeneron Extend Development Program for VEGF Trap-Eye to Include Central Retinal Vein Occlusion

... with CRVO. About the Phase 3 CRVO Program In the Phase 3 CRVO program for VEGF Trap-Eye, Regeneron and Bayer HealthCare will conduct two identical multinational clinical studies: COPERNICUS ( CO ntrolled P hase 3 E valuation of R epeated i N travitreal administration of VEGF Trap-Eye ...

Boston Scientific Submits Final Modules to FDA for Approval of Second-Generation Small Vessel and Long Lesion Stents

... and TAXUS Liberte Long Stents with Boston Scientific's first-generation TAXUS Express Stent. While the second-generation TAXUS Liberte Stent uses identical drug dose, polymer and release kinetics as the TAXUS Express Stent, it features thinner struts and a uniform architecture specifically designed for ...

Video: Femara(R) First Aromatase Inhibitor to Indicate Survival Benefit Versus Tamoxifen When Taken for Five Years After Breast Cancer Surgery

... a new invasive cancer in the contralateral breast; any second, non-breast cancer; or death without a prior cancer event, which is similar but not identical to the endpoint definitions used in other AI adjuvant trials. Other endpoints included time to breast cancer recurrence [including invasive ...

Research Highlights New Approaches to Prevent Blood Clots in Several High-Risk Patient Populations Including Largest Study Ever to Examine Use of Blood-Thinning Medication in Patients With Cancer

... embolism (1.6 percent versus 1.8 percent) were similar with both idrabiotaparinux and idraparinux. Levels of Factor Xa activity were identical in both treatment groups throughout the six-month study. Of the 52 idrabiotaparinux patients re-randomized to receive avadin or placebo, 41 were ...

Research Explores the Effects of Stem Cell Source and Patient Age on Stem Cell Transplantation Outcomes

... cells after the culture, with an average total nucleated cell fold increase of 660 (range 146 to 1496). A control group of 17 patients underwent an identical transplant regimen, but received two non-cultured cord blood units. A relatively rapid engraftment time, averaging 14 days, was observed in ...

Phase III Data Demonstrate Efficacy and Tolerability of Carisbamate as an Adjunctive Therapy for Partial Onset Seizures

... age and older, was presented today during the poster sessions of the 32nd Annual Meeting of the American Epilepsy Society. Results from two identical placebo-controlled clinical trials investigating the efficacy, safety and tolerability of carisbamate as an adjunctive treatment for patients with ...

A Window Into Parkinson's Disease

... causes the sensitive cells in the brain to die in the first place. Answering this question has been especially difficult because there are two nearly identical types of brain cells that produce dopamine and they are mixed together in the same brain regions. However, only one cell type is affected in ...

Pivotal Phase III Data Confirm the Efficacy and Safety of Arpida's Intravenous Iclaprim in Treating Patients With Complicated Skin and Skin Structure Infections

... of iclaprim in the treatment of patients with cSSSI known or suspected to be caused by Gram- positive pathogens. The trials were of essentially identical design, making a combined analysis of iclaprim possible in a larger population. A 95 percent confidence interval was used to determine ...

St. Jude Study Finds Treatment With New Drug Might Make Tumor Cells More Sensitive to Therapy

... that leads to irreparable, double-stranded DNA breaks. "We found that inhibition of ATM activity with CP466722 produces cellular effects that are identical to those seen in cells that lack ATM," Kastan said. "It's as if we temporarily turned normal cells into cells indistinguishable from those of ...

AFFiRiS: Milestone Reached in Clinical Trial of Alzheimer's Vaccine

... the company enables scientists to create both molecules with very specific binding characteristics and molecules that differ in structure but exhibit identical binding characteristics. These strengths are now being used in developing the AD01 and AD02 vaccines, both of which align the immune system against ...

Bad News to Bad Bugs: Northern Antibiotics Develops Novel Polymyxins With Reduced Toxicity

... NAB 739, the lead compound of the second series, acts directly against enteric bacteria. For E. coli (including ESBL-producing strains) the MIC90 is identical to that of polymyxin B. While NAB 739 is already alone highly active against multidrug-resistant strains of Acinetobacter baumannii, it also at very ...

Results Published in the Journal 'Cancer' Demonstrate that Oral Talactoferrin Alfa is Active as Monotherapy in Previously Treated Patients with Metastatic Renal Cell Carcinoma

... the Gut Associated Lymphoid Tissue (GALT), in infants. Talactoferrin is produced in Aspergillus niger, a filamentous fungus, and is structurally identical to native human lactoferrin in all material respects, differing only in its glycosylation. Talactoferrin is an orally administered protein that ...

The New England Journal of Medicine Publishes Study Investigating the Safety and Efficacy of Baxter's Cell-Based Pandemic, Avian Flu Vaccine

... from animals. Baxter's candidate avian flu vaccine is derived from the H5N1 strain A/Vietnam/1203/2004. Its antigen composition and structure are identical to the actual virus circulating in nature without the need to enhance an immune response by including adjuvants, additives that may cause ...

Novavax Announces Proprietary Method to Create SARS Vaccine and Renewal of NIH Funding for SARS Vaccine Development

... of SARS and other structural proteins that combine with cell membranes to form distinctive SARS coronavirus nanoparticles, which are nearly identical to the human SARS virus but lack the genetic material needed to replicate and cause disease." "This new approach to create VLPs will allow us to ...

BARC Announces Long-Term Cooperation In South African Biobanking for HIV Vaccine Trials

... rapid delivery of laboratory data. Worldwide testing is performed on equivalent instrumentation and integrated into a single global database with identical reference ranges and report. BARC South Africa Pty., Ltd., established in 1999, is the South African arm of BARC, The local head office is in ...

Tioga Pharmaceuticals' Asimadoline Demonstrates Positive Results in a Phase 2b Clinical Trial for the Treatment of Irritable Bowel Syndrome

... and A-IBS patients were recruited. Patients underwent a two-week screening, a 12-week treatment and a four-week follow-up period, and they received identical appearing placebo, 0.15 mg, 0.5 mg or 1.0 mg tablets of asimadoline twice daily for the treatment period. Throughout the trial, patients entered data ...

Diplomat Specialty Pharmacy Develops and Launches Best-In-Class Electronic Navigator (eNAV(TM)) Patient Care System

... C, Multiple Sclerosis, Rheumatoid Arthritis and Psoriasis. Other specialty areas include Transplant, Fertility, Dialysis Medication Management, Bio- identical Hormone Replacement Therapy and Specialty Compounding. The company's Health Services division specializes in disease management programs for Chronic ...

Dr. Calvin Grant Presents Results from Xibrom(TM) Combination Therapy with Lucentis(R) at the 2008 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO)

... cataract surgery. Xibrom was the fastest-growing ophthalmic product in 2007, according to IMS data. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the ...

EnVivo Pharmaceuticals Announces Initiation of Clinical Safety and Biomarker Study of Alpha-7 Nicotinic Agonist, EVP-6124, in Patients with Schizophrenia

... Schizophrenia. Mismatch negativity is assessed by the ability of the patient to detect a unique stimulus imbedded in a repetitive train of otherwise identical auditory stimuli. Assessments of the effects of EVP-6124 on the P50 evoked response and mismatch negativity may be very useful in determining the ...

ISTA Pharmaceuticals Announces Results of Clinical Trial of Xibrom(TM) QD (Once-Daily) Formulation

... following cataract surgery. Xibrom is the fastest growing ophthalmic product in 2007, according to IMS data. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the ...

PAREXEL Expands Global Clinical Pharmacology Capabilities

... Research Units in Berlin. With the recent expansion, the units now have 160 total beds. The two sites have dedicated medical teams that utilize identical equipment and systems to assure harmonized procedures and workflow. The units have sleep research capabilities and a sleep laboratory, as well as ...

SPIRIT II Explores Long-Term Performance of XIENCE V Stent

... (binary restenosis) within the stents (2.1 percent with the XIENCE V stent vs. 2.9 percent with the Taxus stent). In-stent late loss was virtually identical (0.33 mm vs. 0.34 mm, on average, respectively). Dr. Serruys will present the two-year results of the SPIRIT II study on Monday, March 31 at 8:45 ....

Oral Talactoferrin Alfa Improves Overall Survival in Patients With Refractory Non-Small Cell Lung Cancer: Final Phase 2 Study Results Presented at the 8th Annual Targeted Therapies for the Treatment Of Lung Cancer Meeting

... the Gut Associated Lymphoid Tissue (GALT), in infants. Talactoferrin is produced in Aspergillus niger, a filamentous fungus, and is structurally identical to native human lactoferrin in all material respects, differing only in its glycosylation. Talactoferrin is an orally administered protein that ...

ISTA Pharmaceuticals Announces Physician-Sponsored Clinical Study of Xibrom(TM) Combination Therapy with Lucentis(R)

... cataract surgery. Xibrom was the fastest-growing ophthalmic product in 2007, according to IMS data. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the ...

New 48-Week Efficacy and Safety Data Presented for INTELENCE(TM) (etravirine) as Part of HIV Combination Therapy

... have not been established in pediatric patients or in treatment-nave adult patients. DUET-1 and -2 Study Design The DUET-1 and -2 studies, identical in design but conducted in different regions, assessed the 24- and 48-week efficacy and safety of INTELENCE in combination with a BR in ...

IDM Pharma Announces Phase 3 Mifamurtide (L-MTP-PE) Study Demonstrating Improved Survival Published in the Journal of Clinical Oncology

... resectable osteosarcoma without metastatic disease. Patients received one of four prospectively randomized treatments and all patients received identical cumulative doses of cisplatin, doxorubicin, and methotrexate and underwent definitive surgical resection of primary tumor. Patients were randomly ...

ImpactRx Tracks Decline in Zetia and Vytorin Prescribing

... on the basis of the ENHANCE study alone'. Both medicines were generally well tolerated and the overall incidence rates of cardiac events were nearly identical between both treatment groups, it concluded. The College specifically noted, 'There should be no reason for patients to panic'," Kain continued, "but ...

Genzyme Corporation Selects Diplomat Specialty Pharmacy for 2008 Renagel Medicare Part D Assistance Program

... C, Multiple Sclerosis, Rheumatoid Arthritis and Psoriasis. Other specialty areas include Transplant, Fertility, Dialysis Medication Management, Bio- identical Hormone Replacement Therapy and Specialty Compounding. The company's Health Services division specializes in disease management programs for Chronic ...

Roche responds to announcement of 'IDEAL' hepatitis C trial results

... trial to determine if a lower dose of Peg-Intron (1.0 mcg/kg) was as effective as the approved dose of 1.5 mcg/kg, both in combination with identical ribavirin regimens. A third arm was added to the study in which patients received PEGASYS 180 mcg with a different ribavirin dosing schedule. This ...

Kibow Biotech Obtains Australian, Chinese and Indian Patents Protecting the Composition and Basic Technology Behind Its Oral Probiotic Formulation for Chronic Kidney Failure

... The serial numbers for this patent are: 20022342641 (Australia), ZL 02810078.6 (China) and 1029/MUMNP/2003, 205478 (India). Kibow Biotech has an identical PCT patent pending in Canada, the European Union, Japan, and South Korea. In addition, the term "Enteric Dialysis(TM)" has been recognized as ...

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

... MAb for the treatment of advanced ovarian cancer. Preliminary analysis demonstrates that the studies failed to reach statistical significance. The identical studies, known as IMPACT I and II (IMunotherapy Pivotal ovArian Cancer Trial), were randomized, double-blind, placebo-controlled trials conducted at ...

Two Major Studies Show: Human Pluripotent Stem Cells without Cloning or Destroying Embryo

... and pursue direct reprogramming instead. The power of direct reprogramming is that, like cloning, it generates stem cells that are genetically identical to the patient who donated the adult cells. Reprogrammed cells would not be rejected by the patient's immune system if used for medical therapies. ...

ISTA Pharmaceuticals Presents Results from Two Phase III Clinical Trials of Xibrom(TM) QD (Once-daily) Formulation at the American Academy of Ophthalmology Annual Meeting

... the second highest-prescribed topical NSAID by ophthalmologists on a dollar basis, according to IMS data. Xibrom, under a different trade name but identical formulation, was launched in Japan in 2000 by Senju Pharmaceuticals Co. Ltd. ISTA acquired U.S. marketing rights for Xibrom in 2002 and launched the ...

Positive Five-Year Safety Data for TAXUS(R) Stent Reported in Boston Scientific Trial

... of stent thrombosis for the BMS control group (0.0% vs. 0.2%, p=0.50), with a cumulative rate of stent thrombosis rate through five years being identical -- 2.5% for the TAXUS Stent and 2.5% for BMS (p=0.94). "With the recent reversal of the SCAAR study, positive results from the Ontario database and ...

New Data Reveal Topical Divigel(R) (estradiol gel) 0.1% Significantly Reduces Frequency and Severity of Hot Flashes

... Divigel(R) was approved by the U.S. Food and Drug Administration (FDA) in June 2007. The estrogen in Divigel(R) is derived from plant sources and is identical to the primary estrogen produced by a woman's ovaries before menopause. Divigel(R) is a quick-drying gel that is odorless when dry, and is available ...
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