Colitis in Medical Technology

Procter & Gamble Pharmaceuticals Launches Asacol(R) HD (mesalamine) Delayed-Release Tablets

... for the treatment of moderately active ulcerative colitis (UC), a form of inflammatory bowel disease. UC ... in ASCEND II. (1,2) About Ulcerative colitis (UC) UC involves inflammation of the lining ... or Asacol HD therapy. Acute exacerbation of colitis symptoms can also occur. Caution should be ...

Prometheus Announces New Findings Regarding Patients at Risk for Celiac Disease at DDW

... vs. non-IBD and Crohn's disease vs. ulcerative colitis than using traditional cutoff value analysis of ... difference between Crohn's disease and ulcerative colitis is the location and nature of the inflammation. ... the symptoms of Crohn's disease and ulcerative colitis are so similar, it is sometimes difficult to ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... of inflammatory diseases, including ulcerative colitis in an ongoing companion Phase 2 study." ... also being explored as a treatment for ulcerative colitis (UC). A Phase 2 randomized, double-blind, ... ascertained by endoscopy. Ulcerative colitis is a chronic inflammatory bowel disease ...

ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance

... of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and ... with Vancocin Capsules for pseudomembranous colitis caused by C. difficile. It is noteworthy that ... of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and ...

Takeda Initiates Two Phase III Studies with Vedolizumab (MLN0002) in Patients with Inflammatory Bowel Disease

... to Investigate Novel Therapy for Ulcerative colitis and Crohn's Disease OSAKA, Japan, Jan. 22 ... study vedolizumab for the treatment of ulcerative colitis and Crohn's disease, the two main types of IBD. ... Failure of current medical therapy for ulcerative colitis and Crohn's disease frequently leads to surgical ...

Ardea Biosciences Presents Preclinical Data on RDEA119 Demonstrating Favorable Anti-Inflammatory Profile for Potential Use in Ulcerative Colitis

... bowel disease, including ulcerative colitis and Crohn's disease. RDEA119 was shown to reduce ... murine trinitrobenzene sulfonic acid (TNBS) colitis model and murine dextran sulfate sodium (DSS) colitis model. The beneficial effect observed equaled or ...

New Analysis Shows Efficacy of REMICADE(R) in Treatment of Ulcerative Colitis in Patients with Recent Disease Onset or Long-Standing Disease

... Data from a new analysis of the Active Ulcerative colitis Trials (ACT 1 and ACT 2) showed that at week ... with moderately to severely active ulcerative colitis (UC) receiving REMICADE(R) (infliximab) ... each disease duration subgroup. Ulcerative colitis is a chronic inflammatory disease of the colon ...

Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis

... CXCL10 (also known as IP-10), in ulcerative colitis (UC) and rheumatoid arthritis (RA). MDX-1100 ... of inflammatory diseases such as ulcerative colitis and rheumatoid arthritis. About MDX-1100 ... About Ulcerative Colitis Ulcerative colitis (UC) is a chronic inflammatory bowel disease of ...

Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis

... reinforce the benefits of Asacol for ulcerative colitis patients AVENTURA, Fla., Dec. 5 /PRNewswire/ -- ... for patients with all extents of ulcerative colitis (UC), including isolated proctitis. The results ... These data were presented today at the Crohn's & colitis Foundation of America's (CCFA) National Research ...

New Analyses of Long-Term LIALDA(TM) (mesalamine) Data Presented at ACG

... Daily LIALDA for Mild vs. Moderate Ulcerative colitis Poster Presentation: Tuesday, October 16, 2007, ... (117/166) of patients with mild ulcerative colitis and 64.2 percent (183/285) of patients with moderate ulcerative colitis were in remission at 12 months. LIALDA for ...

New One-Year Data from REMICADE(R) SONIC Trial Show Sustained Efficacy Compared with Azathioprine in Treatment of Crohn's Disease

... (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and ... mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE and azathioprine or 6-mercaptopurine. ...

New Genes Found for Inflammatory Bowel Disease in Children

... The study team also found an association between ulcerative colitis and genes on the major histocompatiblity complex (MHC) on chromosome 6. ... Institutes of Health, the IBD Family Research Council, the Crohn's and colitis Foundation of America, the Koss Foundation, the NIH General Clinical ...

Cerimon Pharmaceuticals Initiates Phase II Study to Evaluate Simulect(R) (Basiliximab) for Noninfectious Uveitis

... study for patients with moderate-to-severe, steroid-refractory ulcerative colitis (UC) in April 2007. "The initiation of this proof-of-concept study is ... for the treatment of moderate-to-severe, steroid-refractory ulcerative colitis the following year. In December 2007, Cerimon entered into an agreement ...

Analysis of Ulcerative Colitis (UC) Time to Symptom Resolution Data from Pivotal Study of LIALDA(TM) (mesalamine) Presented at DDW

... a study (study 302) of Shire plc's (LSE: SHP, Nasdaq: SHPGY) ulcerative colitis (UC) drug, LIALDA(TM), will be presented today at Digestive Disease Week ... in this class to be approved since 2000. LIALDA is the only ulcerative colitis treatment that utilizes MMX(R) Technology. LIALDA with MMX Technology ...

New Analysis of Study Data Shows That Asacol(R) (Mesalamine) Delivers Rapid Symptom Relief for Ulcerative Colitis Patients

... symptom relief in patients with mildly to moderately active ulcerative colitis (UC). The analysis was based on data pooled from the ASCEND I and II ... and moderately active UC was 26 days (95% CI 24, 33). About Ulcerative colitis (UC) UC involves inflammation of the lining of the colon and rectum. ...

PROTECT-1 Phase II/III Induction-Stage Results for ChemoCentryx's Traficet-EN(TM) Presented in Oral Session at DDW 2009 Conference

... tract. The trafficking of T cells to the small and large intestine causes persistent inflammation that may result in Crohn's disease or ulcerative colitis - the two principal forms of IBD. In preclinical studies, the compound worked both therapeutically and prophylactically in models of Crohn's disease ...

Shire Presented Results of a New Database Analysis on Lialda(R) (Mesalamine) and Other 5-ASAs for Ulcerative Colitis at Digestive Disease Week

... the refill. Lialda is an FDA-approved, once-daily oral medication for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC). Safety and effectiveness of Lialda beyond eight weeks have not been established. "Patients who have UC often face adherence challenges, ...

Scientific Data Relating to Cinryze(TM) Presented at 6th Annual C1 Inhibitor Deficiency Workshop

... Vancocin(R) (vancomycin hydrochloride capsules, USP), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus , including methicillin-resistant strains, and Cinryze(TM) (C1 ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

... arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular ...

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

... arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular ...

ViroPharma Announces Discontinuation of Maribavir Phase 3 Study in Liver Transplant Patients

... Vancocin(R) (vancomycin hydrochloride capsules, USP), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus , including methicillin-resistant strains, and Cinryze(TM) (C1 ...

FDA Grants Priority Review of a Supplemental Biologics License Application for Cinryze(TM) C1 Inhibitor (Human) as Treatment for Acute Attacks of Hereditary Angioedema (HAE)

... Vancocin(R) (vancomycin hydrochloride capsules, USP), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus , including methicillin-resistant strains, and Cinryze(TM) (C1 ...

ViroPharma Announces Presentation of Cinryze(TM) Data in Acute Treatment of Hereditary Angioedema

... Vancocin(R) (vancomycin hydrochloride capsules, USP), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, and Cinryze(TM) (C1 ...

New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients

... and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular ...

ViroPharma Incorporated Completes Acquisition of Lev Pharmaceuticals

... Vancocin(R) (vancomycin hydrochloride capsules, USP), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains, and Cinryze (C1 inhibitor ...

Ardea Biosciences Presents Preclinical Anti-Inflammatory Data on its Lead MEK Inhibitor, RDEA119, at the ACG 2008 Annual Meeting

... that a poster entitled "RDEA119, a Potent and Highly Selective MEK1/2 Inhibitor is Beneficial in Dextran Sulfate Sodium (DSS) -- induced Chronic colitis in Mice," was presented at the American College of Gastroenterology (ACG) 2008 Annual Meeting in Orlando, Florida. The poster, which provided data ...

New Findings Show Efficacy of REMICADE(R) Compared With Azathioprine in Treatment of Crohn's Disease According to First-of-its Kind Study

... broad clinical utility in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC), pediatric Crohn's disease (PCD) and psoriasis (PsO). The safety and efficacy of REMICADE have been well established in clinical trials over ...

Cerimon Pharmaceuticals Announces Positive Results from a Phase II Clinical Study of Its Diclofenac Sodium Patch for Acute Pain

... has completed a Phase IIb study evaluating Simulect(R) (basiliximab) for the treatment of moderate-to-severe, steroid-refractory ulcerative colitis (UC) and expects data shortly. Cerimon is also evaluating Simulect in a Phase II study in individuals with noninfectious uveitis. Furthermore, based ...

Ardea Biosciences to Present Data on Lead MEK Inhibitor, RDEA119, at American College of Gastroenterology Annual Scientific Meeting

... a Potent and Highly Selective MEK1 / 2 Inhibitor is Beneficial in Dextran Sulfate Sodium (DSS)-Induced Chronic colitis in Mice" Poster Number: P1050 Session Title: Inflammatory Bowel Disease Location: Florida Exhibit Halls About Ardea Biosciences, Inc. Ardea ...

Medarex Highlights Strength in Antibody Development and Underlying Pipeline Strategy at R&D Day Event in New York City

... a breakthrough mechanism of action for inflammatory disease and is being investigated in separate Phase 2 proof-of-concept trials for ulcerative colitis and rheumatoid arthritis. Interim data from these trials are expected in 2009. -- MDX-1401 is a fully human antibody that targets CD30, a member ...

Current Concepts in Clostridium difficile Infection: A Focus on Recurrent Disease

... difficile infection (CDI) is a serious condition that causes disease with a wide spectrum of severity, ranging from mild diarrhea to pseudomembranous colitis and death. Recurrent CDI can occur in up to 20% of patients who develop an initial case of CDI.(1) These patients are at increased risk of ...

ChemoCentryx Completes Enrollment of PROTECT-1, a Phase II/III Clinical Trial of CCR9 Antagonist CCX282-B (Traficet-EN(TM)) in Crohn's Disease

... tract. The trafficking of T cells to the small and large intestine causes persistent inflammation that may result in Crohn's disease or ulcerative colitis - the two principal forms of IBD. In preclinical studies, the compound worked both therapeutically and prophylactically in models of Crohn's disease ...

Preliminary Data from Ongoing Phase 1 Data of Investigational Anti-PD-1 Antibody Presented at American Society of Clinical Oncology Annual Meeting

... that responded to oral corticosteroid treatment. Of the 11 patients that were eligible for re-treatment, one patient with ocular melanoma developed colitis 3 weeks after receiving a fifth dose of 1 mg/kg (over 9 months), and is improving with medical treatment of this immune- related adverse event ...

Wyeth Receives Approvable Letter from FDA for TYGACIL for the Treatment of Patients with Community-Acquired Pneumonia

... has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis -- Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective -- The use of TYGACIL during ...

ViroPharma Announces Completion of Enrollment in Phase 3 Study of Maribavir in Stem Cell Transplant Patients

... in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing ...

Safety and Efficacy Results Presented From Largest Prospective Controlled Clinical Study of Ulcerative Colitis

... demonstrated efficacy in secondary endpoints: clinical remission, rectal bleeding, stool frequency and sigmoidoscopy improvement. About Ulcerative colitis (UC) UC involves inflammation of the lining of the colon and rectum. It varies in clinical severity with patients having mild, moderate or ...

PEGASYS(R)/COPEGUS(R) Show Benefit in Hard-to-Treat Latino Population with Hepatitis C

... arthritis and interstitial nephritis), pulmonary disorders (dyspnea, pneumonia, bronchiolitis obliterans, interstitial pneumonitis and sarcoidosis), colitis (ulcerative and hemorrhagic/ischemic colitis), pancreatitis, and ophthalmologic disorders (decrease or loss of vision, retinopathy including macular ...

More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL

... has been reported with use of nearly all antibacterial agents, including TYGACIL, and may range in severity from mild diarrhea to fatal colitis -- Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective -- The use of TYGACIL during ...

ViroPharma Announces Discontinuation of HCV-796 Development

... in hospital settings. ViroPharma commercializes Vancocin(R) approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains (for prescribing ...

ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008

... in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin- resistant strains (for prescribing ...