Navigation Links
REMICADE® Receives FDA Approval as First Biologic Treatment for Pediatric Ulcerative Colitis
Date:9/23/2011

174; 5 mg/kg induced clinical response in 73 percent of patients at week 8 and demonstrated a safety profile consistent with previous clinical trials conducted in an adult population.  

"Today's approval of REMICADE® is significant for children and their families who are affected by this devastating disease and are seeking an effective treatment option," said Rob Bazemore, President, Janssen Biotech, Inc.  "We are proud of our heritage in the continued pursuit of expanding treatment options for patients living with immune-mediated inflammatory diseases like IBD."

REMICADE® was designated orphan drug status by the FDA on November 12, 2003, and the supplemental Biologics License Applications (sBLA) for pediatric UC received priority review following its submission to the FDA in December 2010. The FDA's Gastrointestinal Drugs Advisory Committee (GIDAC) recommended the approval of REMICADE® in pediatric patients with UC.

On September 1, 2011, Janssen Inc. announced Health Canada approved REMICADE® for the treatment of pediatric patients (age six to 17 years) with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

About the Study

The Phase 3 randomized, multicenter, open-label trial was designed to evaluate the efficacy of a 3-dose REMICADE® regimen in inducing clinical response in pediatric patients with moderately to severely active UC and to evaluate the safety of REMICADE® during induction and maintenance treatment.  A total of 60 patients, aged 6-17, with a median disease duration of 1.4 years were included in the study.  Patients had a median Mayo score of 8.0, and median Pediatric Ulcerative Colitis Activity Index (PUCAI) score of 55.  All pat
'/>"/>

SOURCE Janssen Biotech, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. New Anti-TNF Study Shows Patients With Rheumatoid Arthritis Receiving REMICADE® After Inadequate Response to Enbrel® or Humira® Demonstrate Marked Clinical Improvement
2. Centocor Ortho Biotech Inc. Submits Application to FDA Seeking REMICADE® Pediatric Ulcerative Colitis Indication
3. FDA Advisory Committee Recommends Approval of REMICADE® for Treatment of Pediatric Ulcerative Colitis
4. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
5. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
6. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
7. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
8. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
9. CryoCor Receives FDA Approval for Right Atrial Flutter
10. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
11. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)...  ProteinSimple announced today that it has launched a ... allows users to detect all proteins separated in the ... can analyze proteins without the need for an antibody.  ... analysis as we know it today. First, the Simple Western ... messy gels, no transfer tanks, no blots, no imaging ...
(Date:7/28/2014)... and LONDON , July 28, 2014 ... to create and commercialize companion diagnostic using genomic data ...  for non-small cell lung cancer patients  New ... test and is planned to run on Rotor-Gene Q, member of ... enabled by AstraZeneca master framework agreement adds to QIAGEN,s ...
(Date:7/28/2014)... England , July 28, 2014 ... is investing £2.5 million to help it meet ... consumer goods, healthcare, pharmaceuticals and logistics. Albion joins ... ) Over the past 18 ... in its platform, its management team and its ...
Breaking Medicine Technology:ProteinSimple Says "Never Run a Gel Again!" 2QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients 2QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients 3QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients 4QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients 5QIAGEN and AstraZeneca Collaborate to Develop Liquid Biopsy-Based Companion Diagnostic to Advance EGFR Mutation Profiling in Lung Cancer Patients 6OmPrompt Funded for Customer Automation Management Market Expansion 2
... WOODLANDS, Texas, Dec. 5 Lexicon,Pharmaceuticals, Inc. (Nasdaq: ... in a Phase 2a clinical trial with LX6171, ... impairment associated with disorders such as,Alzheimer,s disease, schizophrenia, ... will assess the bioavailability of a new oral-suspension,formulation ...
... ulcerative colitis patients, AVENTURA, Fla., Dec. 5 ... that Asacol, an oral, non-steroidal medication that belongs,to ... (5-ASAs), is an,effective and well-tolerated treatment for patients ... proctitis. The results showed,that patients with isolated proctitis ...
Cached Medicine Technology:Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive Disorders 2Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive Disorders 3Lexicon Initiates Phase 2a Trial of LX6171 Drug Candidate for Cognitive Disorders 4Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis 2Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis 3Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis 4Study Data Show Asacol(R) (Mesalamine) is Effective in Treating All Extents of Ulcerative Colitis Including Isolated Proctitis 5
(Date:7/28/2014)... July 28, 2014 Humility of Mary Health ... 20 at St. Elizabeth Boardman Health Center, 8401 Market St., ... provides information about more than 200 common health problems as ... preventing illness and injury, and advice on when to seek ... a.m. to noon, the evening session runs from 5:30 to ...
(Date:7/28/2014)... 2014 For those with dust allergies, home ... dust allergies—commonly settle in mattresses, bedding, and upholstered furniture and ... mites are microscopic insects that feed on the dead skin ... to keep a million dust mites fat and happy. When ... microscope, the decaying bodies and feces of dust mites can ...
(Date:7/28/2014)... July 28, 2014 Scientists in Japan ... an improved blood test for the asbestos cancer mesothelioma. ... new research. Click here to read it now. ... at Tokyo’s Juntendo University Graduate School of Medicine say ... is a step above the old test. , ...
(Date:7/28/2014)... 2014 Maternal and Family Health Services ... which will be presented at the agency’s 43rd Annual ... at the Westmoreland Club in Wilkes-Barre. , The late ... long-time employee of MFHS. She dedicated her life ... health advocate, and champion for women, children and families ...
(Date:7/28/2014)... new study has found that following a healthy lifestyle ... metabolic syndrome. Published early online in CANCER , ... findings indicate that children with cancer and adults who ... about how their lifestyle may influence their long-term health. ... known to be at increased risk for the metabolic ...
Breaking Medicine News(10 mins):Health News:HMHP Offers ‘Health at Home’ Workshop 2Health News:AllergyEasy® Announces No-shots Immunotherapy to Mitigate Dust Allergies 2Health News:AllergyEasy® Announces No-shots Immunotherapy to Mitigate Dust Allergies 3Health News:Test Results Look Promising for New Mesothelioma Blood Test, According to Surviving Mesothelioma 2Health News:MFHS Seeking Nominations for Rose Allan Tucker Award 2Health News:Lifestyle choices may affect the long-term heart health of childhood cancer survivors 2
... Pa., Jan. 15 Today marked the launch ... http://www.nabita.org ). NaBITA,s mission: The National Behavioral ... education, development and support to professionals in schools ... to make their campuses and workplaces safer through ...
... 15 Eli Lilly and Company,(NYSE: ... resolution with the United,States Attorney for the Eastern ... Litigation of the Department of Justice regarding the,previously-reported ... promotional practices for the antipsychotic medication,Zyprexa(R) (olanzapine). , ...
... of the revolutionary MyFluVaccine program launches new website as it ... ... (Vocus) January 15, 2009 -- FFF Enterprises, the nation’s largest ... critical-care biopharmaceuticals announced today the unveiling of its new and ...
... Valley Hospital chooses IVANS LIME, impressed with quick turnaround time and ... ... 15, 2009 -- IVANS , the leading provider of corporate ... choosing high-speed Internet technology over dial-up to access Medicare as they ...
... January 15 Essilor,International announced today that its ... share purchase agreement whereby it has offered to ... of ophthalmic lenses. The,agreement is subject to certain ... Signet Armorlite,s main host,countries. The acquisition is expected ...
... great friend to The Brain Tumor Foundation lost his battle ... surrounded by his family.David fought his illness with courage and ... website, 38lemon.com , he shared his personal battle and ... cancer. So named because of his diagnosis of a ...
Cached Medicine News:Health News:Preventing the Next Virginia Tech -- The National Behavioral Intervention Team Association Launched Today 2Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 2Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 3Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 4Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 5Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 6Health News:Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices 7Health News:FFF Enterprises Launches New MyFluVaccine Website 2Health News:FFF Enterprises Launches New MyFluVaccine Website 3Health News:Healthcare Providers Choosing IVANS High-Speed Technology to Succeed Within Medicare Modernization Era 2Health News:Healthcare Providers Choosing IVANS High-Speed Technology to Succeed Within Medicare Modernization Era 3Health News:Essilor Agrees to Acquire Signet Armorlite 2
Shahinian lachrymal cannula, blunt tapered with side port....
Shahinian lacrimal cannula, bullet shaped tip, 0.3 mm side opening, straight....
Button Tip Manipulator, 0.50 mm diameter button tip, angled 45 degrees, 15 mm from tip to bend....
Round serrated handle, polished finish, overall length 130 mm....
Medicine Products: