Navigation Links
Takeda's New Investigational Drug Vedolizumab is Granted Priority Review Status by U.S. Food and Drug Administration for Ulcerative Colitis
Date:9/4/2013

60;

The BLA filings were supported by the GEMINI™ Studies, a four-study clinical program investigating vedolizumab in 2,700 patients in nearly 40 countries, making it the largest Phase 3 clinical trial program conducted to date simultaneously evaluating both CD and UC. Enrolled patients had failed at least one conventional therapy, including glucocorticoids, immunomodulators and/or a tumor necrosis factor-alpha (TNF-alpha) antagonists. TNF-alpha antagonist and conventional therapy failure patients included those with inadequate response (primary non-responders), loss of response (secondary non-responders) or those who were intolerant.

Phase 3 study results for vedolizumab were published recently in the New England Journal of Medicine.

About the GEMINI™ Studies
Announced in early 2009, the GEMINI™ Studies is a Phase 3 program evaluating the effect of vedolizumab on clinical response and remission (along with effect on mucosal healing in UC), and long-term safety in moderately to severely active CD and UC patients who had failed at least one conventional therapy or a TNF-alpha antagonist. The GEMINI program consists of four separate studies – a placebo-controlled induction and maintenance study in patients with UC (GEMINI I), a placebo-controlled induction and maintenance study in patients with CD (GEMINI II), a placebo-controlled induction study in patients with CD with prior TNF-alpha antagonist failure (GEMINI III) and an open-label long-term safety study in patients with either CD or UC (GEMINI LTS).

About Crohn's disease and ulcerative colitis
Crohn's disease (CD) and ulcerative colitis (UC) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the GI tract. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. UC impacts the large intestine
'/>"/>

SOURCE Takeda Pharmaceutical Company Limited
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine technology :

1. Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohns Disease
2. FDA Grants Orphan Drug Status To Eisais Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma
3. New Data for Abbotts Investigational High Sensitive Troponin Test Shows It May Help Doctors Predict Heart Attack Risk
4. Grifols Implements Its First Automated Inventory Management Carousel System for Investigational Pharmacies at Emory University
5. Signum Dermalogix Investigational New Drug (IND) Application Cleared by FDA: SIG990 a Potential Treatment for Rosacea
6. Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300
7. Phase III study finds investigational agent empagliflozin significantly reduced blood glucose in adults with type 2 diabetes and impaired kidney function
8. Phase III data show investigational compound empagliflozin significantly reduced blood glucose in adults with type 2 diabetes
9. Follow-up Phase II Data Analysis Adds to Body of Evidence for Investigational Novel Basal Insulin, LY2605541
10. Phase III data show significant reduction in blood glucose with investigational compound empagliflozin added to metformin or metformin plus sulfonylurea in adults with type 2 diabetes
11. Takeda Submits Biologics License Application for a New Investigational Drug Vedolizumab, in Moderately to Severely Active Crohns Disease and Ulcerative Colitis in the United States
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... 30, 2015  Astellas today announced topline results ... efficacy and safety of intravenous (IV) and oral ... development for adults with candidemia and other invasive ... demonstrated that the trial did not meet its ... in isavuconazole-treated patients at the end of IV ...
(Date:7/29/2015)... July 29, 2015 Insulet Corporation (NASDAQ: PODD ... its OmniPod ® Insulin Management System, today announced ... 30, 2015. The Company also announced that it will ... results and conference call from Thursday, July 30, as ... Revenue Highlights: , Preliminary second ...
(Date:7/29/2015)...  UBM Canon brings MEDevice San Diego Conference & ... on September 1-2, 2015, with a multi-track conference program ... Business Development track will be a panel on How ... featuring Renee Ryan , Vice President of Venture ... , Partner, Canaan Partners; and Jordan Kramer , ...
Breaking Medicine Technology:Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 2Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 3Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 4Astellas Provides Update on Phase 3 Study Evaluating Isavuconazole in Patients with Candidemia and Other Invasive Candida Infections 5Insulet Reports Preliminary Second Quarter 2015 Revenue Results 2Insulet Reports Preliminary Second Quarter 2015 Revenue Results 3Insulet Reports Preliminary Second Quarter 2015 Revenue Results 4Insulet Reports Preliminary Second Quarter 2015 Revenue Results 5MEDevice San Diego Offers Tips on Securing Financial Backing from Investors 2
... PXS; Nasdaq: PXSL) today announced that the company ... reached agreement on the phase 3,registration trial of ... The SPA process allows for FDA evaluation ... primary basis of an efficacy claim in support ...
... 19 The Australian company Fermiscan,who is using ... new breast cancer,screening test through the analysis of ... 69% in detecting breast cancer., (Photo: ... the Journal of the American Medical,Association(1) (US study), ...
Cached Medicine Technology:Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial 2Pharmaxis Concludes Special Protocol Assessment with FDA for Bronchitol Phase 3 Trial 3New Australian Technology: Detecting Breast Cancer With Hair 2New Australian Technology: Detecting Breast Cancer With Hair 3New Australian Technology: Detecting Breast Cancer With Hair 4
(Date:7/30/2015)... ... ... Bird B Gone, the leader in bird control products for commercial, industrial ... birds from the AC units and ventilation systems on hospital roofs. Bird droppings can ... Nile virus. When these droppings dry, the fine powder can be carried into hospitals ...
(Date:7/30/2015)... , ... July 30, 2015 , ... ... at multinational organizations and NGO’s, according to a new survey by leading international ... that property damage and employee medical expenses represented the largest sources of financial ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... After a ... Argus II retinal implant, more commonly known as the “bionic eye,” researchers have determined ... safe and viable tool for patients facing or already affected by complete vision loss ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... ... are living longer and do not find a complete removable denture acceptable. The ... of care. The practices that incorporate less expensive, immediate loading techniques will have ...
(Date:7/30/2015)... Orem, UT (PRWEB) , ... July 30, 2015 , ... When trying to gain weight, many people place a lot ... the amount of calories that need to be consumed. However, another key component to successful ... to gain weight. To assist with this, CB-1 Weight Gainer gives three tips on ...
Breaking Medicine News(10 mins):Health News:Bird B Gone’s New Bird Hazing System Keeps Disease-Carrying Bird Droppings Out of Hospitals 2Health News:New Clements Worldwide Global Risk Survey Shows Political Risk and Instability Top Managers' Concerns 2Health News:New Clements Worldwide Global Risk Survey Shows Political Risk and Instability Top Managers' Concerns 3Health News:The Vision Enhancing “Bionic Eye” Deemed Safe For Long Term Use After Three Year Clinical Trial 2Health News:Chicago Implant Dentist/Implantologist Dr. Irfan Atcha Speaks to Local Dentists about Advances in Dental Implants in August. 2Health News:Chicago Implant Dentist/Implantologist Dr. Irfan Atcha Speaks to Local Dentists about Advances in Dental Implants in August. 3Health News:CB-1 Weight Gainer Gives Three Tips on When to Eat to Gain Weight 2Health News:CB-1 Weight Gainer Gives Three Tips on When to Eat to Gain Weight 3
... fatty acids may be unwise for those with weakened immunity.,Researchers ... for many years now and know that one of their ... - rich in omega-3s - often benefit those with arthritis, ... response is a key component of the immune system in ...
... the September 11 terrorist acts in New York and ... put on hold for several days, which severely affected ... are shipped via air due to their specific nature. ... pharmaceuticals with a radioactive component, and are used in ...
... study of middle-aged women suggests that those who eat the ... wide variety of foods. The Healthy Eating Index (HEI) is ... quality of someone's diet. This emphasises your eating pattern rather ... ten for servings of grains, vegetables, fruit, milk or meat, ...
... The balance of fats and oils in your diet can ... degeneration (AMD) is a currently untreatable disease of the eye ... suggests, it gets worse with age and diet has been ... Massachusetts Eye and Ear Infirmary carried out a study of ...
... not help the sickest patients, according to the latest ... the alveoli - are progressively destroyed, leaving the patient ... activities like climbing stairs or carrying their shopping. In ... surgery was beneficial for people with emphysema. It appeared ...
... The Food and Drug Administration has few details about ... are needed to protect both foreign patients taking experimental ... results. ,The number of pharmaceutical researchers working outside ... the FDA increased 16-fold from 1990 to 1999, dwarfing ...
Cached Medicine News:
... of any biological activity but appears to ... of insulin. Although insulin and C-Peptide are ... fasting levels of C-Peptide are 5-10 fold ... the longer half-life of C-Peptide. The glucagon ...
... The Array Multifocal IOL was designed ... with independence from glasses in most situations. ... IOL is similar to that of a ... usually much better and about 19 in ...
Inquire...
... IgG Enzymelinked Immunosorbent Assays(ELISA) is intended for ... antibody to Measles Rubeola) virus in human ... for the determination of immune status. Paired ... demonstrate seroconversion or a significant rise in ...
Medicine Products: