Navigation Links
FDA Grants Fast Track Designation to Tioga Pharmaceuticals' Asimadoline for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome
Date:6/1/2011

SAN DIEGO, June 1, 2011 /PRNewswire/ -- Tioga Pharmaceuticals, Inc. announced today that its investigational compound asimadoline has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with diarrhea-predominant irritable bowel syndrome (D-IBS). Tioga is conducting a multi-center Phase 3 clinical trial evaluating asimadoline in D-IBS, conducted under a Special Protocol Assessment agreement with the FDA for U.S. registration.

The Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions and that demonstrate the potential to address unmet medical needs. New drug applications for products in the Fast Track program ordinarily are eligible for priority review.

"The FDA's granting of Fast Track designation for asimadoline signals the agency recognizes that diarrhea-predominant irritable bowel syndrome is a serious illness and that patients lack a safe and effective therapy," said Stuart Collinson, Ph.D., Chairman and CEO of Tioga Pharmaceuticals.

For information about Tioga Pharmaceuticals' Phase 3 D-IBS trial, go to www.clinicaltrials.gov.

About Irritable Bowel Syndrome

Irritable bowel syndrome (IBS) is a common, chronic gastrointestinal disorder characterized by recurrent episodes of abdominal pain or discomfort associated with a change in bowel pattern, such as loose or more frequent bowel movements, diarrhea and/or constipation. While the exact etiology of IBS is unknown, it is believed to be due to a disturbance in the interaction between the intestines, the brain and the autonomic nervous system that alters regulation of bowel motility or sensory function. IBS patients fall into different subtypes based on their predominant symptoms: IBS with diarrhea (D-IBS), IBS with c
'/>"/>

SOURCE Tioga Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2

Related biology technology :

1. FDA Grants Full Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
2. GlaxoSmithKline To Post Quarterly US Grants Report
3. FDA Grants Fast Track Designation for OncoGenex Pharmaceuticals Lead Product Candidate OGX-011
4. CV Therapeutics Reports Option Grants Under Nasdaq Marketplace Rule 4350
5. Repligen Receives Research Grants to Support Friedreichs Ataxia Development Program
6. Cardinal Health Invites Health Care Providers to Apply for $1 Million in Grants to Fund Patient Safety Initiatives
7. EMEA Grants Kiadis Pharma Lead Product ATIR(TM) Orphan Drug Designation
8. Isis Announces Award of Up to $8.4 Million in New Government Grants and Contracts to Its Ibis Biosciences Subsidiary for Pathogen Detection and Human Forensics
9. Nasdaq Grants VirtualScopics Request for Continued Listing
10. InNexus Biotechnology Receives Patent Grants in Europe
11. New Young Investigator Grants for Probiotics Research Announced
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/18/2013)... June 18, 2013 (PRWEB) June 18, 2013 ... and attendance system in North America, has introduced ... employee data and payroll records between ExakTime’s software ... automates ExakTime software setup and keeps employee ... employee data from a business’ current payroll software, ...
(Date:6/18/2013)... (PRWEB) June 18, 2013 Nasseo, Inc. ... Innovation Challenge Winner out of hundreds of applicants by ... spring Arizona Innovation Challenge . The Arizona Innovation ... for a technology commercialization challenge, granting a financial award ... promising technology ventures. Nasseo’s state of the art dental ...
(Date:6/18/2013)... ALBANY, N.Y. , June 18, 2013 /PRNewswire/ ... that its Burlington, Mass. , ... U.S. Drug Enforcement Administration (DEA) registration to handle ... represents the DEA,s acknowledgement of Burlington,s ... inventory control and documentation. (Logo: ...
(Date:6/18/2013)... DUBLIN , June 18, 2013 /PRNewswire/ ... http://www.researchandmarkets.com/research/5g3rx5/dna_sequencing ) has announced the addition of ... Markets and Companies " to their offering. ... This report briefly reviews basics of human ... their applications. Current large and small sequencers ...
Breaking Biology Technology:ExakTime Introduces AccountLinx Plus 2Nasseo Named 2013 Innovation Challenge Winner by Arizona Commerce Authority 2AMRI Burlington Receives DEA Approval to Handle Controlled Substances 2DNA Sequencing: Technologies, Markets and Companies - 2013 Report 2
... -- Third Wave Technologies Inc , a maker ... its Invader 2D6 analysis panel, which provides clinical trial ... assays available for the important 2D6 gene. , ,The ... trial laboratories the ability to configure custom assay panels. ...
... of competing together to race the fastest cars they can ... of 20 engineers, scientists and technicians from Ohio State University ... to win the $1 million dollar grand prize awarded to ... , ,The Defense Advanced Research Projects Agency (DARPA) has a ...
... DNASTAR, Inc . announced today the hiring and appointment ... of the Madison-based bioinformatics company. Schwei has 25 years ... with Promega Corporation, PanVera Corporation and Invitrogen Corporation. ... management and leadership, said Fred Blattner, DNASTARs chief of ...
Cached Biology Technology:Third Wave Releases Gene Test 2Oshkosh Truck Teams with OSU to Compete in DARPA Million Dollar Tech Derby 2Oshkosh Truck Teams with OSU to Compete in DARPA Million Dollar Tech Derby 3
(Date:6/18/2013)... engineer has been awarded a $394,300 grant from ... quality and flow in the new facilities of ... UT Arlington associate professor of civil engineering, will ... monochloramine to the water in an effort to ... and pipelines. Adding monochloramine is widely practiced throughout ...
(Date:6/18/2013)... a very large "dead zone" in the Gulf of ... the Chesapeake Bay this year, based on several NOAA-supported ... Michigan, Louisiana State University, and the Louisiana Universities ... Mexico hypoxic "dead" zone will be between 7,286 and ... ten largest recorded. That would range from an area ...
(Date:6/18/2013)... The National Institutes of Health has awarded $12.7 ... a selection of pharmaceutical industry compounds to explore ... including Alzheimer,s disease, Duchenne muscular dystrophy and schizophrenia. ... Uses for Existing Molecules, is led by the ... funded by the NIH Common Fund. , The ...
Breaking Biology News(10 mins):UT Arlington research to benefit quality, flow in 150-mile Integrated Pipeline 2NOAA, partners predict possible record-setting deadzone for Gulf of Mexico 2NOAA, partners predict possible record-setting deadzone for Gulf of Mexico 3NOAA, partners predict possible record-setting deadzone for Gulf of Mexico 4NIH to fund collaborations with industry to identify new uses for existing compounds 2NIH to fund collaborations with industry to identify new uses for existing compounds 3NIH to fund collaborations with industry to identify new uses for existing compounds 4
... projected this century for Oregon,s Upper Willamette River ... transportation systems, human health, forests, and fish and ... University of Oregon,s Climate Leadership Initiative and the ... The authors say that extensive efforts should begin ...
... the DNA in the nucleus of each of our cells is ... molecules serve as coding templates for the synthesis of proteins. Of ... a scant few are known: they inhibit the activity of genes ... packaged within cells. What the rest of them do within cells ...
... University of Leeds are developing methods of helping contaminated ... such as vinegar. , The harmful chromium compounds ... former textiles factories, smelters, and tanneries have been linked ... with the kidneys, liver, lungs and skin. , The ...
Cached Biology News:Eugene-Springfield face Upper Willamette climate threats 2Eugene-Springfield face Upper Willamette climate threats 3Eugene-Springfield face Upper Willamette climate threats 4CSHL researchers pinpoint structure-building role for 2 non-coding RNAs 2CSHL researchers pinpoint structure-building role for 2 non-coding RNAs 3Cleansing toxic waste -- with vinegar 2
The HQ505, 20 OptiGreen filter for the Molecular Imager FX is a band pass filter used for detection of Cy2 and FITC with 532 nm excitation....
The filter 530DF28 for the Molecular Imager FX is a band pass filter for ECL Plus, AttoPhos, SYBR Green, Alexa Fluor 488, FITC, Cy2, and Pro-Q Emerald dyes....
... Fluorescein In Situ Apoptosis Detection Kit ... the indirect TUNEL method, utilizing an ... a Fluorescein reporter molecule. It provides ... Results are analyzed using either flow ...
... 3000 system, 220-240 V, is used for nucleic ... vertical slab gel format. The system includes the ... of separating nucleic acids with single base-pair resolution ... (IPC and bonded inner glass plate, outer glass ...
Biology Products: