Navigation Links
Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
Date:5/31/2013

WASHINGTON, May 31, 2013 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (VANDA) (NASDAQ: VNDA) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tasimelteon, a circadian regulator. Vanda is seeking FDA approval of tasimelteon for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. Tasimelteon was developed to address a significant unmet medical need, the treatment of Non-24, for which there are currently no FDA approved products.

Non-24 is a serious and rare, circadian rhythm disorder that affects the majority of totally blind individuals who lack light perception and who therefore cannot entrain (synchronize) their master body clock to the 24-hour day.  

"The NDA submission of tasimelteon for Non-24 represents a significant accomplishment for Vanda in our efforts to address unmet medical needs," said Mihael H. Polymeropoulos M.D ., Vanda's President and Chief Executive Officer.  "We are excited to have submitted an application for the first circadian regulator, representing a new class of therapeutics.  The data demonstrates that tasimelteon is able to reset the master body clock and synchronize the melatonin and cortisol circadian rhythms, resulting in significant clinical benefits to patients".   

Vanda previously announced that the FDA confirmed, at a recent pre-NDA meeting, that the efficacy, safety and supporting data package proposed to be included in the NDA would be adequate to support filing of the NDA for review by the Agency.  The tasimelteon Non-24 NDA includes data from the largest clinical program conducted to date for any investigational therapy for the treatment of Non-24.   

About Non-24-Hour Disorder
Non-24 is a serious, rare, and chr
'/>"/>

SOURCE Vanda Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Vanda to Present Tasimelteon Non-24 Phase III Data at Two Medical Meetings
2. Vanda Pharmaceuticals Named the 2013 Life Science Firm of the Year by the Tech Council of Maryland
3. Vanda Pharmaceuticals to Announce First Quarter 2013 Financial Results on May 9, 2013
4. Vanda Pharmaceuticals to Present at the BioCentury Future Leaders in the Biotech Industry Conference
5. Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
6. Vanda Pharmaceuticals to Present at the Cowen and Company 33rd Annual Health Care Conference
7. Vanda Pharmaceuticals Reports Fourth Quarter 2012 and Full Year 2012 Results
8. Vanda Announces Phase IIb/III Clinical Study In Major Depressive Disorder Did Not Meet The Primary Endpoint
9. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
10. Vanda Pharmaceuticals to Announce Fourth Quarter 2012 Financial Results on February 12, 2013
11. Vanda Pharmaceuticals Reports Third Quarter 2012 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... Sept. 2, 2014 Reportbuyer.com has added ... Markets and Technologies for Molecular Imaging Devices ... AND OBJECTIVES The objectives of this study ... imaging devices used for diagnostic purposes, present global ... all possible market segments as well as forecast ...
(Date:9/2/2014)... 2, 2014  On July 31, the Food and ... it is moving forward to regulate laboratory-developed tests (LDTs). ... laboratories throughout the U.S. will need to comply with ... medical laboratories may subscribe to the strategy to simply ... guidelines in place, it,s widely acknowledged that failure to ...
(Date:9/2/2014)... , Sept. 2, 2014 Reportlinker.com ... available in its catalogue: BRIC ... http://www.reportlinker.com/p02343483/BRIC-Bariatric-Surgery-Devices-Market-Outlook-to-2020.html BRIC ... Summary GlobalData,s new report, ... provides key market data on the BRIC Bariatric ...
Breaking Medicine Technology:Global Markets and Technologies for Molecular Imaging Devices 2Global Markets and Technologies for Molecular Imaging Devices 3Global Markets and Technologies for Molecular Imaging Devices 4Global Markets and Technologies for Molecular Imaging Devices 5Global Markets and Technologies for Molecular Imaging Devices 6Global Markets and Technologies for Molecular Imaging Devices 7Global Markets and Technologies for Molecular Imaging Devices 8Global Markets and Technologies for Molecular Imaging Devices 9Global Markets and Technologies for Molecular Imaging Devices 10Global Markets and Technologies for Molecular Imaging Devices 11Global Markets and Technologies for Molecular Imaging Devices 12Global Markets and Technologies for Molecular Imaging Devices 13Global Markets and Technologies for Molecular Imaging Devices 14Global Markets and Technologies for Molecular Imaging Devices 15Global Markets and Technologies for Molecular Imaging Devices 16Global Markets and Technologies for Molecular Imaging Devices 17Global Markets and Technologies for Molecular Imaging Devices 18Global Markets and Technologies for Molecular Imaging Devices 19Global Markets and Technologies for Molecular Imaging Devices 20Global Markets and Technologies for Molecular Imaging Devices 21Global Markets and Technologies for Molecular Imaging Devices 22Global Markets and Technologies for Molecular Imaging Devices 23Global Markets and Technologies for Molecular Imaging Devices 24Global Markets and Technologies for Molecular Imaging Devices 25FDA Tells Congress It Intends to Regulate LDTs! Web Conference to Provide Straight Talk on Essential Steps Clinical Laboratories and Pathology Groups Will Need to Take to Comply 2FDA Tells Congress It Intends to Regulate LDTs! Web Conference to Provide Straight Talk on Essential Steps Clinical Laboratories and Pathology Groups Will Need to Take to Comply 3BRIC Bariatric Surgery Devices Market Outlook to 2020 2BRIC Bariatric Surgery Devices Market Outlook to 2020 3BRIC Bariatric Surgery Devices Market Outlook to 2020 4BRIC Bariatric Surgery Devices Market Outlook to 2020 5BRIC Bariatric Surgery Devices Market Outlook to 2020 6BRIC Bariatric Surgery Devices Market Outlook to 2020 7BRIC Bariatric Surgery Devices Market Outlook to 2020 8BRIC Bariatric Surgery Devices Market Outlook to 2020 9BRIC Bariatric Surgery Devices Market Outlook to 2020 10
... widely used to treat,inflammatory conditions but can increase the risk of ... of patients on long-term therapy at risk(1,2), - Study of ... with Reclast than with risedronate, a current established therapy(3) ... prevention of ...
... listeners in nine,cities across the United States, ... Show and nine Radio One gospel radio stations ... on Thursday, April 3,2008, benefiting St. Jude Children,s ... States, the national fundraiser helped raise,awareness for St. ...
Cached Medicine Technology:Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids 2Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids 3Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids 4Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids 5Study Shows Once-Yearly Reclast Better than Risedronate at Increasing Bone Mass in Patients With Osteoporosis Caused by Glucocorticoids 6The Yolanda Adams Morning Show and Radio One Gospel Stations Raise More Than $1 Million During National Radiothon Benefiting St. Jude 2The Yolanda Adams Morning Show and Radio One Gospel Stations Raise More Than $1 Million During National Radiothon Benefiting St. Jude 3
(Date:9/2/2014)... TUESDAY, Sept. 2, 2014 (HealthDay News) -- Complications ... mastectomy and reconstruction, a new study indicates. ... mastectomy was associated with a slightly higher risk ... The study included more than 18,000 breast cancer ... a double mastectomy with breast reconstruction and were ...
(Date:9/2/2014)... women diagnosed with early-stage breast cancer in California, the ... and 2011, although this procedure was not associated with ... radiation, according to a study in the September 3 ... that surgery for the removal of one breast was ... other options examined in the study. , Randomized trials ...
(Date:9/2/2014)... for their own spread throughout the body by coaxing ... according to a new report by Johns Hopkins scientists. ... Nature Communications , the researchers describe animal and cell-culture ... released by breast cancer cells. These molecules cause lymphatic ... to produce proteins called CCL5 and VEGF. CCL5 attracts ...
(Date:9/2/2014)... Medex Analytic Services is delighted to ... Coral Springs, Fla. due to their greater than forecasted ... for the 2014 year by distinguishing Medex in the ... a higher level of service and professionalism in the ... the industry has responded.” , The location of the ...
(Date:9/2/2014)... Operators in the Community Services industry ... care and counsel for those in need. In 2014-15, ... derive $39.4 billion in revenue, which includes a combination ... five years through 2014-15, the subdivision is forecast to ... of 4.1% in 2014-15. , As the population ages ...
Breaking Medicine News(10 mins):Health News:Complication Rates Low With Mastectomy, Breast Reconstruction: Study 2Health News:Increase seen in use of double mastectomy 2Health News:Increase seen in use of double mastectomy 3Health News:‘Prepped’ by tumor cells, lymphatic cells encourage breast cancer cells to spread 2Health News:Medex Analytic Services Announces New Location for Corporate Headquarters 2Health News:Community Services in Australia Industry Market Research Report Now Updated by IBISWorld 2Health News:Community Services in Australia Industry Market Research Report Now Updated by IBISWorld 3
... NEW YORK, Nov. 10 The United Spinal Association, ... help,center, Ask VetsFirst (http://www.VetsFirst.org ) an interactive gateway ... veterans and their,families., Paul Tobin, President of United ... Veterans Day it is only fitting,that as we honor ...
... According to the American,Diabetes Association there are 23.6 ... have diabetes and approximately one million people are,diagnosed ... million diagnosed,diabetics in the U.S. resulted in $116 ... this growing epidemic, Health Management Corporation,(HMC), a nationally ...
... re-opens in centrally located Family First Health Center; Members now have ... access by public ... Pharmacy celebrated its grand re-opening at 116 South George,Street in York, ... thousands of local York residents who are part of the,Healthy York ...
... combat the problem , , MONDAY, Nov. 10 (HealthDay News) -- ... peanuts, milk and fish is rising rapidly. , At the ... these allergies, according to two reports to be presented Monday ... meeting, in Seattle. , An estimated 3 million children under ...
... N.Y., Nov. 10 In a listing of ... 2008," announced in the,publication,s November 17 edition, Preferred ... nationally, with an overall quality and customer,service score ... 22nd,nationally and its parent company, MVP Health Care,s ...
... CINCINNATI Researchers have generated the first comprehensive ... light on the genetic and molecular dynamics of ... sponsored by the National Institute of Diabetes and ... led by Cincinnati Children,s Hospital Medical Center reports ...
Cached Medicine News:Health News:United Spinal Association Launches VetsFirst.org Help Center: The Next Generation Veterans Service Organization 2Health News:Health Management Corporation Incorporates Clinically Proven Care Diabetes Management Program With Programming From dLife 2Health News:Health Management Corporation Incorporates Clinically Proven Care Diabetes Management Program With Programming From dLife 3Health News:Capital BlueCross Sponsors Healthy Community Pharmacy's Move to New Community-Focused Location in York 2Health News:Capital BlueCross Sponsors Healthy Community Pharmacy's Move to New Community-Focused Location in York 3Health News:Childhood Food Allergies on the Rise 2Health News:Childhood Food Allergies on the Rise 3Health News:Preferred Care Gold Ranked Number One Medicare Advantage Health Plan Nationally In U.S. News & World Report/NCQA 'America's Best Health Plans 2008' Listing 2Health News:Genetic blueprint revealed for kidney design and formation 2Health News:Genetic blueprint revealed for kidney design and formation 3
Developed to meet the infusion needs in NICU, Anesthesia and Critical Care, the AUTO SYRINGE AS50 Infusion Pump delivers precise, controlled infusions....
... MULTI-THERAPY Infusion Pump delivers ... profiles that provide accurate, ... Designed for clinician and ... MULTI-THERAPY Pump enhances safety, ...
... pumps can be customized with selectable performance ... sites and therapies. The COLLEAGUE pumps ... be used for both gravity and pump ... From simple infusions to medication therapies requiring ...
... to the Division of Pathology and Laboratory ... the nation's largest and most comprehensive academic ... nearly 700 employees and more than 40 ... 7 million laboratory test results, interpretations and ...
Medicine Products: