Navigation Links
Vanda Pharmaceuticals Receives Orphan Drug Designation in Europe for tasimelteon
Date:3/8/2011

ROCKVILLE, Md., March 8, 2011 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA), announced today that the European Commission (EC) has granted orphan drug designation for tasimelteon, an oral dual melatonin receptor agonist in Phase III clinical trails for Non-24-Hour Sleep/Wake Disorder (N24HSWD) in blind individuals with no light perception. This follows the positive opinion on the designation that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency adopted previously in the November 2010 COMP Committee Meeting.

Orphan designation for a medicinal product by the EC provides benefits that can take a variety of forms including tax incentives, protocol assistance, eligibility for grants and initiatives supporting research and development related to this orphan indication, reduction of marketing application fees and annual fees for qualifying companies, and potential marketing exclusivity for up to 10 years in the European Union.

"We are very pleased to receive orphan designation from the European Commission," said Mihael H. Polymeropoulos, M.D., President and Chief Executive Officer of Vanda.  "This status represents an acknowledgement of the significant unmet medical need to develop and commercialize a treatment that may alleviate sleep/wake problems in people who are totally blind with no light perception."

About Non-24-Hour Sleep/Wake Disorder (N24HSWD)

N24HSWD is a chronic circadian rhythm sleep disorder that occurs when individuals are unable to synchronize their internal clock to the 24-hour light/dark cycle. As a result, the sleep/wake cycle of these individuals moves gradually later and later each day if their circadian period is more than 24 hours or earlier and earlier each day if their circadian period is less than 24 hours.  This condition occurs almost entirely in individuals who are tot
'/>"/>

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

Page: 1 2 3 4

Related medicine technology :

1. Vanda Pharmaceuticals Submits Iloperidone New Drug Application
2. Vanda Pharmaceuticals Reports Third Quarter 2007 Results
3. Vanda Pharmaceuticals Receives FDA Acceptance of Iloperidone New Drug Application
4. Vanda Presents Phase III Iloperidone Efficacy Data
5. Phase III Data Show Vanda Pharmaceuticals Tasimelteon (VEC-162) Significantly Improves Sleep in Patients with Chronic Insomnia
6. Vanda Pharmaceuticals Provides Update on Iloperidone
7. Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet
8. FDA Approves Vanda Pharmaceuticals Fanapt(TM) for the Treatment of Schizophrenia
9. Vanda Pharmaceuticals Enters into an Exclusive License Agreement for the Commercialization and Development of Fanapt(TM) in the U.S. and Canada for the Treatment of Schizophrenia
10. Vanda Pharmaceuticals Announces Expiration of Hart-Scott -Rodino Waiting Period for Exclusive License of Fanapt(TM)
11. Vanda Pharmaceuticals Announces U.S. Patent Allowance for a Long-Acting Injectable Formulation of Fanapt(TM) (iloperidone) in the U.S.
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2015)... A lot of discussion in the medical community revolves around ... or conditions. As medical science advances, doctors and surgeons often ... they consider to be more cutting edge. Yet, when it ... of treatment that stands out as the best solution in ...
(Date:1/23/2015)... WYNNEWOOD, Pa. , Jan. 23, 2015  MedScope ( ... has been nominated for a 2015 Connected World ... Personal Emergency Response System (mPERS), that can be used ... M2M technology partner.  In nominating MedScope, ...
(Date:1/23/2015)... , Jan. 23, 2015  HyGreen, Inc., a leader ... and partnership with RCA Medical, a subsidiary of Ascendis ... . Each year, hundreds of millions of ... infections as organisms are transmitted from patient to patient ...
Breaking Medicine Technology:No One-Size-Fits-All Remedy for Hernia Correction 2MedScope Nominated by RacoWireless for Prestigious 2015 Connected World Magazine Connected World Award 2HyGreen Partners with RCA Medical in Johannesburg, South Africa 2
...   OncoSec Medical Incorporated (OTCBB:ONCS), which is ... therapies to treat solid tumor cancers, today announced ... company,s Phase II Merkel cell carcinoma clinical trial, ... The Journal Newspaper.    (Logo: ...
... AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX ), ("AcelRx"), ... commercialization of innovative therapies for the treatment of acute ... in a Phase 3 study for ARX-01, the Sufentanil ... This first ARX-01 Phase 3 study is a randomized, ...
Cached Medicine Technology:OncoSec's OMS ElectroImmunotherapy Technology Platform and its Ongoing Phase II Merkel Cell Carcinoma Clinical Trial Featured in Seattle Newspaper 2OncoSec's OMS ElectroImmunotherapy Technology Platform and its Ongoing Phase II Merkel Cell Carcinoma Clinical Trial Featured in Seattle Newspaper 3OncoSec's OMS ElectroImmunotherapy Technology Platform and its Ongoing Phase II Merkel Cell Carcinoma Clinical Trial Featured in Seattle Newspaper 4AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 2AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 3AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 4AcelRx Announces Initiation of Phase 3 Clinical Program for ARX-01, the Sufentanil NanoTab® PCA System for the Treatment of Post-Operative Pain 5
(Date:1/23/2015)... 23, 2015 Hastings and Hastings, a law ... a record number of legal representation client review requests for ... been a steady rise in the number of slip and ... home throughout the Valley. With that said, a large number ... by an experienced law firm. Hastings and Hastings is a ...
(Date:1/22/2015)... Va. (PRWEB) January 22, 2015 Liberty University ... Counseling (M.A.) program from the Council for Accreditation ... program, part of Liberty’s Center for Counseling & Family ... founding dean of the university’s new School of Behavioral Sciences. ...
(Date:1/22/2015)... Woodloch Pines, an all-inclusive family resort ... TripAdvisor as the number one best large hotel for families ... world for their annual Travelers’ Choice Awards. , TripAdvisor ... website is home to millions of unbiased and honest traveler ...
(Date:1/22/2015)... 23, 2015 VogueQueen is a seasoned and ... and many designers are thrilled to have it lead the ... its new collection of prom dresses for the global market. ... the strategic vision and he focuses on continuing the goal ...
(Date:1/22/2015)... Blue Cross and Blue Shield of Minnesota (Blue Cross) wants ... “Live Fearless.” , The “Faces of Fearless” campaign ... how they or someone they know has faced a challenge, ... moment. By telling these types of stories through livefearlessmn.com, participants ...
Breaking Medicine News(10 mins):Health News:Hastings and Hastings Reports a Record Number of Client Review Requests for Slip and Fall Accidents in 2014 2Health News:Liberty University's Resident Master’s Counseling Program Receives CACREP Accreditation 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 2Health News:TripAdvisor Names Woodloch Pines Best Hotel for Families in America 3Health News:VogueQueen Unveils New Designs of Prom Dresses for 2015 2Health News:Blue Cross and Blue Shield of Minnesota to Showcase “Faces of Fearless” 2
... When children with asthma get the flu, they often land ... Boston have found a previously unknown biological pathway explaining why ... online May 29 by the journal Nature Immunology , ... cells called natural helper cells presenting a completely new ...
... 27 (HealthDay News) -- Contrary to the belief of ... violence doesn,t make kids enjoy them more, a new ... of children,s TV shows now contain some degree of ... watching animated shows identified more with non-violent characters. ...
... University of British Columbia,s Faculties of Medicine, Science ... trial aimed at improving outcomes for patients undergoing ... by the Terry Fox Research Institute, the Canadian ... or COOLS Study, involves universities and hospitals in ...
... the connection between vitamin D and multiple sclerosis in African ... San Francisco has discovered that vitamin D levels in the ... compared to African Americans who do not. "It seems ... of the UCSF Multiple Sclerosis Center, director of the UCSF ...
... -- People with rheumatoid arthritis are twice as likely ... (COPD), a large new study finds. The ... disorder was evident even when factors such as smoking, ... Israeli researchers. The study was to be presented Thursday ...
... the creation of two Franco-German joint research laboratories to promote ... a new form of cooperation in life sciences and health ... will be set up for an initial period of five ... cofinanced by the two institutions, will be located in France, ...
Cached Medicine News:Health News:Why does flu trigger asthma? 2Health News:Violence Doesn't Make TV Shows More Enjoyable for Kids 2Health News:UBC researchers to lead $4.7-million study on early-stage oral cancer 2Health News:Low vitamin D levels seen as multiple sclerosis risk for African-Americans, UCSF study finds 2Health News:Low vitamin D levels seen as multiple sclerosis risk for African-Americans, UCSF study finds 3Health News:Rheumatoid Arthritis May Double Risk of COPD 2Health News:The Helmholtz Association and Inserm create 2 joint research laboratories in France 2Health News:The Helmholtz Association and Inserm create 2 joint research laboratories in France 3
Weight adjuster flexible back, comfortably places more weight on hips, less weight on shoulders....
The Skirts and Vests are made with .50mm Pb in the front and .25mm Pb in the back. When worn, the overlap areas in the front of both the skirt and vest provide 1.0mm Pb protection. The velcro fastene...
Designed to fit the body and priced to fit the budget! The Economy Tie apron has a belt that wraps around the body and ties in the front. Don't let the price fool you.... this apron provides the same...
Setting a new standard in protective apparel. The unique, patented Cool-Tech™ mesh-back design fits the natural contour of the body while reducing the amount of weight carried on the shoulders ...
Medicine Products: