Navigation Links
FDA Accepts Tasimelteon New Drug Application For Priority Review In The Treatment Of Non-24-Hour Disorder In The Totally Blind
Date:7/29/2013

cessary to entrain the master body clock in the brain with the 24-hour day-night cycle.  Most people have a master body clock that naturally runs longer than 24-hours and light is the primary environmental cue that resets it to 24 hours each day.  Individuals with Non-24 have a master body clock that is not reset, and continually delays, resulting in prolonged periods of misalignment between their circadian rhythms and the 24-hour day-night cycle, including the timing of melatonin and cortisol secretion.  As a result of this misalignment, Non-24 is associated with significant disruption of the sleep-wake cycle and impairments in social and occupational functioning, and marked subjective distress.  Currently there is no approved treatment for Non-24.  For more information on Non-24, please visit www.Non-24.com.

About Tasimelteon
Tasimelteon is a circadian regulator in development for the treatment of Non-24.  Tasimelteon is a dual melatonin receptor agonist (DMRA) with selective agonist activity at the MT1 and MT2 receptors.  Tasimelteon aims to reset the master body clock in the suprachiasmatic nucleus (SCN), resulting in the entrainment of the body's melatonin and cortisol rhythms to align to the 24-hour day-night cycle.  The patent claiming tasimelteon as a new chemical entity extends through December 2022, assuming a 5-year extension to be granted under the Hatch-Waxman Act.  Tasimelteon has been granted orphan drug designation for the treatment of Non-24 from both the U.S. and the European Union.  Tasimelteon has not been approved by the FDA or any other regulatory authority.

About Tasimelteon NDA
Summary of Efficacy
The efficacy of tasimelteon as a circadian regulator of the master body clock in the treatment of Non-24 was studied in two randomized, double-masked, placebo-controlled, multicenter, parallel-group trials, SET (Safety and E
'/>"/>

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

Page: 1 2 3 4 5

Related medicine technology :

1. European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Companys empagliflozin*, an investigational type 2 diabetes treatment
2. FDA Accepts Takeda and Lundbecks Submission of the New Drug Application for Vortioxetine for the Treatment of Major Depressive Disorder
3. FDA Accepts Novens NDA For An Investigational Nonhormonal Therapy For Menopausal Vasomotor Symptoms
4. Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
5. Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder
6. Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
7. Vanda to Present Tasimelteon Non-24 Phase III Data at Two Medical Meetings
8. Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
9. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
10. EPGL Medical Invents Self Powered Contact Lenses for Medical and Consumer Applications
11. FDA Grants Priority Review To New Drug Application For MNK-795 Submitted By Depomed Licensee Mallinckrodt
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... Australia , July 11, 2014  Australian drug ... announced that it has raised A$19.3 million via a ... Europe , the U.S., Asia ... A$3 million from a share purchase plan (SPP) to ... million will be made in two tranches. ...
(Date:7/11/2014)... -- On Thursday, July 10, 2014, ... Jones Industrial Average finished the day 0.42% lower at 16,915.07, ... losses were broad based as eight out of ten sectors ... Sector Index ended the day at 711.88, down 0.02%, while ... Investor-Edge has initiated coverage on the following equities: Covidien PLC ...
(Date:7/11/2014)... , July 11, 2014 ... Market Research "Endoscopy Devices Market (Endoscopes, Endoscopic Operative Devices, ... Growth, Trends and Forecast, 2013-2019" the global endoscopy devices ... and is expected to grow at a CAGR of ... value of USD 36.9 billion in 2019. ...
Breaking Medicine Technology:Phosphagenics' A$19.3 million Capital Raising 2Phosphagenics' A$19.3 million Capital Raising 3Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 2Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 3Health Care Equipment Equities Movers and Shakers -- Research on Covidien, Baxter, DexCom, and Boston Scientific 4Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 2Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 3Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 4Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 5Global Endoscopy Devices Market is Expected to Reach USD 36.9 Billion by 2019: Transparency Market Research 6
... July 28 HemaQuest Pharmaceuticals, a clinical stage ... disease, beta thalassemia and EBV-related cancers, announced today the ... Series B financing by new investor, Latterell Venture Partners. ... $16M . The financing is intended to help ...
... DIEGO , July 27, 2010 Amylin Pharmaceuticals, Inc. (Nasdaq: ... MAC: Management Access Conference in New York on Tuesday, August ... PT .   Alex Casdin , vice president, finance of Amylin ... , , ...
Cached Medicine Technology:HemaQuest Pharmaceuticals Raises Additional $4M to Bring Total to $16M in Series B Financing 2Amylin Pharmaceuticals to Present at the Wedbush Life Sciences Conference 2010 2
(Date:7/11/2014)... (PRWEB) July 11, 2014 With the ... in men seeking cosmetic surgery and hair transplant procedures, ... such an expansive range of medical tourism destinations, the ... plastic surgery costs and achieve the look they ... renowned as the top name in the medical tourism ...
(Date:7/11/2014)... Lake City, UT (PRWEB) July 11, 2014 ... at work at the Kilimanjaro Kids Community in Tanzania. Opened ... 40 goats, 150 chickens, and two cows. HOP Founder, Dean ... provide education for some of the orphaned children he encountered ... the HOP Team visited the children, who have all made ...
(Date:7/11/2014)... HealthDay Reporter THURSDAY, July 10, 2014 (HealthDay ... for stroke, a new study suggests. The study found ... or a transient ischemic attack (TIA) by 86 percent. ... risk by 59 percent. And hostility doubled the risk, the ... temporary blockage of blood flow to the brain. However, ...
(Date:7/11/2014)... 11, 2014 Recently, Fadhits.com, the distinguished wedding ... kids prom dresses . To bring more benefits to ... also launched a special offer for these brand new items. ... , The company’s sales manager says gladly, “We are happy ... offer is to acknowledge all new and old customers and ...
(Date:7/11/2014)... Fadhits.com, the distinguished wedding dress manufacturer and ... holiday dresses . To top it all off, ... discounted prices, up to 65% off. Clients who place ... offer. , Fadhits.com is devoted to designing and ... the global clients. All its items come with very ...
Breaking Medicine News(10 mins):Health News:VisitandCare.com Reports Increase in Cosmetic and Hair Transplant Procedures for Men 2Health News:VisitandCare.com Reports Increase in Cosmetic and Hair Transplant Procedures for Men 3Health News:Human Outreach Project Sees Incredible Progress in the Kilimanjaro Kids Community 2Health News:Stress, Depression May Boost Stroke Risk, Study Finds 2Health News:Stress, Depression May Boost Stroke Risk, Study Finds 3Health News:Promotion for Kids Prom Dresses Now Provided at Fadhits.com 2Health News:Elegant Lace Holiday Dresses Released by Fadhits.com 2
... are soul sisters, says University of Illinois professor Constance ... pregnant and deliver babies that become the center of ... feel defeated and alone. Shapiro,s new book When ... that by providing a sisterhood of survivors who have ...
... more easily diagnosed and that its effects may be more ... in The FASEB Journal ( http://www.fasebj.org ), scientists ... and have discovered that drugs which affect the methylation state ... of drug is already being used in some cancer treatments. ...
... and shampoos, for instance, to breast development, , THURSDAY, ... in a wide range of consumer products may lead ... their risk for health problems later in life, U.S. ... -- phenols, phthalates and phytoestrogens -- are known as ...
... , ... is a great travel booking website for the vacationer who plans in advance, looking for ... a last-minute specials and deals. , ... Los Angeles, CA (PRWEB) April 8, 2010 -- SVH Tours & Travel, a ...
... prescription drugs , THURSDAY, April 8 (HealthDay News) -- Medical ... included -- are poorly informed about herbal medicines and that ... misplaced, according to a new survey. , The survey was ... and Therapeutics Bulletin , which published the results online April ...
... Thomas Mower Sr., Chairman of ... in the growth and success of Sportsmen for Fish and Wildlife (SFW), according to Founder Don ... Salt Lake City (PRWEB) April ... of the Utah Jazz, have been key players in the growth and success of Sportsmen for ...
Cached Medicine News:Health News:The Scarlet I: Infertility survivors lend voices to U of I prof's new book 2Health News:New study of autism reveals a 'DNA tag' (methylation) amenable to treatment 2Health News:Chemicals in Beauty Products Tied to Early Puberty in Girls 2Health News:Agency Pioneer SVH Tours & Travel Launches AppleSpecials.com, New Travel Booking Web Site that Showcases First-Hand Videos and Last Minute Specials 2Health News:Agency Pioneer SVH Tours & Travel Launches AppleSpecials.com, New Travel Booking Web Site that Showcases First-Hand Videos and Last Minute Specials 3Health News:Insight on Herbals Eludes Doctors, Patients Alike 2Health News:Thomas E. Mower And Karl Malone Instrumental To Success Of Sportsmen For Fish And Wildlife Organization 2Health News:Thomas E. Mower And Karl Malone Instrumental To Success Of Sportsmen For Fish And Wildlife Organization 3Health News:Thomas E. Mower And Karl Malone Instrumental To Success Of Sportsmen For Fish And Wildlife Organization 4
...
... within reach of virtually any facility...from a ... advanced cardiology hospital. This PC-based system includes ... for a Philips ergonomic stress cart and ... is designed to interface with the TrackMaster ...
... Cardioscan Viewer Phonocardiogram (PCG). The ZAC-Viewer ... you to record, condition, display and print ... The product acquires and displays the ... four sites, and allows user-selectable filtering of ...
... The biograph 6 offers ... improved disease diagnosis and treatment ... It delivers high-quality PET/CT whole ... 15 minutes. Our comprehensive suite ...
Medicine Products: