Navigation Links
Investigational New Drug Application Cleared by FDA for OMS824 in Huntington's Disease
Date:5/23/2013

l needs and typically provides priority review status.

"Cognitive impairment is a hallmark of Huntington's disease and schizophrenia, and there currently are no drugs that improve cognition in either disorder," stated Gregory A. Demopulos , M.D., chairman and chief executive officer of Omeros. "In Huntington's disease, OMS824 also has the potential to improve motor control and to reduce the rate of neurodegeneration, slowing disease progression. We are pleased that the FDA has now cleared the way for us to evaluate OMS824 in both patients with Huntington's disease and schizophrenia, and we look forward to initiating enrollment in our Phase 2 clinical trials."

About Orphan Drug Status
Orphan drug designation is granted by the FDA's Office of Orphan Products Development for drugs that are expected to provide significant therapeutic advantage over existing treatments and that target conditions affecting 200,000 or fewer U.S. patients annually. Orphan drug designation qualifies a company for several benefits under the Orphan Drug Act of 1983. The benefits apply across all stages of drug development and include accelerated approval process; seven years of market exclusivity following marketing approval; tax credits on U.S. clinical trials; eligibility for orphan drug grants; and waiver of certain administrative fees.

About FDA's Fast Track Program
The FDA's Fast Track program facilitates the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs. Fast Track drugs are eligible for more frequent and timely meetings with the FDA to discuss the development plan and to ensure that data needed for approval are collected appropriately. Drugs in the Fast Track program typically are granted priority review status and their respective New Drug Applications are accepted and reviewed by the FDA as rolling submissions.

About Omeros' PDE1
'/>"/>

SOURCE Omeros Corporation
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. AbbVie Initiates Phase 3 Study of Its Investigational Compound Atrasentan on Renal Outcomes in Patients with Diabetic Nephropathy
2. AbbVie to Present Data on Investigational Anti-Cancer Compounds at American Society of Clinical Oncology Annual Meeting
3. Boehringer Ingelheim Presents Progression-Free Survival Data for Investigational Afatinib and Nintedanib in Advanced NSCLC
4. AbbVie and Alvine to Collaborate on Investigational Oral Therapy for Celiac Disease
5. AbbVies Investigational HCV Regimen Receives Breakthrough Therapy Designation from the U.S. Food and Drug Administration
6. Bayer Initiates Phase III Trial of Investigational Inhaled Amikacin Solution (BAY41-6551T) in Mechanically Ventilated Patients with Gram-negative Pneumonia
7. Bayers Investigational Riociguat Granted U.S. FDA Priority Review for Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
8. Positive Preclinical Data for NKTR-214, an Investigational Cancer Immunotherapy Targeting the IL-2 Receptor Complex, Presented at AACR Annual Meeting 2013
9. European Medicines Agency accepts marketing authorization application for Boehringer Ingelheim and Eli Lilly and Companys empagliflozin*, an investigational type 2 diabetes treatment
10. Boehringer Ingelheim and Eli Lilly and Company submit new drug application to FDA for empagliflozin, an investigational type 2 diabetes treatment
11. Genocea Publishes Preclinical Data For Investigational Vaccine Candidate For HSV-2
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... 22, 2014 NxStage Medical, Inc. (NASDAQ: ... dialysis products, announced today that the U.S. Food ... One™ to perform hemodialysis overnight while the patient ... hemodialysis. NxStage,s® System One is the first and ... this indication. Home nocturnal hemodialysis ...
(Date:12/22/2014)... , Dec. 22, 2014 Research and Markets ... the "US Self-monitoring Blood Glucose Market" report ... This market insight focuses on the ... the United States . Reimbursement analysis and ... product analyses for more than 73 SMBG meters have ...
(Date:12/22/2014)... 2014 Research and Markets ( ... "Investment Analysis of the US Medical Device ... http://photos.prnewswire.com/prnh/20130307/600769 ... device sector identifies the key trends and rationale ... and mergers and acquisitions. The study ...
Breaking Medicine Technology:NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3US Self-monitoring Blood Glucose Market 2Investment Analysis of the US Medical Device Sector 2
... Pa., Feb. 27, 2012 Auxilium Pharmaceuticals, Inc. (Nasdaq: ... participate in the 2012 Cowen Healthcare Conference to be ... in Boston.  Mr. Jim Fickenscher, Chief Financial Officer, is ... its product pipeline at 9:20 a.m. ET on Tuesday, ...
... (Pink Sheets: TROV.PK), a developer of trans-renal molecular diagnostics, ... to expand its business development activities and monetize the ... "Trovagene owns a significant portfolio of molecular diagnostic intellectual ... applications. While the company will focus its internal R&D ...
Cached Medicine Technology:Auxilium Pharmaceuticals to Present at the 2012 Cowen Healthcare Conference 2Auxilium Pharmaceuticals to Present at the 2012 Cowen Healthcare Conference 3Auxilium Pharmaceuticals to Present at the 2012 Cowen Healthcare Conference 4Trovagene Expands Business Development Efforts Through a Partnership with Leomics Associates, Inc. 2Trovagene Expands Business Development Efforts Through a Partnership with Leomics Associates, Inc. 3
(Date:12/25/2014)... BambooFlooringChina.com sells many bamboo products and the business is ... company announces big discounts on its bamboo mats , ... is the world’s leader in bamboo flooring. According to ... 20, 2015. , The bamboo mats are made from ... All the bamboo strips for the mats are boiled ...
(Date:12/25/2014)... December 25, 2014 Recently, LunaDress.co.uk has updated its ... and related accessories. Now, all of the models at LunaDress.co.uk come ... a groom lifts the wedding veil can turn out to be ... charm. A wedding veil can always bring surprise to a wedding. ... on how to choose veils for a big day . ...
(Date:12/25/2014)... (HealthDay News) -- Overeating is common during the holidays, but ... an expert says. "Don,t arrive at a party hungry. ... know you,ll be attending a party, but deprivation leads to ... at Northern Westchester Hospital in Mount Kisco, N.Y., said in ... during the day and even to have a snack before ...
(Date:12/25/2014)... AngelWeddingDress.com tries its best to translate the experience ... business has introduced its new collection of 2015 prom ... The new prom outfits are guaranteed to contain the ... are specially designed for 2015. Anyone who wants to ... its website before Jan. 26, 2015, the deadline of ...
(Date:12/25/2014)... California (PRWEB) December 25, 2014 Plugin ... of ProFire 5k. A fully customizable business presentation tool ... , “Adding the ProFire 5k business tool, users can ... Christina Austin, CEO of Pixel Film Studios. “ProFire 5k ... and style to add professionalism to a presentation” , ...
Breaking Medicine News(10 mins):Health News:Various Styles of Bamboo Mats in Many Colors from BambooFlooringChina.com 2Health News:LunaDress Provides Professional Tips On Shopping Wedding And Prom Dresses 2Health News:Angelweddingdress 2015 Prom Dresses Online Now 2Health News:Announcing a new ProFire 5k plugin from Pixel Film Studios for Final Cut Pro X Professionals 2
... Conseco, Inc. (NYSE:,CNO) today announced that it ... Partners II, L.P. to increase its percentage ownership ... response letter sent to Steel Partners by Conseco ... insurance companies help protect working American,families and seniors ...
... CRGN ) today announced that it had received ... regained compliance with the,requirements for continued listing on the ... In a letter dated January 28, 2008, NASDAQ ... 28, 2008 to regain compliance with,Marketplace Rule 4450(a)(5) by ...
... PORTLAND, Ore. New research from the Oregon Health ... may bring a wellspring of hope to many patients. ... kinds of DNA abnormalities that can occur in a ... with different kinds of acral and mucosal melanomas, which ...
... cochlear implant patients seen by Indiana University School of ... that cochlear implants in both ears significantly improves quality ... that the cost of the second implant is offset ... in the May issue of the journal Otolaryngology-Head and ...
... used to prepare a powerful cancer-killing agent may be ... the natural product attacks, according to findings published in ... Chemistry. , Building on their earlier research into neocarzinostatin, ... University of Wisconsin, Madison discovered that one of the ...
... goes to the Senate, SACRAMENTO, Calif., May ... in just as many years, the pro-assisted,suicide group ... 2747,(Berg/Levine). This new bill represents a strategy change ... their future efforts. As part of a,coordinated national ...
Cached Medicine News:Health News:Conseco Declines Proposal from Steel Partners II, L.P.; Proposal Would Reduce Conseco's Financial Flexibility and Potentially Disadvantage Other Shareholders 2Health News:Conseco Declines Proposal from Steel Partners II, L.P.; Proposal Would Reduce Conseco's Financial Flexibility and Potentially Disadvantage Other Shareholders 3Health News:Conseco Declines Proposal from Steel Partners II, L.P.; Proposal Would Reduce Conseco's Financial Flexibility and Potentially Disadvantage Other Shareholders 4Health News:CuraGen Corporation Regains NASDAQ Listing Compliance 2Health News:CuraGen Corporation Regains NASDAQ Listing Compliance 3Health News:OHSU Cancer Instutute researchers find abnormalities in gene for melanoma 2Health News:Bilateral cochlear implants: A case when 2 are definitely superior to 1 2Health News:Enzyme may hold key to improved targeting of cancer-fighting drugs 2Health News:Californians Against Assisted Suicide - Controversial Bill, AB 2747 Narrowly Passes Assembly 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
Medicine Products: