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:7/30/2015)... July 30, 2015  Alimera Sciences, Inc. (NASDAQ: ... the research, development and commercialization of prescription ophthalmic pharmaceuticals, ... fiscal year 2015 financial results after the market close ... will follow on the same day at 4:30 p.m. ... and Chief Executive Officer, and Rick Eiswirth , ...
(Date:7/30/2015)... 2015 EnteroMedics Inc. (NASDAQ: ETRM ), ... treat obesity, metabolic diseases and other gastrointestinal disorders, today ... Thursday, August 6, 2015, at 11:00 AM Eastern Time ... June 30, 2015, and to provide an update on ... via the Maestro® System. Conference Call Details ...
(Date:7/30/2015)... 2015 Tissue Regenix Group ... medical devices company, announces that it has further ... market as Tissue Regenix Wound Care Inc. has ... First Coast Service Options Inc. ("First Coast") whose ... Puerto Rico and the US ...
Breaking Medicine Technology:Alimera Sciences To Release Second Quarter Fiscal Year 2015 Financial Results 2EnteroMedics to Host Second Quarter 2015 Financial Results and Company Update Conference Call 2EnteroMedics to Host Second Quarter 2015 Financial Results and Company Update Conference Call 3Tissue Regenix Group plc: First Coast Service Options Inc. Approves Medicare Coverage for DermaPure 2Tissue Regenix Group plc: First Coast Service Options Inc. Approves Medicare Coverage for DermaPure 3
... , , , , , , ... MIVI-TRUST Phase III Program With Microplasmin Recruits a Total of Over,640 ... (Euronext Brussels: THR), a biopharmaceutical company,focused on the discovery and development ... that it has completed,the enrolment of the second Phase III trial ...
... , NORCROSS, Ga., Dec. 15 Immucor, Inc. (Nasdaq: ... to the blood transfusion industry, today announced that it will ... 6, 2010 after the market close. The Company will host ... a.m. (Eastern Time) to discuss the results. , ...
Cached Medicine Technology:ThromboGenics Completes Patient Enrolment of Second Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease 2ThromboGenics Completes Patient Enrolment of Second Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease 3ThromboGenics Completes Patient Enrolment of Second Phase III Trial of Microplasmin for the Non-Surgical Treatment of Eye Disease 4
(Date:7/30/2015)... ... July 30, 2015 , ... ... at the annual All-Stars Summit. Google Partners is the platform for search marketing ... the full support and tools necessary to run successful search marketing campaigns. Google ...
(Date:7/30/2015)... ... , ... Quintessa Medical Spa is happy to offer patients the latest treatment ... for the elimination of excess tissue under the chin, referred to as submental fat. ... to offer this innovative treatment. , Developed by Kythera Biopharmaceuticals, Kybella was approved by ...
(Date:7/30/2015)... ... July 30, 2015 , ... The American ... Chuck Rosenberg’s announcement of the reinstitution of National Prescription Drug Take-Back Days. The ... from 10:00 AM to 2:00 PM local time. On the 26th, the DEA, ...
(Date:7/30/2015)... Raleigh, NC (PRWEB) , ... July 30, 2015 , ... ... older patients. Click here to read more on the Surviving Mesothelioma website. ... Orthopedic Rehabilitation Hospital in Missouri reviewed more than 12,000 cases of mesothelioma occurring between ...
(Date:7/30/2015)... ... 30, 2015 , ... 1Heart Caregiver Services LLC is offering its 1st Business ... in the Booming Homecare Business.” This will be held in its main headquarters at ... event will be hosted by 1Heart’s very own Randy Clarito (Director of Business and ...
Breaking Medicine News(10 mins):Health News:Boston Web Marketing Attends Google Partners All-Stars Summit 2Health News:Quintessa MedSpa Offers Nonsurgical Double-chin Elimination 2Health News:AAPCC Supports National Prescription Drug Take-Back Day 2Health News:AAPCC Supports National Prescription Drug Take-Back Day 3Health News:Study Finds Mesothelioma Behaves Differently in Younger People, According to Surviving Mesothelioma 2Health News:Upcoming Business Seminar at 1Heart Caregiver Services Headquarters Los Angeles California 2
... overeating, slothful horse leads to an obese horse. Unlike humans, ... obese horse. Caretakers may see no harm in giving their ... unhealthy as obesity in humans and can lead to fatal ... humans and horses when it comes to obesity," said Philip ...
... All India Institute of Medical Sciences (AIIMS) has developed ... cancer, underdeveloped genitals.// ,Doctors at the premier ... suffering from such problems, achieving 100 percent success. ... over 50 patients with not a single case of ...
... Divers scouring the sea-bed for abalone are paying with their ... while pursuing abalone, which is used in sushi// and a ... dollars apiece on the black market. ,Abalone are ... this mollusk is considered a delicacy in certain parts of ...
... Gulping down several litres of water to keep oneself cool ... won’t make much difference, warns scientists for marathon runners//. ... average runner will potentially lose almost a litre of sweat ... degrees, two degrees above normal. The sporting community has long ...
... called levodopa or L-dopa that helps in reviving cellular ... may experience motor complications and a reduced response to ... process of destruction of brain cells which produce dopamine. ... up as tremors in the arms, legs and face. ...
... and the possible reasons for them, a survey was ... revealed that present statistics of stillborns remained unchanged upon ... one in 200 pregnancies resulted in stillbirth, the survey ... Health (CEMACH) revealed that there were 3,600 ...
Cached Medicine News:Health News:Humans Aren't the Only Ones With Obesity Problems 2Health News:Artificial Testis Developed by AIIMS a Boon to Suffering Patients 2Health News:Hunt for Sea Delicacy Taking a Toll in California 2Health News:Hunt for Sea Delicacy Taking a Toll in California 3Health News:Large Fluid Intake Won’t Help to Keep Cool for Marathon Runner 2Health News:Stillbirth Figures Stand Still 2
Straight shafts with 1 x 2 teeth. Flat handle with haoles and polished finish. Delicate teeth. Most popular size or model....
Straight shafts with 0.12 mm teeth and 5 mm tying platform. Serrated handle with polished finish. Manufactured in titanium....
Straight shafts with polished finish. Teeth: 0.12 mm. Tying platform: 5.0 mm. Wide Serrated....
Straight shafts with 1 x 2 teeth and 5 mm tying platform. Serrated handle with dull finish....
Medicine Products: