Navigation Links
Oramed Submits Pre-IND Package to FDA for ORMD-0901 (oral exenatide), an Oral GLP-1 Analog for the Treatment of Type 2 Diabetes
Date:9/3/2013

JERUSALEM, September 3, 2013 /PRNewswire/ --

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has submitted a pre-Investigational New Drug (pre-IND) package to the U.S. Food and Drug Administration (FDA) for ORMD-0901, an orally administered exenatide capsule.  Oramed's pre-IND package submission follows its recently announced meeting request letter submitted to the FDA.

The submitted pre-IND package provides the FDA with information on Oramed's ORMD-0901 research conducted to-date, as well as a clinical trial outline for a proposed U.S. clinical trial. The FDA's response to the pre-IND package will serve as a guide to the Company for product development and preparation of a full IND application.  

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed's technology is based on over 30 years of research by top research scientists at Jerusalem's Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently initiating Phase 2 clinical trials on patients with type 2 diabetes (T2DM) under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), with trials on healthy volunteers (Phase 1b) and T2DM patients (Phase 2a) underway. Oramed is also moving forward with clinical trials of ORMD-0801 for the treatmen
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. Oramed CEO to be Panelist at BIO International Convention Breakout Session on Israel Becoming Biotech Leader
2. Oramed Pharmaceuticals Moves Forward with Investigational New Drug Application for Oral Insulin
3. Bioassociate Announces Initiation of Coverage on Oramed Pharmaceuticals, Inc.
4. Oramed Pharmaceuticals Announces Reverse Stock Split
5. Oramed Pharmaceuticals Granted 2nd Patent in New Zealand; 3rd Patent for Core Technology on Oral Delivery of Proteins
6. Marrone Bio Innovations Submits New Bioherbicide for EPA Registration
7. Janssen Submits Additional Marketing Applications for ZYTIGA® in the U.S. and European Union
8. iBio, Inc. Submits Plan to Satisfy NYSE Amex Continued Listing Standards
9. WellnessFX Launches New Products e-HealthAnswers and Womens Fertility Package
10. XY Precision Positioning Stage Provides Nanometer Incremental Motion in a Small Package: PI introduces Affordable 2-Axis Piezo Positioner, Model P-763
11. FDA/PhUSE Collaboration: Study Data Reviewer’s Guide Work Package v1.1 Available
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... December 23, 2014 Nashville Fertility Center ... elected treasurer for the American Society for Reproductive Medicine ... and research in reproductive medicine. In his new ... on the executive board and will have a voice ... Hill has actively supported ASRM since 1984 when he ...
(Date:12/24/2014)... 23, 2014 PharmaBoardroom,s new ... today and available for free download , digs deep ... and growth in the sector today. One area ... has been in developing a homegrown pharmaceutical manufacturing base, even ... still remains some way off. A cursory comparison with neighboring ...
(Date:12/22/2014)... , Dec. 22, 2014   ... a developer of pathogen-specific therapies for serious ... protecting the microbiome, today announced positive topline ... 1a clinical trial of SYN-004, the Company,s ... of Clostridium difficile (C. difficile) ...
(Date:12/22/2014)... The American Journal of Hematology/Oncology, ... reviews and editorials addressing developments and pathways related ... a provocative article exploring the role of follicle-stimulating ... treatment of prostate cancer. , The article ... possibility that there could be a connection to ...
Breaking Biology Technology:Nashville Fertility Center Announces Dr. George A. Hill Selected to Serve as ASRM Treasurer for 2014-15 2Nashville Fertility Center Announces Dr. George A. Hill Selected to Serve as ASRM Treasurer for 2014-15 3PharmaBoardroom Releases New Algeria Pharmaceuticals Report 2PharmaBoardroom Releases New Algeria Pharmaceuticals Report 3Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 2Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 3Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 4Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of C. difficile Infection 5Prostate Cancer Experts Dissect the Role of Follicle-stimulating Hormone in the Development, Progression and Potential Treatment of Prostate Cancer 2Prostate Cancer Experts Dissect the Role of Follicle-stimulating Hormone in the Development, Progression and Potential Treatment of Prostate Cancer 3Prostate Cancer Experts Dissect the Role of Follicle-stimulating Hormone in the Development, Progression and Potential Treatment of Prostate Cancer 4
... John Madison, Wis. The ... to serve as general director for the WiSys ... technologies. , ,Founded in 2000 as a supplementary organization ... of the other 25 UW System campuses by protecting ...
... 2004, Inc. from Sharon Farmer. In the summer of ... meeting between Senator John Kerry and technology executives in Silicon ... of the presidential campaign, and I had no particular interest ... , ,Six months later, I had the opportunity to interview ...
... amid a group of Midwest technology consultants and you want to get ... work for free? Its an amazing thing. , ,You can ply your ... outstanding resume and all you have to do is hang out a ... and asking you to perform your services for no money. , ,When ...
Cached Biology Technology:WiSys new manager plans system-wide research awareness 2John Kerry talks technology 2John Kerry talks technology 3John Kerry talks technology 4Dont work for free on a maybe someday 2Dont work for free on a maybe someday 3Dont work for free on a maybe someday 4
(Date:12/17/2014)... Dec. 15, 2014 The Defense Logistics ... easier to detect and prevent counterfeit microcircuits from ... the agency started performing an in-house microcircuit anti-counterfeit ... the authenticity of purchased microcircuits while increasing their ... control measures will be conducted at DLA,s Electronics ...
(Date:12/17/2014)...  Automation is fundamentally transforming the travel experience ... international borders. Over the past decade, ePassports, biometric ... travelers to self process through border control via ... an increasing number of airports, seaports, and land ... to Maxine Most , Principal at Acuity ...
(Date:12/11/2014)...  That blood pressure plays a role in human health ... medical term for high blood pressure – was first described ... cuff that,s used in measuring blood pressure was invented in ... about hypertension, its triggers and its effects. In fact, recent ... the best ways to treat it. For example, ...
Breaking Biology News(10 mins):Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 2Defense Logistics Agency Launches DNA Marking Capability to Strengthen Microcircuit Supply Chain 3Automated Border Control (ABC) Transforms the Global Travel Experience With More Than 2500 ABC eGates and APC Kiosks Deployed In Airports, Seaports, and Land Borders Worldwide 2Research points to need for new approaches to treatment of high blood pressure 2Research points to need for new approaches to treatment of high blood pressure 3Research points to need for new approaches to treatment of high blood pressure 4
... girls exposed to high levels of the pesticide DDT ... to develop hypertension,when they become adults, according to a ... Previous studies have shown that adults exposed ... pressure. But this study, published online March 12 in, ...
... combination of extreme cold temperatures, man-made chemicals and a ... Arctic ozone hole of 2011, a new NASA study ... undergo ozone losses during the winter, the Arctic,s ozone ... Antarctic,s. This is because the three key ingredients needed ...
... was shown that pumpkins and cucumbers can be traced back ... an understanding of Cucurbitaceae evolution and diversity, a new checklist ... information on that family. The study was published in the ... are essential components of a healthy daily diet, not just ...
Cached Biology News:Prenatal exposure to pesticide DDT linked to adult high blood pressure 2NASA pinpoints causes of 2011 Arctic ozone hole 2NASA pinpoints causes of 2011 Arctic ozone hole 3A new checklist confirms Indian origins of pumpkins and cucumbers 2
... weight determinations for petroleum-based applications. Multiple solvents can be used, such as water, benzene, formamide, ... ... ... ...
Growth Medium / Media...
... the end of determination; triple-point calibration verification; refrigerator eliminates need for pumps and bath liquid; rapid cooldown; bench-saver ... * Range: 0-3000 mOsm/kg ... ... ...
Request Info...
Biology Products: