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:10/19/2014)... 2014 The Asia-Pacific Bromine Market ... Asia-Pacific with analysis and forecast of revenue. , ... Bromine Market report, to get an idea of ... glimpse of the segmentation in the Asia-Pacific bromine ... figures. , http://www.micromarketmonitor.com/market/asia-pacific-bromine-6741503144.html , Bromine ...
(Date:10/19/2014)... The Asia-Pacific Speech Analytics market report defines ... analysis and forecast of revenue. This market is estimated ... million by 2019, at a Compound Annual Growth Rate ... through the TOC of the Asia-Pacific Speech Analytics market ... provided. It also provides a glimpse of the segmentation ...
(Date:10/19/2014)... The Asian Orthopedic braces and support systems report defines and ... of revenue. The Orthopedic braces and support systems market in ... 2018, at a developing CAGR of 4.4% from 2013 to ... braces and support systems market, to get an idea of ... the segmentation of orthopedic braces and support systems market in ...
(Date:10/19/2014)... 2014 According to market research ... WLAN Controllers; Wireless gateways)]- Global Advancements, Forecasts and ... global Outdoor Wi-Fi market with analysis and forecasting ... also identifies the drivers and the restrains for ... opportunities and challenges. , Browse 65 market data ...
Breaking Biology Technology:The Asia-Pacific Bromine Market is estimated to grow to $4,080.1 million by 2018 - New Report by MicroMarket Monitor 2The Asia-Pacific Bromine Market is estimated to grow to $4,080.1 million by 2018 - New Report by MicroMarket Monitor 3The Asia-Pacific Speech Analytics market is estimated to reach $208 million by 2019 - New Report by MicroMarket Monitor 2The Asia-Pacific Speech Analytics market is estimated to reach $208 million by 2019 - New Report by MicroMarket Monitor 3The Asia-Pacific Speech Analytics market is estimated to reach $208 million by 2019 - New Report by MicroMarket Monitor 4The Asian Orthopedic braces and support systems market is estimated to grow to around $416.5 million by 2018 - New Report by MicroMarket Monitor 2The Asian Orthopedic braces and support systems market is estimated to grow to around $416.5 million by 2018 - New Report by MicroMarket Monitor 3The Asian Orthopedic braces and support systems market is estimated to grow to around $416.5 million by 2018 - New Report by MicroMarket Monitor 4Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 2Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 3Outdoor Wi-Fi Market (by Access Points, WLAN Controllers, Wireless gateways) Expected to Cross $37.2 Billion by 2018 - New Report by MarketsandMarkets 4
... up nearly 23% of fund raising goal for Central ... Company,(NYSE: LLY ) President and Chief Executive Officer ... United Way of Central Indiana for,its and other United ... of Lilly employees and retirees across the,United States with ...
... 13 Palatin Technologies,Inc. (Amex: PTN ) will ... Monday, November 17, 2008 before the open of the ... conference call and live audio webcast,hosted by Palatin,s executive ... discuss the results of operations in greater detail and ...
... 13 , - Announce Winners of ... Elsevier, the world,s leading research publisher of ... Institutions announced,today winners of the first annual ... to recognize outstanding young scientists and researchers,in ...
Cached Biology Technology:Lilly Contributes $11.1 Million to United Way Annual Campaign 2Palatin Technologies to Report Fiscal Year 2009 First Quarter Results; Conference Call and Webcast on November 17, 2008 2Elsevier and the Association of Southeast Asian Institutions 2Elsevier and the Association of Southeast Asian Institutions 3Elsevier and the Association of Southeast Asian Institutions 4
(Date:10/16/2014)... -- NXT-ID, Inc. (NASDAQ: NXTD and ... focused on the growing mobile commerce market announces that ... Smart Wallet, at the 13 th annual Future ... conference on the intersection of technology and the economy. ... founder and publisher of the Strategic News Service™, the ...
(Date:10/15/2014)... The book ,Models of Life, is a non-traditional biophysics ... itself. The book is a journey of discovery into ... of life and biological regulation. It is about how ... strategic communication between the billions of cells in an ... the relationships between principles, which can be found on ...
(Date:10/15/2014)... have linked increased resistance to bacterial pneumonia in female ... hormone estrogen. , Females are naturally more resistant to ... scientists has shown that increased resistance to bacterial pneumonia ... oxide synthase 3 (NOS3). They also show that this ... female sex hormone estrogen. , The team, lead by ...
Breaking Biology News(10 mins):NXT-ID Inc. to Present at 13th Annual FiRe Conference 2NXT-ID Inc. to Present at 13th Annual FiRe Conference 3New book about life as seen from physics 2
... Canadell, from the Global Carbon Project and CSIRO Marine and ... deforestation releases 1.5 billion tonnes of carbon each year into ... nearly 20 per cent of carbon emissions due to human ... to 130 billion tonnes of carbon by 2100, which is ...
... you’re grazing normally on algae in the rocky intertidal zone ... infected by a parasite. But the better news is, according ... you might have more to eat if plenty of your ... Proceedings of the National Academy of Sciences Early Edition ( ...
... rapid genetic adaptations in the nematode Acrobeloides nanus. ... lay more eggs under polluted conditions than the ... demonstrated this in her study into the long-term ... , Environmental pollution is an important cause of ...
Cached Biology News:Confirmed -- deforestation plays critical climate change role 2Parasites' impact goes beyond host to affect ecosystem 2Parasites' impact goes beyond host to affect ecosystem 3Asexual worm quickly adapts to soil contamination 2