Navigation Links
Generex Provides Corporate Update
Date:8/2/2011

ical Development Plan.  At the Company's annual meeting of stockholders on June 8, 2011, Dr. James H. Anderson, Jr., MD, FFPM, FACE, Generex's Senior Scientific Advisor, provided a synopsis on the clinical and regulatory program for Generex Oral-lyn™.  The Company had received written guidance from the US Food and Drug Administration (FDA) in late May in response to data submitted on Generex Oral-lyn™.  The FDA response did not comment on any safety issues identified in the clinical trials, nor were there safety questions raised by the FDA.  The FDA did not express any concerns about the RapidMist™ delivery device.  There were a variety of questions about preclinical, clinical, toxicology, manufacturing, and regulatory and product labeling issues related to the wide variety of formulations and prior protocol changes that were made historically.  The Company is in the process of providing the additional information requested for complete clarification.  The FDA guidance placed no limitations or restrictions on the types of patients included or trial designs of current or future clinical studies.   The Company's new clinical development plan for Generex Oral-lyn™ will focus on fast-track registration in the North American major markets, highlighting the product's rapid absorption and sharp peak in plasma insulin concentration mimicking normal insulin secretion, and its short duration of activity reducing the potential for hypoglycemia.  Studies will include a key activity/effect (pharmokinetic/glucodynamic) study using the final formulation and a series of small, well-designed phase 3 studies (potentially conducted as one study with multiple arms).  It is anticipated that these studies would be completed during 2013.  A consensus meeting with the FDA to obtain agreement with the clinical plan and submission data package is planned this year to insure timely regulatory agency review
'/>"/>
SOURCE Generex Biotechnology Corporation
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Generex Biotechnology Corporation Initiation Coverage Review Issued By Scimitar Equity, LLC
2. Generex Announces Distribution Agreement for Generex Oral-lyn™ in Chile
3. Generex Announces Presentations of Novel Vaccine Strategies
4. Generex Announces Approval of Adjournment Proposal and Adjourned Special Meeting Date
5. Generex Announces Sales Agreement with Elias Shaker & Company
6. Generex Presents Abstract at EASD Annual Meeting
7. Generex Awarded a New Patent in Canada for its Proprietary Buccal Drug Delivery System
8. Generex Biotechnology Provides a Corporate Update to Address Managements Strategic Initiatives for Growth
9. Generex Reaches Agreement to Acquire 51% Stake in Global Medical Direct, a Nationwide Durable Medical Equipment and Pharmaceutical Provider Specializing in Direct-to-Consumer Diabetes Supplies
10. Generex Provides Clarification for Special Meeting Voting
11. Generex Announces That Adjournment Will be Sole Matter Considered at Reconvened Special Meeting of Stockholders on October 15, 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/28/2015)... -- The report "Eubiotics Market by Type (Probiotics, Prebiotics, Organic ... & by Region ( North America , ... Rest of the World) - Global Trends and Forecast to ... valued at USD 4.62 Billion in 2014 and is projected ... of 7.4% from 2015 to 2020. Browse ...
(Date:8/27/2015)... Mass. , Aug. 27, 2015  A ... the KSSTA Knee Journal, compared the Arthrosurface HemiCAP® ... Arthroplasty design, versus an "onlay" design implant for ... similar improvements in function and pain scores, none ... progression of osteoarthritis (OA). However, 53% of the ...
(Date:8/27/2015)... INDIANAPOLIS , Aug. 27, 2015  Eli Lilly ... Morgan Stanley Global Healthcare Conference on Thursday, September 17, ... and president of Lilly Oncology and Richard Gaynor ... medical affairs for Lilly Oncology, will participate in a ... A live audio webcast will be available ...
Breaking Medicine Technology:Eubiotics Market Worth 7.05 Billion USD by 2020 2Eubiotics Market Worth 7.05 Billion USD by 2020 3Eubiotics Market Worth 7.05 Billion USD by 2020 4Eubiotics Market Worth 7.05 Billion USD by 2020 5Study Demonstrates Dramatic Reduction in Progression of Osteoarthritis with the Arthrosurface "Inlay" Patellofemoral Implant Design Compared to Traditional "Onlay" Implant 2Study Demonstrates Dramatic Reduction in Progression of Osteoarthritis with the Arthrosurface "Inlay" Patellofemoral Implant Design Compared to Traditional "Onlay" Implant 3Lilly to Participate in Morgan Stanley Global Healthcare Conference 2
(Date:8/28/2015)... ... , ... As reported by Medical Daily on August 22 , Cellfina, ... last for two years, the longest of any cellulite reduction system currently on the ... long-lasting, effective solution for their cellulite, according to Dr. Robert Weiss, director of the ...
(Date:8/28/2015)... (PRWEB) , ... August 28, 2015 , ... On May ... Michigan, joined as sponsor of the “Music With A Mission” benefit concert in Mendon, ... the event was to raise money to support music education programs in the underfunded ...
(Date:8/28/2015)... ... August 28, 2015 , ... ... of high grade protein with zero fat, carbs, sugar, gluten, lactose or caffeine ... a finalist for the 2015 SupplySide CPG Editor’s Choice Awards. , Five consumer ...
(Date:8/28/2015)... ... August 28, 2015 , ... Altima Technologies, Inc., the ... and data center assets and audio-video devices, recently released Visio Stencils for the ... HP ProLiant Gen9, EMC VNX Series , Super Micro Computer SuperStorage, Hitachi Data ...
(Date:8/28/2015)... ... August 28, 2015 , ... Medical Solutions, one of the nation’s largest travel ... in Healthcare by Modern Healthcare and will be honored at an awards dinner ... year, the Best Places to Work in Healthcare program recognizes outstanding employers in the ...
Breaking Medicine News(10 mins):Health News:Maryland Dermatologists Discuss Non-Invasive Cellulite Reduction System Cellfina Receiving 2-Year FDA Clearance 2Health News:Maryland Dermatologists Discuss Non-Invasive Cellulite Reduction System Cellfina Receiving 2-Year FDA Clearance 3Health News:New Video Released on "Music With A Mission" Benefit Concert Headlining Artist Cadillac Three & Best Drug Rehabilitation 2Health News:Pocket Protein™ Named 2015 CPG Editor’s Choice Award Finalist by Informa’s SupplySide 2Health News:Pocket Protein™ Named 2015 CPG Editor’s Choice Award Finalist by Informa’s SupplySide 3Health News:Altima Updates NetZoom™ Visio® Stencil Library for Cisco, HP, and EMC Devices 2Health News:Altima Updates NetZoom™ Visio® Stencil Library for Cisco, HP, and EMC Devices 3Health News:Medical Solutions Recognized as One of 2015 Best Places to Work in Healthcare 2Health News:Medical Solutions Recognized as One of 2015 Best Places to Work in Healthcare 3
... 2011, DENVER Continuous positive airway pressure, or CPAP, ... for sufferers of obstructive sleep apnea (OSA), even if ... by researchers in Europe. Patients enrolled in the study ... of beginning CPAP treatment. The study will be ...
... (HealthDay News) -- As Americans head toward attics, roofs and ... warn that spring cleaning can lead to a spring visit ... people injured themselves on a stepladder, and more than 41,000 ... the U.S. Consumer Product Safety Commission. In addition, over 127,000 ...
... FRIDAY, May 13 (HealthDay News) -- Like all good pet owners, ... her home in Austin, Texas, when her cat, Kiki, wasn,t feeling ... After running a blood and urine test, the doctor discovered ... as America,s cats and dogs grow fatter, according to a new ...
... in Science demonstrates the use of computational methods ... capable of targeting specific surfaces of flu virus molecules. ... block molecular mechanisms involved in cell invasion and virus reproduction. ... also have diagnostic and therapeutic potential in identifying and fighting ...
... , FRIDAY, May 13 (HealthDay News) -- Learning ... but sharing wind instruments can spread disease-causing bacteria and ... to several days on a number of commonly shared ... to a report from Tufts University School of Medicine. ...
... population rates of Emergency Department (ED) use for adults with ... Clinical Evaluative Sciences (ICES) and the Centre for Addiction and ... IDD and mental illness visited the ED at least once ... at least 5 times. "A lot of attention ...
Cached Medicine News:Health News:CPAP improves daytime sleepiness even in patients with low levels of symptoms 2Health News:Spring Cleaning Lands Many Americans in Hot Water 2Health News:Fat Cats, Dogs Developing Diabetes, Report Finds 2Health News:Fat Cats, Dogs Developing Diabetes, Report Finds 3Health News:Scientists design new anti-flu virus proteins using computational methods 2Health News:Scientists design new anti-flu virus proteins using computational methods 3Health News:Musical Instruments a Breeding Ground for Germs: Study 2Health News:First North American study to look at ED use by adults with intellectual disabilities 2
Inquire...
Inquire...
Inquire...
The modular, high-end stereomicroscope; meets even the most critical demands in research and quality control provides high-contrast images with excellent depth of field and color fidelity...
Medicine Products: