Navigation Links
BYDUREON™ Recommended for Approval in Europe
Date:4/15/2011

INDIANAPOLIS, SAN DIEGO and WALTHAM, Mass., April 15, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), together with Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes, Inc. (Nasdaq: ALKS), announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of exenatide 2 mg powder and solvent for prolonged release suspension for injection (proposed trade name BYDUREON) in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies. This application to the European regulatory authorities is for use of BYDUREON as a once-weekly 2 mg dose to improve glycemic control in adults who have not achieved adequate glycemic control on maximally tolerated doses of these oral therapies. If approved, BYDUREON would be the first once-weekly type 2 diabetes treatment.

The CHMP's positive opinion is now referred for final action by the European Commission, which has the authority to approve medicines for the European Union. The Commission usually makes a decision on CHMP recommendations within two to three months.

"The CHMP's positive opinion is a pivotal step toward marketing authorization for BYDUREON in Europe. If approved, BYDUREON will offer patients the benefits of a GLP-1 receptor agonist in a once-weekly injection," said Enrique Conterno, president, Lilly Diabetes. "We remain deeply committed to advancing the treatment of diabetes through innovative treatment options and solutions that meet the specific needs of millions of people living with diabetes."

The positive opinion was reached after CHMP review of the submission package, including data from studies in the DURATION clinical program in which exena
'/>"/>

SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine technology :

1. Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™
2. BYETTA® and BYDUREON™ to be Featured in More Than a Dozen Study Presentations at EASD 2010
3. Novartis Drug Afinitor® Recommended by FDA Oncology Advisory Committee for Approval to Treat Advanced NET of Pancreatic Origin
4. Cephalon Launches Recommended Takeover Bid For Australian Biopharmaceutical Company, ChemGenex Pharmaceuticals Limited
5. $1,700,000 Funding of NeoStems Very Small Embryonic-Like Stem Cells Being Developed to Treat Osteoporosis Recommended by the Department of Defense Peer Reviewed Medical Research Program
6. Half of All Women Do Not Get Regular Mammograms Despite Recommended Guidelines
7. Encisions Active Electrode Monitoring Technology Recommended at Minimally Invasive Gynecology Congress
8. DaTSCAN™ (Ioflupane I 123 Injection) Recommended in Updated European Guidelines for Diagnosis of Alzheimers Disease
9. Alaska EHR Alliance Selects e-MDs as Recommended Electronic Health Record Vendor
10. With 2009 H1N1 Cases on the Rise, New CDC-Recommended Vaccine Helps Protect Families Against Illness
11. Study Shows Lantus(R) Helped People Living with Type 2 Diabetes Reach the ADAs Recommended Target for Blood Sugar Control
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/1/2015)... SAN DIEGO , July 1, 2015  MEI Pharma, ... the clinical development of novel therapies for cancer, announced today ... Executive Officer, will present at the inaugural Cantor Fitzgerald Healthcare ... time from Le Parker Meridien in ... can be accessed at www.meipharma.com . A replay will ...
(Date:7/1/2015)... Lupin , Strides , ... Sub-licensees to Fourteen Companies     ... of its network of generic manufacturers to 14 companies now ... (ARVs). New companies Lupin and Strides Arcolab recently signed agreements ... MPP licensed from ViiV Healthcare two months after its approval ...
(Date:7/1/2015)... SAN DIEGO , July 1, 2015  AVACEN, Inc. ... a second AVACEN patent covering the medical technology platform supporting ... Logo - http://photos.prnewswire.com/prnh/20150630/227364LOGO ... The apparatus and methods patent no. 9,066,781 - Methods And ... devices manufactured by AVACEN and specific methods of use, referred ...
Breaking Medicine Technology:MEI Pharma to Present at Cantor Fitzgerald Healthcare Conference 2The Medicines Patent Pool Increases its Generic Manufacturing Network to Ramp-Up Production of Low Cost Antiretrovirals (ARVs) 2The Medicines Patent Pool Increases its Generic Manufacturing Network to Ramp-Up Production of Low Cost Antiretrovirals (ARVs) 3AVACEN Medical Patent Issued 2
... address to a conference on Regional Innovation Clusters today, ... Eli Lilly and Company (NYSE: LLY ), ... innovation as a key to renewing the nation,s economy. ... of the Obama administration, at a conference co-hosted by ...
... that a new market research report is available in ... PharmaVitae Profile http://www.reportlinker.com/p0201761/Eli-Lilly--Co-PharmaVitae-Profile.html ... and forecast performance for Eli Lilly in the prescription ... and pipeline analysis and assessment of financial per ...
Cached Medicine Technology:Lilly CEO Says Regional Innovation Clusters Can Renew the Nation's Economy 2Lilly CEO Says Regional Innovation Clusters Can Renew the Nation's Economy 3Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 2Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 3Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 4Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 5Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 6Reportlinker Adds Eli Lilly & Co.: PharmaVitae Profile 7
(Date:7/1/2015)... ... ... Trevor L. Williams, DMD holds a Bachelor of Science degree in Biomedical Sciences ... in Microbiology. He graduated from the University of Florida College of Dentistry in 2015 ... and the Academy of General Dentistry. Dr. Williams was born in Tampa and is ...
(Date:7/1/2015)... (PRWEB) , ... July 01, 2015 , ... Scoliosis is a disorder in which the ... Scoliosis Foundation, it affects 2 to 3 percent of the population, or an estimated 6 ... often develops in children between the ages of 10 and 15. Most types of scoliosis ...
(Date:7/1/2015)... ... July 01, 2015 , ... Franklin University, one of the leading educators of ... has been named Dean of the College of Health & Public Administration . ... support the vision and mission of Franklin University via curriculum planning, course scheduling, faculty ...
(Date:7/1/2015)... ... 2015 , ... A Priority Setting Partnership put in place ... they hope will guide future mesothelioma research. Surviving Mesothelioma has just posted an ... , More than 450 mesothelioma patients, caregivers, and healthcare professionals answer the mesothelioma ...
(Date:7/1/2015)... ... 2015 , ... Amada Senior Care, premier provider of non-medical in-home care and ... – their Mesa, Arizona location . Amada franchise partners Kris Patmos and Kimberly ... rights to the area after years of experience in the sales and healthcare industries. ...
Breaking Medicine News(10 mins):Health News:Trevor L. Williams, D.M.D. Joins Enlow & Vance Dental Partners in Tampa, Florida 2Health News:Scoliosis: A Guide for Parents from Orthopedic Surgeon Dr. Fabien Bitan 2Health News:Scoliosis: A Guide for Parents from Orthopedic Surgeon Dr. Fabien Bitan 3Health News:Scoliosis: A Guide for Parents from Orthopedic Surgeon Dr. Fabien Bitan 4Health News:Franklin University Appoints Dean of College of Health & Public Administration 2Health News:New Report Identifies Top 10 Mesothelioma Research Priorities, According to Surviving Mesothelioma 2Health News:Amada Senior Care Expands to Greater Phoenix Area 2
... SWEDESBORO, N.J., Oct. 1 Wedgewood Pharmacy ... entered an agency agreement,through which Midwest will ... clinics in 27 states. The relationship is,effective ... that Midwest has represented a,compounding pharmacy service. ...
... Attorneys from McKissock & Hoffman, PHILADELPHIA, Oct. ... Cherin and Mellott, LLC today announced that it ... of 22 attorneys from,McKissock & Hoffman including name ... in the continued expansion of Eckert Seamans, Philadelphia,and ...
... a supplier,of affordable medical imaging systems to healthcare providers, ... president of Sales,and Business Development for the company. ... to the,next level," says Tom Hacking, chairman and chief ... forward to the many contributions he,will make." With ...
... Educational ... Resource at IDSA Annual Meeting, HADDON HEIGHTS, N.J., Oct. ... continuing education,resource as part of their exhibit booth at the ... October 4-7, in San Diego,California. Project CDAD: Outbreak Prevention and ...
... pinch in the arm can help save 36,000 lives ... the,beginning of flu season, which will put up to ... is easily prevented with an inexpensive,vaccination. AARP is urging ... begins its annual spread., (Logo: http://www.newscom.com/cgi-bin/prnh/20070209/NYF043LOGO ...
... 1 BD (Becton,Dickinson and Company) (NYSE: BDX ... of its fourth fiscal quarter 2007 earnings conference call ... will issue a press,release detailing the quarter,s earnings earlier ... will be accessible through BD,s,website at http://www.bd.com/investors ...
Cached Medicine News:Health News:Wedgewood Pharmacy and Midwest Veterinary Supply Sign New Agency Agreement 2Health News:Wedgewood Pharmacy and Midwest Veterinary Supply Sign New Agency Agreement 3Health News:Eckert Seamans Announces Major Expansion in Philadelphia, West Chester and Harrisburg 2Health News:Eckert Seamans Announces Major Expansion in Philadelphia, West Chester and Harrisburg 3Health News:National Experts Team Up to Help Hospitals Prevent and Control C. difficile Outbreaks 2Health News:AARP Reminds All People 50-Plus to Get a Flu Shot This Year 2
... Accutome Ultrasound Advent Pachymeter exceeds previous product ... ALK and other lamellar procedures, the measurement ... microns. High end range is 1000 microns ... care. Newly designed 55 angle probe ensures ...
Precision that fits in the palm of your hand and measures down to 125 microns, the Pocket Pachymeter is about 8" X 4" x 2" and really does fit in a lab coat pocket or briefcase....
15 segment Vertical Prism Bar provides 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 25, 30 PD (Note: 30 PD is on the bar). 4447 xx Vertical Prism Bar....
Valleylab Surgistat II generator provides exceptional performance, reliability, and safety benefits in a compact, easy to use unit....
Medicine Products: