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

0

GOOD

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:5/23/2013)... 2013 Halozyme Therapeutics, Inc. (NASDAQ: ... David A. Ramsay as ... Vice President, Corporate Development at Halozyme. ... his established financial management experience and his recent ... our commercial group for the last four years, ...
(Date:5/23/2013)... SAN DIEGO , May 23, 2013  MedVantx, ... to consumer pharmaceutical distribution channel announced today the Company ... platform to manage $1.5B in pharmaceutical products and the ... quality akin to cGMP facilities in its specialty home ... . The Company provides leading pharmaceutical manufacturers, physicians, health ...
(Date:5/23/2013)... , May 23, 2013   BioLife Solutions ... of proprietary clinical grade hypothermic storage and ... and contract aseptic media manufacturer , today announced ... & Regenerative Medicine Congress 2013 this week in ... http://photos.prnewswire.com/prnh/20090814/BIOLIFELOGO ) Dr. Aby J. Mathew, BioLife,s ...
Breaking Medicine Technology:Halozyme Therapeutics Names David A. Ramsay Chief Financial Officer 2MedVantx Achieves Significant Milestone of Managing $1.5B in Prescription Medications and Completes Facilities Expansion While Upgrading To Offer Current Good Manufacturer Practices (cGMP)-level Quality Systems in their Home Delivery Pharmacy 2MedVantx Achieves Significant Milestone of Managing $1.5B in Prescription Medications and Completes Facilities Expansion While Upgrading To Offer Current Good Manufacturer Practices (cGMP)-level Quality Systems in their Home Delivery Pharmacy 3BioLife Solutions Announces Presentation at 8th World Stem Cells & Regenerative Medicine Congress 2BioLife Solutions Announces Presentation at 8th World Stem Cells & Regenerative Medicine Congress 3
... , RALEIGH, N.C., Dec. 9 ... Head of Infectious Diseases Carl Kraus, M.D., Vice President ... with John Powers, M.D., Assistant Professor of Medicine ... considerations in anti-infective drug development. , Understanding the current ...
... SAN DIEGO, Dec. 9 Sangart, Inc., a global ... to enhance the perfusion and oxygenation of ischemic (oxygen ... initiation of a dose-finding study designed to evaluate the ... care in severely injured trauma patients with lactic acidosis ...
Cached Medicine Technology:PRA International Hosts an Infectious Diseases Audio Conference 2PRA International Hosts an Infectious Diseases Audio Conference 3Sangart, Inc. Initiates Phase IIa Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock 2Sangart, Inc. Initiates Phase IIa Study of Oxygen Therapeutic Agent MP4OX in Severe Trauma Patients With Hemorrhagic Shock 3
(Date:5/23/2013)... A medical malpractice case which was filed ... by Lori Mandel, an office manager in her 50’s, ... Ms. Mandel sought the medical expertise of an ... that affected the quality of her life and her ... that her doctor rendered conservative treatment for 2 years, ...
(Date:5/23/2013)... can cause rapidly progressing, life threatening meningitis and meningococcal ... have not known how it attaches to the human ... attaches to the airway to colonise", People can be ... while some people progress to invasive disease. To ... how the bacterium colonises the airway. Now that the ...
(Date:5/23/2013)... , , WEDNESDAY, May 22 (HealthDay News) -- The success of ... born with a serious airway malformation sheds light on new ... A report in the May 23 New England Journal ... At first, the baby born five weeks early seemed ... eating when he was 6 weeks old. Just two weeks ...
(Date:5/23/2013)... DRE, Inc. is now offering the DRE ... upgrade older model DRE or BFW halogen headlights to ... , DRE and BFW customers can easily and affordably ... to LED with DRE’s American-made Xavier-C3 LED headlight conversion ... a bright, clean and even field of illumination with ...
(Date:5/23/2013)... May 23, 2013 In Florida, residents have ... This doesn’t mean, however, that Florida’s good luck will continue, ... . This year, he encourages residents, it is important to ... 2013, forecasters are predicting there to be a 50-percent chance ... . With hurricane season lasting from June 1 to November ...
Breaking Medicine News(10 mins):Health News:New York Law Journal Releases Top Medical Malpractice Case for 2012: NY Supreme Court Awards $8.6 Million to Plaintiff after Doctor's Misdiagnosis Led to Personal Injury 2Health News:New York Law Journal Releases Top Medical Malpractice Case for 2012: NY Supreme Court Awards $8.6 Million to Plaintiff after Doctor's Misdiagnosis Led to Personal Injury 3Health News:New discovery in fight against deadly meningococcal disease 2Health News:Docs Use 3-D Printer to Create Lifesaving Airway Device for Infant 2Health News:Docs Use 3-D Printer to Create Lifesaving Airway Device for Infant 3Health News:New DRE, Inc. LED Conversion Kit Allows Doctors to Upgrade Older Halogen Technology Without Replacing Entire Lighting Systems 2Health News:New DRE, Inc. LED Conversion Kit Allows Doctors to Upgrade Older Halogen Technology Without Replacing Entire Lighting Systems 3Health News:As Hurricane Season Nears, Skylake Insurance Encourages Florida Residents To Prepare Early For Safety 2
... There,s little benefit to parents or baby in learning before ... new study suggests. Researchers led by Dr. James Robbins, ... 235 mothers of children aged 2 to 7 years with ... condition was identified before birth (prenatally) in 46 percent of ...
... , FRIDAY, Nov. 26 (HealthDay News) -- Most American ... the topic is far less likely to arise in homes without ... half of American households have a gun, and nearly 30 children ... owned by the child,s family or friends, according to researchers at ...
... HealthDay Reporter , WEDNESDAY, Nov. 24 (HealthDay News) ... and want to keep the weight off, a new Danish ... refined carbohydrates. Based on the findings, the researchers advise ... whole-grain breads. The glycemic index (GI) is a measure of ...
... devastating cholera outbreaks in refugee camps in earthquake-wracked Haiti, ... George Washington University, and the International Vaccine Institute (IVI) ... stockpile of cholera vaccines for future humanitarian use. ... maintaining a stockpile of several million doses of cholera ...
... Amanda Gardner HealthDay Reporter , WEDNESDAY, Nov. 24 ... blood cancers with bone marrow and blood stem cell transplants ... and death, a new study shows. Between the early ... the overall risk of death in an analysis of more ...
... year has brought to light both the promise and ... the most deadly form of skin cancer. Early clinical ... cancer-causing gene revealed impressive results in patients whose cancers ... short-lived, as the tumors invariably returned a few months ...
Cached Medicine News:Health News: Gun-Safety Talk a Safe Bet for All Families, Experts Say 2Health News:More Protein, Fewer Refined Carbs May Keep Weight Off 2Health News:More Protein, Fewer Refined Carbs May Keep Weight Off 3Health News:Experts urge US to create emergency cholera vaccine stockpile for humanitarian use 2Health News:Experts urge US to create emergency cholera vaccine stockpile for humanitarian use 3Health News:Experts urge US to create emergency cholera vaccine stockpile for humanitarian use 4Health News:Study Finds Big Strides Made in Treating Leukemia, Lymphoma in Past Decade 2Health News:Study Finds Big Strides Made in Treating Leukemia, Lymphoma in Past Decade 3Health News:Study Finds Big Strides Made in Treating Leukemia, Lymphoma in Past Decade 4Health News:Researchers shine light on how some melanoma tumors evade drug treatment 2Health News:Researchers shine light on how some melanoma tumors evade drug treatment 3
Used to introduce balloon, closed and non-tapered end catheters or other devices for intervention....
Used to introduce balloon, electrode, closed or non-tapered end catheters and other devices for intervention....
Used to introduce large balloon, closed and non-tapered end catheters or other devices for intervention....
Used to introduce large devices for vascular intervention....
Medicine Products: