Navigation Links
Amgen Receives CHMP Positive Opinion for XGEVA™ (Denosumab) in the European Union
Date:5/20/2011

THOUSAND OAKS, Calif., May 20, 2011 /PRNewswire/ -- Amgen (Nasdaq: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a positive opinion for the marketing authorization of XGEVA™ (denosumab) for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumors.  If approved by the European Commission, Amgen would receive marketing authorization for XGEVA in all European Union (EU) Member States.  The CHMP also recommended to grant XGEVA an additional year of data and market exclusivity in the EU since the indication was considered significantly new for XGEVA, and based on the significant clinical benefit of the product in comparison with existing therapies.  

Bone metastases, the spread of cancer to the bones, are a common and serious concern for patients with advanced cancer and present a burden to the healthcare system. Weakened bones due to metastases can lead to fractures and compression of the spinal cord and necessitate procedures like major surgery and radiation, collectively called skeletal-related events (SREs). The primary goal of treatment for bone metastases is to prevent the occurrence of these debilitating and costly SREs.

"A diagnosis of skeletal-related events associated with bone metastases is devastating for patients living with cancer, and our goal is to prevent the occurrence of these debilitating bone complications, which can disrupt a patient's life and cause disability, pain, and hospitalization," said Willard Dere, M.D., senior vice president and international chief medical officer, Amgen. "XGEVA provides patients with superior efficacy over Zometa in preventing skeletal-related events in patients with solid tumors and prolong
'/>"/>

SOURCE Amgen
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Arthritis Foundation Announces Amgen and Wyeth to Be Presenting Sponsor of the 2008 Arthritis Walk (R)
2. Medarex to Receive Milestone Payment from Amgen
3. AMT Obtains License to Amgens GDNF Gene to Develop Treatment for Parkinsons Disease with AMTs Proprietary Gene Therapy Platform
4. Amgen, Takeda and Millennium Provide Update on Phase 3 Trial of Motesanib in Patients With Non-Small Cell Lung Cancer
5. CDC Foundation Partners with Amgen, CDC to Reduce Infections Among Cancer Patients
6. Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)
7. Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
8. Amgen Announces Top-Line Results of Trial to Reduce Cardiovascular Events With Aranesp(R) Therapy (TREAT) in CKD Patients With Type-2 Diabetes
9. Amgen Presents Data From First Nplate(R) Study in Children With Chronic ITP
10. Amgen Highlights Data to be Presented at American Society for Bone and Mineral Research (ASBMR) Meeting
11. Amgen Board Authorizes $5 Billion Increase in Stock Repurchase Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/19/2013)... YORK , June 19, 2013 /PRNewswire-iReach/ -- ... pioneer of modern hair transplant procedures and founder ... was included in the ,Best Doctors, issue of ... (Photo:  http://photos.prnewswire.com/prnh/20130619/CG34629 ) ... Best Doctors issue, and his reputation as world-renowned ...
(Date:6/19/2013)... The American Association for Homecare (AAHomecare), along with ... , announced today the filing of a lawsuit ... , asking that the scheduled July 1 expansion of the ... be stopped because of serious licensing irregularities. The ... (HHS) Secretary Kathleen Sebelius as the defendant. HHS ...
(Date:6/19/2013)... , June 19, 2013 /PRNewswire/ ... a new market research report is ... Partnerships, Licensing, Investments and M&A ... in Pharmaceuticals http://www.reportlinker.com/p0925641/Partnerships-Licensing-Investments-and-MA-Deals-and-Trends-for-May-2013-in-Pharmaceuticals.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Investment_Banking ... and M&A Deals and Trends for ...
Breaking Medicine Technology:Dr. Robert Bernstein in NY Magazine's 'Best Doctors' Issue for 14th Consecutive Year 2Dr. Robert Bernstein in NY Magazine's 'Best Doctors' Issue for 14th Consecutive Year 3AAHomecare and Maryland DME Provider Take Medicare Agency to Court Over Competitive Bidding Program 2AAHomecare and Maryland DME Provider Take Medicare Agency to Court Over Competitive Bidding Program 3AAHomecare and Maryland DME Provider Take Medicare Agency to Court Over Competitive Bidding Program 4AAHomecare and Maryland DME Provider Take Medicare Agency to Court Over Competitive Bidding Program 5Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 2Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 3Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 4Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 5Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 6Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 7Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 8Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 9Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 10Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 11Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 12Partnerships, Licensing, Investments and M&A Deals and Trends for May 2013 in Pharmaceuticals 13
... New Data to be Presented at ASCO Shows Survival ... Partial Responders Compared with Chemotherapy ... (OTC Bulletin Board: GNTA) announced the results of long-term,followup ... oncology product,Genasense(R) (oblimersen sodium) Injection, in patients with chronic,lymphocytic ...
... Wyeth,Pharmaceuticals, a division of Wyeth (NYSE: WYE ... Administration (FDA) has granted Fast Track designation,to the ... toddlers. Wyeth is seeking a pediatric indication for,active ... caused by serotypes included in the vaccine. The ...
Cached Medicine Technology:Long-Term Followup in Phase 3 CLL Trial Shows Genasense(R) is Associated with Significantly Increased Survival in All Responders 2Long-Term Followup in Phase 3 CLL Trial Shows Genasense(R) is Associated with Significantly Increased Survival in All Responders 3Long-Term Followup in Phase 3 CLL Trial Shows Genasense(R) is Associated with Significantly Increased Survival in All Responders 4Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers 2Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers 3Wyeth Receives FDA Fast Track Designation for its 13-valent Pneumococcal Conjugate Vaccine for Infants and Toddlers 4
(Date:6/19/2013)... 2013 Brand new Hypertrophy Max bonus just released ... sale on the Hypertrophy Max program. Vince and Ben are ... those that are interested must act quickly. , What is the ... bonus is a free 12 month all access pass to the ... Ryan Davids "Live Large TV is a Monday night show where ...
(Date:6/19/2013)... Neb. (PRWEB) June 20, 2013 Author Byron ... give children a basic explanation of how the body’s defense ... Brownie Bill and the Health Pirates ” (published by Trafford ... and the Health Pirates” tells the story of Bobbie, a ... fever one morning. His mother takes him to visit Doctor ...
(Date:6/19/2013)... Colorado (PRWEB) June 19, 2013 Daily Gossip ... vertical jump training method will be published on their ... preview of the article to inform readers about the information ... declaration made by reporters working at Daily Gossip, the article ... Guide . , Hiller has understood during the vast ...
(Date:6/19/2013)... (PRWEB) June 19, 2013 PrettySkin4Less announces ... organic skin serums by top skin care manufacturer ... high concentrations of vitamins, minerals and active organic ingredients ... that so many other beauty products offer. For this ... lining up. , "I like products that do ...
(Date:6/19/2013)... UT (PRWEB) June 19, 2013 ... , In July 2013, Orriant is launching a ... rates, and maintain compliance with regulations. New ... to receive wellness incentives if their employer offers ... they have been compliant with these standards for ...
Breaking Medicine News(10 mins):Health News:New Hypertrophy Max Bonus Just Released and Only Available for 24 Hours 2Health News:New Book Shows Children How the Body Fights Germs 2Health News:The Jump Manual Review: Reveals Hiller’s Method of Vertical Jump Training 2Health News:PrettySkin4Less Launches New Innovative Skin Serums with Active Organic Ingredients to World Wide Consumer Base 2Health News:New Tool to Increase Participation Rates for Corporate Wellness Programs in July 2013 Will Help Maintain Compliance with Federal Regulations 2Health News:New Tool to Increase Participation Rates for Corporate Wellness Programs in July 2013 Will Help Maintain Compliance with Federal Regulations 3
... common type of disorder in which the patient develops tingling and ... approved the drug to be sold to treat the disorder. It ... about 10% of the people are affected by this disorder. ... of now it is used to treat mild to moderate or ...
... here lawyers in California have sued PepsiCo alleging one of ... drink in question is Pepsi Twist drink, and it is ... firms has been drawn into a legal battle. ,Lawyers ... Twist has been falsely promoted as a safe consumer product, ...
... the anti-quota camp, the Supreme Court Friday reversed an ... seats on an all-India basis// for scheduled castes and ... 2006-07 academic year. ,A bench of judges K.G. ... of Additional Solicitor General Gopal Subramaniam that enforcing the ...
... of Orissa, declared that his health is normal. // The ... after he ran an astounding 65km earlier this week. ... Bhubaneswar for a medical check up on the orders of ... Biranchi Das was exploiting the boy for his personal gains. ...
... India (MCI) has condemned the poor infrastructure, lack lustre teaching ... // ,The (MCI) delegation, headed by Dr Lalita ... college and its failure to set up proper infrastructure over ... the college building was another factor of contention and a ...
... Lomb Inc. is in serious trouble after an eye infection ... its lens care products.// There are complaints arising from Asia, ... lens care products might be linked to a spate of ... a handful of cases of the infection had also been ...
Cached Medicine News:Health News:Supreme Court Quashed Reservation Quotas For PG Medical Courses 2Health News:Marathon Kid Budhia’s Health Not Compromise 2
Medpor 2/3 Orbit implants are designed to replace non load bearing bony structures in the orbital area....
... Orbital Rim implant can provide up to ... to be trimmed to meet the needs ... allows it to rest on the most ... flange allows easier positioning of the implant ...
Flattened points in vertical plane, straight shafts, cross action, round handle....
1.5 mm inner cutting edge....
Medicine Products: