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

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:8/27/2014)... and MENLO PARK, Calif. , Aug. ... DMPI), developer of advanced cancer therapeutics , will ... Annual Rodman & Renshaw Global Investment Conference, sponsored by ... take place Tuesday, September 9th at 2:55 p.m. EDT ... New York Palace Hotel in New York ...
(Date:8/27/2014)... 2014  Decision Resources Group finds that physicians ... rheumatology, gastroenterology, endocrinology and nephrology) expect the robustness ... has been assessed in to be the strongest ... prescribe. Other key findings from ... Acceptance of Biosimilars Across Physician Specialties ...
(Date:8/27/2014)... TAMPA, Fla. , Aug. 27, 2014 ... announced today that it has released a preview of ... helping the pharmaceutical industry avoid drug shortages and maintain ... world-wide. The Plan, a first for ... pharmaceutical and biopharmaceutical industry members and describes how industry ...
Breaking Medicine Technology:DelMar Pharmaceuticals To Present At The 16th Annual Rodman & Renshaw Global Investment Conference 2DelMar Pharmaceuticals To Present At The 16th Annual Rodman & Renshaw Global Investment Conference 3DelMar Pharmaceuticals To Present At The 16th Annual Rodman & Renshaw Global Investment Conference 4Surveyed Physicians Expect to Choose Between Future Biosimilars Based on Robustness and Number of Clinical Trials 2ISPE Releases First Look at its Plan to Prevent Drug Shortages 2ISPE Releases First Look at its Plan to Prevent Drug Shortages 3ISPE Releases First Look at its Plan to Prevent Drug Shortages 4
(Date:8/27/2014)... Best SEO Hosting, a well-known SEO Hosts Review Site, has ... and GoDaddy are the most recommended suppliers for webmasters from ... hosting (including VPS and cloud hosting). , As one ... serving hosting small business websites since 1998. With more than ... the hosting industry for its affordable and easy to manage ...
(Date:8/27/2014)... The Latinos In Action Festival 2014 is being ... Florida State Fair Grounds from 9am - 9pm. Latinos ... from around the world. Latinos in Action Festival is ... and Univision Mobile, a service provided by T-Mobile company. ... 4,000 people from different backgrounds, cultures and nationalities. Come ...
(Date:8/27/2014)... Dennis Thompson HealthDay ... Someone who has been mugged in a dark alley will ... with a fear of being attacked. But neuroscientists working ... how memories are linked with positive and negative emotions. And ... emotions attached to a memory. In essence, they made ...
(Date:8/27/2014)... Texas (PRWEB) August 28, 2014 BRIC ... Outlook to 2020?, provides key market data on the ... of US dollars, volume (in units) and average prices ... Tip Video Laparoscopes and Flexible Tip Video Laparoscopes), Robotic ... are a number of advantages to the patient with ...
(Date:8/27/2014)... 27, 2014 Dr. Stewart Shofner ... see multitudes of patients suffering from impaired vision. Some ... Cataract vision correction surgery . Recently, Dr. Shofner has ... during an eye exam and also online. To help ... five myths about glaucoma. , 1)    Myth: People with perfect ...
Breaking Medicine News(10 mins):Health News:Well-known SEO Hosts Review Site Top10BestSEOHosting.com Recommends iPage, Bluehost and GoDaddy To Webmasters 2Health News:Marc Anthony to Perform at "Nieves Productions" Latinos in Action Festival 2Health News:Scientists 'Rewrite' Bad Memories in Mice 2Health News:Scientists 'Rewrite' Bad Memories in Mice 3Health News:Laparoscopes & Endoscopic Reprocessors Market in BRIC (Brazil, Russia, India & China) to 2020 Report Available at RnRMarketResearch.com 2Health News:Laparoscopes & Endoscopic Reprocessors Market in BRIC (Brazil, Russia, India & China) to 2020 Report Available at RnRMarketResearch.com 3Health News:Laparoscopes & Endoscopic Reprocessors Market in BRIC (Brazil, Russia, India & China) to 2020 Report Available at RnRMarketResearch.com 4Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 2Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 3Health News:Renowned Eye Surgeon Dr. Stewart Shofner Debunks Top Five Myths About Glaucoma 4
... ... With the Launch of New Bioactive Beverages , ... PROVO, UT (Vocus) April 14, 2010 -- Tahitian Noni International ... bioactive beverages , sales around the world have increased dramatically. Sales in North America have ...
... ... Dr. David Blyweiss in Boca Raton, FL finds that diet and supplements can play an ... (PRWEB) ... abdominal discomfort and altered bowel habits of the puzzling functional disorder named IBS. It has ...
... , ... Management Medicine Group (AMMG) responds to rising physician demand with a new age management ... ... Medicine Group (AMMG), an organization of physicians and healthcare providers presenting CME-accredited events, ...
... ... online service assisting patients in obtaining legal medical cannabis recommendations from qualified medical ... ... search and booking platform for medical marijuana evaluations, MarijuanaDoctors.com , today announced ...
... global use of known and proven maternal and childcare techniques, ... women, newborns and children each year, according to a new ... technical experts on maternal and child health. The meeting is ... a plan of action to reduce it. ...
... Mount Sinai School of Medicine will present several studies ... including a potential new drug for the treatment of ... in the disease,s severity. The meeting will take place ... Placebo Added to Glatiramer Acetate for 6 Months in ...
Cached Medicine News:Health News:Worldwide Sales in March Increase Dramatically At Tahitian Noni International 2Health News:Dr. David Blyweiss Announces New IBS Relief Protocol 2Health News:Dr. David Blyweiss Announces New IBS Relief Protocol 3Health News:Age Management Medicine Conference Reports 21% Spike in Physician Registration, Linked To Frustrations With New Health Reform Legislation 2Health News:Age Management Medicine Conference Reports 21% Spike in Physician Registration, Linked To Frustrations With New Health Reform Legislation 3Health News:Age Management Medicine Conference Reports 21% Spike in Physician Registration, Linked To Frustrations With New Health Reform Legislation 4Health News:MarijuanaDoctors.com Launches the First Online Search and Booking Engine for Patients Seeking Medical Marijuana Doctors 2Health News:MarijuanaDoctors.com Launches the First Online Search and Booking Engine for Patients Seeking Medical Marijuana Doctors 3Health News:Dying: Millions of women in childbirth, newborns and young children 2Health News:Dying: Millions of women in childbirth, newborns and young children 3Health News:Dying: Millions of women in childbirth, newborns and young children 4Health News:Dying: Millions of women in childbirth, newborns and young children 5Health News:Dying: Millions of women in childbirth, newborns and young children 6Health News:Dying: Millions of women in childbirth, newborns and young children 7Health News:Dying: Millions of women in childbirth, newborns and young children 8Health News:Dying: Millions of women in childbirth, newborns and young children 9Health News:Dying: Millions of women in childbirth, newborns and young children 10Health News:Groundbreaking MS research to be presented at American Academy of Neurology Annual Meeting 2Health News:Groundbreaking MS research to be presented at American Academy of Neurology Annual Meeting 3
... These specialty Eraser instruments have been ... with the right tool for situations ... a series of 25 gauge intraocular, ... discrete treatment of target tissues for ...
... itself to over 2,000 medical clinics nation ... user in mind, ChartingPlus relies heavily on ... features to improve documentation quality and increase ... Our medical content is specific to your ...
Transfer your exams to AltaPoint with our EMR Exam Word Lists. Document systems as normal and annotate exceptions to the systems in the exam. AltaPoint EMR is configured to allow a specialty to cust...
... Clinic Pro Software developed a touchscreen EHR ... spring. While a user can choose to ... practitioner to maintain eye contact while recording ... Clinic Pro EHR also runs on a ...
Medicine Products: