360° SearchNetwork Hot Spots Trends Time Series

XGEVA

Type: Product

Name: XGEVA

First reported 6 hours ago - Updated 6 hours ago - 1 reports

Xgeva approved to treat GCTB in adults and some adolescents

FDA approved the expanded use of denosumab (Xgeva, Amgen) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.Xgeva is the first FDA-approved treatment for this rare disease and was approved ... [Published Drugtopics.com - 6 hours ago]

Entities: XGEVA, Amgen Inc, Tumor, Patient

First reported Jun 17 2013 - Updated Jun 17 2013 - 1 reports

Dynavax Technologies Corp

Dynavax Technologies Corporation (DVAX), Elan Corporation, plc (ADR) (ELN): This Week in Biotech

With the SPDR S&P Biotech Index up 29% over the trailing-12-month period, it’s evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let’s have a look at some of the rulings, studies, and companies that ... [Published InsiderMonkey.com - Jun 17 2013]

Entities: Dynavax Technologies Corp, Élan Corporation plc, Biotechnology

First reported Jun 14 2013 - Updated Jun 15 2013 - 4 reports

Amgen Inc

Amgen Wins Expanded Xgeva Approval for GCTB

The FDA Thursday approved an additional indication for Amgen’s Xgeva to treat adults and some adolescents with giant cell tumor of the bone (GCTB), which is rare and usually non-cancerous. ... [Published FDA News - Jun 15 2013]

Entities: XGEVA, Amgen Inc, Tumor

First reported Jun 15 2013 - Updated Jun 15 2013 - 1 reports

Amgen's Investor's Business Daily

Amgen's (AMGN) Xgeva received FDA approval for treating giant cell tumors of the bone. Xgeva had prior OK to treat osteoporosis and cancers that have spread to the bone. The approval came under the FDA's expedited review program. Shares fell 1.1% to ... [Published Yahoo! Finance - Jun 15 2013]

Entities: XGEVA, Osteoporosis, Tumor

First reported Jun 13 2013 - Updated Jun 14 2013 - 39 reports

FDA Food & Drug Administration

US FDA approves Xgeva to treat giant cell tumour of the bone

Xgeva is a monoclonal antibody that binds to RANKL, a protein essential for maintenance of healthy boneThe US Food and Drug Administration (US FDA) expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumour ... [Published Express Pharma - Jun 14 2013]

Entities: XGEVA, Tumor, FDA Food & Drug Administration

First reported Jun 14 2013 - Updated Jun 14 2013 - 1 reports

Weekly Roundup – 6/14/13

Happy Flag Day! It is difficult to comprehend the speed with which the year is going by – in just two weeks, 2013 will be half over. I am kind of still in 1996 in my head… In any case, this week happened, with storms to spare, and here is a bit ... [Published Eye on FDA - Jun 14 2013]

Entities: FDA Food & Drug Administration, XGEVA, Medical Devices

First reported Jun 14 2013 - Updated Jun 14 2013 - 1 reports

New Indication for Xgeva

2013The FDA has approved Amgenâs Xgeva (denosumab) for the treatment of adults and some adolescents with giant cell tumor of the bone (GCTB). Xgeva is intended for patients whose GCTB cannot be surgically removed or when surgery is likely to result in ... [Published Facts & Comparisons - Jun 14 2013]

Entities: XGEVA, Denosumab, bone metastases

First reported Jun 14 2013 - Updated Jun 14 2013 - 1 reports

FDA Approves New Use For Drug From Ventura County Based Biotech Giant

The federal Food And Drug Administration has approved a new use for a major selling drug from a Ventura County based biotech giant.The federal regulatory agency okayed the use of Xgeva for a certain type of bone tumor. It was previously approved as a ... [Published KCLU - Jun 14 2013]

Entities: FDA Food & Drug Administration, Biotechnology, XGEVA, Drugs

First reported Jun 13 2013 - Updated Jun 13 2013 - 1 reports

Xgeva OK'd for Rare Bone Tumor

(MedPage Today) -- SILVER SPRING, Md. -- The bone-active biologic drug denosumab (Xgeva) may be used to treat giant cell tumor of the bone when surgery is contraindicated, the FDA announced Thursday. ... [Published MedPageToday.com - medical news plus CME for ph ... - Jun 13 2013]

Entities: XGEVA, Denosumab, Tumor, FDA Food & Drug Administration, Drugs

First reported Jun 12 2013 - Updated Jun 12 2013 - 2 reports

Amgen's Management Presents at 2013 Goldman Sachs Healthcare Conference (Transcript)

Amgen Inc. (AMGN)2013 Goldman Sachs Healthcare ConferenceJune 11, 2013 2:20 pm ET Jonathan M. Peacock - EVP and Chief Financial OfficerAnthony C. Hooper - EVP, Global Commercial Operations Terrence Flynn - Goldman Sachs & Co. Terrence Flynn - Goldman ... [Published Yahoo! Finance - Jun 12 2013]

Entities: Tony Hooper, Goldman Sachs Group Inc, Patient, Drugs, Amgen Inc

First reported Jun 06 2013 - Updated Jun 06 2013 - 1 reports

Amgen Inc. Is A Buy For Short Term Investors

In the race to find possible cures for many serious illnesses, Amgen (AMGN) is one of the several companies that are engaged in the healthcare sector of the United States, focusing on the biotechnology industry. Amgen is credited as the world's largest ... [Published Seeking Alpha - Jun 06 2013]

Entities: Amgen Inc, Drugs, XGEVA, Prolia

First reported May 30 2013 - Updated May 30 2013 - 1 reports

Amgen's Management Presents at 2013 Deutsche Bank dbAccess Health Care Conference (Transcript)

Amgen Inc. (AMGN)2013 Deutsche Bank dbAccess Health Care ConferenceMay 30, 2013 9:20 am ET Arvind Sood - Vice President, Investor Relations Robyn Karnauskas - Deutsche Bank Research Robyn Karnauskas - Deutsche Bank Research Good morning everyone. My name ... [Published Yahoo! Finance - May 30 2013]

Entities: Enbrel, epoetin alfa, Omontys, Deutsche Bank AG, HUMIRA

Quotes

...of bone that cannot be adequately treated with surgery," said Sean E Harper, MD, executive vice president of Research and Development at Amgen. "Advances in our understanding of the underlying biology of this rare disorder have allowed Amgen to generate compelling clinical evidence to address the medical needs of patients and their healthcare providers."

Amgen's Xgeva receives US FDA approval for treatment of giant cell tumour of bone [Published PharmaBiz - Jun 15 2013]

...and we are hopeful that we will achieve the same outcome with the Phase 3 program," stated Hank Fuchs, M D , Chief Medical Officer of BioMarin. "Adult patients with PKU and patients on the severe end of the disease spectrum still represent a very high unmet medical need. With PEG-PAL, it may be possible to provide a treatment benefit to this population."

BioMarin Initiates Phase 3 Trial for PEG-PAL; Elan To Proceed with Formal Sale Process [Published BioMedReports - Jun 15 2013]

FDA CenterCenter for Drug Evaluation and ResearchResearch Office of Hematology and Oncology Products director Dr Richard Pazdur said; "Today's approval of Xgeva provides a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery."

FDA approves Xgeva to treat giant cell tumour of the bone [Published Pharmaceutical Technology - Jun 14 2013]

More From BioPortfolio on "Amgen’s Xgeva Gains FDA Nod For Use In Rare Bone Tumor"

Amgens Xgeva Gains FDA Nod For Use In Rare Bone Tumor [Published BioPortfolio - Jun 14 2013]

More Content

sort by: Date \| Relevance
Xgeva approved to treat GCTB in adults and some... [Published Drugtopics.com - 6 hours ago]
Postmenopausal Hormone Receptor–Positive Advanc... [Published Cancernetwork.com - Jun 18 2013]
Healthcare Review: Medivation, Atossa Genetics ... [Published BioMedReports - Jun 17 2013]
Dynavax Technologies Corporation (DVAX), Elan C... [Published InsiderMonkey.com - Jun 17 2013]
Overtraded Stocks: SolarCity, Tesla Motors, Eli... [Published Galaxy Stocks - Jun 17 2013]
FDA Approves Denosumab for Giant Cell Tumor of ... [Published American Society of Clinical Oncology - Jun 15 2013]
Amgen Wins Expanded Xgeva Approval for GCTB [Published FDA News - Jun 15 2013]
Amgen's Xgeva receives US FDA approval for trea... [Published PharmaBiz - Jun 15 2013]
Amgen's Investor's Business Daily [Published Yahoo! Finance - Jun 15 2013]
BioMarin Initiates Phase 3 Trial for PEG-PAL; E... [Published BioMedReports - Jun 15 2013]
Amgen's Xgeva gets new approval, just not one i... [Published FiercePharma - Jun 14 2013]
Amgen's Denosumab Gets FDA OK for Giant-Cell Tu... [Published Genetic Engineering News - Jun 14 2013]
US FDA approves Xgeva to treat giant cell tumou... [Published Express Pharma - Jun 14 2013]
Amgens Xgeva gets new approval just not one it ... [Published Big News Network - Jun 14 2013]
FDA approves Amgen?s XGEVA® (denosumab) for the... [Published European Pharmaceutical Review - Jun 14 2013]
FDA approves Xgeva to treat giant cell tumour o... [Published Pharmaceutical Technology - Jun 14 2013]
Weekly Roundup – 6/14/13 [Published Eye on FDA - Jun 14 2013]
FDA Approves Xgeva to Treat Giant Cell Tumor of... [Published Drugs.com - Jun 14 2013]
FDA Backs New for Amgen Drug for Rare Bone Ttumors [Published Big News Network - Jun 14 2013]
6/14/13 - FDA approves Amgen's Xgeva for treati... [Published Pharmacy Choice - Jun 14 2013]
FDA Approves New Use for Amgen’s Xgeva, in GCTB [Published Pharma-Mag - Jun 14 2013]
FDA clears Amgen's Xgeva for rare bone condition [Published PMLive - Jun 14 2013]
Xgeva (Denosumab) Approved For Giant Cell Tumor... [Published Medical News Today - Jun 14 2013]
New Indication for Xgeva [Published Facts & Comparisons - Jun 14 2013]
FDA approves drug for rare bone condition [Published PredictWallStreet - Jun 14 2013]
Xgeva (Denosumab) Approved For Giant Cell Tumor... [Published MediLexicon - Jun 14 2013]
Amgen receives US FDA's approval for XGEVA for ... [Published Individual.com - Jun 14 2013]
Amgens XGEVA receives FDA approval to treat gia... [Published Big News Network - Jun 14 2013]
Amgen's XGEVA receives FDA approval to treat gi... [Published PBR - News - Jun 14 2013]
Xgeva receives FDA approval for treating giant ... [Published Big News Network - Jun 14 2013]

Blogs

sort by: Date \| Relevance
Weekly Roundup – 6/14/13 [Published Eye on FDA - Jun 14 2013] Happy Flag Day! It is difficult to comprehend the speed with which the year is going by – in just two weeks, 2013 will be half over. I am kind of still in 1996 in my head… In any case, this week happened, with storms to spare, and here is a bit ...
FDA Approves New Use for Amgen’s Xgeva, in GCTB [Published Pharma-Mag - Jun 14 2013] FDA approved Amgen ’s Xgeva® (denosumab) for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone (GCTB) that is unresectable, or in cases where surgical resection is likely to result in severe morbidity. The RANKL-binding ...
Amgen's XGEVA receives FDA approval to treat gi... [Published PBR - News - Jun 14 2013] The US Food and Drug Administration (FDA) has given its clearance to Amgen's XGEVA (denosumab) to treat adult or skeletally mature patients suffering from giant cell tumor of bone (GCTB). ...
Opinion/decision on a Paediatric Investigation ... [Published Opinion/decision on a Paediatric Investigation ... - May 31 2013]
Drug Costs In Hospitals & Clinics To Rise 4 Per... [Published Pharmalot - Feb 19 2013] The cost of medications administered by clinics and hospitals are expected to rise by as much as 4 percent this year, which is less than in previous years, thanks to the increasing availabitily of lower-cost generics, according to a study in the American ...

Press Releases

sort by: Date \| Relevance
FDA Approves Amgen's XGEVA® (denosumab) For The... [Published PR Newswire: Policy & Public Interest - Jun 13 2013]
Research and Markets: Xgeva (Prostate Cancer) -... [Published Business Wire Health News - Mar 20 2013]