Navigation Links
Medarex and Bristol-Myers Squibb Joint Statement on Submission Status of Ipilimumab
Date:4/25/2008

PRINCETON, N.J., April 25 /PRNewswire-FirstCall/ -- Medarex, Inc. (Nasdaq: MEDX) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that, after meeting with the U.S. Food and Drug Administration (FDA), the companies will delay the Biologics License Application (BLA) submission for ipilimumab, an investigational immunotherapy for patients with advanced metastatic melanoma. The FDA has requested additional overall survival (OS) data to further demonstrate the benefit of ipilimumab. Revised timelines are under development, but a BLA for ipilimumab will not be submitted to the FDA in 2008.

The randomized Phase 3 trial evaluating the efficacy of ipilimumab in combination with dacarbazine versus dacarbazine alone in patients with untreated unresectable Stage III or Stage IV melanoma is ongoing under Special Protocol Assessment (SPA). The companies are engaged in discussions with the FDA to change the primary endpoint in this trial from progression free survival (PFS) to OS. A potential submission for melanoma would include survival data from patients in the Phase 2 second-line studies and the randomized Phase 3 first-line trial currently ongoing.

Bristol-Myers Squibb and Medarex remain committed to the development of ipilimumab. The companies also have ongoing Phase 2 studies in hormone-refractory prostate cancer and lung cancer as well as a Phase 3 study, to be initiated shortly, in adjuvant melanoma.

Twelve abstracts evaluating ipilimumab in melanoma will be presented at the American Society
'/>"/>

SOURCE Medarex, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Medarex Announces 2007 Fourth Quarter and Year End Financial Results
2. Medarex to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology & Medical Device Conference
3. Medarex to Receive Milestone Payment for Submission of Regulatory Applications Requesting Approval of Ustekinumab (CNTO 1275) for Treatment of Psoriasis
4. PharmAthene and Medarex Announce Additional $0.8 Million U.S. Government Appropriation for Continued Development of Anthrax Therapeutic Valortim(TM)
5. Medarex to Present at the JPMorgan Small/Mid Cap Conference
6. Ono and Medarex Announce Allowance of Investigational New Drug Application for Fully Human Anti-PD1 Antibody
7. Former Bristol-Myers Squibb Senior Vice President Indicted for Lying to the Federal Government About Popular Blood-Thinning Drug
8. Bristol-Myers Squibb to Announce Results for the First Quarter of 2008 on April 24
9. Bristol-Myers Squibb to Present at Healthcare Conferences
10. Bristol-Myers Squibb Company Reports Financial Results for the Fourth Quarter and Twelve Months of 2007
11. Avista Capital Partners Completes Acquisition of Bristol-Myers Squibb Medical Imaging
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2014)... 11, 2014 Shoulder instability is a ... return to play has not been regularly determined following ... Society for Sports Medicine’s ( AOSSM ) Annual Meeting ... approximately 90 percent no matter what the stabilization procedure ... rate of return to play following shoulder stabilization surgery. ...
(Date:7/11/2014)... occur more than 200,000 times a year, but the ... may determine how long you stay in the game, ... Meeting of the American Orthopaedic Society of Sports Medicine ... in a young athletic population, allografts (tissue harvested from ... harvested from the patient)," said Craig R. Bottoni, MD, ...
(Date:7/11/2014)... (PRWEB) July 11, 2014 Woodland Hills ... founder of the Anacapa Dental Art Institute in Woodland Hills ... Biocare World Symposium in Marina Del Rey, Calif. , ... master class on the permanent teeth in one day dental ... teeth in one day was developed 15 years ago, Dr. ...
(Date:7/11/2014)... (PRWEB) July 11, 2014 The World Cup ... according to recent reports , many star soccer players left ... in the media to American football when it comes to ... risk is always there. While none of the soccer superstars ... possibility remains. Beverly Hills spine surgeon Dr. Gravori reveals some ...
(Date:7/11/2014)... 2014 On Tuesday, July 9, Eric ... VA office joined CBS affiliate WUSA’s Andrea Roane ... the audience about the number of ways Shady Grove ... motherhood possible for women after they undergo cancer ... patients in the developing field known as oncofertility which ...
Breaking Medicine News(10 mins):Health News:Stabilizing Shoulder Surgery Helps NFL Players Return to the Game 2Health News:ACL reconstructions may last longer with autografts 2Health News:Woodland Hills Dental Expert Speaking at Nobel Biocare World Symposium in One Week 2Health News:Woodland Hills Dental Expert Speaking at Nobel Biocare World Symposium in One Week 3Health News:Woodland Hills Dental Expert Speaking at Nobel Biocare World Symposium in One Week 4Health News:Woodland Hills Dental Expert Speaking at Nobel Biocare World Symposium in One Week 5Health News:As World Cup Comes to an End, Injuries are Star of the Show 2Health News:As World Cup Comes to an End, Injuries are Star of the Show 3Health News:Baby After Cancer Is a Reality as Shady Grove Fertility Provides Successful Treatment for Cancer Survivors 2Health News:Baby After Cancer Is a Reality as Shady Grove Fertility Provides Successful Treatment for Cancer Survivors 3Health News:Baby After Cancer Is a Reality as Shady Grove Fertility Provides Successful Treatment for Cancer Survivors 4
... The University of Houston (UH) will soon open its doors ... a new joint venture between the UH Graduate College of ... Cancer Center Division of Cancer Prevention and Population Sciences. CHEER ... the newly opened center at UH GCSW. CHEER ...
... blood vitamin D levels, there,s uncertainty about where the ... threshold amount has become controversial as several scientific societies ... University of Washington researchers conducted an observational study. They ... circulating in the blood to lower the risk of ...
... , TUESDAY, May 1 (HealthDay News) -- Children with ... hospitalized than children without arthritis, a new study says. ... higher infection risk among kids with arthritis, other arthritis ... inhibitors -- were not. Researchers analyzed Medicaid ...
... can have as much effect on the teens, substance ... "Among friendship groups with ,good parents, there,s a ... aware of your whereabouts, and your friends, parents are ... you are less likely to use substances," said Michael ...
... announced today the inaugural class of its Presidential ... early career researchers with financial support to attend ... exclusive networking and mentoring opportunities with AcademyHealth leadership ... "The presidential scholarships are an opportunity for ...
... 1, 2012 Scientists at Joslin Diabetes Center have identified ... rapamycin) protein kinase, a critical regulator of cell growth which ... finding not only illuminates the physiology of aging but could ... conditions, such as cancer, type 2 diabetes, and neurodegeneration. ...
Cached Medicine News:Health News:University of Houston Graduate College of Social Work announces partnership with MD Anderson 2Health News:Researchers determine vitamin D blood level for reducing major medical risks in older adults 2Health News:Arthritis in Children Linked to Infections 2Health News:It takes a village to keep teens substance free 2Health News:First recipients of AcademyHealth's Presidential Scholarship announced 2Health News:Joslin scientists identify important mechanism that affects the aging process 2Health News:Joslin scientists identify important mechanism that affects the aging process 3
(Date:1/15/2014)... 15, 2014 Most osteoporosis patients want a choice ... online survey* sponsored by Mission Pharmacal Company. The survey, ... Foundation online support community, revealed that 74 percent of ... in a form other than a pill or a ...
(Date:1/15/2014)... (the "Company") (NASDAQ: CLSN ) today announced ... purchase an aggregate of approximately $15 million of the ... led by a dedicated health care fund. ... investors pursuant to which the Company agreed to sell ...
(Date:1/15/2014)... 15, 2014  Manufacturers, suppliers and distributors of innovative ... protect their most important business assets, intellectual property ... Because of the highly-competitive nature of ... of the most litigious industry sectors of cases ...
Breaking Medicine Technology:Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 2Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Intellectual Property Insurance for Medical-related Products and Services 2
... Md., June 01, 2007 /PRNewswire-FirstCall/ --,EntreMed, Inc. ... the treatment of cancer and inflammatory diseases,announced ... Aurora,kinase - angiogenesis inhibitor, ENMD-981693. The data ... EntreMed,scientists at the 2nd Protein Kinases in ...
... Calif., June 01, 2007,/PRNewswire-FirstCall/ -- Sunesis Pharmaceuticals, Inc. ... ongoing clinical,studies of SNS-595 and SNS-032 at the ... held June 7-10, 2007 in Vienna,Austria. , Presentations ... 1 clinical trial of SNS-595 in acute leukemias, ...
Cached Medicine Technology:EntreMed's Aurora Kinase Inhibitor Induces Tumor Regression in,Preclinical Models 2EntreMed's Aurora Kinase Inhibitor Induces Tumor Regression in,Preclinical Models 3Sunesis Pharmaceuticals to Present Data at the 12th Congress of the,European Hematology Association 2Sunesis Pharmaceuticals to Present Data at the 12th Congress of the,European Hematology Association 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: