Navigation Links
FDA Issues Complete Response Letter For Trabectedin Combined With DOXIL
Date:9/10/2009

HORSHAM, Pa., Sept. 10 /PRNewswire/ -- Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for trabectedin when administered in combination with DOXIL(R) (doxorubicin HCI liposome injection) for the treatment of women with relapsed ovarian cancer. The agency has requested additional information, including overall survival data from the company's ongoing pivotal trial and additional clinical pharmacology studies.

Centocor Ortho Biotech Products continues to believe that trabectedin has an important role in the treatment of patients with ovarian cancer. The company is reviewing the FDA's letter and will respond to the agency's questions as quickly as possible.

The NDA for trabectedin was submitted to the FDA in November 2008.

About Trabectedin

Trabectedin is a novel cytotoxic antitumor agent that was originally derived from the marine tunicate, Ecteinascidia turbinata. The compound is now produced synthetically. Trabectedin binds to the minor groove of DNA and bends it toward the major groove, causing DNA adducts that interfere with cell division and genetic transcription processes and DNA repair machinery. Under a licensing agreement with PharmaMar SAU of Spain, Centocor Ortho Biotech Products, L.P. has worldwide marketing rights for trabectedin except in Europe, where the product is marketed as YONDELIS(R) by PharmaMar SAU and Japan, where PharmaMar SAU and Taiho Pharmaceutical CO., LTD. have a licensing agreement to develop and commercialize YONDELIS.

About Centocor Ortho Biotech Products, L.P.

Centocor Ortho Biotech redefines the standard of care in immunology, nephrology, and oncology. The company was formed when Centocor, Inc
'/>"/>

SOURCE Centocor Ortho Biotech Products, L.P.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

Related biology technology :

1. Pharmos Issues Letter to Shareholders
2. MichBio Issues 2007/8 Michigan Life Sciences Directory and Resources Guide
3. HHS Issues First Department-Wide Report on Personalized Health Care
4. CalbaTech Issues Update; Beginning Training for Adult Stem Cell Collections in Atlanta
5. Symmetry Medical Discloses Accounting Issues at Sheffield, UK Operating Unit and Possible Restatement
6. CCPM Issues Statement on FDAs GIVE Initiative
7. Maryland Stem Cell Commission Issues Nationwide Request for Applications for New Post-Doctoral Fellowship Grants
8. FDA Issues Approvable Letter for LUVOX(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
9. Baxter Issues Urgent Nationwide Voluntary Recall of Heparin 1,000 Units/mL 10 and 30mL Multi-Dose Vials
10. Insmed CEO Issues Statement on White House FY09 Budget and FDA Statements on Follow-On Biologics
11. Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early Communication
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... PHILADELPHIA , Sept. 2, 2014  TransCelerate ... developed a recommended approach for protecting personal data ... with researchers, patients and others. The document describes ... personal information from CSRs and other related clinical ... The goal of the TransCelerate CSR ...
(Date:9/2/2014)... Opertech Bio, Inc., a company ... effective approach to sensory evaluation, today announced the ... U.S. Patent and Trademark Office, encompassing high-throughput sensory ... “Opertech’s taste evaluation technology called Microtiter Operant Gustometer ... system for rapid characterization of taste sensory properties,” ...
(Date:9/2/2014)... 2014 /PRNewswire/ - Oncothyreon Inc. (Nasdaq: ONTY ) announced ... Executive Officer, will present at the Rodman & Renshaw 16 ... York on Tuesday, Sept. 9, 2014 at 2:05 ... of the presentation will be accessible by visiting the Oncothyreon ... About Oncothyreon Oncothyreon is ...
(Date:9/2/2014)... 02, 2014 PMG Research, Inc ... clinical research site: PMG Research of Rocky Mount. Effective ... of the clinical research department at Boice-Willis Clinic ... in eastern North Carolina. This new site enhances PMG’s ... in Rocky Mount and the surrounding communities, this brings ...
Breaking Biology Technology:TransCelerate BioPharma Inc. Releases Recommended Approach for Protecting Personal Data in Clinical Study Reports 2TransCelerate BioPharma Inc. Releases Recommended Approach for Protecting Personal Data in Clinical Study Reports 3Opertech Bio Receives U.S. Patent for High-Throughput Taste Evaluation Technology 2PMG Research Announces the Formation of its Eleventh Site 2PMG Research Announces the Formation of its Eleventh Site 3
... Cell Technologies, Inc., a leader in adult stem cell research and ... Stemedica,s Scientific Advisory Board. In this capacity, she will help ... and cellular delivery system for burn and wound management. , ... ...
... the American Society of Clinical Oncology (ASCO) annual meeting, May ... at 5:00 p.m. Eastern Time - REDWOOD CITY, Calif., April ... today announced that the QUASAR validation study met its ... II colon cancer patients following surgery, and that the colon ...
... and CAMBRIDGE, Mass., April 14 ( AACR ... Genstruct Inc. , a systems biology company focused ... develop novel therapeutics, molecular diagnostics and patient-specific therapies, today ... one of its top pharmaceutical partners will be presented ...
Cached Biology Technology:Stemedica Signs Scientific Advisory Board Agreement with Leading Pediatric Burn & Wound Care Researcher 2Stemedica Signs Scientific Advisory Board Agreement with Leading Pediatric Burn & Wound Care Researcher 3Stemedica Signs Scientific Advisory Board Agreement with Leading Pediatric Burn & Wound Care Researcher 4Genomic Health Announces Positive Preliminary Results from QUASAR Validation Study of Oncotype DX(R) Colon Cancer Assay 2Genomic Health Announces Positive Preliminary Results from QUASAR Validation Study of Oncotype DX(R) Colon Cancer Assay 3Genomic Health Announces Positive Preliminary Results from QUASAR Validation Study of Oncotype DX(R) Colon Cancer Assay 4Genstruct to Present Results of Collaboration with Top Pharmaceutical Company at American Association for Cancer Research's Annual Meeting 2
(Date:9/2/2014)... of Human Genetics (ASHG) and the National Human ... Institutes of Health, have named Elizabeth P. Tuck, ... School in Columbus, Ohio, the first ASHG/NHGRI Genetics ... , The Genetics and Education Fellowship is intended ... experience, and network to prepare for a career ...
(Date:9/2/2014)... of Evolutionary Biology study provides evidence that ... diversification. , Investigators argue that the same factor ... Galpagos Islands is also responsible for the linguistic ... barriers that impede interaction between speech communities. Therefore, ... due to a reduction of linguistic contact. , ...
(Date:9/2/2014)... sequence their genetic information. How is it possible ... parts of the body are so different? While every ... additional regulatory layer exists that determines which of the ... modifications of genome-bound histone proteins or the DNA itself ... top of the genetic information and is thus called ...
Breaking Biology News(10 mins):ASHG and NHGRI award first genetics and education fellowship 2Throwing a loop to silence gene expression 2
... the momentum of,September,s impressive showing at the ePassports EAC ... ) advances its role as the,world,s ePassport leader by ... to advanced second-generation ePassports based on the,Extended Access Control ... "Second-generation ePassports represent the beginning of an evolution that,will ...
... WALNUT CREEK, Calif. The U.S. Department of Energy Joint ... assembly of the soybean (Glycine max) genetic code, making ... new breeding strategies for one of the world,s most ... 70 percent of the world,s edible protein, but also ...
... as an homage to achievement in the field of coral ... link between corals of the Pacific and Atlantic. Dr. Ann ... McNeill of the University of Miami named a new species ... some six million years old after renowned coral reef ...
Cached Biology News:The Finnish Population Register Centre to Deploy Entrust EAC ePassport CA Solution 2The Finnish Population Register Centre to Deploy Entrust EAC ePassport CA Solution 3The Finnish Population Register Centre to Deploy Entrust EAC ePassport CA Solution 4DOE Joint Genome Institute completes soybean genome 2DOE Joint Genome Institute completes soybean genome 3Isopora or isn't it? 2
Rat integrin a6b1, mainly associated with epithelial cells. Does not react with rat fibroblasts....
Rabbit polyclonal to Streptococcus Enterotoxin C ( Abpromise for all tested applications)....
Mouse monoclonal [4i144] to HLA Class II DQ1 7 ( Abpromise for all tested applications). Antigen: Full length protein (Human): HLA Class 2 Antigen DQ1,7....
... 100 g monoclonal antibody which can ... V from heart mitochondria. Also included are ... control immunocapture. The Complex V immunocapture kit ... (E.C. 3.6.3.14) from small amounts of tissue. ...
Biology Products: