Navigation Links
FDA Extends Review of Genasense(R) NDA Appeal in Chronic Lymphocytic Leukemia
Date:1/14/2008

BERKELEY HEIGHTS, N.J., Jan. 14 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced today that the Food and Drug Administration (FDA) has extended its review of Genta's appeal of the non- approvable decision for a New Drug Application (NDA) that proposed the use of Genasense(R) (oblimersen sodium injection) plus chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia. The Company had previously provided guidance that a final decision would be available in the fourth quarter of 2007. Genta now envisions receiving this notification later in the current quarter.

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. Ganite(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, plea
'/>"/>

SOURCE Genta Incorporated
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Baxa Corporation Extends Global Reach With New Distribution Agreements in Colombia and the Dominican Republic
2. Quark Pharmaceuticals Extends Research Agreement with State University of New York for Proprietary siRNA Compounds for Acute Hearing Loss
3. Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS)
4. Halozyme Therapeutics Announces Peer-Reviewed Publications of the INFUSE-LR Clinical Trial Results and Clinical Practice Experience With Hylenex
5. Berkery Noyes Represented The Thomson Corporation in the Sale of CenterWatch and New England Institutional Review Board to Jobson Medical Information
6. FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma
7. Initiation of Coverage Informational Review Issued by Scimitar Equity Research
8. Sulodexide Data Safety Monitoring Committee Completes Additional Review of Phase 3 Study Data
9. Emphasys Medical Granted Expedited Review From FDA for Zephyr(R) Endobronchial Valve
10. Review of Probiotic Trial Research Finds Only Bifantis(R) Able to Claim Efficacy versus Placebo for IBS Symptoms
11. Risks Associated With Face Transplants May Be Lower Than Previously Thought, ASPS Journal Review Suggests
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2015)... -- Protein purification involves the process of isolating proteins ... properties. The objective of a protein purification process is ... fewest contaminants. The global protein purification and isolation market ... 5% to 6% during the forecast period. This market ... and biotechnological fields, growing need to identify new protein-based ...
(Date:5/27/2015)... 2015  Precision Advisors ( www.precisionadvisors.com ), a Precision ... Digital Trends Study of 145 managed care executives. The ... concepts of big data and predictive analytics, but are ... The Health Information Technology for Economic and Clinical Health ... use of electronic medical records (EMRs) by 2014. While ...
(Date:5/27/2015)... , May 27, 2015 ... announced the addition of the  "US Cancer ... their offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... into to two broad categories of prophylactic ... cancer vaccines belong to both of these ...
Breaking Medicine Technology:Protein Purification & Isolation Market by Technology by Product by Application & End User - Global Forecast to 2020 2Protein Purification & Isolation Market by Technology by Product by Application & End User - Global Forecast to 2020 3Precision Advisors Digital Trends Study: Less Than Half of Managed Care Organizations Have Access to Electronic Medical Records Data 2Precision Advisors Digital Trends Study: Less Than Half of Managed Care Organizations Have Access to Electronic Medical Records Data 3US Cancer Vaccine Market Outlook 2020 2US Cancer Vaccine Market Outlook 2020 3
(Date:5/27/2015)... The Case Management Society of ... provide CMSA's Career and Knowledge Pathways educational program ... strengthen the case/care management workforce by offering aptitude ... mutually beneficial agreement provides Medix, a workforce solutions ... in the healthcare, scientific and IT industries, access ...
(Date:5/27/2015)... SAN DIEGO, May 27, 2015 – Memorial Hospital, ... provider along the Gulf Coast to pioneer a ... partnership with MD Revolution, a digital care management ... that enables healthcare providers to easily meet Medicare’s ... user-friendly program is designed to improve patient engagement, ...
(Date:5/27/2015)... 2015 CompanionDx announced that ... genomic analysis in personalized cancer therapy: Non-small cell lung ... Society of Clinical Oncology (ASCO) as part of their ... , The molecular and clinical data used for the ... database. The study reports improved patient outcomes from a ...
(Date:5/27/2015)... IL (PRWEB) May 27, 2015 On ... North-based advertising agency, will partner with LifeSource to host ... event will take place in a LifeSource donor coach ... a.m. to 4:00 p.m. , Demand for whole blood ... in Illinois, during the summer months. LifeSource requires approximately ...
(Date:5/27/2015)... Dallas, Texas (PRWEB) May 27, 2015 ... on the current state of the Omega-3 industry. ... industry including definitions, classifications, applications and industry chain ... the international markets including development trends, competitive landscape ... Products, Gc Rieber Oils, Camanchaca Fishing Company, Seadragon ...
Breaking Medicine News(10 mins):Health News:Case Management Society of America Partners with Medix to Offer Career and Knowledge Pathways 2Health News:Case Management Society of America Partners with Medix to Offer Career and Knowledge Pathways 3Health News:Memorial Hospital Selects MD Revolution's Digital Health Platform to Deliver a New Form of Chronic Care Management 2Health News:Memorial Hospital Selects MD Revolution's Digital Health Platform to Deliver a New Form of Chronic Care Management 3Health News:CompanionDx® Analyzes Non-small Cell Lung Cancer Data for Personalized Cancer Therapy 2Health News:CompanionDx® Analyzes Non-small Cell Lung Cancer Data for Personalized Cancer Therapy 3Health News:Donate Your Break and Save Lives at the River North Blood Drive 2Health News:Omega-3 Market: Global 2015 Analysis & 2020 Forecasts on Market Size 2
... The number of heat-related deaths is underestimated and underreported ... study published in Biomedical Market Newsletter//(R). ,A ... of heat-related deaths is actually 54% higher than previously ... hyperthermia as a contributing cause of death increased by ...
... estimate of the repercussions of a potential flu pandemic showed ... the underprivileged nations, could pay// with their life. , ... infamous 1918 Spanish flu, which wiped out nearly 20 million ... of Public Health and the University of Queensland studied the ...
... pain are effective, a new review of studies has ... such as// depression and health-related quality of life, they ... ,“Because this analysis was both more inclusive and more ... to date that these interventions are helpful,” said psychologist ...
... eight year old cancer patient may be forced to undertake ... the painful radiotherapy. Having beaten the condition called Wilm’s Tumour ... been confronted by the tumour after a three year respite. ... attack has left the child with a poor quality of ...
... Journal of Neurology Neurosurgery and Psychiatry published a study which ... for treating wrinkled skin could ease writer’s cramp as well. ... hand, arms or fingers which causes pain. This can also ... with their other hand, but in one in four cases, ...
... recently published a study which proves that fish oil supplements ... ,The trial was done on 98 women who ... from 20th week of their pregnancy till the birth of ... not routinely eat more than two weekly portions of fish ...
Cached Medicine News:Health News:Psychological Treatments Improve Outcomes for Back Pain Sufferers 2Health News:Psychological Treatments Improve Outcomes for Back Pain Sufferers 3Health News:Fish Oil Improves Toddler’s Hand-eye Coordinatio 2
25 mm blunt, double-edged blade. Flat handle....
For use with N4096 R, N4097 R and N4098 R. 18 mm wide x 167 mm long. Ten per package. Designated most popular model or size....
5 mm small, sharp, protected blade. Angled at 105 degrees. Flat handle. Designated most popular model or size....
4 mm blade. Bayonet. Flat handle....
Medicine Products: