Navigation Links
TREANDA New Drug Application for the Treatment of Chronic Lymphocytic Leukemia Granted Priority Review Status by FDA
Date:12/3/2007

FRAZER, Pa., Dec. 3 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review designation to the TREANDA(R) (bendamustine HCl) New Drug Application (NDA) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL). CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States. Cephalon filed the TREANDA NDA for CLL in September 2007 and the FDA will make a review decision by the end of March 2008.

"If approved, TREANDA will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be available as soon as the second quarter of 2008," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations.

The FDA assigns priority review to drugs that, if approved, would offer major advances in treatment or would provide treatment to patients where no adequate therapy exists. Priority review reduces the targeted NDA review time from 10 months to six months. FDA granted orphan drug status for TREANDA for CLL in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity in the United States, if the product is approved for this indication.

About TREANDA

TREANDA is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that this rationally designed hybrid acts in two ways to kill cancer cells. TREANDA damages the DNA in cancer cells, which leads to the normal path of cell death (apoptosis). It also stops cancer cells from dividing to create new cancer cells. This dual-action of TREANDA may be attributable to its unique chemical design.

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH. Bendamustine HCl, the active ingredient in
'/>"/>

SOURCE Cephalon, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Cephalon Submits New Drug Application for TREANDA for the Treatment of Chronic Lymphocytic Leukemia
2. Schering-Plough/Merck Pharmaceuticals Announce FDA Filing Acceptance of New Drug Application for Loratadine/Montelukast Tablet
3. Investigational New Drug Application for Fat Melting Injections Cleared by the FDA
4. PreMD Provides Update on 510(k) Application for PREVU(x) POC
5. Mindray Selects Actel Low-Power Flash FPGAs for Demanding Medical Equipment Applications
6. Medical Services International Inc. Completes Testing for European Union (EU) Application
7. Pharsight Files Application for Nasdaq Capital Market Listing
8. PartsSource Awarded US Patent for PartsFinder(TM) Application
9. HealthCentral.com Launches Greeting Card Application on Facebook.com
10. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
11. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... 24, 2014 (HealthDay News) -- Not getting the right ... colitis, a new study suggests. Those who sleep ... hours per night may be more prone to developing ... researchers report. The study authors concluded that duration and ... among patients with inflammatory bowel diseases. "Both short ...
(Date:10/25/2014)... Oct. 23, 2014 (HealthDay News) -- Current osteoporosis ... younger postmenopausal women at risk for osteoporosis-related fractures, ... to prevent fractures, we need tools that help ... injuries so that we can target these at-risk ... Crandall, professor of medicine in the division of ...
(Date:10/22/2014)... 22, 2014 At a time when ... parents and athletes at all levels, the UPMC ... the current discussion where two powerful messages are lost: ... that result in full recoveries every day. , In ... in fact and research, UPMC and the Concussion Program ...
(Date:10/22/2014)... 2014 Medical Solutions , ... happy to announce that our co-founder and CFO, ... Analysts’ Staffing 100 for 2014. Anderson was also ... influential people in the staffing industry,” in 2013.     ... 13th-largest healthcare staffing company in the U.S., was ...
(Date:10/22/2014)... HealthDay Reporter , TUESDAY, Oct. 21, ... Ebola cases in Dallas. But, mental health specialists say overblown ... President Barack Obama on Friday appointed an Ebola "czar" to ... two Dallas nurses who cared for a Liberian man who ... But the U.S. cases are miniscule in the context ...
Breaking Medicine News(10 mins):Health News:Sleep Duration Linked to Ulcerative Colitis Risk in Study 2Health News:Osteoporosis Screening Guidelines May Miss Younger Women at Risk 2Health News:University of Pittsburgh Medical Center Launches Initiative to Emphasize Concussions Are Treatable 2Health News:University of Pittsburgh Medical Center Launches Initiative to Emphasize Concussions Are Treatable 3Health News:University of Pittsburgh Medical Center Launches Initiative to Emphasize Concussions Are Treatable 4Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 2Health News:Medical Solutions Co-Founder/CFO Scott Anderson Named to Staffing Industry Analysts’ 2014 Staffing 100 3Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 2Health News:Ebola Anxiety: A Bigger Threat Now Than the Virus Itself 3
... capture school,portraits for years to come. However, most teens ... prefer to erase -- and replace. To encourage,teens to ... to,kick-off the launch of the CLEAN & CLEAR(R) Advantage(R) ... to,"Erase Their Worst Year Book Picture" at a pop-up ...
... 15 When we hear somebody,described as "frosty" or ... antisocial. There are numerous examples in our daily,language of ... such as loneliness, despair and sadness. We are taught ... descriptive and are not supposed to be,taken literally. However, ...
... Human Services ... Academic Excellence Award, SEATTLE, Sept. ... and its new innovative center, Partners for Our,Children (POC) has ... the recipient of the 2008 Academic Excellence Award., "The ...
... for Global Health (HIGH) has been selected to receive ... from the National Institutes of Health,s Fogarty International Center., ... additional $300,000 grant from the University and support HIGH,s ... The grant will fund the Fostering Opportunities for Nutrition ...
... Notes, NEW YORK, Sept. 15 Cell Therapeutics, ... MTA: CTIC) today announced,that a single institutional investor has ... Senior Notes due 2012, with a,conversion price of $1.27 ... to,price, volume and other requirements exercisable no later than ...
... child who receives an antipsychotic medicine is first prescribed ... olanzapine and risperidone. However, there has never been evidence ... first-generation medications., ,Now a study from the University of ... that molindone, a first-generation drug, is as effective as ...
Cached Medicine News:Health News:CLEAN & CLEAR(R) Is Inviting Teens to 'Erase Their Worst Yearbook Picture' With The NEW CLEAN & CLEAR(R) Advantage(R) Blackhead Eraser(TM) Exfoliating Cleanser 2Health News:Cold and Lonely: Does Social Exclusion Literally Feel Cold? 2Health News:Cold and Lonely: Does Social Exclusion Literally Feel Cold? 3Health News:University of Washington School of Social Work and Partners for Our Children Awarded Top National Recognition 2Health News:University of Washington School of Social Work and Partners for Our Children Awarded Top National Recognition 3Health News:Harvard University recipient of Global Health Nutrition grant 2Health News:Cell Therapeutics, Inc. Announces Single Institutional Investor to Purchase Up to $18 Million of Senior Convertible Notes 2Health News:Cell Therapeutics, Inc. Announces Single Institutional Investor to Purchase Up to $18 Million of Senior Convertible Notes 3Health News:First generation antipsychotic drugs as effective as newer ones in some children 2Health News:First generation antipsychotic drugs as effective as newer ones in some children 3
(Date:10/25/2014)... ARBOR, Mich. , Oct. 24, 2014 Advanced ... second quarter (ending September 26, 2014) financial results on Monday, ... will be released after the close of the market and ... discuss the results at 4:30 p.m. EDT on the same ... Richard Kurtz (CEO and Director), Rob Risser ...
(Date:10/25/2014)... Oct. 24, 2014  In 2008, two of Dr. ... of multiple controlled substances, on a regular basis, that ... that Dr. Gurney was practicing "all the time" while ... of his employees said that Dr. Gurney was prone ... patients." Dr. Gurney,s behavior became increasingly erratic ...
(Date:10/25/2014)... HILL, N.C. , Oct. 24, 2014 /PRNewswire/ ... to provide Medical Affairs leaders with a forum ... face. The consortium has developed a mechanism for ... discussions where leaders discuss key findings from the ... Practices has completed the analysis for the first ...
Breaking Medicine Technology:Advanced Photonix to Webcast Fiscal 2015 Second Quarter Earnings 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 2Doctors That Harm: The Real Stories Insurance Companies Against Prop 46 Don't Want You To Know, Part 8 of Consumer Watchdog Campaign Series 3Strong Participation in Best Practices' Medical Affairs Consortium Survey 2
... company at the forefront of immunology treatment and research, is ... Washington, D.C. by reinforcing its commitment to improving the lives ... a large body of UCB data will highlight the potential ... Crohn,s disease. "ACG is an opportunity for UCB ...
... Zimmer Holdings, Inc. (NYSE and SIX: ZMH), a ... be participating in the 2011 Credit Suisse Annual Health ... in Phoenix, Arizona on November 9, 2011, at 8:00 ... of the presentation can be accessed via Zimmer,s Investor ...
Cached Medicine Technology:UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 2UCB Proudly Reinforces Long-Standing Commitment to Patients and Physicians at American College of Gastroenterology 2011 Annual Scientific Meeting 3Zimmer Holdings to Present at 2011 Credit Suisse Annual Health Care Conference 2
Includes conservation device, matched regulator, standard supply tubing, cannula, carrying case, batteries, and instruction booklet....
... Control Catheter with Accutrol is similar in ... except that it incorporates a temperature probe ... The temperature probe can accurately determine the ... catheter provides temperature accuracy comparable to a ...
... Insertion Through A 1.0mm Incision., ,Special Direct ... ... Comfortable Approach., ,Recessed Jaws For Improved Sub-Incisional ... Of Jaws During Sterilization., ,Reusable, Autoclaveable, Guaranteed ...
... Spatula Tips That Mimic Corneal Curvature. Designed To ... Created With The IntraLase TMFS Laser System., ... Of The Forceps Are Designed To Facilitate Access ... Achieved, The Cross-Action Forceps Design Allows The Surgeon ...
Medicine Products: