Navigation Links
Delcath Submits New Drug Application For Proprietary Chemosaturation System To The U.S. Food And Drug Administration
Date:8/15/2012

NEW YORK, Aug. 15, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for the Company's proprietary chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver. The Company included its Generation 2 filter in its NDA submission as a technical change to the Chemistry, Manufacturing, and Control (CMC) module.

"Our team has achieved a significant milestone with the filing of our NDA," said Eamonn P. Hobbs, President and CEO of Delcath Systems. "We believe that our chemosaturation system provides the opportunity to satisfy a high unmet medical need to treat patients with unresectable metastatic melanoma in the liver. We also believe including our Generation 2 filter in the CMC module represents the fastest regulatory review path for the Generation 2 system, and that it is in the best interest of U.S. patients that we accelerate the potential availability of Generation 2."

"We have requested priority review of our NDA by the FDA. Assuming the NDA is accepted and that priority review is granted, our expected Prescription Drug User Fee Act (PDUFA) date would be in February of next year.  Based upon the strength of our Phase 1, 2 and 3 data, along with the limited treatment options available for patients with unresectable melanoma metastases in the liver, we believe that our application meets the FDA's criteria for priority review."

In Delcath's Phase 3 clinical trial (April 2010 data cutoff), comparing treatment with the Company's proprietary chemosaturation system to best alternative care (BAC) revealed that patients treated with chemosaturation therapy experienced a statistically significant extension in median hepatic progression free survival (hPFS) o
'/>"/>

SOURCE Delcath Systems, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Delcath Systems, Inc. Secures $20 Million Credit Facility
2. Delcath Highlights First Quarter 2012 And Recent Accomplishments
3. Delcath to Webcast Managements Presentation at Annual Meeting of Stockholders
4. Delcath Prices $20 Million Public Offering of Common Stock and Warrants
5. Delcath To Offer Second Generation Hemofiltration Cartridge In U.S. Expanded Access Program
6. Delcath Announced Changes To Board Of Directors
7. Delcath To Present At JMP Securities Healthcare Conference On July 12
8. Delcath To Conduct Second Quarter 2012 Results Conference Call
9. Delcath Reports Second Quarter 2012 Financial Results And Highlights Recent Accomplishments
10. Delcath To Present At Upcoming Investor Conferences
11. Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro™ for Treatment of Chronic Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/26/2014)... Nov. 26, 2014 Zynerba Pharmaceuticals , ... of innovative transdermal synthetic cannabinoid treatments, today announced that ... Annual Healthcare Conference 2014. The conference will be held ... in New York . Zynerba,s Chairman ... 4:50 pm on Tuesday, December 2. To ...
(Date:11/26/2014)... DALLAS , November 25, 2014 ... Surgical Instruments Market by Power Source (Electric, Battery, ... Console, Cables, Blade, Burr, Cart), by Application (Orthopedic, ... 2019" published by MarketsandMarkets, the global Powered Surgical Instruments ... to $1.6 Billion in 2014 and is expected ...
(Date:11/26/2014)... EMERYVILLE, Calif. , Nov. 25, 2014 ... nanotechnology company focused on the development of ... more accurate testing in hospital and pre-hospital ... Standards Organization (ISO) 13485:2003 certification.  The certification ... (BSI), one of the world,s leading certification ...
Breaking Medicine Technology:Zynerba Pharmaceuticals to Present at Piper Jaffray 26th Annual Healthcare Conference 2014 2Powered Surgical Instruments Market Worth $2.1 Billion by 2019 2Powered Surgical Instruments Market Worth $2.1 Billion by 2019 3Powered Surgical Instruments Market Worth $2.1 Billion by 2019 4Nanomix Receives ISO 13485:2003 Certification 2
... Tarsa Therapeutics today announced that the Phase III ORACAL ... treatment of postmenopausal osteoporosis was successfully concluded and yielded ... used to support a New Drug Application (NDA) submission ... the fourth quarter of 2011, based on the study ...
... YORK, March 24, 2011 Reportlinker.com announces that ... its catalogue: RNAi Drug ... http://www.reportlinker.com/p0461653/RNAi-Drug-Delivery-Technologies-and-Global-Markets.html THIS ... to how the RNAi (ribonucleic acid interference) technologies market ...
Cached Medicine Technology:Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis 2Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis 3Tarsa Therapeutics Reports Positive Top-Line Results From Pivotal Phase III ORACAL Trial of its Oral Calcitonin in Treatment of Postmenopausal Osteoporosis 4Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 2Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 3Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 4Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 5Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 6Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 7Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 8Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 9Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 10Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 11Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 12Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 13Reportlinker Adds RNAi Drug Delivery: Technologies and Global Markets 14
(Date:11/27/2014)... OXNARD, CA (PRWEB) November 27, 2014 ... All-on-4™ dental implants procedure will help one person ... rehabilitation. , Dr. Saj Jivraj and Dr. Mamaly Reshad ... Woodland Hills, Calif., have launched a website devoted to ... A section of the website would be devoted to ...
(Date:11/27/2014)... 27, 2014 Dr. Ronald Receveur, who has ... a few oral health tips before patients dig into the ... and New Albany affordable cosmetic dentistry, and his ... starch and sugar. While the staff wishes everyone a happy ... for how patients can enjoy a feast that is also ...
(Date:11/27/2014)... At The Little Gym, we know that being ... surprise when a recent study confirmed that regular physical ... Journal of Pediatrics found that “Promoting physical activity ... school years may be important not only for health, ... two groups of children; those that were engaging in ...
(Date:11/27/2014)... November 27, 2014 Ethane Web Technologies, an ... will provide a 10% Christmas discount on PPC service. The ... The discount offer will begin on 1 December 2014 and ... About this offer, a PPC professional working at Ethane Web ... for small businesses, as this big discount would make the ...
(Date:11/26/2014)... Il (PRWEB) November 27, 2014 ... excited to announce the kick-off of its annual ... encourages people to go to donate to those ... partner with local organizations to distribute the donations ... 20th, participating AlignLife locations will be accepting donations ...
Breaking Medicine News(10 mins):Health News:World-Renowned Oxnard All-on-4™ Dental Implants Experts to Give Away Full Mouth Rehabilitation Annually 2Health News:World-Renowned Oxnard All-on-4™ Dental Implants Experts to Give Away Full Mouth Rehabilitation Annually 3Health News:World-Renowned Oxnard All-on-4™ Dental Implants Experts to Give Away Full Mouth Rehabilitation Annually 4Health News:World-Renowned Oxnard All-on-4™ Dental Implants Experts to Give Away Full Mouth Rehabilitation Annually 5Health News:New Albany Dental Practice Offers Oral Health Tips For Thanksgiving 2Health News:New Albany Dental Practice Offers Oral Health Tips For Thanksgiving 3Health News:New Albany Dental Practice Offers Oral Health Tips For Thanksgiving 4Health News:Ethane Web Technologies Announces 10% Christmas Discount on PPC Service 2
... , Montreal, December 3rd, 2008 A Canadian and ... from the Research Institute at the Montreal Children,s Hospital of ... Canadian Institutes of Health Research (CIHR) and the Foundation Fighting ... research project to develop innovative gene therapies for a number ...
... released today from an undercover camera inside an abortion clinic ... mandatory reporting laws for sexual abuse. , ... UCLA student journalist and president of right-to-life advocacy group ... with a Planned Parenthood nurse, Rose says she has been ...
... Inc.,(NYSE: HRC ) today announced its fiscal 2009 ... by Hill-Rom,s Board of Directors on,December 2, 2008, and is ... December 17, 2008. , ... Hill-Rom is a leading worldwide manufacturer and provider of ...
... Berkeley -- An anti-cancer compound found in broccoli and ... associated with rapidly advancing breast cancer, according to a ... the online early edition of the journal Proceedings ... compound, indole-3-carbinol, is already undergoing clinical trials in humans ...
... Va., Dec. 3 Their goal is ambitious. They want to ... support it, doctors advise it and still, behavior is not changing fast ... News Release, go to: http://www.prnewswire.com/mnr/beyondboobs/36272/ , , ... proclaims Rene Bowditch, co-founder of Beyond Boobs. And what message is she ...
... research center focused,on improving the quality of life of ... Chattanooga, led by a world-renowned researcher whose,concepts and tools ... The Siskin Center for Child and Family Research ... nonprofit organization focused,on education, outreach and support for children ...
Cached Medicine News:Health News:CA$2.4 million toward gene therapy for human degenerative retinal diseases 2Health News:Live Action: New Video Shows Indiana Planned Parenthood Covering Up Rape of 13-year old Girl 2Health News:Broccoli compound targets key enzyme in late-stage cancer 2Health News:Broccoli compound targets key enzyme in late-stage cancer 3Health News:Photos: 'Changing Behavior, One Woman at a Time' 2Health News:Photos: 'Changing Behavior, One Woman at a Time' 3Health News:Siskin Center for Child and Family Research to Focus on Early Childhood Development and Special Education 2Health News:Siskin Center for Child and Family Research to Focus on Early Childhood Development and Special Education 3Health News:Siskin Center for Child and Family Research to Focus on Early Childhood Development and Special Education 4
... used only with the E3671 twisted snare wires. ... wing nut and the loop can be stopped ... so that the loop can be slipped down ... - 5.6 inches. Comes with one package of ...
Open 14 mm fixation ring with teeth to prevent damage to conjuctiva. Gauge is marked every 10 degrees to determine the extent of the arc to be incised. Two broad marks align with steep axis....
... to fixate the eye during ... ring can easily be pivoted ... smooth side on the eye. ... the eye to increase internal ...
For sterilizing, carrying and storage of a Storz diamond knife and barrel gauge....
Medicine Products: