Navigation Links
Vemurafenib New Drug Application Submitted to FDA for Melanoma
Date:5/11/2011

PARSIPPANY, N.J. and TOKYO, May 11, 2011 /PRNewswire/ -- Daiichi Sankyo announced that applications have been submitted for market approval for vemurafenib (PLX4032/RG7204) for the treatment of metastatic melanoma to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).  Additionally, a pre-marketing application for approval for a companion diagnostic test has been submitted in the U.S.; the test also will be registered in Europe.  Vemurafenib is an oral, novel drug that targets the oncogenic BRAF mutation present in about half of melanoma cancers and about eight percent of all solid tumors.

In April 2011, Daiichi Sankyo, Co., Ltd. acquired Plexxikon, which discovered and is co-developing vemurafenib with Roche. Daiichi Sankyo, Inc. will co-promote vemurafenib in the U.S. with Genentech under Plexxikon's co-promote agreement with Genentech, a member of the Roche Group.

"The NDA submission to FDA for vemurafenib only six years after its discovery reflects Plexxikon's highly efficient research platform to identify unique molecules as well as the team's strategic approach to early development," said Glenn Gormley, MD, PhD, chief science officer and president, Daiichi Sankyo Pharma Development. "This is the very reason Daiichi Sankyo is proud to have made Plexxikon part of the Daiichi Sankyo Group, and from now on, to jointly bring forward novel medicines for the patients who need them." 

"Daiichi Sankyo has brought on board a highly experienced sales team to co-promote vemurafenib with Genentech in the U.S., pending FDA approval, and we look forward to working with our partner to bring this new personalized approach to this deadly type of cancer to patients and providers," said John Gargiulo, president and CEO, Daiichi Sankyo, Inc. "We are fortunate and excited that vemurafenib has the potential to be the first entry into the oncology market for Daiichi Sankyo, Inc., and we expect it will be followe
'/>"/>

SOURCE Daiichi Sankyo, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Roche Submits Application for Clearance of Chlamydia and Gonorrhoeae Test
2. Savient Pharmaceuticals Submits European Marketing Authorization Application for KRYSTEXXA®
3. ULURU Inc. Announces the Filing of a 510(k) Application for Altrazeal® Collagen
4. Netsmart Technologies Launches Exchange for Customers to Share Applications and Information
5. ePharmaSolutions Launches Major Release of Its Global Safety Letter Distribution and Tracking Application in More Than 90 Countries
6. HealthWarehouse.com Launches Application of Google Commerce Search for Prescription Medications
7. Hospira Submits 510(k) Application to FDA for Symbiq™ Infusion System Modifications
8. Alternative Probiotic Applications Offer $2 Billion+ Market Potential
9. FDA Approves Hyperopia Application for the MEL 80 Excimer Laser from Carl Zeiss Meditec
10. China Medicine Corporation Voluntarily Withdraws Application for Nasdaq Listing
11. EMDT, MD+DI, and Qmed Announce Virtual Event Dedicated to Developments in Materials for Medical Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/24/2015)... Research and Markets ( http://www.researchandmarkets.com/research/pmbmv2/global_biobanking ) ... Market 2015-2019" report to their offering. ... at a CAGR of 7.07% over the period 2014-2019 ... into two segments: Equipment and Consumables. This report covers ... Global Biobanking market for the period 2015-2019. ...
(Date:4/24/2015)... , April 24, 2015  Novartis Pharmaceuticals Corporation (NPC) has ... year in a row on the annual DiversityInc Top 50 ... 2015 Top 50 Companies for Diversity on April 23 at ... . NPC also ranked second on the DiversityInc Top 10 ... Companies for Employee Resource Groups list. ...
(Date:4/24/2015)... , April 24, 2015  Lannett Company, Inc. (NYSE: ... and increased its five-year revolving credit facility to $120 ... accordion feature that will allow the company to increase ... $30.0 million, subject to securing additional commitments from existing ... the credit facility remains December 18, 2018.   ...
Breaking Medicine Technology:Global Biobanking Market Report 2015-2019 - Increase in Strategic Collaborations with Beckman Coulter, Tecan & Thermo Fischer Scientific Dominating 2Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 2Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 3Novartis Pharmaceuticals Corporation is first company to receive number one ranking two years in a row on DiversityInc Top 50 Companies for Diversity list 4Lannett Expands Revolving Credit Facility To $120 Million 2
(Date:4/26/2015)... TN (PRWEB) April 26, 2015 ... to grow throughout the Southeast. MidSouth Pain Treatment Center ... locations in Cordova, Southaven, Oxford and Jackson, two ambulatory ... laboratory in the Southaven and Cordova locations. , ... ”I went into medicine to help people, and ...
(Date:4/25/2015)... April 25, 2015 In observance of ... join The Million Nets Pledge, a two-year pledge by ... protect refugee families with one million bednets by 2016. ... work with UN partners to protect children, refugees, and ... , “There has been a large surge in ...
(Date:4/25/2015)... Carinsurancequotesinfo.com has released a new blog post that ... for flatbed trucks. , Flatbed trucks are ... They are mainly used for commercial purposes and thus ... explains that by comparing multiple offers, drivers can find ... vehicles. , It is now possible to compare free ...
(Date:4/25/2015)... April 25, 2015 Gardant Management ... wellness, management and operations, and sales and marketing ... Exhibition scheduled to be held from April 29 ... Illinois is the largest eldercare association in Illinois. ... services for older adults, including senior housing, assisted ...
(Date:4/25/2015)... TX/Minneapolis, MN (PRWEB) April 25, 2015 ... the recipient of RFID Journal’s annual Best Implementation Award. ... that has demonstrated the best use of RFID technology ... The winner is the company that best demonstrates how ... award was presented at RFID Journal Live! 2015 in ...
Breaking Medicine News(10 mins):Health News:Growing Pains for MidSouth Pain Treatment Center 2Health News:Supporters Worldwide Join The Million Nets Pledge on World Malaria Day 2Health News:Supporters Worldwide Join The Million Nets Pledge on World Malaria Day 3Health News:Supporters Worldwide Join The Million Nets Pledge on World Malaria Day 4Health News:Auto Insurance Quotes for Flatbed Trucks Available Online! 2Health News:Gardant Management Solutions Staff Shares Operational Expertise 2Health News:Seeonic’s Industry Leading Technology Powers Interstate Batteries to Winning Award 2
... Jan. 6 Karen Ignagni, President and CEO of America,s ... by CMS today showing that health spending in the United ... 6.1 percent in 2007. According to the CMS report, ... same rate as in 2006, but much lower than the ...
... 2009) MAQUET Inc., a subsidiary of the ... and largest surgical equipment companies in the world, ... first installation of its advanced, prefabricated VARIOP ... now enables hospitals and surgical centers to reconfigure ...
... San Francisco has received a $7.5 million grant from ... shortage of healthcare workers in Tanzania. The two-year grant ... Sciences and the Muhimbili University of Health Allied Sciences ... to enable MUHAS and other African institutions to meet ...
... veterans struggling financially due to a job loss or decreased ... of programs that can relieve the costs of health care ... in the economy, VA recognizes that many veterans will feel ... Peake. "Therefore, it is important that eligible veterans learn of ...
... Cutting calories can cut down on pounds in middle age, ... less, weigh less. , While it may sound painfully obvious, ... to long-term weight loss, because the practice can sometimes boomerang, ... suggests that eating less can pay big dividends, particularly as ...
... A survey recently conducted by the Society of ... Compliance Association (HCCA) reveals that the declining economy may ... in business. In addition, this increased risk is ... risks are expected to at best hold steady, if ...
Cached Medicine News:Health News:AHIP Statement on National Health Expenditure Data 2Health News:MAQUET opens North America's first VARIOP prefabricated operating suite system 2Health News:UCSF-Tanzania get $7.5M from Gates Foundation for partnership to train African health workers 2Health News:It Pays to Eat Less as You Age 2Health News:Legal and Ethical Violations Risks Seen Rising, But Not Resources to Control the Risk 2Health News:Legal and Ethical Violations Risks Seen Rising, But Not Resources to Control the Risk 3
Designed to be used for neuromuscular blockage monitoring. Provides for easy placement over the ulnar nerve on a patient's wrist. Dual element permits non-invasive monitoring using a single electrode...
... Modes of Operation: , Standby: A standby switch ... pulses. , Twitch: 1 s (1 pulse/s); 2 ... , Tetanus: 50 Hz (50 pulses/s) or 100 ... s; repeats every 10 s , Output Current: ...
... of easy to use instruments for nerve ... peripheral nerve stimulator, and muscle locator, together ... hub, and pencil point needles., ,The ... and easy to use stimulator, designed to ...
... Based on the original ... includes electrosurgery certification, enhanced keypad ... designs., ,The MiniStim® MS-IV ... used for neuromuscular monitoring in ...
Medicine Products: