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:11/26/2014)... 25, 2014  goBalto, Inc., the leading provider of ... a winner of Red Herring,s Top 100 Global ... North America award in 2013, marking its emergence as ... Red Herring,s Top 100 Global list has become ... and entrepreneurs. Red Herring editors were among the first ...
(Date:11/26/2014)...   Heska Corporation (NASDAQ: HSKA ) ... of advanced veterinary diagnostic and other specialty veterinary products ... will attend The Benchmark Company, LLC,s Micro Cap Discovery Conference ... held at The Palmer House Hilton, 17 E. Monroe Street, ... 2:30 p.m. Please email hska@haydenir.com or contact your ...
(Date:11/26/2014)... LONDON , Nov. 25, 2014 ... AZN ) today announced that AMAGINE-2 TM , a ... in more than 1,800 patients with moderate-to-severe plaque psoriasis, met ... (ustekinumab) and placebo at week 12. Brodalumab 210 mg given ... each shown to be superior to Stelara on the primary ...
Breaking Medicine Technology:goBalto Selected as a 2014 Red Herring Top 100 Global Company 2goBalto Selected as a 2014 Red Herring Top 100 Global Company 3Heska to Attend Benchmark Micro Cap Discovery Conference 2Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 2Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 3Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 4Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 5Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 6Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 7Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 8Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 9Amgen And AstraZeneca Announce Positive Results From Third And Final Pivotal Phase 3 Study Of Brodalumab In Patients With Moderate-To-Severe Plaque Psoriasis 10
(Date:11/28/2014)... November 28, 2014 Dr. Paul Vitenas, one of ... a Glitter & Glow Holiday Event for those in the area ... at his practice. Glitter & Glow will take place on December ... new location in the heart of Houston at 4208 Richmond Ave. ... and hope that you will come and celebrate the season with ...
(Date:11/28/2014)... Celebration can quickly turn to tragedy if popular turkey ... Over the last decade, more than 141 serious fires ... turkey fryers, according to the U.S. Consumer Product Safety ... who tried to deep fry the turkey indoors, which ... Arthur Sanford, a burn surgeon at Loyola University Health ...
(Date:11/28/2014)... PreDiabetes Centers , a ... employees learn their risk for type 2 diabetes ... a local school in partnership with the American ... , As the Presenting Sponsor for the ... is co-hosting diabetes-prevention presentations at Austin-area companies with ...
(Date:11/28/2014)... (PRWEB) November 28, 2014 More ... have now been filed in a New Jersey ... implants, Bernstein Liebhard LLP reports. , A ... County Superior Court reflects the filing of 2,160 ... hip stems, which were voluntarily recalled on July ...
(Date:11/28/2014)... 28, 2014 Patten Pecans, based in ... With those passions driving them, they've added a pecan ... tried other pecans oils, they've found this pecan ... be exceptionally flavorful, retaining the buttery pecan notes that ... nutritional benefits found in pecans nuts is found ...
Breaking Medicine News(10 mins):Health News:Cosmetic Surgeon Dr. Paul Vitenas to Host Glitter & Glow Holiday Event 2Health News:Cosmetic Surgeon Dr. Paul Vitenas to Host Glitter & Glow Holiday Event 3Health News:Turkey Fryer Mishaps Can Cause Serious Burns 2Health News:PreDiabetes Centers Offers Workplace Diabetes Screening at Local School 2Health News:More than 2,100 Stryker Hip Lawsuits Included in New Jersey Litigation after Settlement Announcement, Bernstein Liebhard LLP Reports 2Health News:More than 2,100 Stryker Hip Lawsuits Included in New Jersey Litigation after Settlement Announcement, Bernstein Liebhard LLP Reports 3Health News:Patten Pecans Goes Local with Nutritious Georgia Pecan Oil 2
... older we get, the ,more difficulty we seem to have remembering ... each morning, but unless we park in the ,same space each ... whether we left the SUV in the second or fifth row. ... and will have forgotten ,their names before the handshake is over. ...
... - 13 May 2011 Elsevier, the world,s ... announced today that Syngene, India,s first contract research ... provide unlimited access to Reaxys for all Syngene ... competitiveness and productivity in the ever-expanding and highly ...
... , FRIDAY, May 13 (HealthDay News) -- A common ... the development of life-threatening heart arrhythmias (when the heart ... a new study. In pinpointing this gene, ... help doctors determine which patients are likely to benefit ...
... Lombard, IL, May 13, 2011 Dynamic chest ... compression has been well studied in events such ... not been studied during chiropractic manipulation. In a ... of Manipulative and Physiological Therapeutics , researchers quantified ...
... Ga. In a time of transition for rural ... them stay focused on their goals and avoid potential ... an ongoing University of Georgia study., The study, published ... of Community Psychology, is part of a broader ...
... New data offer hints to why Parkinson,s disease so ... say researchers at Washington University School of Medicine in ... communications including the signals that control movement. As Parkinson,s ... problems moving and other symptoms. The new research ...
Cached Medicine News:Health News:As time goes by, it gets tougher to 'just remember this' 2Health News:As time goes by, it gets tougher to 'just remember this' 3Health News:Gene Variant Linked to Sudden Cardiac Death Risk in Blacks 2Health News:Chiropractic manipulation results in little or no risk of chest injury 2Health News:Study finds youth-mentor relationships particularly helpful for those experiencing hardship 2Health News:Disruption of nerve cell supply chain may contribute to Parkinson's 2Health News:Disruption of nerve cell supply chain may contribute to Parkinson's 3
5 inch (12.7 cm), 2 x 5 mm blade....
Nicati foreign body spud....
In reversible handle for removing foreign bodies....
... Focus Night & Day soft contact ... to protect the cornea and to relieve ... or chronic ocular pathologies such as bullous ... corneal dystrophies as well as post-surgical conditions ...
Medicine Products: