Navigation Links
U.S. FDA Grants Priority Review to the New Drug Application for Bayer's Regorafenib to Treat Patients with Metastatic Colorectal Cancer
Date:6/28/2012

WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., June 28, 2012 /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals (NASDAQ:  ONXX) announced today that the U.S. Food and Drug Administration (FDA) has granted priority review designation to Bayer HealthCare's New Drug Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

The FDA grants priority review to medicines that provide a treatment where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within six months from the receipt of the NDA submission, rather than the standard 10-month review cycle. 

The submission was based upon data from the pivotal, global Phase III CORRECT study.

About Regorafenib
Regorafenib is an investigational oral multi-kinase inhibitor and is currently being investigated in clinical trials for its potential to treat patients with various tumor types.

Regorafenib is an investigational agent and is not approved by the FDA, EMA or other health authorities. 

Regorafenib is one of several cancer compounds in Bayer's development pipeline. In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc., under which Onyx will receive a royalty on any future global net sales of regorafenib in oncology. Bayer and Onyx will co-promote regorafenib in the U.S.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty phar
'/>"/>

SOURCE Bayer HealthCare Pharmaceuticals Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Community Foundation Announces $2.6 Million In Grants From Centinela Medical Funds
2. Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
3. Schulman Associates IRB offers oncology-focused review board
4. HemoShear Publishes Key Review on Human-Relevant Organotypic Systems
5. Webcast Alert: Isis Pharmaceuticals Hosts Dr. Sotirios Tsimikas to Review KYNAMRO™ data Presented at the European Atherosclerosis Society 2012 Meeting
6. Frost & Sullivan Research Preview: Top 20 Telehealth Markets
7. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
8. HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
9. New Wireless Keyboard Rechargeable, Washable for Healthcare Applications
10. Shire Announces that the US Food and Drug Administration has Responded to its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generic Adderall XR
11. New, Affordable Flow Cytometer Cell Sorter Expands Access to Wider Range of Life Science Applications
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/30/2015)... Calif. , April 30, 2015  Accuray ... it has signed an agreement with MIM Software ... the TomoTherapy ® and CyberKnife ® product ... Accuray and MIM technology. This is Accuray,s second ... the development of the first iPad-based treatment plan ...
(Date:4/30/2015)... , April 30, 2015  Thoratec Corporation (NASDAQ: ... therapies to save, support and restore failing hearts, said ... Merrill Lynch 2015 Healthcare Conference on Thursday, May 14. ... Chief Executive Officer, will provide an update on the ... p.m., Eastern Daylight Time). The presentation will ...
(Date:4/30/2015)... 2015  DURECT Corporation (Nasdaq: DRRX ) announced ...  Total revenues were $4.8 million and net loss was ... 2015 as compared to total revenues of $6.3 million ... months ended March 31, 2014.At March 31, 2015, we ... cash and investments of $34.9 million at December 31, ...
Breaking Medicine Technology:Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 2Accuray Signs Agreement with MIM Software Inc. to Develop Adaptive Therapy Software 3Thoratec Presentation At Bank Of America Merrill Lynch Healthcare Conference To Be Webcast 2DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 2DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 3DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 4DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 5DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 6DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 7DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 8DURECT Corporation Announces First Quarter 2015 Financial Results and Update of Programs 9
... /PRNewswire/ -- Argus Health Systems, Inc., a ... with Walmart to provide expanded network services. This Preferred ... provide the lowest prescription benefit cost to Argus customers. ... customers a more cost-effective pharmacy network alternative. Access to ...
... Sept. 22, 2011 Watson Pharmaceuticals, Inc. (NYSE: ... and Sandoz Inc. have filed suit against Amphastar Pharmaceuticals, ... United States District Court for the District of Massachusetts. ... which Watson has the exclusive right to distribute in ...
Cached Medicine Technology:Argus Announces Retail Network Relationship 2Watson Confirms Amphastar Patent Lawsuit 2Watson Confirms Amphastar Patent Lawsuit 3
(Date:5/1/2015)... Caicos Islands, BWI (PRWEB) May 02, 2015 ... website! It is http://www.thevenetiangracebay.com , and it ... it incorporates the stunning white and attractive turquoise hues ... study of Google, sixty seven percent of leisure travelers ... study showed that smartphones were used in the planning ...
(Date:5/1/2015)... 2015 Jusuru International has been awarded ... repositioning of its flagship nutritional supplement, Liquid BioCell™ Life, ... new name, new logo, new packaging, new products, and ... designed to identify and promote programs that serve as ... “DSA congratulates Jusuru International for their outstanding accomplishments and ...
(Date:5/1/2015)... The Workgroup for Electronic Data Interchange ... use of health IT to create efficiencies in healthcare ... the United States Government Accountability Office (GAO) for a ... Medicare. The report, “ Potential Uses of Electronically Readable ... the public on Apr. 24, 2015 and examines the ...
(Date:5/1/2015)... 01, 2015 It’s raining bills on Capitol ... proposals to expand federal support for telemedicine. , ... has been working with Congress,” said Jonathan Linkous, CEO of ... the nation is poised to embrace the use of telecommunications ... step in fulfilling ATA’s mission to improve quality, access, equity ...
(Date:5/1/2015)... KY (PRWEB) May 01, 2015 Ernst ... CEO, Dr. Joshua Rosenthal, Co-Founder & CSO, and Burak ... finalists for the EY Entrepreneur Of The Year® ... Ernst & Young is a global leader in ... to be one of the top audit companies ...
Breaking Medicine News(10 mins):Health News:Turks and Caicos Resort, The Venetian on Grace Bay, Launches New Web Presence 2Health News:Jusuru International Receives 2015 DSA Ethos Award 2Health News:Jusuru International Receives 2015 DSA Ethos Award 3Health News:Jusuru International Receives 2015 DSA Ethos Award 4Health News:Jusuru International Receives 2015 DSA Ethos Award 5Health News:WEDI Contributes to Newly Released U.S. Government Accountability Office (GAO) Study on Potential Use of Electronically Readable Medicare Cards 2Health News:WEDI Contributes to Newly Released U.S. Government Accountability Office (GAO) Study on Potential Use of Electronically Readable Medicare Cards 3Health News:ATA: Congress Floods the Halls with Telemedicine Proposals 2Health News:RowdMap, Inc. Named as a Ernst & Young Entrepreneur Of The Year® 2015 Award Finalist 2
... research shows , , FRIDAY, June 13 (HealthDay News) -- ... the morning may help ease some stresses you might ... rats inhaled the aroma of roasted coffee beans, a ... proteins with healthful antioxidant activity, the researchers reported. ...
... Md., June 13 EntreMed, Inc.,(Nasdaq: ... for the treatment of cancer and inflammatory ... and Chief Executive Officer,will present a Company ... Industry Organization 2008 Annual International Convention,being held ...
... blames traffic-related pollution for increasing the risk of allergy and ... more, the closer children live to roads, the higher their ... are likely to be exposed not only to a higher ... more freshly emitted aerosols which may be more toxic," wrote ...
... the most commonly ... June 13 Roche announced today that,its new test ... allowing it to be sold for clinical use in ... approach to help ensure,reliability of test results even when ...
... Arthritis is the Leading Cause of Work Disability ... data announced today,showed that treating patients with early, ... methotrexate (MTX) resulted in an,indirect cost savings of ... the time of the study) per patient per ...
... Lower Manhattan, the terrorist attacks of September 11, 2001, ... the Health Department,s World Trade Center Health Registry, show ... posttraumatic stress disorder (PTSD) two to three years after ... developed PTSD at three times the usual rate in ...
Cached Medicine News:Health News:Coffee Beans May Be Newest Stress-Buster 2Health News:Coffee Beans May Be Newest Stress-Buster 3Health News:EntreMed to Present at the BIO 2008 Annual International Convention 2Health News:Road pollution blamed for higher allergy risk in kids 2Health News:New Roche Chlamydia Test Approved for Use in European Union 2Health News:New Roche Chlamydia Test Approved for Use in European Union 3Health News:HUMIRA(R) (adalimumab) Data Show That Treating Early Rheumatoid Arthritis With Combination Treatment Resulted in Cost Savings From Improved Work Productivity 2Health News:HUMIRA(R) (adalimumab) Data Show That Treating Early Rheumatoid Arthritis With Combination Treatment Resulted in Cost Savings From Improved Work Productivity 3Health News:HUMIRA(R) (adalimumab) Data Show That Treating Early Rheumatoid Arthritis With Combination Treatment Resulted in Cost Savings From Improved Work Productivity 4Health News:HUMIRA(R) (adalimumab) Data Show That Treating Early Rheumatoid Arthritis With Combination Treatment Resulted in Cost Savings From Improved Work Productivity 5Health News:HUMIRA(R) (adalimumab) Data Show That Treating Early Rheumatoid Arthritis With Combination Treatment Resulted in Cost Savings From Improved Work Productivity 6Health News:HUMIRA(R) (adalimumab) Data Show That Treating Early Rheumatoid Arthritis With Combination Treatment Resulted in Cost Savings From Improved Work Productivity 7Health News:1 in 8 Lower Manhattan residents had signs of PTSD 2 to 3 years after 9/11 2
This aron protects at 0.5 mm Pb equivalency and is 20% lighter than our Standard Back-Aid Apron - yet it contains no lead products that can be harmful to the environment!...
Crisscross shoulder design facilitates better posture and distributes weight to back and hips for greater comfort. Shoulder pads soften shoulder contact with apron for additional comfort....
Use this workhorse apron where 360 of protection from direct and scatter radiation is required....
... Our popular Back-Aid Apron now ... Universal Back-Saver Belt that has ... more weight off your shoulders! ... strap redistribute weight from the ...
Medicine Products: