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:1/23/2015)... ( http://www.researchandmarkets.com/research/vzhr6h/video ) has announced the addition of ... Growth, Trends and Forecast 2014 - 2020" report to ... of fascination since the era of the cold war between ... Russia. Earlier even a small glimpse of human form was ...
(Date:1/23/2015)... analysis of Centers for Medicare and Medicaid Services, (CMS) ... percent of seniors chose lower-cost preferred pharmacy plans that ... The findings were released by Drug Channels . ... of Medicare Part D," said Pharmaceutical Care Management Association ...
(Date:1/23/2015)... DUBLIN , Jan. 23, 2015  Immune Therapeutics, Inc. ... Biotechnology, Inc. for the compounding, packaging and distributing of its ... the United States . ... of compounding naltrexone tablets in various strengths for individual patients ...
Breaking Medicine Technology:Video Telemedicine Market- Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 2Video Telemedicine Market- Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 - 2020 3New Analysis: 81 Percent of Medicare Part D Seniors Choose "Preferred Pharmacy" Plans in 2015 2Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 2Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 3Immune Therapeutics, Inc. Announces Agreement with KRS Global Biotechnology, Inc. 4
... 2012  The use of an injectable, clot-preventing drug known ... advanced cancer complicated by blood clots increased steadily between ... in The Oncologist , funded by the National ... despite previous research indicating LMWH is the preferred first-line ...
... 2012  MolecularHealth, Inc., a leader in clinico-molecular informatics™, ... collaboration agreement with the U.S. Food and Drug ... Molecular Analysis of Side Effects (MASE), a ... assessment and prediction. The FDA,s Center ...
Cached Medicine Technology:Injectable Treatment for Blood Clots in Advanced Cancer Patients Increases, According to New Research 2Injectable Treatment for Blood Clots in Advanced Cancer Patients Increases, According to New Research 3MolecularHealth and FDA to Collaborate on Analytical Tools for Mechanism-Based Drug Safety Assessment 2
(Date:1/22/2015)... January 22, 2015 Thousand of GranuFlo ... Care recalled its GranuFlo and NaturaLyte dialysis concentrates continue ... in U.S. District Court, District of Massachusetts, Bernstein Liebhard ... the Court has remanded a case filed by the ...
(Date:1/22/2015)... 2015 Carinsurancesavings.biz has released a new blog ... dismemberment insurance . , Purchasing an accidental death and ... advantageous. This type of rider provides benefits if the insured ... considered a lesser form of life insurance. , AD&D ...
(Date:1/22/2015)... 2015 Yesterday, Senator Holly Mitchell ... Kristin Olsen (R-Modesto) were honored by the California ... biotechnology, biomedical science, medical device and pharmaceutical innovation ... the “2014 Life Sciences Champion” award from CHI ...
(Date:1/22/2015)... years since the release of their debut recording Love is King, ... & Matthew Love – the duo are pleased to announce their ... Swan Records on February 24, 2015. , THE ROAD offers the ... all of us to walk out of the mire of our ...
(Date:1/22/2015)... 2015 As interest in the value of ... momentum worldwide, Rev. Eric J. Hall , president and ... (HCCN), will be the keynote speaker on January 27 at ... health system. , The conference, “Hope and Resilience: Innovative and ...
Breaking Medicine News(10 mins):Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 2Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 3Health News:Court Overseeing Federal GranuFlo Lawsuits Remands Louisiana Claim Back to State Court, Bernstein Liebhard LLP Reports 4Health News:Accidental Death and Dismemberment Insurance Can Be Purchased at Low Prices Online 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3
... , MONDAY, Nov. 8 (HealthDay News) -- A solar-powered blood-pressure ... rising rates of cardiovascular disease in low-income nations, according to ... in Africa -- two in Uganda and one in Zambia ... in agreement with the standard blood-pressure testing method for systolic ...
... HealthDay Reporter , MONDAY, Nov. 8 (HealthDay News) -- ... deployed to Iraq, Afghanistan and other war zones to ... non-deployed parents, a new study suggests. Researchers examined ... between the ages of 3 and 8, and found ...
... of statins among a group of postmenopausal women did not ... of a prospective analysis of data from the large population-based ... study are consistent with the majority of the literature suggesting ... statins," said Michael S. Simon, M.D., professor of oncology in ...
... good and bad outcomes against each other in breast cancer ... determined in part by whether or not their tumor has ... researchers, led by Roman Perez-Fernandez and colleagues, at the University ... subset of patients with breast cancer, a marker associated with ...
... now being used at UCLA allow doctors to more ... ventricular arrhythmias serious abnormal rhythms in the heart,s ... Generally, arrhythmias can be controlled by medications, and sometimes ... a ventricular tachycardia, which originates in one of the ...
... (HealthDay News) -- Among certain patients with a history ... Pradaxa (dabigatran) appears to be as effective as the ... German research reveals. Specifically, the new study suggests ... stroke as effectively as warfarin among those facing an ...
Cached Medicine News:Health News:Solar Blood-Pressure Device Shows Promise for Use in Poor Nations 2Health News:Kids of Deployed Soldiers May Face More Mental Health Woes 2Health News:Kids of Deployed Soldiers May Face More Mental Health Woes 3Health News:Kids of Deployed Soldiers May Face More Mental Health Woes 4Health News:Statins did not reduce colorectal cancer in WHI analysis 2Health News:JCI online early table of contents: Nov. 8, 2010 2Health News:JCI online early table of contents: Nov. 8, 2010 3Health News:JCI online early table of contents: Nov. 8, 2010 4Health News:JCI online early table of contents: Nov. 8, 2010 5Health News:UCLA uses new hybrid, precision heart procedures to help stop deadly arrhythmias 2Health News:UCLA uses new hybrid, precision heart procedures to help stop deadly arrhythmias 3Health News:New Drug, Pradaxa, May Prevent Second Stroke in Certain Heart Patients 2Health News:New Drug, Pradaxa, May Prevent Second Stroke in Certain Heart Patients 3
ThermalSeal RT (2mil) is Optically Clear for Real Time PCR and easy to apply. Works for all plates....
DMSO-resistant microplate sealing film...
Sealing tape, white Rayon, breathable, NS...
Sealing tape, slightly stiffer than Polyolefin tape. Certified RNase and DNase free....
Medicine Products: