Navigation Links
Bayer and Onyx Submit Supplemental New Drug Application for Nexavar to Treat Liver Cancer

Bayer HealthCare Pharmaceuticals Inc. (NYSE: BAY) and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) today announced that a Supplemental New Drug Application (sNDA) for Nexavar(R) (sorafenib) tablets has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.

Nexavar is currently approved in more than 50 countries for the treatment of advanced kidney cancer. The companies also confirmed that they are planning a company- sponsored Phase 3 study of Nexavar in the adjuvant treatment of HCC following the complete removal of early stage liver cancer.

The sNDA submission is based on positive data from the international, Phase 3, placebo-controlled Sorafenib HCC Assessment Randomized Protocol (SHARP) trial which demonstrated that Nexavar extended overall survival by 44 percent in patients with HCC (HR=0.69; p=0.0006) versus placebo.

There were no significant differences in serious adverse event rates between the Nexavar and placebo-treated groups with the most commonly observed adverse events in patients receiving Nexavar being diarrhea and hand-foot skin reaction. Currently, there are no FDA-approved drug therapies that significantly extend survival of patients with liver cancer.

"These results are particularly meaningful considering that death rates from liver cancer continue to increase," said Susan Kelley, M.D., vice president, Therapeutic Area Oncology, Bayer HealthCare Pharmaceuticals. "After more than 100 clinical studies of many agents over three decades.

Nexavar is the first drug therapy to demonstrate a significant survival benefit for patients with HCC, and, if approved, may fulfill a serious unmet need with a manageable toxicity profile."

HCC, the most common form of liver cancer, is responsible for about 90 percent of the primary liver cancers in adults. It is the fifth
'"/>




Page: 1 2

Related medicine news :

1. Bayer Voluntarily Withdraws BAYCOL - A Drug Associated With 50 Deaths
2. Bayer Wins Positive Response For Marketing Its Cancer Drug
3. Genomatix Licensed By Bayer Healthcare
4. Bayer to Market Biocon Insulin in China
5. Test for Esophageal Reflux Licensed to Bayer by University
6. Recd Number of Abstracts Submitted for Sci Cong on Osteoporosis
7. MBBS Aspirants Get 90 Days To Submit Caste Validity Certificate
8. New Drug Application Submitted for Investigational Antibiotic Doripenem
9. New Supplemental Therapy for Common Jaw Disorder
10. Prostate Cancer Can Be Treated By Application Of LASER Technology
11. Varied Applications of Adult Stem Cells to Treat Host of Disorders in Human
Post Your Comments:
(Date:8/22/2014)... 2014 Today, Zane Benefits, the #1 ... Account-Based Health Plans. , According to Zane Benefits, employers ... to lower the cost of healthcare without reducing coverage ... accounts, however, can be confusing. , The new guide ... four main types of ABHPs. It also explains ...
(Date:8/22/2014)... Las Vegas, NV (PRWEB) August 22, 2014 ... affordable email marketing services that currently helps more ... marketing efforts has caught the attention of Shane Michaels, ... a still a crucial element for any online marketing ... media replacing email in the marketing world,” reports Michaels. ...
(Date:8/22/2014)... 2014 Top 10 Best SEO ... hosting companies and highly recommended FatCow ( http://www.top10bestseohosting.com/go/FatCow.com/ ... manager of Top 10 Best SEO Hosting states, ... server hosting supplier. Actually, these companies have outperformed ... and customer support. People can get the best ...
(Date:8/22/2014)... NV (PRWEB) August 22, 2014 ... that is written by marketing experts for marketers to ... links has caught the attention of Shane Michaels, prompting ... with Internet marketing in any way knows that content ... in the industry,” reports Michaels. “But even though content ...
(Date:8/22/2014)... (PRWEB) August 23, 2014 Recently, UWDress.com, a ... outfits, has added a new range of empire bridesmaid ... the company has launched a summer promotion for these high ... discounted rates, from 25 to 75 percent off. , ... ladies. Also, UWDress.com offers efficient assistance on its website. It ...
Breaking Medicine News(10 mins):Health News:AWeber: Review Exposes Affordable Provider of Opt-In Email Marketing Services 2Health News:FatCow Reviews Released by Top10BestSEOHosting.com 2Health News:My Writers: Review Exposes Online Source for Quality Marketing Content 2Health News:Discounted Empire Bridesmaid Dresses Online At UWDress.com 2
... is widespread disgust and outrage expressed over the housing together ... Sebastian Wheeler, 43, and his boyfriend Victor Leslie Urquhart, ... Australia. ,The two men were convicted ... him for 20 days, before he was rescued. The pair ...
... tuberculosis, researchers say. ,A study of 131 people found ... to inhibit the growth of the bacteria causing the disease, reported ... has evaluated the effect of Vitamin D on the body's immunity ... researchers took blood from all the participants and infected with mycobacteria. ...
... Low-income African-American high school students with asthma who ... reported fewer days and nights with symptoms, ... activity, and less hospitalization for asthma during a ... students. ,Christine L. M. Joseph, M.P.H, ...
... At least eight people have died due to sunstroke in ... ,While three deaths have been reported from the ... from the districts of Balasore, Kandhamal, Kendrapada, Nuapada and Sundergarh, ... told IANS. ,We received complaints of about 53 ...
... not that killer body that the opposite sex takes into account ... if you are a man. ,To find our ... from the University of Western Australia in Crawley led by Marianne ... photographs. ,The volunteers were asked to rate attractiveness on ...
... that Alzheimers drug Donepezil may help people who have ... Berthier of the M dico-Sanitarias Research Centre in Malaga, ... ability to communicate. ,The researchers wanted to ... a condition characterised by an inability to pronounce or ...
Cached Medicine News:Health News:Outrage Against Gay PartnersInCrime Kept Together 2Health News:Web-based Asthma Program Improves Disease Management for Black Students 2
(Date:8/22/2014)... 22, 2014  Medical Science Liaisons serve as a ... the healthcare sector. As the impact of technology in ... how Medical Science Liaisons (MSLs) interact with physicians and ... the tablet to not only share important disease and ... thought leader interactions across geographies and therapeutic areas. ...
(Date:8/22/2014)... 22, 2014 ... has announced the addition of the  "Global ... their offering.       (Logo: http://photos.prnewswire.com/prnh/20130307/600769) ... instrument for any modern science laboratory as ... materials. It can be broadly classified into ...
(Date:8/22/2014)... Research and Markets ( ... the  "Global Operating Room Equipment Market 2014-2018" ... (Logo: http://photos.prnewswire.com/prnh/20130307/600769) , ,An operating room is ... a healthcare facility used to perform surgical ... equipment, which ensures patient care and enhanced ...
Breaking Medicine Technology:iPads Enhancing Medical Science Liaison Interactions with Thought Leaders, New Study Shows 2Global Laboratory Electronic Balance Market 2014-2018: Key Vendors are A&D Company, Mettler-Toledo, Sartorius and Thermo Fisher 2Global Operating Room Equipment Market 2014-2018: Key Vendors are Getinge, STERIS, Stykron and TRUMPF Medical Systems 2
... June 13 Telmisartan, an angiotensin receptor blocker, ... been studied in clinical trials in more than 50,000 patients. ... market exposure of 34.5 million patient years. Convincing safety data ... the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which ...
... Scientists from the Barbara Ann Karmanos Cancer Institute in ... agents used to promote bone health and inhibit resorption, may ... early stage breast cancer who take them for their anti-osteoporosis ... Society of Clinical Oncology Annual Meeting. , ...
Cached Medicine Technology:Boehringer Ingelheim Affirms Safety of Telmisartan With an Analysis of 50,000 Patients and Strongly Disagrees With the Publication of Sipahi et al in Lancet Oncology June 2010 2Boehringer Ingelheim Affirms Safety of Telmisartan With an Analysis of 50,000 Patients and Strongly Disagrees With the Publication of Sipahi et al in Lancet Oncology June 2010 3Boehringer Ingelheim Affirms Safety of Telmisartan With an Analysis of 50,000 Patients and Strongly Disagrees With the Publication of Sipahi et al in Lancet Oncology June 2010 4Boehringer Ingelheim Affirms Safety of Telmisartan With an Analysis of 50,000 Patients and Strongly Disagrees With the Publication of Sipahi et al in Lancet Oncology June 2010 5Karmanos Cancer Institute Researchers Study Bisphosphonates and Their Affect on Early Stage Breast Cancer 2Karmanos Cancer Institute Researchers Study Bisphosphonates and Their Affect on Early Stage Breast Cancer 3Karmanos Cancer Institute Researchers Study Bisphosphonates and Their Affect on Early Stage Breast Cancer 4
... Crossover system of implants and instruments provides ... posterior rod construct in the thoracic and ... system are available in three size ranges: ... can be used with the Isola, Pediatric ...
Portable ultrasound doppler system for peripheral and transcranial investigation....
Multiwindow transcranial and peripheral Doppler system....
Bi-Directional doppler volume flowmeter....
Medicine Products: