Nexavar News and Research

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Bayer receives priority review designation from FDA for regorafenib NDA

Bayer HealthCare and Onyx Pharmaceuticals 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.

29 Jun 2012

Growing number of countries adopting flexible IP regulations after India issues country's first compulsory license

"A growing number of countries are adopting India's intellectual property regulations, which give enough flexibility to local companies to produce generic versions of popular drugs to safeguard public health," India's Economic Times reports, noting, "In March, India issued the country's first compulsory license, allowing Natco Pharma to legally manufacture and sell a low-cost version of German drugmaker Bayer AG's patented cancer drug, Nexavar, at 3 percent of the original medicine's price on the grounds that Bayer's drug was not meeting public health requirement."

23 Jun 2012

Onyx announces data from regorafenib Phase 3 trial on GIST

Onyx Pharmaceuticals today announced data from the Phase 3 GRID (GIST – Regorafenib In Progressive Disease) trial evaluating the investigational drug regorafenib, a Bayer compound, in patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease had progressed despite prior treatment with imatinib and sunitinib.

4 Jun 2012

Bayer’s Nexavar Phase 3 trial on NSCLC does not meet primary endpoint

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that a Phase 3 trial evaluating Nexavar (sorafenib) tablets in patients with advanced relapsed or refractory non-squamous non-small cell lung cancer (NSCLC) whose disease progressed after two or three previous treatments, did not meet its primary endpoint of improving overall survival.

22 May 2012

Onyx announces results from regorafenib Phase 3 trial on GIST

Onyx Pharmaceuticals, Inc. today announced results from the Phase 3 trial GRID (GIST – Regorafenib in Progressive Disease) evaluating the investigational compound regorafenib (BAY 73-4506), a Bayer-owned compound, for the treatment of patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib.

3 Apr 2012

Indian patent court licenses generic copy of Bayer’s blockbuster anticancer drug

Last week an Indian patent court shocked the $600 billion global pharmaceutical business by ordering Bayer, the German health care giant, to allow a tiny Indian generic drug company to sell cheap copies of the blockbuster cancer drug Nexavar – even though everyone agrees that the drug is protected by a patent. Instead, the court decided that Bayer had an obligation to make Nexavar available to people in India who needed it.

20 Mar 2012

First-ever compulsory license issuance in India could have implications for HIV medication

"On Monday, the Indian Patent Office effectively ended German drug maker Bayer's monopoly for its cancer drug Nexavar and issued its first-ever compulsory license allowing local generic maker Natco Pharma to make and sell the drug cheaply in India," Reuters reports.

15 Mar 2012

Onyx reports total operating revenue of $237.0M for fourth quarter 2011

Onyx Pharmaceuticals, Inc. today reported its financial results for the full year and fourth quarter 2011. Onyx reported non-GAAP net income of $42.0 million, or $0.66 per diluted share, for the full year 2011 compared to non-GAAP net income of $39.2 million, or $0.63 per diluted share, for the same period in 2010.

23 Feb 2012

Three new targeted drugs can lead to fatal cancer complications

Treatment with three relatively new "targeted" cancer drugs has been linked to a slightly elevated chance of fatal side effects, according to a new analysis led by scientists at Dana-Farber Cancer Institute. They added that the risk remains low, but should be taken into account by physicians and patients.

7 Feb 2012

Enrollment opens in sorafenib vs. radioembolization in advanced hepatocellular carcinoma trial

'SARAH' - a French national collaborative randomized controlled trial of radioembolization with yttrium-90 resin microspheres versus sorafenib in advanced hepatocellular carcinoma is now open for recruitment

3 Feb 2012

Survey reveals high interest in Xalkori among medical oncologists

According to survey results gathered from 80 Medical Oncologists in the United States there is an extreme interest in Xalkori, with 75% of respondents stating a high interest in prescribing the product, virtually no physicians stating they have low interest in prescribing the therapy.

13 Jan 2012

Progress report on commercialization of BENLYSTA to be announced at JPMorgan Healthcare Conference

Human Genome Sciences, Inc. will today announce its priority goals for 2012 and report on progress with the commercialization of BENLYSTA (belimumab), the first approved drug for systemic lupus in 56 years, during a presentation this afternoon by H. Thomas Watkins, President and Chief Executive Officer, to financial analysts and investors at the 30th Annual JPMorgan Healthcare Conference in San Francisco.

9 Jan 2012

Positive results from Can-Fite BioPharma's CF102 Phase 1/2 study on HCC

Can-Fite BioPharma Ltd, a biotechnology company developing small molecule drugs for the treatment of inflammatory, and liver diseases, traded on the Tel Aviv Stock Exchange announced today the successful results of the Phase 1/2 study of its drug candidate CF102 in the treatment of hepatocellular carcinoma.

4 Jan 2012

Jennerex commences enrollment in JX-594 Phase 2b trial for HCC

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic virus products for cancer, together with its international commercialization partners, today announced that enrollment has been initiated and the first patient has been randomized in a Phase 2b clinical trial called TRAVERSE.

4 Nov 2011

AVEO third quarter net loss increases to $23.8 million

AVEO Pharmaceuticals, Inc. today reported consolidated financial results for the third quarter of 2011 and provided an update on the tivozanib clinical program.

2 Nov 2011

Bayer's regorafenib Phase 3 trial on metastatic colorectal cancer meets primary endpoint

Onyx Pharmaceuticals, Inc. today announced results from a Bayer HealthCare Pharmaceuticals Phase 3 trial evaluating the investigational compound regorafenib (BAY 73-4506) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed after approved standard therapies.

27 Oct 2011

Positive results from Nexavar Phase 2b trial on breast cancer presented at ASCO

Accelerated Community Oncology Research Network, Inc., reported positive results of a large double-blind, randomized Phase 2b trial in patients with breast cancer at the American Society of Clinical Oncology (ASCO) 47th annual meeting in Chicago, June 3-7.

1 Jul 2011

Final analysis of AVEO's tivozanib Phase 2 trial on kidney cancer patients presented at ASCO 2011

AVEO Pharmaceuticals, Inc., today announced data from the final analysis of its Phase 2 randomized discontinuation trial evaluating tivozanib, its lead product candidate designed to optimally block the VEGF pathway by inhibiting all three VEGF receptors, in patients with advanced renal cell carcinoma.

2 Jun 2011

Ardea reports additional results from lesinurad-allopurinol Phase 2b study in hyperuricemia, gout

Ardea Biosciences, Inc. announced that additional positive clinical and preclinical results from its development program of lesinurad, the Company's lead product candidate for the treatment of hyperuricemia and gout, were presented at the Annual European Congress of Rheumatology hosted by the European League Against Rheumatism in London, UK.

26 May 2011

Jennerex presents positive preliminary data from JX-594 Phase 2 trial for advanced liver cancer

Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the design, development and commercialization of first-in-class targeted oncolytic products for cancer, today presented preliminary data from a randomized dose-ranging Phase 2 trial of JX-594 in patients with advanced liver cancer showing a benefit in overall survival for the high dose group.

20 May 2011