Vinorelbine is an anticancer drug that belongs to the family of plant drugs called vinca alkaloids.
ADVENTRX Pharmaceuticals, Inc. today announced the results of stability tests performed on samples of ANX-530 (vinorelbine injectable emulsion), or Exelbine™, manufactured at the Company's intended commercial manufacturing site. The 6-month stability data are on track to support the submission of the New Drug Application (NDA) for Exelbine.
Although more than two fifths of lung cancers are diagnosed in patients over 70, data from clinical trials on the safest and most effective treatments for this age group are scarce.
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ADVENTRX Pharmaceuticals, Inc. today announced that it will meet the U.S. Food and Drug Administration in Washington D.C. during the last week of April 2010 to review the Company's New Drug Application for ANX-530 (vinorelbine injectable emulsion) and the FDA's refusal-to-file letter.
ADVENTRX Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration has accepted the proposed proprietary name "Exelbine™" for the Company's product candidate ANX-530 (vinorelbine injectable emulsion).
ADVENTRX Pharmaceuticals, Inc. announced today that it received a refuse to file letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion). In the letter, the FDA indicated that the data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. FDA identified only the one chemistry, manufacturing and controls (CMC) reason for the refusal to file. ADVENTRX plans to meet with the FDA as soon as possible to discuss its response.
ADVENTRX Pharmaceuticals, Inc. announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion).
Genentech, Inc., a wholly owned member of the Roche Group, today announced results from a Phase III study (RIBBON 2) of Avastin® (bevacizumab) in women who had previously been treated with initial (first-line) chemotherapy for advanced HER2-negative breast cancer and needed additional (second-line) treatment.
Pfizer Inc. today announced results from studies evaluating neratinib (HKI-272), an investigational, orally administered, pan-ErbB inhibitor, in patients with human epidermal growth factor receptor-2 (HER2, also known as ErbB2) positive breast cancer at the 2009 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS).
Pfizer Oncology announced today that it will be presenting study findings evaluating several compounds including those from its newly expanded breast cancer portfolio following the recent acquisition of Wyeth, focusing on the needs of multiple breast cancer patient populations at the CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) being held December 9 – 13.
Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has launched vinorelbine injection, USP, an anti-mitotic chemotherapy drug. According to IMS, 2008 sales of vinorelbine injection, USP in the United States approximated $17 million. Sagent will begin marketing and shipping vinorelbine injection immediately.
Genentech, Inc. today announced that a Phase III study (RIBBON 2) of Avastin (bevacizumab) in combination with chemotherapy increased the time women with metastatic HER2-negative breast cancer whose initial chemotherapy had stopped working lived without the disease worsening (progression-free survival or PFS), compared to chemotherapy alone.
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it has completed the previously announced sale of shares of its 5% Series C convertible preferred stock pursuant to a registered direct offering to a single institutional investor, representing gross proceeds of approximately $0.9 million.
At the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), researchers from the Mayo Clinic campus in Florida report that using a combination of capecitabine, vinorelbine, and trastuzumab offers a treatment option that is at least as beneficial as other current options - and doesn't cause hair loss in patients.
Seattle Genetics, Inc. has announced that data from its antibody-drug conjugate (ADC) programs, SGN-35 and SGN-75, were presented at the 2009 Annual Meeting of the American Association for Cancer Research (AACR) being held in Denver, CO. Preclinical data with SGN-35 further elucidate its mechanism of action and demonstrate its superior antitumor activity in lymphoma compared with non-targeted agents. In addition, data with SGN-75 indicate its therapeutic potential in multiple types of solid tumors.
Adding chemotherapy to established methods of symptom management does not appear to enhance the quality of life or survival of patients suffering from an asbestos-induced form of lung cancer called malignant plural mesothelioma (MPM). These are the results of MS01, a large UK and Australian study published in the Lancet, which set out to assess the potential benefits of combining active symptom control (ASC) with chemotherapy.
Barcelona, Spain: Researchers have found that the breast cancer susceptibility gene, BRCA1, plays a significant role in non-small cell lung cancer (NSCLC).
Using a technology that can quickly screen all 20,000-plus human genes for biological activity, scientists have isolated 87 genes that seem to affect how sensitive human cancer cells are to certain chemotherapy drugs.
Gamma-linolenic acid (GLA), a substance in evening primrose oil and several other plant oils used in herbal medicine, inhibits action of Her-2/neu, a cancer gene that is responsible for almost 30 percent of all breast cancers, Northwestern University researchers report.
A Canadian national clinical trial has found that chemotherapy following surgery for early-stage non-small cell lung cancer significantly improves survival for the disease over just surgery alone.