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Generon begins Phase II trial of investigational treatment for chemotherapy-induced neutropenia
What's This?
After receiving clearance from the Food and Drug Administration, Shanghai-based Generon Corp. Ltd. started a Phase II study of F-627 in women with breast cancer who are receiving myelotoxic chemotherapy. Approximately 200 patients will be included in the randomized, open-label trial. The main objective is to evaluate the efficacy and safety of various once-per-cycle dosing of F-627 as compared with standard dosing of Amgen Inc.'s Neulasta (pegfilgrastim) in patients with breast cancer who...
After receiving clearance from the Food and Drug Administration, Shanghai-based Generon Corp. Ltd. started a Phase II study of F-627 in women with breast cancer who are receiving myelotoxic chemotherapy.
Approximately 200 patients will be included in the randomized, open-label trial. The main objective is to evaluate the efficacy and safety of various once-per-cycle dosing of F-627 as compared with standard dosing of Amgen Inc.'s Neulasta (pegfilgrastim) in patients with breast cancer who are undergoing myelotoxic chemotherapy.
Generon described F-627 as a newer generation recombinant human granulocyte colony-stimulating factor (G-CSF) that helps patients with cancer to recover from chemotherapy-induced neutropenia.
OCEANS trial shows PFS benefit with Avastin in recurrent ovarian cancer 
What's This?
The addition of Genentech Inc.'s Avastin (bevacizumab) to a chemotherapy regimen consisting of gemcitabine hydrochloride and carboplatin leads to improvements in progression-free survival (PFS) for patients with platinum-sensitive recurrent ovarian, primary peritoneal or fallopian tube cancers, according to data from the Phase III OCEANS trial.
Additional data from the trial suggested that Avastin was also associated with improvements in...
Genentech, Dako partner to seek regulatory approval of Dako's companion diagnostics for use with Genentech's trastuzumab emtansine
What's This?
Genentech Inc. and Dako A/S agreed to collaborate on the U.S. regulatory submissions for Dako's HercepTest and HER2 (human epidermal growth factor receptor 2) FISH (fluorescence in situ hybridization) pharmDx kit as companion diagnostics for Genentech's investigational compound trastuzumab emtansine.
The regulatory submissions will seek Food and Drug Administration...
Roche to seek approval of trastuzumab emtansine for metastatic breast cancer based on new study data
What's This?
Roche reported top-line results from the first randomized Phase III study of trastuzumab emtansine, and based on the findings, the company plans to submit regulatory applications in the United States and Europe this year.
The open-label trial, EMILIA, involved 991 patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer whose disease progressed after initial...
Researchers find poorer performance on measures of breast cancer care quality at safety-net hospitals
What's This?
In a study designed to explore the differences between safety-net hospitals and non-safety-net hospitals with regard to breast cancer care, researchers found that women treated at safety-net hospitals experienced 48 percent longer wait times after receiving a diagnosis before they underwent mastectomy as compared with women treated at non-safety-net hospitals, and the rate of reconstruction following mastectomy was lower at safety-net hospitals.
The researchers used data from...
30th Annual SABCS
December 12-16, 2007 San Antonio, Texas- Completion axillary dissection may not be required after positive sentinel node biopsy
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- Continuation of tamoxifen beyond standard 5 years reduces breast cancer recurrence, preliminary data show
- Anastrozole appears superior to tamoxifen in reducing risk of recurrence in patients with early breast cancer, data show
- Docetaxel plus cyclophosphamide improves overall survival better than standard chemotherapy in women with breast cancer, data show
