February 19, 2008
In Second Trial, Avastin Is Found Effective in Treating Breast Cancer | www.nytimes.com
New data with low and high dose of Avastin with Taxoter
improve Overall survival in prostate cancer
February 19, 2008
Dendreon Presents Data Correlating the Cumulative Potency of PROVENGE(R) to Overall Survival | www.pipelinereview.com
esults showed that PROVENGE patients experienced improved survival if they received more cells across the three doses of PROVENGE (higher cumulative TNC count (p=0.019)) or higher cumulative CD54 upregulation values (p=0.009). The effect on survival for TNCs appeared to reflect in part the patients' baseline prognostic factors. However, the CD54 upregulation ratio appeared to be an independent predictor of survival in patients who received PROVENGE, as the correlation remained strong even after adjusting for baseline prognostic factors (p=0.022). Data is very impressive. This may lead FDA approval in prostate cancer in next 3-6 months.
December 7, 2007
F.D.A. Criticizes Avastin Use for Breast Cancer | www.nytimes.com
“On face value the data look very good,” said Buzdar, who voted with the slim (5-4) majority against the drug. In the study that was the basis of Genentech’s application, Avastin appeared to slow the progress of the disease. advanced breast cancer who had already tried other drugs. He said he’s never used Avastin to treat breast cancer, but he knows other doctors do, despite the lack of FDA’s blessing. “Physicians always want to do something for the patient,” he said. But he believes the panel’s vote “will make them think twice” before they try Avastin for breast cancer. “This drug is a good drug,” Buzdar added. “It does work in a number of other cancers where it not only prolongs control of the disease but it keeps more patients alive. In breast cancer, it has not panned out.”
August 29, 2007
New Medicare Regulations Adopted To Reduce Certain Hospital Infections And Medical Errors | www.medicalnewstoday.com
CMS is doing right thing. This will aviod pt fall and bedsore during hospitalzation
August 9, 2007
Bristol-Myers Squibb and Imclone Systems Significantly Expand ERBITUX Clinical Development Program | www.pipelinereview.com
The comprehensive clinical program will supplement the significant body of clinical data existing for ERBITUX in colorectal and head and neck cancers by exploring the use of ERBITUX in additional tumor types including brain, breast, bladder, gastric, lung, pancreas and prostate
August 9, 2007
Bristol-Myers Squibb and Imclone Systems Significantly Expand ERBITUX Clinical Development Program | www.pipelinereview.com
The coverage restrictions placed on the FDA-approved indication have no scientific basis and are incompatible with good clinical practice," said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Global Research and Development at Amgen. "We are concerned that inappropriately limiting coverage for ESAs at hemoglobin levels less than 10 g/dL will both increase blood transfusions and severely compromise the high quality of cancer care delivered by American physicians. In our view, restricting coverage in this way is unreasonable, impractical and unworkable. Moreover, through this coverage decision, the CMS has undermined the ability of physicians to decide how best to administer ESA therapy to their patients through carefully defined dosing guidance articulated by the FDA."
August 6, 2007
Amgen Responds to Final CMS National Coverage Determination on Use of Erythropoiesis-Stimulating Agents in Oncology | www.pipelinereview.com
My understading id medicare need to cover all FDA indicated drugs. Here CMS violating FDA indication for Aranesp and procrit
August 3, 2007
Amgen Responds to Final CMS National Coverage Determination on Use of Erythropoiesis-Stimulating Agents in Oncology | www.pipelinereview.com
Decrease use by 20-25% use of ESA. This may lead discounting and higher rebate from both amgen and orto-biotech to sustain market share. Since most of amgen contract with aranesp and neulasta use. It may effect use of neulasta. Next 6 month CMS may restrict use of Neulasta and neupogen for neutropenia associated with chemotherapy.
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Medtech M&A activity accelerates in 2011
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