| Ortho Biotech to Submit Official Request for Reconsideration to CMS ...
BRIDGEWATER, N.J., Nov. 8 /PRNewswire/ -- Ortho Biotech Products, L.P., the company that markets PROCRIT(R) (Epoetin alfa), today will formally request that the Centers for Medicare and Medicaid Services (CMS) reconsider its final National Coverage Determination (NCD) for erythropoiesis-stimulating agents (ESAs). The company's request will be available online at www.orthobiotech.com and www.VoiceForCancerPatients.com. The company will provide new scientific evidence and highlight specific areas in which it believes that CMS materially misinterpreted existing data in reaching its current NCD. These two conditions are specified by CMS as necessary for reconsideration of an NCD. "The goal of our reconsideration request is to re-open an evidence-based dialogue with CMS to ensure that Medicare reimbursement for ESAs supports safe and effective treatment of anemia for patients receiving chemotherapy," said Craig Tendler, M.D., Vice President, Medical Affairs, Oncology/Nephrology, Ortho Biotech Products L.P.
Pharmion's Amrubicin Shows Encouraging Results Compared To Standard Of ...
Pharmion Corporation (Nasdaq: PHRM) released interim findings from its Phase 2 trial of Amrubicin in second-line chemo-sensitive small cell lung cancer (SCLC). Amrubicin, the company's third-generation synthetic anthracycline, is a potent topoisomerase II inhibitor currently in development for the treatment of SCLC. These findings indicate favorable interim results in terms of response rate and survival for Amrubicin in second-line treatment of small-cell lung cancer patients with extensive disease (ED) SCLC. The early results of this study were presented at the 2007 Chemotherapy Foundation Symposium in New York City.
"Treatment options for second-line SCLC are limited and preliminary data from the US-based Phase 2 sensitive SCLC trial indicate that Amrubicin may provide a new option for SCLC patients who desperately need more treatment choices," said principal investigator Robert M.
GSK Receives Approval for HYCAMTIN(R) (topotecan) Capsules for the ...
PHILADELPHIA, Oct. 15 /PRNewswire-USNewswire/ -- GlaxoSmithKline (NYSE: GSK) announced today approval by the U.S. Food and Drug Administration (FDA) for oral HYCAMTIN(R) (topotecan) capsules for the treatment of relapsed small cell lung cancer (SCLC). Specifically, HYCAMTIN capsules are indicated for patients who had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment. HYCAMTIN capsules are the only oral single-agent chemotherapy approved for the treatment of SCLC after failure of first-line therapy. The product will be available in 2008. "The approval of HYCAMTIN capsules is particularly important for patients with relapsed small cell lung cancer as they now have an effective treatment option that has been shown to provide a survival benefit and can be conveniently taken at home," said Debasish Roychowdhury, M.D., Vice President, Global Clinical Development, Oncology Medicine Development Center, GSK.
|
